Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Drug Pricing and Intellectual Property: The
March 31, 2021
Legislative Landscape for the 117th Congress
Kevin J. Hickey
Intellectual property (IP) rights play an important role in the development and pricing of
Legislative Attorney
pharmaceuticals, such as prescription drugs and biological products (biologics). To provide

incentives for research and development (R&D), IP law grants innovators exclusive rights that
Kevin T. Richards
may prevent others from making generic or biosimilar versions of a drug or biologic, enabling
Legislative Attorney
makers of brand-name pharmaceuticals to charge higher prices in some circumstances. In the

pharmaceutical context, such higher-than-competitive prices are intended to allow
pharmaceutical manufacturers an opportunity to recoup substantial R&D costs, including clinical
Erin H. Ward
trials and other tests necessary to obtain regulatory approval from the Food and Drug
Legislative Attorney
Administration (FDA). Although many factors other than IP rights contribute to the cost of

prescription drugs and biologics, pharmaceutical products are frequently protected by IP rights,
and IP rights are often among the most important factors driving high drug prices.

New pharmaceutical products may benefit from two main forms of IP protection: patents and regulatory exclusivities. Patents
are granted by the U.S. Patent and Trademark Office (PTO) to a wide range of inventions that are new, useful, nonobvious,
and directed at patent-eligible subject matter. The holder of a valid patent generally has the exclusive right to make, use, sell,
or import a patented invention within the United States for a roughly 20-year term. Regulatory exclusivities are granted by
FDA for certain categories of pharmaceuticals upon the completion of the regulatory process required before manufacturers
can market drugs and biologics in the United States. Generally, regulatory exclusivities prevent FDA from accepting or
approving an application for a generic or biosimilar product, or preclude a competitor from relying on safety and efficacy
data submitted by the original manufacturer, for a set period. There are many different types of regulatory exclusivities,
ranging from six months to 12 years, depending on the type of pharmaceutical product and other factors.
Because of the connection between drug pricing and IP rights, many legislative proposals in the 116th Congress that sought
to affect drug pricing focused on reforms to pharmaceutical patents and regulatory exclusivities. For example, a number of
bills sought to change the use or enforcement of patent rights in pharmaceuticals, such as by increasing patent transparency;
curtailing alleged tactics such as “evergreening,” “product hopping,” “patent thickets,” or “pay-for-delay” settlements; or
altering procedures for PTO administrative challenges to pharmaceutical patents. Other bills would have changed the scope
or length of various FDA regulatory exclusivities, including those for the new biological products, new chemical entities, or
orphan drugs. Still other bills would have allowed the federal government to limit IP rights based on pricing, imposed
conditions on IP rights arising from government-supported innovation, or directed the federal government itself to directly
manufacture generic drugs and biosimilars. Finally, some bills focused primarily on IP rights in Coronavirus Disease 2019
(COVID-19) countermeasures (such as treatments and vaccines) or combined IP provisions with other drug-pricing or health
care provisions not directly related to IP rights.
Dozens of pharmaceutical IP bills were introduced, more than a dozen were reported out of committee, several were passed
by the Senate or the House of Representatives, and at least four were enacted into law. Issues relating to drug pricing and IP
may continue to be debated in the 117th Congress. To facilitate consideration of these issues, this report summarizes
legislative proposals introduced in the 116th Congress that concern drug pricing and relate to patent and regulatory
exclusivity rights in drugs and biologics. Among other things, this report classifies bills by legislative status and type, and
analyzes and compares bills addressing similar subject matter.

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Contents
Legislative Progress of Pharmaceutical IP Bills in the 116th Congress .......................................... 4
Pharmaceutical IP Proposals by Category: Comparison and Analysis ............................................ 6
Pharmaceutical Patenting Reforms ........................................................................................... 6
Bills Relating to Patent Transparency ................................................................................. 7
Bills Relating to Patent “Evergreening” ............................................................................. 9
Bills Relating to “Product Hopping” and “Patent Thickets” ............................................ 12
Bills Relating to “Pay-for-Delay” Patent Litigation Settlements ...................................... 15
Bills Relating to Administrative Patent Challenges .......................................................... 19
Regulatory Exclusivity Reforms ............................................................................................. 21
Bills Relating to the 180-Day First-Generic Exclusivity .................................................. 22
Bills Relating to the New Biological Product Exclusivity ................................................ 24
Bills Relating to the New Chemical Entity Exclusivity .................................................... 26
Bills Relating to the Orphan Drug Exclusivity ................................................................. 28
Government-Directed Price Regulation or IP Limitations ...................................................... 30
Limiting IP Rights Based on Drug Pricing ....................................................................... 30
Government-Supported Innovation Reforms .................................................................... 33
Government Production of Pharmaceuticals..................................................................... 34
COVID-19-Specific Bills ........................................................................................................ 36
Omnibus Drug Pricing Bills with Pharmaceutical IP Provisions ............................................ 38

Tables
Table 1. Pharmaceutical IP Bills in the 116th Congress by Legislative Progress ........................... 5
Table 2. Bills in the 116th Congress Relating to Patent Transparency ............................................ 9
Table 3. Bills in the 116th Congress Relating to Patent “Evergreening” ....................................... 11
Table 4. Bills in the 116th Congress Relating to “Product Hopping” or “Patent Thickets” .......... 15
Table 5. Bills in the 116th Congress Relating to “Pay-for-Delay” Patent Settlements ................. 19
Table 6. Bills in the 116th Congress Relating to Administrative Patent Challenges ..................... 21
Table 7. Bills in the 116th Congress Relating to the 180-Day First-Generic Exclusivity ............. 23
Table 8. Bills in the 116th Congress Relating to the New Biological Product Exclusivity ........... 25
Table 9. Bills in the 116th Congress Relating to the New Chemical Entity Exclusivity ............... 28
Table 10. Bills in the 116th Congress Relating to the Orphan Drug Exclusivity .......................... 30
Table 11. Bills in the 116th Congress Limiting IP Rights Based on Drug Pricing ........................ 32
Table 12. Bills in the 116th Congress Relating to Government-Supported Innovation ................ 34
Table 13. Bills in the 116th Congress Relating to Government Pharmaceutical Production ........ 36
Table 14. COVID-19-Specific Pharmaceutical IP Bills in the 116th Congress ............................. 38
Table 15. Omnibus Drug Pricing Bills with Pharmaceutical IP Provisions in the 116th
Congress ..................................................................................................................................... 38

Table A-1. Drug Pricing and IP Legislation in the 116th Congress ............................................... 40

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Appendixes
Appendix A. Drug Pricing and IP Legislation in the 116th Congress ........................................... 40
Appendix B. Glossary of Acronyms .............................................................................................. 44

Contacts
Author Information ........................................................................................................................ 45

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ntellectual property (IP) rights play an important role in the development and pricing of
pharmaceutical products, such as prescription drugs and biological products (biologics).1 To
I provide incentives for development, IP law grants creators exclusive rights that may prevent
others from making generic or biosimilar versions of a drug or biologic.2 By limiting competition,
IP rights enable makers of brand-name pharmaceuticals (the brand) to charge higher prices in
some circumstances.3 In the pharmaceutical context, IP rights are intended to allow
pharmaceutical manufacturers an opportunity to recoup substantial costs in research and
development (R&D), including clinical trials and other tests necessary to obtain regulatory
approval from the Food and Drug Administration (FDA).4 Although many factors other than IP
rights contribute to the cost of prescription drugs and biologics,5 IP rights frequently protect
pharmaceutical products,6 and IP rights are often among the most important factors driving high
drug prices.7
A companion product, CRS Report R46679, Drug Prices: The Role of Patents and Regulatory
Exclusivities, reviews the essential legal background relating to IP rights in pharmaceuticals,
including the basics of patent law, the FDA drug approval process, FDA regulatory exclusivities,
and the specialized procedures for pharmaceutical patent disputes. It also discusses various
alleged pharmaceutical patenting practices that have attracted legislative attention, such as
“product hopping,” “patent thickets,” and “pay-for-delay” settlements. This report presumes
knowledge of this legal background and terminology in order to compare and summarize the
legislation introduced or enacted in the 116th Congress relating to drug patents and regulatory
exclusivities. Accordingly, the report offers only a basic legal overview in the introduction before
turning to discussion of the legislative proposals.
New pharmaceutical products generally benefit from two main forms of IP protection: patents and
regulatory exclusivities. Patents, which are available to a wide range of technologies, are granted

1 See Henry G. Grabowski et al., The Roles of Patents and Research and Development Incentives in Biopharmaceutical
Innovation, 34 HEALTH AFFS. 302, 302 (2015) (“Patents and other forms of intellectual property protection are generally
thought to play essential roles in encouraging innovation in biopharmaceuticals.”).
2 See, e.g., 21 U.S.C. § 355(c)(3)(E)(ii), (j)(5)(F)(ii); 35 U.S.C. § 271; 42 U.S.C. § 262(k)(7).
3 See FTC v. Actavis, Inc., 570 U.S. 136, 147 (2013) (“[Patent rights] may permit the patent owner to charge a higher-
than-competitive price for the patented product.”); WILLIAM M. LANDES & RICHARD A. POSNER, THE ECONOMIC
STRUCTURE OF INTELLECTUAL PROPERTY LAW 299–300 (2003).
4 See Grabowski et al., supra note 1, at 302 (“[T]he process of developing a new drug and bringing it to market is long,
costly, and risky, and the costs of imitation are low. After a new drug has been approved and is being marketed, its
patents protect it from competition from chemically identical entrants (or entrants infringing on other patents) for a
period of time.”); LANDES & POSNER, supra note 3, at 24, 317.
5 See generally CRS Report R44832, Frequently Asked Questions About Prescription Drug Pricing and Policy, by
Suzanne M. Kirchhoff, Judith A. Johnson, and Susan Thaul, at 3–13.
6 See, e.g., LANDES & POSNER, supra 3, at 313 (citing data that new drug manufacturers are unusually “avid in seeking
patent protection”); Emily Michiko Morris, The Myth of Generic Pharmaceutical Competition under the Hatch-
Waxman Act, 22 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 245, 252 (2012) (“[P]harmaceuticals are also widely
recognized as one of the industries most dependent on patent protection to recoup its enormous research, development,
regulatory, and post-marketing costs.”); Adi Gillat, Compulsory Licensing to Regulated Licensing: Effects on the
Conflict Between Innovation and Access in the Pharmaceutical Industry, 58 FOOD & DRUG L.J. 711, 722 (reviewing
data “supporting relatively high dependency of the pharmaceutical industry on patent rights”).
7 See, e.g., Aaron S. Kesselheim et al., The High Cost of Prescription Drugs in the United States: Origins and
Prospects for Reform, 316 JAMA: J. AM. MED. ASS’N 858, 861 (2016) (“The most important factor that allows
manufacturers to set high drug prices for brand-name drugs is market exclusivity, which arises from [IP rights].”);
Generic Competition and Drug Prices, FOOD & DRUG ADMIN. (Nov. 28, 2017), https://www.fda.gov/aboutfda/
centersoffices/officeofmedicalproductsandtobacco/cder/ucm129385.htm (finding association between generic
competition and lower drug prices) [hereinafter Generic Competition and Drug Prices].
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

by the U.S. Patent and Trademark Office (PTO) on inventions that are new, useful, nonobvious,
and directed at patent-eligible subject matter.8 The holder of a valid patent generally has the
exclusive right to make, use, sell, or import a patented invention within the United States for a
term beginning when the patent issues and ending 20 years after the date of the patent
application.9
Regulatory exclusivities are granted by FDA upon the completion of the regulatory process
required before manufacturers can market drugs and biologics in the United States.10 Generally,
regulatory exclusivities prevent FDA from accepting or approving an application for a generic or
biosimilar product, or preclude a competitor from relying on safety and efficacy data submitted
by the original manufacturer, for a set period.11 There are many different types of regulatory
exclusivities, ranging from six months to 12 years, depending on the type of pharmaceutical
product and other factors.12
Because of the connection between drug pricing and IP rights, many legislative proposals in the
116th Congress that sought to affect drug pricing focused on reforms to patent and FDA law.13
This report reviews legislative proposals introduced in the 116th Congress that sought to address
drug pricing through changes to patent and regulatory exclusivity rights in drugs and biologics.
To better understand and compare the proposed reforms, this report classifies pharmaceutical IP
bills into the following five categories:
1. Pharmaceutical Patent Reforms. These bills would have changed the use or
enforcement of patent rights in pharmaceuticals, including proposals that sought
(i) to increase patent transparency; (ii) to curtail so-called patent “evergreening,”
“product hopping,” “patent thickets,” or “pay-for-delay” settlements; or (iii) to
change the laws relating to PTO administrative challenges to pharmaceutical
patents.
2. Regulatory Exclusivity Reforms. These bills would have changed the scope or
length of various FDA regulatory exclusivities, including (i) the 180-day
exclusivity for the first-filed generic drug application; (ii) the new biological
product exclusivity; (iii) the new chemical entity exclusivity; or (iv) the orphan
drug exclusivity.
3. Government-Directed Price Regulation or IP Limitations. These bills would
have allowed the federal government to regulate drug prices more directly or to
limit IP rights based on pricing. For example, these bills would have (i) permitted
compulsory patent licensing; (ii) imposed pricing conditions on government-
supported innovation, such as federally funded R&D; or (iii) directed the federal
government to manufacture generic drugs and biosimilars to bring down prices.
4. COVID-19 Specific Bills. The provisions in these bills—some of which may fall
into other categories as well—were focused on medical countermeasures for
Coronavirus Disease 2019 (COVID-19), such as vaccines or treatments.

8 See 35 U.S.C. §§ 101–103, 131. Patent applications must also conform to a number of requirements related to the
sufficiency of the technical disclosure in the patent. Id. § 112.
9 Id. §§ 154(a)(2), 271(a).
10 See generally CRS In Focus IF11217, Drug Pricing and the Law: Regulatory Exclusivities, by Erin H. Ward.
11 Id. at 1.
12 Id. at 1–2.
13 See infra “Drug Pricing and IP Legislation in the 116th Congress.”
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

5. Omnibus Drug Pricing Bills with Pharmaceutical IP Provisions. These bills
contained one or more provisions from the categories above, but also contained
other drug-pricing or health care provisions not related to IP rights.
This report focuses on legislative proposals that are related to IP rights in pharmaceuticals,
specifically patent rights and regulatory exclusivities. Many other legislative proposals in the
116th Congress that were related to drug pricing, but were indirectly or not related to IP, are
outside the scope of this report. For example, this report does not address bills introduced in the
116th Congress that would have permitted the government to negotiate drug prices for Medicare
Part D;14 increased transparency in drug pricing;15 permitted importation of (sometimes cheaper)
drugs in certain circumstances;16 capped out-of-pocket drug costs or required manufacturer
rebates in the Medicare program;17 regulated the actions of pharmaceutical benefit managers;18 or
expanded the Medicare program to cover more Americans.19 Also outside the scope of this report

14 See, e.g., Elijah E. Cummings Lower Drug Costs Now Act, H.R. 3, 116th Cong. tit. I (2019); Medicare Prescription
Drug Price Negotiation Act of 2019, H.R. 275, 116th Cong. (2019); Medicare Drug Price Negotiation Act, H.R. 448,
116th Cong. (2019); Medicare Negotiation and Competitive Licensing Act of 2019, H.R. 1046, 116th Cong. (2019);
Medicare Prescription Drug Savings and Choice Act of 2019, H.R. 4769, 116th Cong. (2019); Life-Sustaining
Prescription Drug Price Relief Act of 2019, H.R. 5039, 116th Cong. (2019); Medicare Drug Price Negotiation Act, S.
99, 116th Cong. (2019); Medicare Negotiation and Competitive Licensing Act of 2019, S. 377, 116th Cong. (2019);
Medicare Prescription Drug Savings and Choice Act of 2019, S. 2650,116th Cong. (2019). Although outside the scope
of this report, a few of these bills do contain provisions related to IP rights in pharmaceuticals; for example, one bill
would allow the government to license patent rights to generic and biosimilars manufacturers if the government is
unable to successfully negotiate an appropriate price. See H.R. 1046 § 2 (proposed 42 U.S.C. § 1395w-111(i)(3)); S.
377 § 2 (proposed 42 U.S.C. § 1395w-111(i)(3)).
15 See, e.g., Prescription Drug Price Transparency Act, H.R. 1035, 116th Cong. (2019); SPIKE Act, H.R. 2069, 116th
Cong. (2019); Drug Price Transparency Act, H.R. 2087, 116th Cong. (2019); Prescription Drug STAR Act, H.R. 2113,
116th Cong. (2019); Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act, H.R. 2115, 116th
Cong. (2019); METRIC Act, H.R. 2296, 116th Cong. (2019); Drug Price Transparency for Medicare Patients Act of
2019, H.R. 3327, 116th Cong. (2019); Prescription Drug Price Reporting Act, H.R. 5239, 116th Cong. (2019); Drug
Price Transparency for Medicare Patients Act of 2019, H.R. 5281, 116th Cong. (2019); Transparency in Prescription
Drug Advertising Act, H.R. 5894, 116th Cong. (2020); SPIKE Act, S. 474, 116th Cong. (2019); Transparent Drug
Pricing Act of 2019, S. 977, 116th Cong. (2019); FAIR Drug Pricing Act of 2019, S. 1391, 116th Cong. (2019); Drug-
price Transparency in Communications (DTC) Act, S. 1437, 116th Cong. (2019); Prescription Drug Price Reporting
Act, S. 1664, 116th Cong. (2019); Strengthening Average Sales Price Reporting Act of 2019, S. 2051, 116th Cong.
(2019); Lower Costs, More Cures Act of 2019, S. 3129. 116th Cong. tit. II (2019).
16 See, e.g., Affordable and Safe Prescription Drug Importation Act, H.R. 447, 116th Cong. (2019); Safe and
Affordable Drugs from Canada Act of 2019, H.R. 478, 116th Cong. (2019); Affordable Insulin Act of 2019, H.R. 1478,
116th Cong. (2019); Safe and Affordable Drugs from Canada Act of 2019, S. 61, 116th Cong. (2019); Affordable and
Safe Prescription Drug Importation Act, S. 97, 116th Cong. (2019); Short on Competition Act, S. 84, 116th Cong.
(2019).
17 See, e.g., H.R. 3 tit. II–III (2019); Pharmaceutical Rebates for Excessive Pricing Above Inflation Act, H.R. 4619,
116th Cong. (2019); Capping Drug Costs for Seniors Act of 2019, H.R. 4649, 116th Cong. (2019); Freedom from Price
Gouging Act, H.R. 4663, 116th Cong. (2019); Lowering Drug Costs for Seniors Act of 2020, H.R. 7877, 116th Cong.
(2020); Prescription Drug Pricing Reduction Act of 2019, S. 2543, 116th Cong. (2019); Prescription Drug Pricing
Reduction Act of 2020, S. 4199, 116th Cong. (2020).
18 See, e.g., Prescription Drug Price Transparency Act, H.R. 1035, 116th Cong. (2019); Public Disclosure of Drug
Discounts and Real-Time Beneficiary Drug Cost Act, H.R. 2115, 116th Cong. (2019); Pharmacy Benefit Manager
Accountability Study Act of 201, H.R. 3223, 116th Cong. (2019); PBM Transparency in Prescription Drug Costs Act,
H.R. 5304, 116th Cong. (2019).
19 See, e.g., Medicare for All Act of 2019, H.R. 1384, 116th Cong. (2019); Medicare for America Act of 2019, H.R.
2452, 116th Cong. (2019); Medicare for All Act of 2019, S. 1129, 116th Cong. (2019). Although outside the scope of
this report, a few of these bills do contain provisions related to IP rights in pharmaceuticals; for example, some would
allow the government to license patent rights to generic and biosimilars manufacturers for excessively priced drugs or
if the government is unable to successfully negotiate an appropriate drug price. See, e.g., H.R. 1384 § 616; H.R. 2452
§§ 111, 303–304.
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are proposals that focused on patent rights generally (but not pharmaceutical patents in
particular),20 or FDA processes generally (but not regulatory exclusivities in particular),21
including efforts to facilitate market entry for generics and biosimilars by limiting tactics such as
denial of drug samples22 or dilatory citizen petitions.23 Finally, executive actions taken with the
aim of reducing drug prices are not within the scope of this report.24 Other CRS products cover
many of these topics.25
Legislative Progress of Pharmaceutical IP Bills in
the 116th Congress
Table 1 lists the pharmaceutical IP legislation that was enacted into law, passed the House or the
Senate, or was reported or ordered to be reported out of a committee.
Some pharmaceutical IP legislative proposals became law as part of other bills, such as P.L. 116-
94 (H.R. 1865), Further Consolidated Appropriations Act, 2020,26 and P.L. 116-260 (H.R. 133),
Consolidated Appropriations Act, 2021.27 Significant differences between the individual bills and
the identical or similar provisions that were enacted into law are discussed in the next section.

20 See, e.g., Targeting Rogue and Opaque Letters Act of 2019, H.R. 108, 116th Cong. (2019); STRONGER Patents Act
of 2019, H.R. 3666, 116th Cong. (2019); IDEA Act, H.R. 4075, 116th Cong. (2019); Inventor Rights Act, H.R. 5478,
116th Cong. (2019); Restoring America's Leadership in Innovation Act of 2020, H.R. 7366, 116th Cong. (2020); IDEA
Act, H.R. 7890, 116th Cong. (2020); PACED Act, S. 440, 116th Cong. (2019); STRONGER Patents Act of 2019, S.
2082, 116th Cong. (2019); PALS Act, S. 2178, 116th Cong. (2019); IDEA Act, S. 2281, 116th Cong. (2019); IDEA
Act, S. 4394, 116th Cong. (2020).
21 See, e.g., Lower Insulin Costs Now Act, H.R. 5444, 116th Cong. (2019); MODERN Labeling Act of 2020, H.R.
5668, 116th Cong. (2020); A Bill to Amend the Biologics Price Competition and Innovation Act of 2009 to Make
Improvements with Respect to the Transition of Biological Products, H.R. 6155 (2020); ADAPT Act, S. 658, 116th
Cong. (2019); Short on Competition Act, S. 844, 116th Cong. (2019); A Bill to Establish a Process for Updating the
Labeling of Certain Drugs, S. 1897, 116th Cong. (2019); Affordable Insulin Approvals Now Act, S. 2103, 116th Cong.
(2019).
22 See, e.g., CREATES Act of 2019, H.R. 965, 116th Cong. (2019) (enacted as amended as P.L. 116-94, div. N, tit. I, §
610); FAST Generics Act of 2019, H.R. 985, 116th Cong. (2019); CREATES Act of 2019, S. 340, 116th Cong. (2019)
(enacted as amended as P.L. 116-94, div. N, tit. I, § 610).
23 See, e.g., Stop STALLING Act, H.R. 2374, 116th Cong. (2019); Stop GAMES Act of 2019, H.R. 2387, 116th Cong.
(2019); Ensuring Timely Access to Generics Act of 2019, H.R. 2455 (2019); Efficiency and Transparency in Petitions
Act, S. 660, 116th Cong. (2019); Ensuring Timely Access to Generics Act of 2019, S. 1169, 116th Cong. (2019); Stop
STALLING Act, S. 1224, 116th Cong. (2019).
24 See, e.g., Most Favored Nation (MFN) Model, 85 Fed. Reg. 76,180 (Nov. 27, 2020) (interim final rule); Exec. Order
No. 13,948, Lowering Drug Prices by Putting America First, 85 Fed. Reg. 59,649 (Sept. 13, 2020); Exec. Order No.
13,947, Lowering Drug Prices by Putting America First, 85 Fed. Reg. 59,171 (July 24, 2020); Exec. Order No. 13,939,
Lowering Prices for Patients by Eliminating Kickbacks to Middlemen, 85 Fed. Reg. 45,759 (July 24, 2020); Exec.
Order No. 13,938, Increasing Drug Importation to Lower Prices for American Patients, 85 Fed. Reg. 45,757 (July 24,
2020).
25 See generally CRS In Focus IF11318, Negotiation of Drug Prices in Medicare Part D, by Suzanne M. Kirchhoff;
CRS In Focus IF11056, Prescription Drug Importation, by Amanda K. Sarata and Agata Bodie; CRS Report R40425,
Medicare Primer, coordinated by Patricia A. Davis; CRS Report R46525, Patent Law: A Handbook for Congress, by
Kevin T. Richards; CRS Legal Sidebar LSB10272, The CREATES Act of 2019 and Lowering Drug Prices: Legal
Background and Overview, by Wen W. Shen; CRS In Focus IF11075, FDA and Drug Prices: Facilitating Access to
Generic Drugs, by Agata Bodie.
26 See P.L. 116-94, div. N, tit. I, §§ 606, 133 Stat. 2534, 3127 (2019).
27 See P.L. 116-260, div. BB, tit. III, subtit. C, §§ 323, 325 (2020).
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Table 1. Pharmaceutical IP Bills in the 116th Congress by Legislative Progress
Bold indicates bill enacted in law (as part of a different piece of legislation where noted); italics indicate
bill passed one house of Congress; underline indicates bill reported or ordered to be reported out of
committee. Caret (^) indicates bill had at least one original cosponsor of a different party than the
sponsor. Asterisk (*) indicates furthest legislative progress as part of another bill.
Original
Cosponsors
Bill No.
Bill Title
(OCs)
Category(s)
Legislative Status
H.R. 1503
Orange Book
Rep. Robin Kelly
Pharmaceutical Patenting
Enacted as P.L. 116-290
Transparency
Reforms (Patent
Act
Transparency)
H.R. 1520
Purple Book
Rep. Eshoo
Pharmaceutical Patenting
Similar to provisions
Continuity Act*28
Reforms (Patent
enacted as P.L. 116-260,
Transparency)
div. BB, tit. III, subtit. C, §
325
H.R. 2011
Protecting
Rep. DeGette
Regulatory Exclusivity
Similar to provisions
Access to
Rep. Reed
Reforms (New Biologic
enacted as P.L. 116-94,
Biosimilars Act
Rep. Schrier
Exclusivity)
div. N, tit. I, § 606
of 2019^*
Rep. Guthrie
S. 1140
Protecting
Sen. Smith
Regulatory Exclusivity
Similar to provisions
Access to
Sen. Cassidy
Reforms (New Biologic
enacted as P.L. 116-94,
Biosimilars Act
Exclusivity)
div. N, tit. I, § 606
of 2019^*
S. 1895
Orphan Drug
Sen. Alexander
Regulatory Exclusivity
Similar to provisions
§ 210
Clarification^*
Sen. Murray
Reforms (Orphan Drug
enacted as P.L. 116-260,

Exclusivity)
div. BB, tit. III, subtit. C, §
323
H.R. 938
BLOCKING Act^*
Rep. Schrader
Regulatory Exclusivity
Passed House as Title I,
Rep. Buddy
Reforms (180-day First
subtitle A of H.R. 987
Carter
Generic Exclusivity)
H.R. 987
Strengthening Health
Rep. Blunt
Omnibus Drug Pricing
Passed House 5/16/19
Care and Lowering
Rochester
Bil s
Prescription Drug
Rep. Castor
Costs Act
Rep. McBath
Rep. Kildee
H.R. 1499
Protecting Consumer
Rep. Rush
Pharmaceutical Patenting
Passed House as Title I,
Access to Generic
Reforms (“Pay-for-
subtitle B of H.R. 987
Drugs Act of 2019*
Delay” Settlements)
H.R. 4712
Fairness in Orphan
Rep. Dean
Regulatory Exclusivity
Passed House 11/17/20
Drug Exclusivity Act^
Rep. Veasey
Reforms (Orphan Drug
Rep. Buddy
Exclusivity)
Carter
Rep. McKinley

28 After passing the House and Senate in non-identical form, the Purple Book Continuity Act (H.R. 1520) was used as a
vehicle for the Further Extension of Continuing Appropriations Act, 2021, which was enacted on December 22, 2020,
to extend funding for the federal government through December 28, 2020. The substantive provisions of the Purple
Book Continuity Act were enacted as part of P.L. 116-260, div. BB, tit. III, subtit. C, § 325.
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Original
Cosponsors
Bill No.
Bill Title
(OCs)
Category(s)
Legislative Status
S. 1636
Ensuring Innovation
Sen. Roberts
Regulatory Exclusivity
Passed Senate 12/14/20
Act^
Sen. Smith
Reforms (New Chemical
Sen. Cassidy
Entity Exclusivity)
H.R. 2375
Preserve Access to
Rep. Nadler
Pharmaceutical Patenting
Reported by House
Affordable Generics Rep. Col ins
Reforms (“Pay-for-
Judiciary Comm. 12/24/20
and Biosimilars
Rep. Cicil ine
Delay” Settlements)
Discharged by House
Act^
Energy and Commerce
12/24/2020
H.R. 3991
Affordable
Rep. Hank
Pharmaceutical Patenting
Ordered to be reported
Prescriptions for
Johnson
Reforms (“Patent
by House Judiciary
Patients Through
Rep. Roby
Thickets”)
Comm. 11/21/19
Improvements to
Patent Litigation
Act of 2019^
H.R. 5133
Affordable
Rep. Cicil ine
Pharmaceutical Patenting
Reported by House
Prescriptions for
Rep. Col ins
Reforms (“Product
Judiciary Comm. 12/24/20
Patients Through
Rep. Nadler
Hopping”)
Promoting
Rep.
Competition Act of
Sensenbrenner
2019^
S. 1416
Affordable
Sen. Cornyn
Pharmaceutical Patenting
Reported by Senate
Prescriptions for
Sen. Blumenthal
Reforms (“Product
Judiciary Comm. 6/28/19
Patients Act of
Hopping” and “Patent
2019^
Thickets”)
S. 1895
Lower Health Care
Sen. Alexander
Omnibus Drug Pricing
Reported by Senate
Costs Act^
Sen. Murray
Bil s
Health, Education, Labor,
and Pensions Comm.
7/8/19
Source: CRS; congress.gov.
Pharmaceutical IP Proposals by Category:
Comparison and Analysis
Pharmaceutical Patenting Reforms
Patent rights represent one of the two main forms of IP rights in pharmaceuticals. Strong patent
rights are viewed by many as necessary to allow manufacturers to recoup substantial R&D costs
and thereby encourage investment in new treatments. Certain pharmaceutical patenting practices
have attracted criticism as unduly extending the period of patent exclusivity and contributing to
higher prices without sufficient benefits for consumers or innovation.29 These practices include
so-called patent “evergreening,” “product hopping,” “patent thickets,” and “pay-for-delay”
settlements.30 The following sections review legislative proposals that seek to increase patent

29 See generally CRS Report R46221, Drug Pricing and Pharmaceutical Patenting Practices, coordinated by Kevin T.
Richards.
30 Id. at 15–32.
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transparency, curtail these practices, or change how pharmaceutical patents may be challenged
through PTO administrative procedures.
Bills Relating to Patent Transparency
A number of bills in the 116th Congress focused on improving patent transparency as a way to
encourage or expedite the market entry of generic drugs or biosimilars, aiming to decrease prices
through increased competition. Table 2 lists information on these bills.
The Orange Book Transparency Act. The Orange Book Transparency Act of 2020 (OBTA),
enacted into law as P.L. 116-290, clarified the patent listing requirements for the Orange Book.31
The Orange Book lists information on drugs approved by FDA, including approved generic
forms, therapeutic equivalence evaluations, and information on patents and regulatory
exclusivities.32 Brand-name drug manufacturers must include any patent that claims the drug or a
method of using the drug as part of their new drug application (NDA); the FDA then lists these
patents in the Orange Book.33
FDA regulations specify that “drug substance (active ingredient) patents, drug product
(formulation and composition) patents, and method-of-use patents” must be listed in the Orange
Book, whereas “[p]rocess patents, patents claiming packaging, patents claiming metabolites, and
patents claiming intermediates” shall not be submitted to FDA.34 The precise set of patents that
may be listed in the Orange Book is important because generic manufacturers must make a patent
certification with respect to Orange Book-listed patents, which may affect the timing of FDA
approval—particularly the availability of the 30-month stay of FDA approval of a generic under
the Hatch-Waxman Act.35
The OBTA, among other things, clarified the types of patents that may be listed in the Orange
Book. Under the OBTA, the Orange Book must include only patents that (1) claim methods of
using the drug for which approval is sought or had been granted, or (2) claim the drug and are a
drug substance (active ingredient) or drug product (formulation) patent.36 The types of patents
that may be listed affect IP rights related to drug pricing because only listed patents may provide
a basis for the 30-month stay of FDA approval of a generic.37
In addition to this provision, the OBTA requires FDA to list in the Orange Book applicable
regulatory exclusivity periods for each drug.38 It also requires NDA holders to notify FDA when
any claim of an Orange Book-listed patent is invalidated in court or by the PTO, so that FDA can

31 Orange Book Transparency Act, H.R. 1503, 116th Cong. (2019) (enacted as P.L. 116-290); see also Lower Health
Care Costs Act, S. 1895, 116th Cong. § 202 (2019) (provisions similar to H.R. 1503). All citations are to the version of
the OBTA as enacted into law.
32 See Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. FOOD & DRUG ADMIN.
(Nov. 2020), https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
33 21 U.S.C. § 355(b)(1), (c)(2).
34 21 C.F.R. § 314.53(b)(1).
35 21 U.S.C. § 355(c)(3)(C), (j)(5)(B)(iii).
36 H.R. 1503 § 2(a); see also 21 C.F.R. § 314.3(b) (defining, inter alia, “drug product” as “a finished dosage form, e.g.,
tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or
more other ingredients”; and defining “drug substance” as the drug’s active ingredient). In either case, the patent must
be one that “for which a claim of patent infringement could reasonably be asserted if a person not licensed by the
owner of the patent engaged in the manufacture, use, or sale of the drug.” H.R. 1503 § 2(a).
37 21 U.S.C. § 355(j)(5)(B)(iii).
38 H.R. 1503 § 2(c).
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

“amend or remove” the information about that patent.39 Finally, OBTA requires FDA to solicit
public comment regarding the patent information that should be included or removed from the
Orange Book, and it requires the Government Accountability Office to submit a report to
Congress detailing the types of patents included in the Orange Book, including data on listed
patents.40
The Purple Book Continuity Act. The Purple Book is the biologics analogue of the Orange Book.
It lists licensed biologics, including licensed biosimilar and interchangeable forms of biological
products.41 Prior to the 116th Congress, FDA was not required by statute to produce and publish
the Purple Book, and patent information was not included.42
The Purple Book Continuity Act of 2020 (PBCA) was enacted, as amended, as a provision in the
Consolidated Appropriations Act, 2021 entitled “Biological Product Patent Transparency.”43 The
PBCA requires FDA to publish the Purple Book in “a searchable, electronic format” and specifies
the information (such as date of licensure and licensure status) that must be included in the Purple
Book.44 The PBCA further requires biologics license application (BLA) holders to provide to
FDA information on patents asserted against a biosimilar company during the Biologics Price
Competition and Innovation Act of 200945 (BPCIA) patent dispute procedures (the so-called
“patent dance”),46 which FDA would then list in the Purple Book.47 Further, the PBCA requires
FDA to revise the Purple Book every 30 days to include (1) any new biologics that FDA licensed
during that period and (2) information on patents that BLA holders provided to FDA during that
period.48 The PBCA also requires FDA to list any exclusivity period that applies to each listed
biologic “for which the Secretary has determined such biological product to be eligible and that
has not concluded.”49 Also, the brand must notify FDA if any biologic license was revoked or
suspended for safety reasons, and FDA must remove that product from the Purple Book for the
relevant period.50 Finally, the PBCA directs the Secretary of Health and Human Services (HHS)

39 Id. § 2(d)(i), (iii).
40 Id. § 2(e)–(f).
41 See Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations, FOOD & DRUG ADMIN. (Aug. 3, 2020), https://purplebooksearch.fda.gov/.
42 See 42 U.S.C. § 262(a); Background Information: Lists of Licensed Biological Products with Reference Product
Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book), U.S. FOOD & DRUG ADMIN. (Aug. 3,
2020), https://www.fda.gov/drugs/biosimilars/background-information-list-licensed-biological-products-reference-
product-exclusivity-and [hereinafter Purple Book Background Information]; Andrew Williams, The Purple Book: The
FDA Announces Welcome Enhancements, WOLF GREENFIELD LIFE SCIS. IP BLOG (Feb. 27, 2020),
https://blog.wolfgreenfield.com/wolf-tracks-life-sciences-blog/the-purple-book-the-fda-announces-welcome-
enhancements.
43 See P.L. 116-260, div. BB, tit. III, subtit. C, § 325 (2020).
44 Id. § 325(a) (to be codified as 42 U.S.C. § 262(k)(9)(A)(i)).
45 P.L. 111-148, Title VII, 124 Stat. 199, 804–21 (2010).
46 See CRS In Focus IF11214, Drug Pricing and the Law: Pharmaceutical Patent Disputes, by Kevin J. Hickey.
Specifically, the bill would apply to proceedings “challenging the validity of patents under section 505(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) with respect to a drug, under section 351(l) of the Public Health
Service Act (42 U.S.C. 262(l)) with respect to a biological product, or a Federal district court proceeding involving
patents that are the subject of an action under section 271(e)(2).” H.R. 3199 § 2(a).
47 Id. (to be codified as 42 U.S.C. § 262(k)(9)(A)(iii)).
48 Id. (to be codified as 42 U.S.C. § 262(k)(9)(A)(ii)-(iii)).
49 Id. (to be codified as 42 U.S.C. § 262(k)(9)(A)(iv)).
50 P.L. 116-260, div. BB, tit. III, subtit. C, § 325(a) (proposed 42 U.S.C. § 262(k)(9)(B)).
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to conduct a study regarding the type of information that should be included in the Purple Book,
and transmit the results to Congress.51
The Biologic Patent Transparency Act. The proposed Biologic Patent Transparency Act (BPTA),
similarly to the PBCA, would have required the Purple Book to be published as a single
searchable list.52 The BPTA’s patent listing requirement was somewhat broader than the PBCA,
however, requiring any patent that the brand “believes a claim of patent infringement could
reasonably be asserted by the holder” (and not just patents provided during the patent dance) to be
listed in the Purple Book.53 Much like the PBCA, the BPTA would have required FDA to update
the Purple Book every 30 days.54 The BPTA would have also barred the brand from bringing an
action for infringement of a patent that should have been, but was not, included in the Purple
Book.55
Table 2. Bills in the 116th Congress Relating to Patent Transparency
Bold indicates bill enacted in law (as part of a different piece of legislation where noted). Caret (^)
indicates bill had at least one original cosponsor of a different party than the sponsor. Asterisk (*)
indicates furthest legislative progress as part of another bill (see Table 1 for details).
Bill No.
Bill Title
OCs
Summary
H.R. 1503
Orange Book
Rep. Robin Kelly
Clarifies the types of patents that may be listed
Transparency
in the Orange Book
Act
H.R. 1520
Purple Book
Rep. Eshoo
Required publication of the Purple Book in a
Continuity Act*
searchable format, including regulatory
exclusivities and some patent information
H.R. 4850
Biologic Patent
Rep. Spanberger
Would require publication of the Purple Book as
Transparency Act^
Rep. Reed
a single, searchable list, including patent and
Rep. Anthony Gonzalez
regulatory exclusivity information
S. 659
Biologic Patent
Sen. Col ins
Would require publication of the Purple Book as
Transparency Act^
(and 5 OCs)
a single, searchable list, including patent and
regulatory exclusivity information
Source: CRS; congress.gov.
Bills Relating to Patent “Evergreening”
Several bills introduced in the 116th Congress sought to curtail patent “evergreening,” the alleged
practice of filing for new patents on secondary features of a pharmaceutical product as earlier-

51 Id. § 325(b).
52 S. 659, 116th Cong. § 2(a) (2019) (proposed 42 U.S.C. § 262(o)(2)(A), o(3)). An identical version of the BPTA has
been introduced in the House of Representatives, see H.R. 4850, 116th Cong. (2019). (For simplicity, all citations
herein are to the Senate version of the BPTA as introduced on March 5, 2019.) In 2020, FDA updated the Purple Book
to make it available as a single, searchable online database. See Purple Book Background Information, supra note 42.
53 S. 659 § 2(a) (proposed 42 U.S.C. § 262(o)(3)).
54 Id. (proposed 42 U.S.C. § 262(o)(2)(B)).
55 Id. § 2(c).
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filed patents expire, thereby extending patent exclusivity past the original 20-year term.56 Table 3
lists information on these bills.
The TERM Act. The Terminating the Extension of Rights Misappropriated (TERM) Act of
201957 sought to curtail patent evergreening by reducing the impact of later-filed patents. The
TERM Act would have established a presumption that, in patent challenges under the Hatch-
Waxman Act58 or BPCIA procedures,59 the patentee “disclaim[s] the patent term for each of the
listed patents after the date on which the term of the first patent expires.”60 In effect, this
presumption would mean that later-expiring patents listed in the Orange Book (or provided
during the BPCIA’s patent dance) would, as a default, be treated as expiring on the date when the
earliest-expiring patent on the drug or biologic expires. The patentee would be able to overcome
this presumption by demonstrating that the later-expiring patents on the drug or biologic claim
“patentably distinct inventions.”61 The law of double patenting already requires later-expiring
patents to cover patentably distinct inventions to be valid,62 but under current law, patents are
presumed valid in a judicial proceeding unless the challenger proves patent invalidity by clear
and convincing evidence.63 The TERM Act would have placed the burden of proving patent
validity on the patentee for certain later-expiring pharmaceutical patents.
The TERM Act would have further required the PTO to determine if changes to patent
examination practice may be necessary. Specifically, the act would have required the PTO to
review the agency’s patent examination procedures to determine whether the PTO is using the
best practices to avoid the issuance of duplicative patents relating to the same drug or biologic.64
The act would have also required the PTO to submit a report to the House Committee on the
Judiciary containing its findings and recommendations.65
The REMEDY Act. The Reforming Evergreening and Manipulation that Extends Drug Years
(REMEDY) Act,66 like the TERM Act, sought to curb evergreening by reducing the benefit of
later-filed patents. Under the REMEDY Act, a generic’s filing of a Paragraph (IV) certification in
an abbreviated new drug application (ANDA) would only trigger Hatch-Waxman’s 30-month stay

56 See Richards et al., supra note 29, at 16–20.
57 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019, H.R. 3199, 116th Cong. (2019).
58 P.L. 98-417, 98 Stat. 1585 (1984).
59 See CRS In Focus IF11214, Drug Pricing and the Law: Pharmaceutical Patent Disputes, by Kevin J. Hickey.
Specifically, the bill would apply to proceedings “challenging the validity of patents under section 505(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) with respect to a drug, under section 351(l) of the Public Health
Service Act (42 U.S.C. 262(l)) with respect to a biological product, or a Federal district court proceeding involving
patents that are the subject of an action under section 271(e)(2).” H.R. 3199 § 2(a).
60 H.R. 3199 § 2(a).
61 Id.
62 See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001) (“The judicially-created doctrine of
obviousness-type double patenting . . . prohibit[s] a party from obtaining an extension of the right to exclude through
claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent.”).
63 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011).
64 H.R. 3199 § 2(b)(2)(A).
65 Id. § 3.
66 Reforming Evergreening and Manipulation that Extends Drug Years Act (REMEDY) Act, S. 1209, 116th Cong.
(2019). An identical bill was introduced in the House. See Reforming Evergreening and Manipulation that Extends
Drug Years Act (REMEDY) Act, H.R. 3812, 116th Cong. (2019). For simplicity, all citations herein are to the Senate
version as introduced on April 11, 2019.
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if the patent claims a “drug substance”—that is, the drug’s active ingredient.67 The stay would not
be available for a patent that claims only a “drug product or method of use for a drug,” unless that
patent also claims the drug substance itself.68 In that case, the bill would have allowed FDA to
approve the generic product without waiting for the litigation to determine the validity of the non-
drug-substance patents.69 This approach aimed to allow generic drugs to enter the market more
quickly by limiting the grounds under which brands can receive a 30-month stay of FDA
approval.70
The act would have also required that patents canceled by the PTO be removed from the Orange
Book.71 Finally, the bill would have clarified that challenging a patent that is later struck from the
Orange Book would not affect the first-generic-filer 180-day exclusivity period.72
In sum, both the TERM Act and REMEDY Act would have limited the benefits of later-filed drug
patents. However, the two bills would have limited those benefits in different ways. The TERM
Act would have created a presumption that the patentee disclaimed the term of all listed patents
that expired after the earliest-expiring patent. Unless the patentee overcame that presumption, all
of those patents would be treated as expired (i.e., they could not be used to exclude the production
of generics) after that date, shortening the life of those patents. Thus, the TERM Act would have
made it more difficult for the brand to assert those later-filed patents by requiring the brand to
establish that the patents are related to distinct inventions, but would allow the brand to assert its
full patent portfolio if it could carry that burden. The REMEDY Act, in contrast, would have
reduced the types of patents that would trigger a 30-month stay of FDA approval due to litigation,
and thus could have allowed for earlier generic approval. Nevertheless, under the REMEDY Act,
the brand could have continued to assert any patents relating to the drug for their full term.
Table 3. Bills in the 116th Congress Relating to Patent “Evergreening”
Caret (^) indicates bill had at least one original cosponsor of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 3199
TERM Act of
Rep. Jeffries
Creates presumption that later-expiring patents on
2019^
(and 4 OCs)
pharmaceuticals expire unless proven to claim patentably
distinct invention
H.R. 3812
REMEDY Act^
Rep. McKinley
Would limit availability of Hatch-Waxman 30-month stay
Rep. Welch
to certain pharmaceutical patents and require removal of
cancelled patents from Orange Book
S. 1209
REMEDY Act^
Sen. Cassidy
Would limit availability of Hatch-Waxman 30-month stay
Sen. Durbin
to certain pharmaceutical patents and require removal of
cancelled patents from Orange Book
Source: CRS; congress.gov.

67 S. 1209 § 2(a)(1).
68 S. 1209 § 2(a)(1).
69 See id.; Ryan Davis, Breaking Down 3 New Senate Bills Targeting Drug Prices, LAW360 (Apr. 18, 2019),
https://www.law360.com/articles/1150045/breaking-down-3-new-senate-bills-targeting-drug-prices.
70 Davis, supra note 69.
71 S. 1209 § 2(b)(1).
72 Id. § 2(b)(2).
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Bills Relating to “Product Hopping” and “Patent Thickets”
Several bills introduced in the 116th Congress sought to curtail product hopping or patent
thickets. “Product hopping” refers to the alleged practice in which brands, facing the expiration of
patents on a particular pharmaceutical, introduce a new, similar product covered by a later-
expiring patent and attempt to switch the market to that product.73 “Patent thickets” refer to the
alleged practice of a brand accumulating numerous, overlapping patents on the same product as a
way to deter generics from entering the market due to the risk of infringement and the high cost
of patent litigation.74 Table 4 lists information on these bills.
The Affordable Prescriptions for Patients Act of 2019. The Affordable Prescriptions for Patients
Act of 2019 (APPA) would have made product hopping an antitrust violation and set a limit on
the number of certain patents that could be asserted in biosimilar litigation.75
Product Hopping Provisions. The first portion of the bill would have amended the Federal Trade
Commission Act of 1974 (FTCA) to make product hopping a violation of the federal antitrust
laws.76 Antitrust law (which generally aims to protect competition) may provide a natural fit for
remedying product hopping because the alleged harm of product hopping is reduced competition
for the original product.77 The Federal Trade Commission (FTC) could prove a prima facie case
of product hopping by showing that a manufacturer had engaged in either a “hard switch” or a
“soft switch,” explained further below, during the relevant time period. The bill would have
addressed “switches” during the time between (1) when the manufacturer first received notice
that an applicant submitted an ANDA or biosimilar license application for a particular product;
and (2) 180 days after the generic drug or biosimilar product is first marketed.78
Current law generally allows manufacturers to take actions that reduce the supply or desirability
of an older product, and to replace that older product with a “follow-on product” (i.e., a new
version of the drug)—a practice referred to as “product hopping.”79 Product hopping tends to take
one of two forms: a “hard switch,” where the brand removes the original product from the market,
and a “soft switch,” where the brand leaves the original product on the market.80 Commentators
have argued that such practices encourage patients to use the new follow-on product, reducing
demand for the original product and the opportunity for competition from any potential generic
for the original product.81 The APPA covers these situations by subjecting both types of switches

73 See Richards et al., supra note 29, at 20–24.
74 See Richards et al., supra note 29, at 24–28.
75 Affordable Prescriptions for Patients Act of 2019, § 2, S. 1416, 116th Cong. (2019). The portion of APPA aimed at
preventing patent thickets was introduced in the House of Representatives as the Affordable Prescriptions for Patients
Through Improvements to Patent Litigation Act of 2019. H.R. 3991, 116th Cong. (2019). The portion aimed at
preventing product hopping was introduced in the House as the Affordable Prescriptions for Patients Through
Promoting Competition Act of 2019. H.R. 4398, 116th Cong. (2019). For simplicity, discussion herein summarizes the
Senate version as reported to the Senate on June 28, 2019.
76 S. 1416 § 2.
77 CRS Report R46679, Drug Prices: The Role of Patents and Regulatory Exclusivities, coordinated by Erin H. Ward,
at 37–41, 46–49.
78 Id. (proposed FTCA § 27(b)).
79 Joanna Shepherd, Deterring Innovation: New York v. Actavis and the Duty to Subsidize Competitors’ Market Entry,
17 MINN. J. OF L., SCI. & TECH. 663, 668–72 (2016); Ward et al., supra note 77, at 46–49.
80 Ward et al., supra note 77, at 46.
81 See, e.g., Dmitry Karshtedt, The More Things Change: Improvement Patents, Drug Modifications, and the FDA, 104
IOWA L. REV. 1129, 1211 (2019); Steven Adamson, Pharmaceutical Patent Wars, Reverse-Payment Settlements, and
Their Anticompetitive Effects for Consumers, 30 LOY. CONSUMER L. REV. 241, 258–59 (2018); Justine Amy Park,
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to the antitrust laws. The APPA defines a “hard switch” as occurring when a manufacturer
requests that FDA withdraw approval for a listed product—possibly preventing a generic from
marketing a competing product, because it would then lack a reference product—and then
markets a “follow-on product” (i.e., a new version of the drug).82 Under the APPA, a “hard
switch” also occurs when the manufacturer markets a follow-on product after announcing the
withdrawal, discontinuation, or intent to withdraw a listed product in a manner that impedes
competition, or after destroying inventory of a listed product in a manner that impedes
competition.83 Taken together, the definition would capture circumstances in which a
manufacturer removes its product from the market, and markets a new version of that product.
The bill’s definition of a soft switch would have aimed to capture other forms of product hopping
that might impede competition but do not specifically fall within the definition of a “hard switch.”
Under the proposed language, a soft switch would occur when a manufacturer markets or sells a
follow-on product and takes actions to impede competition for a generic product or a biosimilar
version of the manufacturer’s product.84 Thus, the definition of “soft switch” would serve as
something of a catchall, capturing anticompetitive conduct not specifically articulated in the
definition of a “hard switch.”
APPA would have allowed a manufacturer to rebut the FTC’s prima facie case of product
hopping.85 First, a manufacturer could justify its conduct by first establishing that it would have
taken the same actions even if a generic had already entered the market.86 For a hard switch, the
manufacturer must also establish either that its actions related to safety risks of the original
product, or that its actions were due to a supply disruption outside of its control.87 For a soft
switch, the manufacturer must establish that it had “legitimate pro-competitive reasons, apart
from the financial effects of reduced competition, to take the action.”88
Patent Thicket Provisions. The APPA also aimed to reduce the impact of patent thickets for
biological products.89 First, the bill would have broadened the types of patents that could be
asserted in pre-marketing litigation to include patents claiming methods or products used to
manufacture a biological product.90 Second, the bill would have limited the number of patents
that a brand biologic manufacturer can assert in litigation against a biosimilar manufacturer to at
most 20 patents meeting certain conditions.91 Certain later-issued patents (i.e., those that issued
after the brand provided its initial list to the biosimilar manufacturer during the patent dance)

Product Hopping: Antitrust Liability and a Per Se Rule, 35 CARDOZO ARTS & ENT. L.J. 745, 760 n.126 (2017); Lars
Noah, Product Hopping 2.0: Getting the FDA to Yank Your Original License Beats Stacking Patents, 19 MARQ.
INTELL. PROP. L. REV. 161, 172–79 (2015).
82 Id. (proposed FTCA § 27(b)(1)(A)(i)-(ii)). The bill defines the term “follow-on product” as an approved drug or
biologic that changes, modifies, or reformulates “the same manufacturer’s previously approved drug or biological
product that treats the same medical condition.” Id. (proposed FTCA § 27(a)(4)).
83 Id.
84 S. 1416 § 2 (proposed FTCA § 27(b)(1)(B)).
85 Id. (proposed FTCA § 27(b)(2)).
86 Id. (proposed FTCA § 27(b)(2)(A)(i)(I)).
87 Id. (proposed FTCA § 27(b)(2)(A)(i)(II)(aa), (bb)).
88 Id. (proposed FTCA § 27(b)(2)(A)(i)(II)(cc)).
89 Id. § 3.
90 Id. § 3(a)(1).
91 Id. § 3(a)(2) (proposed 35 U.S.C. § 271(e)(7)(A)–(B)).
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would have been even further limited.92 The APPA would have nonetheless authorized courts to
increase the number of asserted patents in the interest of justice or for good cause.93
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R.
5133). The Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
(H.R. 5133)94 would have made product hopping an antitrust violation,95 and is very similar to the
product-hopping portion of the APPA (and H.R. 4398). However, H.R. 5133 adds some
provisions that the other bills do not contain.
First, H.R. 5133 adds or changes the scope of certain terms defined in the APPA to clarify that the
bill would not address certain practices. Specifically, H.R. 5133’s definition of a “follow-on
product” specifically excludes an application that has been granted new chemical exclusivity by
FDA,96 and also excludes an application that has been granted reference product exclusivity.97
Moreover, H.R. 5133 defines “disadvantage” to include practices that “impede the listed drug or
reference product’s ability to compete on the merits with the follow-on product.”98 This definition
excludes “truthful, non-misleading promotional marketing” and also excludes “ceasing
promotional marketing for the listed drug or reference product.”99
Second, H.R. 5133 uses a time window for determining whether product hopping occurred that is
potentially more favorable to the original patent holder. APPA sets the window as between (1)
when the manufacturer first received notice that an applicant submitted an ANDA or biosimilar
license for a particular product; and (2) 180 days after the generic drug or biosimilar product is
first marketed. H.R. 5133 sets the window as between (1) when the manufacturer first received
notice that an applicant submitted an ANDA or biosimilar license for a particular product; and (2)
the earlier of 180 days after the generic drug or biosimilar product is first marketed and 3 years
after the date on which the follow-on product is first marketed.100
H.R. 5133 would have broadened the conduct regarded as a hard switch. Whereas the APPA
defines a hard switch as, among other things, announcing “withdrawal of, discontinuance of the
manufacture of, or intent to withdraw the application with respect to the drug or reference product
in a manner that impedes competition from a generic drug or a biosimilar biological product, as
established by objective circumstances,” H.R. 5133 adds actual withdrawal, discontinuation of

92 Id.
93 Id. (proposed 35 U.S.C. § 271(e)(7)(C)). Good cause “shall” be established if the biosimilar company did not supply
information that would allow the brand to determine whether the application product is infringing on the patent. Id.
(proposed 35 U.S.C. § 271(e)(7)(C)(ii)(II)(aa)). Good cause “may” be established if (1) there is a material change to the
biosimilar or a process regarding the biosimilar; (2) the PTO failed to issue or delayed issuing a patent; or (3) the brand
shows other good cause. Id. (proposed 35 U.S.C. § 271(e)(7)(C)(ii)(II)(bb)). The limit only applies if the biosimilar
company completes the patent dance, and does not apply to any patent that claims a method for using a biological
product in “therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.”
Id. (proposed 35 U.S.C. § 271(e)(7)(E)).
94 Because H.R. 5133 has the same title as H.R. 4398, and deals with similar subject matter, the present discussion will
use the bill number for sake of clarity.
95 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019, H.R. 5199, 116th Cong. (2019).
96 Id. § 2 (proposed FTCA § 27(a)(4)(C)).
97 Id. § 2 (proposed FTCA § 27(a)(4)(D)).
98 Id. § 2 (proposed FTCA § 27(a)(6)).
99 Id. § 2 (proposed FTCA § 27(a)(6)(A)-(B)).
100 Id. § 2 (proposed FTCA § 27(b)(1)).
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manufacture, or withdrawal of the application as actions that constitute a hard switch—conduct
that arguably would not fall under the definition of a “hard switch” under the APPA.101
Finally, while the APPA listed specific remedies that the FTC may pursue for a product hopping
violation (such as disgorgement), H.R. 5133 provides that the FTC “shall enforce this section in
the same manner, by the same means, and with the same jurisdiction, powers, duties, and
remedies provided for by all applicable terms and provisions of the” FTCA.102
Table 4. Bills in the 116th Congress Relating to “Product Hopping” or “Patent
Thickets”
Underline indicates bill reported or ordered to be reported out of committee. Caret (^) indicates bill had
at least one original cosponsor of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 3991
Affordable Prescriptions Rep. Hank Johnson
Would limit the number of patents that
for Patients Through
Rep. Roby
biologic manufacturer can assert in litigation
Improvements to Patent
against a biosimilar manufacturer
Litigation Act of 2019^
H.R. 5133
Affordable Prescriptions Rep. Cicil ine
Would make “product hopping” an antitrust
for Patients Through
Rep. Col ins
violation subject to FTC enforcement
Promoting Competition
Rep. Nadler
Act of 2019^
Rep. Sensenbrenner
S. 1416
Affordable Prescriptions Sen. Cornyn
Would make “product hopping” an antitrust
for Patients Act of
Sen. Blumenthal
violation subject to FTC enforcement, and limit
2019^
the number of patents that biologic
manufacturer can assert in litigation against a
biosimilar manufacturer
H.R. 4398
Affordable Prescriptions Rep. Cicil ine
Would make “product hopping” an antitrust
for Patients Through
violation subject to FTC enforcement
Promoting Competition
Act of 2019
Source: CRS; congress.gov.
Bills Relating to “Pay-for-Delay” Patent Litigation Settlements
Patent litigation can result when generic drug and biosimilar manufacturers seek to market a drug
or biological product before patent rights expire, arguing either that the brand-name company’s
patent is invalid or that it does not apply to the generic or biosimilar product. Some brand-name
companies have resolved or settled such litigation through agreements with the generic
manufacturer wherein the brand-name company pays the generic manufacturer a sum of money,
which can be “many millions of dollars,” in return for the generic manufacturer agreeing to wait
to enter the market.103 This practice, referred to as “reverse payment settlements” or “pay-for-
delay settlements,” allows the brand-name company to avoid the risk that its patent will be
invalidated, potentially delay the market entry of generic competition that could lower drug

101 Id. (proposed FTCA § 27(b)(1)(a)(ii)(I)(aa)).
102 Id. (proposed FTCA § 27(c)).
103 See, e.g., FTC v. Actavis, Inc., 570 U.S. 136, 144–45 (2013); In re Androgel Antitrust Litigation, No. 1:09-MD-
2084-TWT, 2018 WL 298483, at *3–4 (N.D. Ga. June 14, 2018).
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prices, and may effectively extend its exclusive right to market the listed drug.104 The FTC and
private parties have alleged that these pay-for-delay agreements entail the brand-name company
paying the generic applicant “many millions of dollars to stay out of its market” and, accordingly,
have “significant adverse effects on competition.”105
Pay-for-delay agreements may contravene existing antitrust laws if they have anticompetitive
effects. Section 1 of the Sherman Act prohibits “contracts . . . in restraint of trade or [interstate]
commerce.”106 The Supreme Court has held that the Sherman Act prohibits only unreasonable
restraints, recognizing that all contracts operate as a restraint on trade.107 Section 5 of the FTCA
further prohibits “unfair methods of competition”108—a category that includes (but is not limited
to) conduct that violates the Sherman Act.109 The Supreme Court has recognized that “reverse
payment settlements . . . can sometimes violate the antitrust laws,”110 and courts have allowed
antitrust litigation challenging certain reverse payment settlements to proceed under existing
law.111
The Supreme Court has observed that pay-for-delay settlements are not inherently
anticompetitive and illegal. A valid patent affords the owner the right to exclude infringing
products from the market, and settlements (among other things) reduce litigation costs and
litigation risk. But “an invalidated patent carries with it no such right,” “[a]nd even a valid patent
confers no right to exclude products or processes that do not actually infringe.”112 Pay-for-delay
agreements terminate the litigation, leaving the questions of validity and infringement open.113
Accordingly, some pay-for-delay settlements may delay the market entry of a generic competitor
with a product that would not have infringed a valid patent, while others might allow the generic
company to enter the market sooner than it would have despite a valid and infringed patent.
Courts generally apply a totality-of-the-circumstances “rule of reason” analysis to practices that
are not per se illegal, such as pay-for-delay settlements.114 The rule of reason requires the
government to demonstrate that a challenged restraint on competition has anticompetitive effects
in a properly defined product and geographic market.115 Only after the government meets this

104 See, e.g., Actavis, 570 U.S. at 154.
105 Id. at 147–48; see also King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp., 791 F.3d 388, 398 (3d Cir.
2015).
106 15 U.S.C. § 1.
107 See, e.g., NCAA v. Board of Regents of Univ. of Okla., 468 U.S. 85, 98 (1984).
108 15 U.S.C. § 45(a).
109 See FTC v. Cement Inst., 333 U.S. 683, 692 (1948).
110 Actavis, 570 U.S. at 141.
111 See, e.g., King Drug Co. of Florence, Inc. v. SmithKlineBeecham Corp., 791 F.3d 388, 403 (3d Cir. 2015); King
Drug Co. of Florence, Inc. v. Cephalon, Inc., 88 F. Supp. 3d 402, 422 (E.D. Pa. 2015); In re Aggrenox Antitrust
Litigation, 94 F. Supp. 3d 224, 245–46 (D. Conn. 2015).
112 Id. at 147.
113 Id.
114 United States v. E.I. du Pont de Nemours & Co., 351 U.S. 377, 387 (1956).
115 See DANIEL CRANE, ANTITRUST 53-6 (2014); see also Herbert Hovenkamp, The Rule of Reason, 70 FLA. L. REV. 81,
103 (2018) (collecting cases); HERBERT HOVENKAMP, FEDERAL ANTITRUST POLICY: THE LAW OF COMPETITION AND ITS
PRACTICE 103 (5th ed. 2015). The Supreme Court has explained that a properly defined market includes the product at
issue and its substitutes—that is, other products that are “reasonably interchangebl[e]” with the relevant product. See
Brown Shoe Co. v. U.S., 370 U.S. 294, 325 (1962). Stated differently, whether two products compete in the same
market depends on the extent to which an increase in the price of one product in a given geographic region would cause
consumers to purchase the other product instead. HOVENKAMP, supra, at 111–17.
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burden is the onus on the defendant to provide evidence of a procompetitive justification for the
challenged practice.116 If the defendant can provide this evidence, the burden of proof shifts back
to the government to show either (1) that the restraint’s anticompetitive effects outweigh its
procompetitive effects or (2) that the restraint’s procompetitive effects could be achieved in a
manner that is less restrictive of competition.117
A number of bills in the 116th Congress focused on proscribing pay-for-delay settlements or
shifting the burden of proof in antitrust litigation over alleged pay-for-delay settlements from the
government to the pharmaceutical companies. Table 5 provides information on these bills.
Preserve Access to Affordable Generics and Biosimilars Act. The Preserve Access to Affordable
Generics and Biosimilars Act (PAAGBA) would have established a presumption that it is
anticompetitive for brand-name manufacturers to compensate generic or biosimilar product
manufacturers for delaying their entry into the market, moving away from a rule-of-reason
analysis.118 The proposed legislation would have amended the FTCA to specifically authorize the
FTC119 to initiate enforcement proceedings against all parties to “any agreement resolving or
settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a
drug product or biological product.”120 Such agreements would have been presumed to have
anticompetitive effects and violate antitrust laws if the brand-name company agrees to provide
the generic with “anything of value,” including monetary payments or distribution licenses, in
exchange for the generic company agreeing “to limit or forego research, development,
manufacturing, marketing, or sales” of the generic product “for any period of time.”121
The bill defined the scope of the presumption to focus on agreements that resemble pay-for-delay
settlements. For example, the presumption that an agreement is anticompetitive would not have
applied to agreements where the only consideration from the brand-name company is the right to
market the product before relevant patents or exclusivities expire, reasonable litigation expenses,
or a covenant not to sue for infringement.122 Even where the presumption would have applied,
moreover, the parties to the agreement would have had the opportunity to overcome the
presumption with “clear and convincing evidence” that (1) the agreement provides compensation
“solely for other goods or services” from the generic company or (2) the agreement’s
“procompetitive benefits . . . outweigh the anticompetitive effects.”123

116 See CRANE, supra note 115, at 54; Hovenkamp, supra note 115, at 103. For example, if a Section 1 plaintiff alleges
that the challenged restraint produces higher prices, the defendant might attempt to contest that allegation or show that
any price increases are offset by improvements in its products or services.
117 See CRANE, supra note 115, at 54; Hovenkamp, supra note 115, at 104.
118 Preserve Access to Affordable Generics and Biosimilars Act, S. 64, 116th Cong. preamble, § 3 (2019) (proposed
FTCA § 27(a)(2)(A)). The Preserve Access to Affordable Generics and Biosimilars Act that was introduced in the
House of Representatives as H.R. 2375 is substantially similar to S. 64. H.R. 2375 did not include a statement of
findings as S. 64 did. H.R. 2375 requires notification of agreements between brand manufacturers and generic
manufacturers, in addition to certification requirements provided for in S. 64. Finally, H.R. 2375 requires the FTC to
provide a recommendation within a year as to whether brand manufacturers should be allowed to provide releases,
waivers, or limitations for claims of damages or other monetary relief as consideration in settlement agreements
without violating the provisions of the act.
119 PAAGBA only addresses actions initiated by the FTC and does not modify the standards that apply to private suits.
See id.
120 Id. (proposed FTCA § 27(a)(1)).
121 Id. (proposed FTCA § 27(a)(2)(A)).
122 Id. (proposed FTCA § 27(c)).
123 Id. (proposed FTCA § 27(a)(2)(B)). When evaluating a party’s evidence to overcome the presumption, the fact-
finder (i.e., jury or, if there is no jury, judge) would have been instructed not to assume that (absent the agreement) the
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If the FTC had proved that the agreement was anticompetitive and illegal under these provisions,
the proposed legislation would have provided for assessment of a civil penalty against each
violating party.124 The civil penalty must have been “sufficient to deter violations,” based on a
variety of factors established in the statute, but the penalty for each party could have been no
more than three times the value gained by that party from the agreement.125 Any penalties
assessed would have been in addition to, rather than in lieu of, any penalties imposed by other
federal law.126 The FTC would also have been able to seek injunctions and other equitable relief,
including cease-and-desist orders.127 In addition, an ANDA filer that was party to such an
agreement would have forfeited its 180-day exclusivity awarded for challenging a patent using a
paragraph (IV) certification.128
Competitive DRUGS Act of 2019. The Competitive DRUGS Act of 2019, much like the
PAAGBA, would have deemed certain pay-for-delay settlements (specifically, those in which an
ANDA filer agreed to limit its activities related to the ANDA product in exchange for receiving
something of value from a brand-name manufacturer) to be an unfair method of competition in
violation of Section 5 of the FTCA.129 As with the PAAGBA, the Competitive DRUGS Act of
2019 would have allowed the parties to demonstrate by clear and convincing evidence either that
the compensation is “solely for other goods or services” the ANDA filer is to provide or that “the
procompetitive benefits of the agreement outweigh the anticompetitive effects of the
agreement.”130 For any such violations, in addition to the remedies provided for under the FTCA,
the Competitive DRUGS Act of 2019 would have clawed back certain R&D tax benefits from
violators.131 The Competitive DRUGS Act of 2019 would have also imposed a 50% tax on funds
received by parties under the violating agreement and precluded the parties from deducting any
payments made pursuant to such an agreement from their taxable income.132
Protecting Consumer Access to Generic Drugs Act of 2019. The Protecting Consumer Access to
Generic Drugs Act of 2019 was substantively similar to the PAAGBA. However, unlike the
PAAGBA and Competitive DRUGS Act of 2019, the Protecting Consumer Access to Generic

generic would not have entered the market until the patent or exclusivity expired (i.e., that the agreement may have
allowed for earlier entry), or that entering the market before the patent or exclusivity period expired would be
procompetitive (i.e., that allowing the generic to enter the market sooner makes the agreement procompetitive). Id.
(proposed FTCA § 27(b)).
124 Id. (proposed FTCA § 27(f)(1)).
125 Id. (proposed FTCA § 27(f)(1)).
126 Id. (proposed FTCA § 27(f)(4)).
127 Id. (proposed FTCA § 27(f)(1) & (2)).
128 Id. § 5 (amending FD&C Act § 505(j)(5)(D)(i)(V)). Other provisions of PAAGBA would amend Section 1112 of
the Medicare Prescription Drug Improvement and Modernization Act of 2003. S. 64 § 4 (proposed Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. § 355 note) § 1112(d)). This section
currently requires parties to submit to the FTC and Department of Justice any agreements between generic and
biosimilar product applicants and brand-name manufacturers, or among generic/biosimilar applicants for the same drug
or biologic, regarding the “manufacture, marketing, or sale” of either the brand-name pharmaceutical product or the
generic/biosimilar product, or the 180-day exclusivity period. 21 U.S.C. § 355 note. PAAGBA would amend this
section to require the CEO or “company official responsible for negotiating any agreement” to file a certification
affirming that the materials filed were the complete agreements between the parties, including any ancillary agreements
or written descriptions of oral agreements. S. 64 § 4 (proposed Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (21 U.S.C. § 355 note) § 1112(d)).
129 Competitive DRUGS Act of 2019, H.R. 1344, 116th Cong. § 4 (2019) (proposed FTCA § 27(a)(2)(A)).
130 Id. (proposed FTCA §27(a)(2)(B)).
131 Id. § 2 (proposed Internal Revenue Code of 1986 (IRC) § 41).
132 Id. § 3 (proposed IRC §§ 162(c)(4) & 4501).
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Drugs Act of 2019 would not have allowed parties to avoid liability by demonstrating that the
agreement’s procompetitive effects outweigh the anticompetitive effects; the exclusion would
have been limited to compensation solely for the ANDA providing other goods or services.133 In
addition, the Protecting Consumer Access to Generic Drugs Act of 2019 would have not amended
the FTCA directly as the PAAGBA and Competitive DRUGS Act of 2019 do.134
Table 5. Bills in the 116th Congress Relating to “Pay-for-Delay” Patent Settlements
Italics indicate bill passed one house of Congress (as part of a different piece of legislation where noted);
underline indicates bill reported or ordered to be reported out of committee. Caret (^) indicates bill had
at least one original cosponsor of a different party than the sponsor. Asterisk (*) indicates furthest
legislative progress as part of another bill (see Table 1 for details).
Bill No.
Bill Title
OCs
Summary
H.R. 1499
Protecting Consumer
Rep. Rush
Would make certain “pay-for-delay” settlements
Access to Generic Drugs
unlawful and subject to FTC enforcement and
Act of 2019*
civil penalties
H.R. 2375
Preserve Access to
Rep. Nadler
Would make certain “pay-for-delay” patent
Affordable Generics
Rep. Col ins
litigation settlements a presumptive antitrust
and Biosimilars Act^
Rep. Cicil ine
violation subject to FTC enforcement and civil
penalties
H.R. 1344
Competitive DRUGS
Rep. Doggett
Would make certain “pay-for-delay” patent
Act of 2019
(and 21 OCs)
litigation settlements a presumptive antitrust
violation and impose tax penalties in addition to
FTC enforcement
S. 64
Preserve Access to
Sen. Klobuchar
Would make certain “pay-for-delay” patent
Affordable Generics
Sen. Grassley
litigation settlements a presumptive antitrust
and Biosimilars Act^
violation subject to FTC enforcement and civil
penalties
Source: CRS; congress.gov.
Bills Relating to Administrative Patent Challenges
Several bills introduced in the 116th Congress would have affected the strength of drug patents by
focusing on patent validity challenges that use PTO administrative proceedings. Those
proceedings, including inter partes review (IPR) and post-grant review (PGR), are explained in
more detail in other CRS products.135 PTO procedures generally provide a lower-cost and
expedited means of challenging patent validity, as compared to district court litigation.136 Table 6
lists information on bills that would have changed these administrative processes as applied to
pharmaceutical patents.
The Hatch-Waxman Integrity Act of 2019. The Hatch-Waxman Integrity Act of 2019 (HWIA)
would have strengthened the IP rights of brand-name patent holders by reducing a generic or
biosimilar manufacturer’s ability to challenge drug patents using IPR and PGR.137 HWIA would

133 Protecting Consumer Access to Generic Drugs Act of 2019, H.R. 1499, 116th Cong. § 2(b) (2019).
134 Id. § 2.
135 See Richards, supra note 25, at 24–28.
136 See H.R. REP. NO. 112-98, at 40 (2011) (legislation creating IPR and PGR “designed to establish a more efficient
and streamlined patent system that will improve patent quality and limit unnecessary and counterproductive litigation
costs”).
137 Hatch-Waxman Integrity Act of 2019, H.R. 990, 116th Cong. § 2 (2019). A bill with the same title and proposed
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have required a generic or biosimilar manufacturer to certify in its application for FDA approval
that neither it nor any other party “in privity with, related to, or cooperating with” it has filed an
IPR/PGR or will petition for IPR/PGR.138 Moreover, HWIA would have required a generic
manufacturer to state as part of its ANDA patent certification (for example, that a patent covering
a reference product is invalid) that it was not “relying in whole or in part on any” decision in an
IPR or PGR.139 In short, HWIA would have constrained generic and biosimilar manufacturers
from using the PTO post-grant processes to attempt to cancel drug patents, thus potentially
benefiting brand-name pharmaceutical manufacturers.
Targeting certain practices of hedge fund managers, HWIA also aimed to prevent use of IPR to
manipulate stock prices.140 Specifically, HWIA would have amended the Securities and Exchange
Act of 1934 to bar “manipulative or deceptive” use of IPR, that is, filing an IPR petition where
the petitioner short sold the patent owner’s publicly traded security “during the 180-day period
beginning on the date that is 90 days before the” petition date.141
The Second Look at Drug Patents Act of 2019. In contrast to HWIA, the Second Look at Drugs
Patents Act of 2019 (SLDPA) would have incentivized administrative challenges to
pharmaceutical patents, specifically patents added to the Orange Book.142 Under SLDPA, a brand
would have been required to notify the PTO that it was adding patents to the Orange Book.143 The
PTO would then publish a notice regarding each patent and request that any eligible person file an
IPR challenging the patent.144 Such patents would be “provisionally” included in the Orange
Book until either the PTO confirmed the relevant patents’ patentability or until a time period
passed without any challenge to the patents (300 days if the patent had issued when FDA
approved the relevant drug, or 15 months if the patent issued after approval).145 If any patent
claims are canceled as a result of an IPR, SLDPA would have required the brand to submit a
request that the patent be removed from the Orange Book (if all claims are canceled) or that the
canceled claims be removed from the Orange Book.146 In sum, SLDPA would have provided
greater notice regarding particular patents that generics may want to challenge and would have
encouraged such challenges.147
HWIA and SLDPA represent different approaches to administrative challenges to pharmaceutical
patents. Under HWIA, all issues relating to patent validity during Hatch-Waxman litigation would
be determined in the courts, not the PTO. Arguably, this would be faithful to the balance struck
when Hatch-Waxman was initially enacted in 1984, but it would forgo some of the potential
efficiencies of the administrative processes that have grown in importance since that time. By

text was also introduced in the Senate. Hatch-Waxman Integrity Act of 2019, S. 344, 116th Cong. (2019). For
simplicity, all citations herein are to the House bill as introduced on February, 6, 2019.
138 Id. §§ 2(a)(3), 2(b)(3), 2(c)(1)(C).
139 Id. §§ 2(a)(3), 2(b)(3).
140 See J. Gregory Sidak & Jeremy O. Skog, Attack of the Shorting Bass: Does the Inter Partes Review Process Enable
Petitioners to Earn Abnormal Returns?, 63 UCLA L. REV. DISC. 120, 122–25 (2015).
141 Id. § 3.
142 S. 1617, 116th Cong. § 2(a) (2019).
143 Id. § 2(a)(2)(C).
144 Id.
145 Id.
146 Id.
147 A similar bill with a subset of identical text was also introduced during the 116th Congress. See Second Look at
Drug Patents Act of 2020, S. 4253, 116th Cong. (2020). S. 4253 would only require that the brand report patents added
to the Orange Book to the PTO, and that the PTO publish and invite challenges to those patents. Id. § 3. It does not
include the “provisional” Orange Book inclusion found in the SLDPA of 2019.
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contrast, SLDPA would have made it easier to challenge patents that would likely be at issue in
Hatch-Waxman litigation by having the PTO publish those patents to a public website and invite
IPR/PGR challenges to those patents.
Table 6. Bills in the 116th Congress Relating to Administrative Patent Challenges
Caret (^) indicates bill had at least one original cosponsor of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 990
Hatch-Waxman
Rep. Flores
Would limit administrative challenges for certain
Integrity Act of 2019
pharmaceutical patents
S. 344
Hatch-Waxman
Sen. Til is
Would limit administrative challenges for certain
Integrity Act of 2019
pharmaceutical patents
S. 1617
Second Look at Drug
Sen. Murray
Would require brand-name drug manufacturers to notify
Patents Act of 2019^
Sen. Cornyn
the PTO of Orange-Book-listed patents and for PTO to
invite administrative challenge to such patents, which
would be “provisionally” listed in the Orange Book pending
such challenges
S. 4253
Second Look at Drug
Sen. Murray
Would require brand-name drug manufacturers to notify
Patents Act of 2020^
Sen. Cornyn
the PTO of Orange-Book-listed patents and for PTO to
invite administrative challenge to such patents
Source: CRS; congress.gov.
Regulatory Exclusivity Reforms
Regulatory exclusivities are granted to qualifying pharmaceutical products upon being approved
or licensed for marketing by FDA. Regulatory exclusivities prevent FDA from accepting or
approving an application by a competitor for FDA approval of a generic or biosimilar version of a
previously approved pharmaceutical or preclude a competitor from relying on safety and efficacy
data submitted by the original manufacturer for a period of time.148 Depending on the type of
pharmaceutical product and other factors, regulatory exclusivities may last anywhere from 6
months to 12 years.149
Because regulatory exclusivities prevent certain competing products from entering the market for
a period of time, pharmaceutical companies may be able to charge higher prices for those drugs or
biologics than they could in a more competitive market.150 Regulatory exclusivities may
accordingly be used to incentivize the development and marketing of certain types of
pharmaceutical products, such as innovative products (e.g., a new active ingredient or new
indication for an existing drug), first applicant generics, or those that serve a specific need (e.g.,
treating rare diseases).151 However, because exclusivities exclude market entry, the benefits
gained from encouraging innovation medicine may be weighed against the lower prices that
typically result from increased competition.152

148 See John R. Thomas, The End of “Patent Medicines”? Thoughts on the Rise of Regulatory Exclusivities, 70 FOOD &
DRUG L.J. 39, 44–49 (2015).
149 Id. at 48.
150 See, e.g., Generic Competition and Drug Prices, supra note 7.
151 See 21 U.S.C. §§ 355(c)(3)(E)(ii)-(iv), 355(j)(5)(F)(ii)-(iv), 355(u), 355(j)(5)(B)(iv)-(v), 356h, 360cc.
152 See, e.g. Generic Competition and Drug Prices, supra note 7; King Drug Co. of Florence, Inc. v. SmithKline
Beecham Corp., 791 F.3d 388, 394 (3d Cir. 2015) (“Congress attempted to balance the goal of ‘mak[ing] available
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A number of bills were introduced in the 116th Congress to address which entities are eligible to
receive certain types of exclusivities and when those exclusivities may be forfeited. This section
addresses bills relating to 180-day first-generic exclusivity, new biological product exclusivity,
new chemical entity exclusivity, and orphan drug exclusivity.
Bills Relating to the 180-Day First-Generic Exclusivity
Brand-name drugs containing a new chemical entity may be covered by patents that prevent
generic manufacturers from obtaining approval even after the five-year exclusivity for new
chemical entities expires. To incentivize generic manufacturers to challenge patents listed in the
Orange Book, the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides 180 days of
exclusivity to the first ANDA applicant that successfully challenges an active patent listed for the
reference listed drug (RLD).153 This exclusivity period precludes FDA from approving another
ANDA for the same RLD during the 180-day period. Three bills in the 116th Congress focused
on preventing first ANDA applicants from sitting on their rights and delaying the 180-day
exclusivity period and, accordingly, their or any other generic entry into the market. Table 7
provides information on the bills.
BLOCKING Act. The Bringing Low-cost Options and Competition while Keeping Incentives for
New Generics Act of 2019 (BLOCKING Act) would have added a new trigger for the 180-day
exclusivity period.154 Under the FD&C Act, the 180-day exclusivity period begins on the date of
first commercial marketing of the drug by a first applicant for the RLD.155 The BLOCKING Act
would have amended this provision to begin the 180-day exclusivity period on the earlier of the
date of first commercial marketing or the date on which four conditions are met: (1) another
ANDA for the same RLD could be made effective but for the first applicant’s exclusivity; (2) at
least 30 months have passed since an ANDA for the RLD was submitted to FDA; (3) patent
litigation proceedings do not preclude approval of at least one first applicant; and (4) no first
applicant’s ANDA has been approved. The effect of this change would have been to make the
180-day exclusivity period begin—and therefore expire—sooner in some cases, giving other
generics an opportunity to seek approval to enter the market.156
FAIR Generics Act. The FAIR Generics Act would have redefined the term “first applicant” for
purposes of the 180-day exclusivity period to exclude ANDA filers that entered into
“disqualifying agreements.”157 A disqualifying agreement, as defined by the act, would have been
one in which an ANDA applicant agrees to delay seeking approval or beginning commercial
marketing until after another ANDA applicant’s 180-day exclusivity period expires.158 An ANDA
applicant that does not file on the first day that any ANDA is filed for the drug would have to
meet three other requirements to qualify as a “first applicant”: (1) the ANDA applicant submitted
and maintained a paragraph (IV) certification for each listed patent certified by the first ANDA

more low cost generic drugs, with the value of patent monopolies in incentivizing beneficial pharmaceutical
advancement.” (citations omitted)); Yaniv Heled, Patents v. Statutory Exclusivities in Biological Pharmaceuticals—Do
We Really Need Both?, 18 MICH. TELECOMM. & TECH. L. REV. 419, 427–30, 434–36 (2012).
153 21 U.S.C. § 355(j)(5)(B)(iv), (j)(5)(D)(iii)(II). A successful challenge is one that obtains a court ruling or settlement
that a patent is invalid or will not be infringed by the ANDA applicant’s product. The exclusivity period may be shared
by multiple applicants if they all file their ANDAs on the same day.
154 BLOCKING Act of 2019, H.R. 938, 116th Cong. §2 (2019) (amending FD&C Act § 505(j)(5)(B)(iv)).
155 21 U.S.C. § 355(j)(5)(B)(iv)(I).
156 H.R. 938 § 2 (amending FD&C Act § 505(j)(5)(B)(iv)).
157 FAIR Generics Act, H.R. 1506, 116th Cong. § 2 (2019) (amending FD&C Act § 505(j)(5)(B)).
158 Id. § 3(a) (amending FD&C Act § 505(j)(5)(B)).
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filer(s); (2) the brand manufacturer did not pursue patent litigation following the certifications or
the litigation resulted in a district court determination that the patents are invalid or not infringed;
and (3) if the first ANDA filer(s) began commercially marketing their generic, the ANDA
applicant waited to begin commercial marketing for at least 30 days after the first filers began
commercial marketing.159 The act would have also required first applicants to notify FDA of the
text or content of any agreement wherein the first applicant agrees to delay seeking approval of its
application, commercial marketing, or both.160 Finally, the bill provided that suit under Hatch-
Waxman procedures is the “exclusive remedy” for infringement of Orange Book-listed patents,
potentially precluding infringement lawsuits if the brand does not sue within the 45-day period
following a paragraph (IV) certification.161
Expanding Access to Low-Cost Generics Act of 2019. As with the BLOCKING Act, the
Expanding Access to Low-Cost Generics Act of 2019 would have changed when ANDAs may be
approved for applicants that are not first applicants.162 Under the Expanding Access to Low-Cost
Generics Act of 2019, FDA could have approved a subsequent ANDA immediately, regardless of
the 180-day regulatory exclusivity, upon a district court entering a decision that the challenged
patents are invalid or not infringed if (1) the infringement proceeding were solely against the
subsequent ANDA applicant and (2) the subsequent ANDA applicant did not stay the patent
litigation, agree to be bound by the judgment as to another applicant, or request that any other
ANDA filer join its petition to challenge the patent before the PTO.163 FDA could have approved
an ANDA that met the requirements of the act regardless of whether a first applicant had been
approved or begun commercial marketing.164
Table 7. Bills in the 116th Congress Relating to the 180-Day First-Generic Exclusivity
Italics indicate bill passed one house of Congress (as part of a different piece of legislation where noted).
Caret (^) indicates bill had at least one original cosponsor of a different party than the sponsor. Asterisk
(*) indicates furthest legislative progress as part of another bill (see Table 1 for details).
Bill No.
Bill Title
OCs
Summary
H.R. 938
BLOCKING Act^*
Rep. Schrader
Would start the 180-day exclusivity period prior to
Rep. Buddy Carter
first commercial marketing in some circumstances
H.R. 1506
FAIR Generics Act
Rep. Barragán
Would preclude generic applicants who enter into
disqualifying agreements to delay seeking approval
or commercial marketing from receiving the 180-
day exclusivity, and would allow certain generic
applicants who file paragraph (IV) certifications but
did not file on the first day any ANDA was filed to
be considered first generic applicants
S. 3092
Expanding Access to
Sen. Smith
Would limit the scope of the 180-day exclusivity by
Low Cost Generics
Sen. Braun
allowing certain non-first generic applicants to
Act of 2019^
obtain a court decision of patent invalidity or
noninfringement to obtain immediate FDA approval

159 Id. § 2 (amending FD&C Act § 505(j)(5)(B)).
160 Id. § 3(a) (amending FD&C Act § 505(j)).
161 Id. § 3(b).
162 Expanding Access to Low-Cost Generics Act of 2019, S. 3092, 116th Cong. § 2 (2019) (amending FD&C Act
§ 505(j)(5)(B)(iv)).
163 Id.
164 Id.
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Source: CRS; congress.gov.
Bills Relating to the New Biological Product Exclusivity
Some pharmaceutical IP bills focus on biologics, which are medical treatments derived from
living organisms, such as a vaccine, blood component, protein, serum, or antibody.165 As
compared to “small molecule” drugs (e.g., inorganic chemical substances), biologics tend to be
large, complex organic molecules.166 Biologics are regulated under different legal provisions than
other drugs, and their complexity raises distinct issues.167 FDA’s regulatory authority, the
available regulatory exclusivities, the procedures for FDA licensure, and the pre-marketing patent
dispute procedures are all distinct for biologics as compared to small-molecule drugs.
Under the BPCIA, which created an abbreviated approval process for biosimilar and
interchangeable products,168 newly licensed biological products are generally entitled to a 12-year
period of regulatory exclusivity.169 More specifically, FDA may not approve an application to
license a biosimilar or interchangeable version of a biologic until 12 years after the date that the
product was “first licensed” by FDA.170 Table 8 lists information on pharmaceutical IP bills in the
116th Congress that focus specifically on this regulatory exclusivity for new biological
products.171
Protecting Access to Biosimilars Act. The Protecting Access to Biosimilars Act of 2019 (PABA),
which was enacted as amended as part of another bill, clarified how the BPCIA’s transition
provision interacts with the new biological product exclusivity.172 Provisions substantively similar
to PABA were enacted into law as a provision in the Further Consolidated Appropriations Act,
2020 entitled “Protecting Access to Biological Products.”173
For historical reasons, certain biological products (including, notably, insulin) were approved and
regulated by FDA as drugs under the FD&C Act, and not as biologics under the Public Health
Service Act (PHSA).174 Under Section 7002(e)(4) of the BPCIA, prior approvals of biological

165 42 U.S.C. § 262(i); U.S. FOOD & DRUG ADMIN., BIOLOGICAL PRODUCT DEFINITIONS,
https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf (last visited Nov. 11, 2020); see
generally CRS Report R44620, Biologics and Biosimilars: Background and Key Issues, by Agata Bodie.
166 See Bodie, supra note 165, at 1–3.
167 See generally Bodie, supra note 165, at 10–19.
168 Biologics Price Competition and Innovation Act of 2009, P.L. 111-148, tit. VII, 124 Stat. 119, 804–21 (2010)
[hereinafter BPCIA]; see 42 U.S.C. § 262(k).
169 See 42 U.S.C. § 262(k)(7)(A).
170 Id.
171 This list discusses bills that would address the new biologic exclusivity generally. Other bills, not included here,
would focus solely on insulin, a particularly important biological product. See, e.g., Insulin Access for All Act, H.R.
366, 116th Cong. (2019); Affordable Insulin Act, H.R. 1478, 116th Cong. (2019); Insulin Price Reduction Act, H.R.
4906, 116th Cong, (2019); End Price Gouging for Insulin Act, H.R. 5364, 116th Cong. (2019); Affordable Insulin for
All Act, H.R. 5749, 116th Cong. (2020); Matt’s Act, H.R. 7722, 116th Cong. (2020); Biosimilar Insulin Access Act,
H.R. 8190, 116th Cong. (2020); Insulin Price Reduction Act, S. 2199, 116th Cong. (2019); End Price Gouging for
Insulin Act, S. 2817, 116th Cong. (2019).
172 Protection Access to Biosimilars Act of 2019, H.R. 2011, 116th Cong. (2019). A nearly identical bill was introduced
in the Senate, see S. 1140, 116th Cong. (2019). For simplicity, all citations are to the House version as introduced on
April 1, 2019.
173 See P.L. 116-94, div. N, tit. I, § 606, 133 Stat. 2534, 3127 (2019).
174 See U.S. FOOD & DRUG ADMIN., INTERPRETATION OF THE “DEEMED TO BE A LICENSE” PROVISION OF THE BIOLOGICS
PRICE COMPETITION AND INNOVATION ACT OF 199: GUIDANCE FOR INDUSTRY 1–2, 14 (Dec. 2018),
https://www.fda.gov/media/119590/download [hereinafter FDA “DEEMED TO BE A LICENSE” GUIDANCE].
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products made under the FD&C Act shall be “deemed to be a license” of a biologic under the
PHSA on March 23, 2020.175 In guidance released in late 2018, FDA interpreted the BPCIA
transition provision to mean that, although a biological product formerly approved under the
FD&C Act will be “deemed” to have a biologics license on March 23, 2020, such a product will
not be eligible for the 12-year new biological product exclusivity.176
PABA, as amended and enacted, codified this FDA guidance by establishing that an approved
application “deemed to be a license” under the BPCIA transition provision shall not be treated as
a “first licensure” of a biological product for purposes of the BPCIA’s regulatory exclusivities.177
The statute further clarifies that the “anti-evergreening” provisions of BPCIA apply to “deemed”
licenses.178
The PRICED Act and the Emergency Access to Insulin Act. The Price Relief, Innovation, and
Competition for Essential Drugs Act (PRICED Act) would have shortened the length of the new
biological product exclusivity from 12 years to 5 years for biologics licensed after the enactment
of the act.179 (The BPCIA’s 12-year exclusivity for new biological products is several years
longer than comparable regulatory exclusivities in some other nations.180)
The Emergency Access to Insulin Act of 2019, in addition to a number of provisions designed to
decrease cost and increase access to insulin (including for uninsured and underinsured
individuals), included provisions that would have shortened the new biological product
exclusivity from 12 years to 7 years.181
Table 8. Bills in the 116th Congress Relating to the New Biological Product
Exclusivity
Bold indicates bill enacted in law (as part of a different piece of legislation where noted). Caret (^)
indicates bill had at least one original cosponsor of a different party than the sponsor. Asterisk (*)
indicates furthest legislative progress as part of another bill (see Table 1 for details).
Bill No.
Bill Title
OCs
Summary
H.R. 2011
Protecting Access
Rep. DeGette
Clarifies that no additional regulatory exclusivity
to Biosimilars Act
Rep. Reed
is available for biological products previously
of 2019^*
Rep. Schrier
regulated as drugs
Rep. Guthrie
S. 1140
Protecting Access
Sen. Smith
Clarifies that no additional regulatory exclusivity
to Biosimilars Act
Sen. Cassidy
is available for biological products previously
of 2019^*
regulated as drugs

175 BPCIA § 7000(e)(4), 124 Stat. at 817; see 42 U.S.C. § 262 note.
176 See FDA “DEEMED TO BE A LICENSE” GUIDANCE, supra note 174, at 9–10.
177 See id.; Protecting Access to Biosimilars Act of 2019, H.R. 2011, 116th Cong. § 2 (2019) (proposed 42 U.S.C. §
262(k)(7)(D)).
178 P.L. 116-94 § 606; H.R. 2011, § 2.
179 PRICED Act, H.R. 3379, 116th Cong. § 2 (2019).
180 CRS In Focus IF11314, USMCA: Intellectual Property Rights (IPR), by Shayerah Ilias Akhtar and Ian F. Fergusson
(noting five-year and eight-year new biologic exclusivities in Mexico and Canada, respectively). Europe generally has
eight years of data exclusivity followed by two years of marketing exclusivity for both biologics and small-molecule
drugs. See Commission Regulation 726/2004, art. 14(11), 2004 O.J. (L 136) 10.
181 Emergency Access to Insulin Act of 2019, S. 2004, 116th Cong. § 5 (2019). An identical bill was introduced in the
House, see H.R. 4010, 116th Cong. (2019).
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Bill No.
Bill Title
OCs
Summary
H.R. 3379
PRICED Act^
Rep. Schakowsky Would shorten regulatory exclusivity for new
(and 16 OCs)
biologics from 12 to 5 years
H.R. 4010
Emergency Access to
Rep. Craig
Inter alia, would shorten new biologic regulatory
Insulin Act of 2019
Rep. Phil ips
exclusivity from 12 to 7 years
S. 2004
Emergency Access to
Sen. Smith
Inter alia, would shorten new biologic regulatory
Insulin Act of 2019^
Sen. Cramer
exclusivity from 12 to 7 years
Source: CRS; congress.gov.
Bills Relating to the New Chemical Entity Exclusivity
Whether the “active ingredient” of a particular drug product is “novel” is an important
consideration for many provisions of the FD&C Act. In particular, FDA must assess the novelty
of the active ingredient in a new drug to determine whether the new drug qualifies for the five-
year “new chemical entity” (NCE) exclusivity.182 FDA generally cannot accept new drug
applications or ANDAs that refer to a drug with NCE exclusivity (i.e., rely on its clinical data and
FDA’s approval of the drug) for five years.183 Companies that receive approval for drugs with
new active ingredients generally enjoy a competitive advantage in the market while the
exclusivity is in effect, because that exclusivity prevents generic drugs from entering the
market.184 Given how expensive it can be to bring a new drug to market,185 when Congress passed
the Hatch-Waxman Amendments in 1984 to allow an abbreviated pathway for approval of generic
drugs, it also created NCE exclusivity to reward innovators of new pharmaceutical products with
an opportunity to recoup their investment.186
It can be technically complicated to determine whether the “active ingredient(s)” of a drug is the
same as that in a previously approved drug.187 For instance, compounds in a final drug product
may convert to other compounds through chemical reactions inside the body before arriving at the
site of the therapeutic effect, and related but distinct drug molecules may be clinically
indistinguishable or convert into the same pharmacologically or physiologically active component
inside the body.188 This phenomenon raises the question of which molecule—the one existing
before or after ingestion—should be the relevant molecule for purposes of determining active
ingredient.

182 21 U.S.C. §§ 355(j)(5)(F)(ii) & 355(c)(3)(E)(ii).
183 Id. ANDAs that challenge non-expired listed patents may be submitted after four years. Id.
184 Generic Competition and Drug Prices, FOOD & DRUG ADMIN. (Nov. 28, 2017), https://www.fda.gov/about-
fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices (finding association between
generic competition and lower drug prices).
185 See generally Joseph A. Di Masi, Henry G. Grabowski, & Ronald W. Hansen, Innovation in the Pharmaceutical
Industry: New Estimates of R&D Costs, 47 J. HEALTH ECON. 20 (2016).
186 See, e.g., King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp., 791 F.3d 388, 394 (3d Cir. 2015)
(“Congress attempted to balance the goal of ‘mak[ing] available more low cost generic drugs,’ H.R. Rep. No. 98-857,
pt. 1, at 14–15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647–48, with the value of patent monopolies in
incentivizing beneficial pharmaceutical advancement, see H.R. Rep. No. 98-857, pt. 2, at 30 (1984), reprinted in 1984
U.S.C.C.A.N. 2686, 2714.”); Yaniv Heled, Patents v. Statutory Exclusivities in Biological Pharmaceuticals—Do We
Really Need Both?, 18 MICH. TELECOMM. & TECH. L. REV. 419, 427–30, 434–36 (2012).
187 See, e.g., 21 U.S.C. § 355(c)(3)(E).
188 See, e.g., Actavis Elizabeth LLC v. FDA, 625 F.3d 760, 762–63, 766 (D.C. Cir. 2010); Abbott Laboratories v.
Young, 920 F.2d 984, 986 (D.C. Cir. 1990).
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Alternatively, two drug molecules with the same core compound may have different compounds
appended to them by either covalent (i.e., shared electrons) or noncovalent (i.e., no shared
electrons) bonds.189 For example, replacing a hydrogen atom in an acid molecule with “a metal or
its equivalent” forms a salt, whereas replacing the hydrogen atom with “an organic radical” forms
an ester.190 These derivatives may or may not vary from each other in clinically significant
ways,191 raising the question of which derivative(s), if any, should be considered as the same
active ingredient as the core or base molecule.
Congress has considered ways to affect drug pricing and IP by addressing how an “active
ingredient” is determined. Generally, a more expansive interpretation of the phrase “active
ingredient” (i.e., one that considers more types of derivatives to be the same active ingredient)
increases the number of drugs that are considered to be previously approved. This, in turn,
reduces the number of drugs eligible for NCE regulatory exclusivity and allows for earlier
introduction of generic versions of those drugs.
Historically, for purposes of the exclusivity provisions, FDA has interpreted the statutory term
“active ingredient” to mean “active moiety,” as defined by FDA regulations.192 The FDA
generally defines active moiety as the core molecule or ion of a drug that is “responsible for the
physiological or pharmacological action of a drug substance.”193 FDA’s interpretation has
generated disputes between FDA and pharmaceutical companies, as FDA’s approach tends to
exclude some drugs from being afforded five-year NCE exclusivity under the FD&C Act.194 In
2015, a federal district court rejected FDA’s interpretation as inconsistent with the statutory
language, though it did not explicitly invalidate FDA’s regulations.195
The Ensuring Innovation Act. The Ensuring Innovation Act would have generally (1) codified
FDA’s interpretation that eligibility for NCE exclusivity should be based on the drug’s active
moiety and (2) incorporated FDA’s definition of active moiety by reference.196 Specifically, the
proposed legislation would have done so by replacing the entire phrase “active ingredient
(including any ester or salt of the active ingredient)” with “active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor
regulations))” wherever it is found, except for a few provisions that expired in 1984.197 This
change would have affected several FD&C Act provisions, including the NCE exclusivity
provision, three-year exclusivity for other changes, and provisions providing priority review

189 Actavis Elizabeth LLC, 625 F.3d at 765–66.
190 Amarin Pharm. Ireland Ltd. v. FDA, 106 F. Supp. 3d 196, 199 n.1 (D.D.C. 2015).
191 Actavis Elizabeth LLC, 625 F.3d at 765–66.
192 See 21 C.F.R. § 314.3; 59 Fed. Reg. 50,338, 50,357–58, 50,368–69 (Oct. 3 1994).
193 21 C.F.R. § 314.3(b).
194 See generally, Actavis Elizabeth LLC v. FDA, 625 F.3d 760 (D.C. Cir. 2010); Abbott Labs. v. Young, 920 F.2d 984
(D.C. Cir. 1990); Otsuka Pharm. Co. v. Burwell, 302 F. Supp. 3d 375 (D.D.C. 2016); Ferring Pharm., Inc. v. Burwell,
169 F. Supp. 3d 199 (D.D.C. 2016).
195 Amarin Pharm. Ireland Ltd. v. FDA, 106 F. Supp. 3d 196, 217–19 (D.D.C. 2015).
196 Ensuring Innovation Act, S. 1636, 116th Cong. (2019). The same provisions are found in the Protecting Access to
Safe and Effective Medicines Act of 2019 that was introduced in the House of Representatives. H.R. 4955, 116th Cong.
(2019). For simplicity, citations herein are to the Senate version of S. 1636 as passed by the Senate on December 14,
2020.
197 See S. 1636; see also H.R. 4955; Lower Health Care Costs Act, S. 1895, 116th Cong. § 208 (2019). Specifically, the
bills would amend 21 U.S.C. § 355(c)(3)(E)(ii) & (iii); 21 U.S.C. § 355(j)(5)(F)(ii) & (iii); 21 U.S.C. § 355(l)(2)(A)(i);
21 U.S.C. § 355(s); 21 U.S.C. § 355(u)(1); 21 U.S.C. § 360b(c)(2)(F)(i), (ii), and (v); 21 U.S.C. § 360n(a)(4)(C); 21
U.S.C. § 360ff(a)(4)(A)(ii); and 21 U.S.C. § 360bbb-4a(a)(4)(D). Note that it is unclear whether FDA currently uses its
definition of active moiety in 21 C.F.R. § 314.3 when administering all of these provisions.
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vouchers for tropical disease treatments, rare pediatric disease treatments, and countermeasures
for agents that threaten national security. 198 The proposed legislation would have both adopted
FDA’s current approach, by incorporating FDA’s current definition, and allowed FDA to modify
its approach going forward as its understanding changed, by including any successor
regulations.199 In effect, the proposed legislation would have left the decision as to which
molecules should be deemed effectively the same and therefore not innovative enough to merit
NCE exclusivity to FDA’s judgment.
Table 9. Bills in the 116th Congress Relating to the New Chemical Entity Exclusivity
Italics indicate bill passed one house of Congress. Caret (^) indicates bill had at least one original cosponsor
of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
S. 1636
Ensuring Innovation
Sen. Roberts
Would codify FDA’s regulatory definition of active
Act^
Sen. Smith
ingredient for, inter alia, purposes of the new
Sen. Cassidy
chemical entity regulatory exclusivity
H.R. 4955
Protecting Access to
Rep. Engel
Would codify FDA’s regulatory definition of active
Safe and Effective
Rep. Guthrie
ingredient for, inter alia, purposes of the new
Medicines Act of
Rep. Schrader
chemical entity regulatory exclusivity
2019^
Rep. Hudson
Source: CRS; congress.gov.
Bills Relating to the Orphan Drug Exclusivity
Congress passed the Orphan Drug Act in 1983 to encourage the development of “orphan drugs”
(i.e., drugs and biologics to treat rare diseases and conditions).200 Because these drugs often treat
small patient populations and there may be fewer financial incentives for pharmaceutical
manufacturers to develop them, the law provides a seven-year marketing exclusivity for
companies that obtain approval for these drugs.201 During the seven-year period, FDA cannot
approve an NDA or BLA for the same product to treat the same disease or condition, even if the
second applicant generates its own safety and efficacy data.202
To receive the orphan drug exclusivity, (1) the drug must be intended to treat a “rare disease or
condition,”203 and (2) FDA must not have previously approved the same drug “for the same use or
indication.”204 To meet the first condition, a sponsor may request, before submitting an NDA or
BLA, that FDA designate its drug as a drug for a rare disease or condition. To be designated as an
orphan drug, FDA must determine that—when the designation is requested—the disease or

198 S. 1636 § 1.
199 S. 1636 § 1.
200 P.L. 97-414, § 1, 96 Stat. 2049 (1983).
201 21 U.S.C. § 360cc(a).
202 Id. § 360cc. This exclusivity is subject to two exceptions: (1) if the exclusivity holder “cannot ensure the availability
of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was
designated,” and (2) if the NDA or BLA holder consents to the approval of another application for the same drug. Id.
§ 360cc(b).
203 21 U.S.C. §§ 360bb, 360cc.
204 Id. § 360cc; 21 C.F.R. § 316.3(b)(12). However, an NDA or BLA filer may receive exclusivity for an already-
approved drug designated for the same rare disease or condition if it can demonstrate clinical superiority. 21 U.S.C.
§ 360cc(c).
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condition the drug will treat “(A) affects less than 200,000 persons in the United States or
(B) affects more than 200,000 in the United States and for which there is no reasonable
expectation that the cost of developing and making available in the United States a drug for such
disease or condition will be recovered from sales in the United States of such drug.”205 Drugs so
designated are entitled to the seven-year exclusivity if they also meet the second condition (i.e.,
that FDA has not previously approved the same drug for the same use).
Fairness in Orphan Drug Exclusivity Act. The Fairness in Orphan Drug Exclusivity Act would
have amended the orphan drug exclusivity provision, Section 527 of the FD&C Act. In order to
qualify for orphan drug exclusivity under the bill, the sponsor would have had to demonstrate, at
the time of FDA’s approval or licensure of the drug or biologic, that the sponsor had “no
reasonable expectation” of recovering the cost of developing and making the drug or biologic
available in the United States within the first 12 years of marketing the drug.206 This requirement
would have applied equally to drugs or biologics that were approved or licensed before the act
was enacted and after, except that sponsors of drugs or biologics approved or licensed before the
date of enactment would have had 60 days from enactment to make the required showing to
FDA.207 This bill could have had the effect of reducing the availability of orphan drug exclusivity
for certain orphan drug sponsors, because existing law requires such a showing only for products
that are intended to treat diseases that affect more than 200,000 people in the United States.208 The
act would also have placed a new limit (12 years) on the period over which the sponsors must
show they cannot recoup their costs.209
Orphan Drug Clarification. In the FDA Reauthorization Act of 2017, Congress imposed a
clinical superiority standard for manufacturers seeking orphan drug exclusivity for a drug that is
the same as an already-approved drug used to treat the same disease or condition.210 Specifically,
to receive the orphan drug exclusivity after the same drug has been approved to treat the same
rare disease or condition, the sponsor must demonstrate that the drug has “significant therapeutic
advantage over and above an already approved or licensed drug in terms of greater efficacy,
greater safety, or by providing a major contribution to patient care.”211 This provision was
intended to prevent later sponsors from receiving the benefit of orphan drug exclusivity—
excluding further competitors from the market for seven years—for drug products already known
to treat the disease or condition that offered no further clinical benefit.
A provision labeled Orphan Drug Clarification (ODC), which was included in several omnibus
drug pricing bills but not introduced as stand-alone legislation,212 was enacted by the 116th
Congress as part of the Consolidated Appropriations Act, 2021.213 ODC clarifies the temporal
scope of the clinical superiority requirement, providing that it applies to all drugs approved after

205 Id.
206 Fairness in Orphan Drug Exclusivity Act, H.R. 4712, 116th Cong. § 2 (2019) (proposed FD&C Act § 527(f)). A
Senate bill of the same name, S. 3271, 116th Cong. 2019), contains very similar provisions to H.R. 4712. For
simplicity, citations herein are to the House version as passed on November 17, 2020.
207 H.R. 4712 § 2 (proposed FD&C Act § 527(f)).
208 Id.; 21 U.S.C. § 360bb(a)(2).
209 H.R. 4712 § 2 (proposed FD&C Act § 527(f)); 21 U.S.C. § 360bb(a)(2).
210 See P.L. 115-52, § 607, 131 Stat. 1005, 1049–50 (2017) (codified at 21 U.S.C. § 360cc(c)–(e)).
211 See 21 U.S.C. § 360cc(c)(2).
212 See Lower Costs, More Cures Act of 2019, H.R. 19, 116th Cong. § 392 (2019); Lower Health Care Costs Act, S.
1895, 116th Cong. § 210 (2019).
213 See P.L. 116-260, div. BB, tit. III, subtit. C, § 323 (2020).
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the FDA Reauthorization Act of 2017, regardless of when the drug received an orphan drug
designation.
Table 10. Bills in the 116th Congress Relating to the Orphan Drug Exclusivity
Bold indicates bill enacted in law (as part of a different piece of legislation where noted); italics indicate
bill passed one house of Congress. Caret (^) indicates bill had at least one original cosponsor of a different
party than the sponsor. Asterisk (*) indicates furthest legislative progress as part of another bill (see
Table 1 for details).
Bill No.
Bill Title
OCs
Summary
S. 1895 § 210
Orphan Drug
Sen. Alexander Clarifies that the clinical superiority standard

Clarification^*
Sen. Murray
applies to all drugs approved after the FDA
Reauthorization Act of 2017
H.R. 4712
Fairness in Orphan Drug Rep. Dean
Would limit orphan drug exclusivity to drugs with
Exclusivity Act^
Rep. Veasey
no reasonable expectation of recouping
Rep. Carter
development costs with U.S. sales, regardless of
Rep. McKinley
patient population
S. 3271
Fairness in Orphan
Sen. Cassidy
Would limit orphan drug exclusivity to drugs with
Drug Exclusivity Act^
Sen. Baldwin
no reasonable expectation of recouping
Sen. Shaheen
development costs with U.S. sales, regardless of
patient population
Source: CRS; congress.gov.
Government-Directed Price Regulation or IP Limitations
Another category of IP-related drug pricing bills would involve more direct government
involvement in drug pricing. Depending on the particular proposal, these requirements may be
focused on a particular class of drugs (e.g., COVID-19 treatments, or drugs developed with
federal funding) or apply more broadly to any drug or biologic. This section groups these
proposals into three categories: bills that sought to (1) limit IP rights based on pricing; (2) impose
pricing and other conditions for government-supported innovation; or (3) direct the federal
government to manufacture generic drugs and biosimilars.
Limiting IP Rights Based on Drug Pricing
In light of the importance of patents and regulatory exclusivities in the pharmaceutical industry,
limiting IP rights based on drug costs is a potential means of leverage over drug prices. Table 11
lists information on bills that would have authorized compulsory patent licensing or otherwise
restricted IP rights based on pricing behavior.
The FLAT Prices Act. The FLAT Prices Act214 aimed to discourage pharmaceutical product
manufacturers from significantly increasing the prices of their products. To this end, the bill
would have shortened the relevant periods of regulatory exclusivity for a pharmaceutical product
if the manufacturer increases the price by more than certain percentages within specified time
periods.215 Specifically, the regulatory exclusivity period would have been shortened by 180 days

214 Identical bills have been introduced in the House of Representatives, see H.R. 1188, 116th Cong. (2019), and the
Senate, see S. 366, 116th Cong. (2019). For simplicity, all citations herein are to the Senate version as introduced on
February 6, 2019.
215 FLAT Prices Act, S. 366, 116th Cong. § 2 (2019). The relevant regulatory exclusivities that would be subject to
reduction for a drug under the bill include (1) the five-year new chemical entity exclusivity, (2) the three-year clinical
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if the price216 increased by more than 10% over a one-year period, 18% over a two-year period, or
25% over a three-year period.217 For every price increase that is 5% over these thresholds, the
exclusivity period would have been further shortened by an additional 30 days.218
The FLAT Prices Act would have also required manufacturers to report significant price increases
to the Secretary of HHS.219 The bill would have authorized the Secretary to waive or decrease an
exclusivity-period reduction if the Secretary determines that “the price increase is necessary to
enable production of the drug, does not unduly restrict patient access to the drug, and does not
negatively impact public health.”220
The Prescription Drug Price Relief Act. The Prescription Drug Price Relief Act of 2019
(PDPRA) would have created a process by which the Secretary of HHS would review the pricing
of all brand-name drugs and biologics to determine whether their prices are “excessive.”221
The bill would have required NDA and BLA holders to submit an annual report to HHS including
information about the pricing of brand-name drugs, including costs, revenues, R&D expenditures,
and the average price of the drug in the United States and reference countries.222 Using this
information, the Secretary would, on at least an annual basis, determine whether the price of any
brand-name drug or biologic is excessive.223 The bill would have established two different criteria
under which the Secretary would determine that a brand-name drug price is excessive. First, the
Secretary would be required to determine that a drug has an excessive price if the “average [U.S.]
manufacturing price” exceeds “the median price charged for such drug in the 5 reference
countries.”224 Second, the Secretary would determine that a drug has an excessive price if “the
price of the drug is higher than reasonable,” taking into account a number of factors.225
If the Secretary determines that a drug price is excessive, he would have the authority to “waive
or void” any government-granted exclusivities, including FDA regulatory exclusivities, and issue
“open, non-exclusive compulsory” licenses allowing any person to make, use, sell, or import the

trial exclusivity, and (3) the 180-day first generic exclusivity. Id. § 2(e). The relevant regulatory exclusivities for a
biological product include (1) the 12-year market exclusivity for a new biological product and (2) the first
interchangeable biological product exclusivity. Id.
216 Under the bill, the relevant price increase is the increase in the drug or biological product’s wholesale acquisition
cost, id. § 2(b), which is “the manufacturer’s list price for the drug or biological to wholesalers or direct purchasers in
the United States, not including prompt pay or other discounts, rebates or reductions in price . . . as reported in
wholesale price guides or other publications of drug or biological pricing data.” 42 U.S.C. § 1395w-3a(c)(6)(B).
217 S. 366 § 2(a)(1), (b).
218 Id. § 2(a)(2).
219 Id. § 2(c)(1). If a manufacturer fails to timely submit the report, the exclusivity period for the relevant drug or
biological product would be shortened by an additional 30 days for each day that the report is late. Id. § 2(c)(2).
220 Id. § 2(d).
221 See Prescription Drug Price Relief Act of 2019, H.R. 465, 116th Cong. § 2 (2019). An identical bill has been
introduced in Senate, see S. 102, 116th Cong. (2019). For simplicity, all citations herein are to the House version as
introduced on January 25, 2019.
222 H.R. 465 § 6(a). “Brand name drugs” are prescription drugs and biologics approved or licensed by FDA under a
nonabbreviated regulatory pathway (i.e., not generic drugs or biosimilars) and that are “claimed in a patent or the use of
which is claimed in a patent.” Id. § 8(3).
223 Id. § 2(a).
224 Id. § 2(b)(1)(A). If information about the price of the drug is not available for all the reference countries, the
Secretary still must make a determination so long as pricing information is available for at least three of the reference
countries. Id. § 2(b)(1)(C).
225 Id. § 2(b)(2). In addition, members of the public would be able to petition the Secretary to make an excessive price
determination with respect to a particular drug under some circumstances. Id. § 2(c).
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excessively priced drug, despite applicable patents.226 The compulsory patent license, which the
bill calls a “excessive drug price license,” would permit the Secretary to authorize third parties to
make and use the excessively priced drug despite patents that claim a brand-name drug or the use
of a brand-name drug.227 It would also allow third parties to “rely upon regulatory test data for
such drug.”228 However, any entity that accepts this compulsory license would be required to pay
a “reasonable royalty” to the applicable patent holder and any NDA holder whose regulatory
exclusivity was voided under the bill’s provisions.229
The Prescription Drug Affordability and Access Act. Like PDPRA, the Prescription Drug
Affordability and Access Act (PDAAA) would have created a system for the government to
determine whether the prices of prescription drugs in the United States are “appropriate.”230 The
bill would have established a Bureau of Prescription Drug Affordability and Access within HHS
to review the wholesale acquisition cost of approved drugs and biologics.231 Based on information
submitted by pharmaceutical manufacturers and upon consideration of a number of factors, the
Bureau would determine whether the cost of the drug is appropriate.232 If the Bureau found that a
drug price is not appropriate, the manufacturer would be directed to lower the price to an
appropriate level and remit the “excess revenue” to the Bureau, which would establish a process
to distribute that revenue to patients.233 Should a drug manufacturer not reduce prices to an
appropriate level, the Secretary of HHS would have been required to authorize the use of patents
and regulatory exclusivities by other entities, who would be permitted to manufacture the drug
and provide “reasonable compensation” to the original manufacturer.234
Table 11. Bills in the 116th Congress Limiting IP Rights Based on Drug Pricing
Bill No.
Bill Title
OCs
Summary
H.R. 465
Prescription Drug Price
Rep. Khanna
Would authorize compulsory licensing for “excessively
Relief Act of 2019
(and 14 OCs)
priced” drugs
H.R. 1188 FLAT Prices Act
Rep. Golden
Would reduce regulatory-exclusivity lengths if drug
(and 5 OCs)
prices are sharply increased
S. 102
Prescription Drug Price
Sen. Sanders
Would authorize compulsory licensing for “excessively
Relief Act of 2019
(and 5 OCs)
priced” drugs

226 Id. § 3(a)(1)–(2).
227 Id. § 8(7).
228 Id.
229 Id. § 4(a)(1). The royalty rate would either be based on an average rate for pharmaceuticals estimated by the Internal
Revenue Service or set by the Secretary based on a number of factors. Id. § 4(a)(2)(A)–(B). Any party accepting a
compulsory license for an excessively priced drug would still need to apply for FDA approval (or licensure) in order to
market a generic (or biosimilar) version. Accordingly, the bill would require FDA to expedite review of such
applications and “act within 8 months.” Id. § 3(b). During the period between the Secretary’s excessive price
determination and generic or biosimilar product approval, the bill would prohibit the brand-name drug manufacturer
from increasing the price of the drug or biologic. Id. § 3(c).
230 Prescription Drug Affordability and Access Act, S. 3166, 116th Cong. § 3 (2020).
231 Id. §§ 2, 3(a)(1), (d).
232 Id. § 3(a)(2)–(3), (e), (f). For “applicable drugs” with limited generic or biosimilar competition, the bill would
establish an “interim appropriate price” based on the median price in a number of foreign countries. Id. § 3(e)(2),
(h)(7).
233 Id. § 3(f), (h)(2).
234 Id. § 3(g)(1).
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Bill No.
Bill Title
OCs
Summary
S. 366
FLAT Prices Act
Sen. Durbin
Would reduce regulatory-exclusivity lengths if drug
(and 4 OCs)
prices are sharply increased
S. 3166
Prescription Drug
Sen. Booker
Would establish independent government agency to
Affordability and Access Sen. Sanders
review whether drug prices are appropriate and permit
Act
Sen. Harris
compulsory licensing for inappropriately priced drugs
Source: CRS; congress.gov.
Government-Supported Innovation Reforms
Several pharmaceutical IP bills in the 116th Congress focused on drugs and biologics that are
developed with federal support, such as federal funding for biomedical R&D. Table 12 lists
information on these bills.
Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019. The Affordable
Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (APTPDA) would have imposed
“reasonable pricing” conditions on certain patents on drugs, biologics, and health care
technologies.235 Specifically, under APTPDA, federal agencies and nonprofits engaged in
federally funded health care R&D would not be able to license or assign patent rights in drug,
biologic, and health care inventions developed with federal funds, unless the licensee or assignee
commits to a “reasonable pricing agreement” with HHS.236 In particular, the reasonable pricing
agreement must not result in “discriminatory pricing” wherein the federal government is charged
more than certain foreign countries.237
We PAID Act. The We Protect American Investment in Drugs Act (We PAID Act) would have
imposed reasonable pricing conditions on prescription drugs that are developed with federal
funding or that rely on federally owned inventions.238 The bill’s provisions would have reached
applicable drugs covered by a “qualifying patent”—that is, a patent owned by the federal
government or within the scope of the Bayh-Dole Act’s239 disclosure requirements for federally
funded inventions.240 For such drugs, the We PAID Act would have established a
nongovernmental nonprofit corporation, the Drug Affordability and Access Committee, tasked
with determining a reasonable price.241 The Committee would rely on a study by the National
Academy of Medicine, input from the public, and information submitted by drug manufacturers
in setting reasonable prices.242

235 Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019, H.R. 4640, 116th Cong. § 2 (2019).
236 Id. § 2(a).
237 Id. § 2(b). The Secretary of HHS may waive the reasonable pricing agreement upon a determination that the public
interest is served by a waiver if he follows specified procedures. Id, § 2(a), (c).
238 We PAID Act, S. 2387, 116th Cong. § 6 (2019).
239 P.L. 96-517, 94 Stat. 3015 (1980) (codified as amended at 35 U.S.C. chs. 18, 30).
240 S. 2357, § 3(1), (5). As the bill’s definitions reach any patent for which government support was required to be
disclosed under the Bayh-Dole Act, see 35 U.S.C. § 202(c)(6), the We PAID Act’s scope would seemingly align with
the “subject inventions” of the Bayh-Dole Act: those conceived or reduced to practice by a federal contractor during the
course of a funding agreement with the federal government, such as a grant from the National Institutes of Health. See
35 U.S.C. § 201(b), (e). For a general overview of the Bayh-Dole Act, see generally Vanessa Bell, The State Giveth
and the State Taketh Away: Patent Rights Under the Bayh-Dole Act, 24 S. CAL. INTERDISC. L.J. 491, 496–527 (2015).
241 S. 2387 §§ 5(a)–(b).
242 Id. §§ 4, 5(f)(2), 6(a).
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Manufacturers of applicable drugs made with federal funding or patents would have been
required, as a condition of licensing a federally owned patent or taking title to a patent on a
federally funded invention, not to exceed the reasonable price set by the Committee and to limit
annual price increases based on inflation.243 Penalties for exceeding these price limits include the
loss of regulatory exclusivities and prohibitions on future federal patent licenses.244 Finally, the
We PAID Act would have created new penalties for failing to disclose federal support on patent
applications as required by the Bayh-Dole Act.245
MMAPPP Act. The Make Medications Affordable by Preventing Pandemic Price-gouging
(MMAPPP) Act, which focused on pricing for COVID-19 treatments developed with support
from the federal government, is discussed in more detail below in the “COVID-19-Specific Bills”
section.
Table 12. Bills in the 116th Congress Relating to Government-Supported Innovation
Caret (^) indicates bill has at least one original cosponsor of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 4640
Affordable Pricing for
Rep. DeFazio
Would require “reasonable pricing” as
Taxpayer-Funded Prescription
condition in licensing drug patents owned by
Drugs Act of 2019
a federal agency or nonprofit developed with
federal funding
H.R. 7296
MMAPPP Act of 2020^
Rep. Schakowsky
Would require open, nonexclusive licensing,
(and 6 OCs)
and reasonable pricing for federally
supported COVID-19 treatments and
prohibit excessive pricing of COVID-19
countermeasures
S. 2387
We PAID Act^
Sen. Van Hol en
For applicable drugs developed with federal
Sen. Rick Scott
funding or patents, would impose reasonable
pricing requirements and penalties for failing
to disclose government support
S. 4439
MMAPPP Act of 2020
Sen. Smith
Would require open, nonexclusive licensing,
(and 4 OCs)
and reasonable pricing for federally
supported COVID-19 treatments and
prohibit excessive pricing of COVID-19
countermeasures
Source: CRS; congress.gov.
Government Production of Pharmaceuticals
The proposals discussed above have largely addressed the incentives of private companies to
manufacture generics and biosimilars. Another means of creating greater competition in the
pharmaceutical market—and, potentially, lower prices—would be for the government itself to
manufacture and sell drugs and biologics. Table 13 lists information on bills that would have
directed the federal government to produce pharmaceuticals.

243 Id. § 6(a)(1), (3)–(4).
244 Id. § 6(b).
245 Id. § 7; 35 U.S.C. § 202(c)(6).
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The Affordable Drug Manufacturing Act. The Affordable Drug Manufacturing Act of 2019
(ADMA) would have directed the government to manufacture certain pharmaceuticals.246 In
particular, ADMA aimed to facilitate competition in the pharmaceutical market by establishing an
Office of Drug Manufacturing within HHS that would oversee the production of “applicable
drugs.”247
“Applicable drugs” within ADMA’s scope would have included drugs and biologics that FDA has
approved or licensed, and which further satisfy one of two conditions.248 Under the first
condition, the relevant regulatory exclusivities and patents must have expired, and, in addition,
the drug must either (a) not be currently marketed in the United States or (b) be marketed by
fewer than three manufacturers (in addition to other criteria, such as a recent price increase).249
Under the second condition, the United States must have a license to use any relevant patents,
including pursuant to exercises of march-in rights under the Bayh-Dole Act or patent “eminent
domain” authority under 28 U.S.C. § 1498.250 (In this way, ADMA differs from many of the
proposals discussed above in that it, in itself, would not have altered existing pharmaceutical IP
rights, but would have introduced the government as a competitor in markets where the
government does not need or can obtain the necessary IP rights.) Insulin, certain antibiotics, and
naloxone are listed specifically as meeting this applicable drug definition; ADMA would have
directed public manufacturing of these drugs within one year of its enactment.251
ADMA would have directed the Office of Drug Manufacturing, with respect to applicable drugs,
to (1) prepare and submit applications for FDA approval, (2) acquire the relevant manufacturing
rights, (3) manufacture the drugs or contract with other entities to do so, and (4) sell the drugs at a
fair price, taking into account specified factors in setting that price.252 The bill would have set
certain criteria for selecting drugs to produce and required a gradual increase in the number of
drugs manufactured by the Office over time.253 The Office would have been required to report to
the President and Congress annually on specified topics, including a description of the status of
applicable drugs for which manufacturing has been authorized.254
The COVID-19 Emergency Manufacturing Act. The COVID-19 Emergency Manufacturing Act
of 2020 (CEMA), is similar to ADMA but would have focused on COVID-19 medical
countermeasures. CEMA is discussed in more detail below in the “COVID-19-Specific Bills”
section.

246 Affordable Drug Manufacturing Act of 2019, H.R. 5501, 116th Cong. § 2 (2019). A related bill, the Affordable
Drug Manufacturing Act of 2020, was introduced in the Senate. S. 3162, 116th Cong. (2020). For simplicity, all
citations are to the House bill as introduced on December 20, 2019.
247 H.R. 5501 § 2 (proposed new PHSA § 310B(a)).
248 Id. (proposed new PHSA § 310B(g)(1)–(2)).
249 Id. (proposed PHSA § 310B(g)(1)).
250 Id. (proposed PHSA § 310B(g)(2)).
251 Id. (proposed PHSA § 310B(d)–(f)).
252 Id. § 2 (proposed PHSA § 310B(a)(4)(A)). In addition, the Office would also manufacture or contract with other
entities to manufacture active pharmaceutical ingredients (APIs) under specified conditions, including if an API is not
readily available from existing suppliers, and set the API’s prices based on specified factors. Id. (proposed PHSA
§ 310B(a)(4)(A)(vi) and § 310B(a)(4)(D)).
253 Id. (proposed PHSA § 310B(a)(6)–(7)).
254 Id. (proposed PHSA § 310B(a)(5)).
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Table 13. Bills in the 116th Congress Relating to Government Pharmaceutical
Production
Bill No.
Bill Title
OCs
Summary
H.R. 5501
Affordable Drug
Rep. Schakowsky
Would create government office to manufacture
Manufacturing Act of 2019
generic drugs and biosimilars
H.R. 7113
COVID-19 Emergency
Rep. Schakowsky
Would create government office to manufacture
Manufacturing Act of 2020
COVID-19 medical countermeasures
S. 3162
Affordable Drug
Sen. Warren
Would create government office to manufacture
Manufacturing Act of 2020
generic drugs and biosimilars
S. 3847
COVID-19 Emergency
Sen. Warren
Would create government office to manufacture
Manufacturing Act of 2020
COVID-19 medical countermeasures
Source: CRS; congress.gov.
COVID-19-Specific Bills
Several pharmaceutical IP bills in the 116th Congress focused more narrowly on COVID-19
medical countermeasures (such as vaccines and treatments), as opposed all drugs and biologics.
Table 14 lists information on these COVID-19-specific bills.
The Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020. The
Make Medications Affordable by Preventing Price-gouging Act of 2020 (MMAPPP Act) would
have addressed COVID-19-related inventions, particularly those owned by the federal
government or developed with federal support.255 First, the MMAPPP Act would have required
that patent licenses granted by the federal government for federally owned COVID-19-related
inventions be open and non-exclusive.256 Second, for drugs intended for use against COVID-19
that are developed with federal funding or support, the MMAPPP Act would have required a
guarantee of “fair and reasonable” pricing by the federal contractor or licensee,257 and would have
further required such federal contractors to grant open and nonexclusive patent licenses with
respect to COVID-19-related inventions developed with federal support.258 Third, for any drug
intended for use against COVID-19 (whether or not federally supported), the MMAPPP Act
would have imposed reporting requirements related to the price of the drug, development
expenditures, and federal benefits received.259 Finally, during the duration of a public health
emergency (not limited to COVID-19), the MMAPPP Act would have authorized compulsory
licensing for excessively priced drugs and biologics used against the disease that is the subject of
the emergency.260
The Facilitating Innovation to Fight Coronavirus Act. The Facilitating Innovation to Fight
Coronavirus Act (FIFCA) would have, among other things, changed the term of certain patents

255 MMAPPP Act of 2020, H.R. 7296, 116th Cong. (2020). A similar bill has been introduced in the Senate. See
MMAPPP Act of 2020, S. 4439, 116th Cong. (2020). For simplicity, all citations are to the House bill as introduced on
June 22, 2020.
256 H.R. 7296 § 2(a), (d)(1), (d)(5).
257 Id. §§ 2(d)(2), 3(a).
258 Id. § 2(b).
259 Id. § 4.
260 Id. § 5. The MMAPPP Act’s compulsory licensing provisions bears some similarity to those of the PDPRA. See
discussion supra in “Limiting IP Rights Based on Drug Pricing.”
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used in the treatment of COVID-19.261 Under the bill, the term for patents issued that claim a new
or existing pharmaceutical, medical device, or other inventions used or intended for use to treat
COVID-19 would not have begun until the national emergency declared by the President with
respect to COVID-19 terminates.262 However, an additional 10 years would have been added to
the term of these COVID-19-treatment patents.263 The overall effect of FIFCA would have been
to delay the start of the effective term for certain patents on COVID-19 treatments—potentially
allowing more companies to produce treatments needed during the COVID-19 national
emergency—but to compensate those patentees by extending the term of these patents by 10
years.
The COVID-19 Emergency Manufacturing Act. The COVID-19 Emergency Manufacturing Act
of 2020 (CEMA) would have created a government office within HHS to manufacture COVID-
19 medical countermeasures—including treatments, vaccines, diagnostic tests, and PPE—and
provided those products at no cost to state and local public health authorities and domestic health
care providers.264 Among other things, CEMA would have authorized the government to
manufacture “applicable COVID-19 products,” with the aim of ensuring an adequate supply of,
and increased access to, COVID-19 medical countermeasures.265
Specifically, CEMA would have created the Emergency Office of Manufacturing for Public
Health (the Emergency Office) within HHS, which would obtain the rights to manufacture
applicable COVID-19 products and manufacture applicable COVID-19 products.266 Such
products would have included not only COVID-19 vaccines and treatments, but also personal
protective equipment (PPE), diagnostic tests, and other drugs, biologics, and medical devices
used to diagnose, prevent, mitigate, treat, or cure COVID-19.267 CEMA would have identified
PPE, materials for COVID-19 diagnostic tests, and certain COVID-19 treatments for immediate
public manufacturing by the Emergency Office.268 The Emergency Office would provide
applicable COVID-19 products at no cost to state, local, and tribal health programs, and other
domestic health care providers, and at cost to other commercial and international entities.269
CEMA would have granted the Secretary of HHS authority to issue compulsory licenses to

261 Facilitating Innovation to Fight Coronavirus Act, S. 3630, 116th Cong. § 3 (2020). The bill would also immunize
health care providers from legal liability for certain actions, such as using or modifying a medical device for an
unapproved use, during the duration of the COVID-19 national emergency declared by the President. Id. § 2.
262 Id. § 3(a), (c).
263 Id. § 3(b).
264 COVID-19 Emergency Manufacturing Act of 2020, S. 3847, 116th Cong. (2020). A similar bill was introduced in
the House, see COVID-19 Emergency Manufacturing Act of 2020, H.R. 7113, 116th Cong. (2020). For simplicity, all
citations are to the Senate version as introduced on June 1, 2020.
265 See S. 3847 § 2 (proposed PHSA § 310B(a)(2), (f)(2)). CEMA also contains provisions for the government to
manufacture and sell, at a fair price, applicable drugs that are included on FDA’s drug shortage list or are vulnerable to
shortage, with the aim of addressing shortages in the strategic national stockpile. Id. § 2 (proposed PHSA
§ 310B(a)(2)(B), (c)(2)).
266 Id. § 2 (proposed PHSA § 310B(a)(4)).
267 Id. § 2 (proposed new PHSA § 310B(b)(1), (b)(3), (f)(2)). CEMA’s definition of “applicable COVID-19 product”
largely traces the definition of “qualified pandemic or epidemic product” under the Public Readiness and Emergency
Preparedness (PREP) Act, plus a specific inclusion for PPE. Compare id. § 2 (proposed PHSA § 310B(f)(2)(A) with 42
U.S.C. § 247d-6d(i)(7); see generally CRS Legal Sidebar LSB10443, The PREP Act and COVID-19: Limiting Liability
for Medical Countermeasures, by Kevin J. Hickey.
268 S. 3847 § 2 (proposed PHSA § 310B(b)(3)).
269 Id. § 2 (proposed PHSA § 310B(a)(4)(A)(vi)–(vii), (c)(1)).
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authorize the use of patented inventions and other IP rights to manufacture and sell applicable
COVID-19 products, provided that “reasonable remuneration” is paid to the rights holders.270
Table 14. COVID-19-Specific Pharmaceutical IP Bills in the 116th Congress
Caret (^) indicates bill has at least one original cosponsor of a different party than the sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 7113
COVID-19 Emergency
Rep. Schakowsky Would create government office to manufacture
Manufacturing Act of 2020
COVID-19 medical countermeasures
H.R. 7296
MMAPPP Act of 2020^
Rep. Schakowsky Would require open, nonexclusive licensing, and
(and 6 OCs)
reasonable pricing for federally supported
COVID-19 treatments and prohibit excessive
pricing of COVID-19 countermeasures
S. 3630
Facilitating Innovation to
Sen. Sasse
Inter alia, would delay the start of, but
Fight Coronavirus Act
subsequently extend, patent terms for COVID-19
treatments
S. 3847
COVID-19 Emergency
Sen. Warren
Would create government office to manufacture
Manufacturing Act of 2020
COVID-19 medical countermeasures
S. 4439
MMAPPP Act of 2020
Sen. Smith
Would require open, nonexclusive licensing, and
(and 4 OCs)
reasonable pricing for federally supported
COVID-19 treatments and prohibit excessive
pricing of COVID-19 countermeasures
Source: CRS; congress.gov.
Omnibus Drug Pricing Bills with Pharmaceutical IP Provisions
A number of bills introduced in the 116th Congress combined pharmaceutical IP proposals with
other provisions. Many of these bills also contained provisions focused on health care costs but
not related to IP, such as Medicare or Medicaid reforms, limits on surprise medical billing, or
transparency provisions. Table 15 lists information on these bills, noting the provisions that
related to drug patents and regulatory exclusivities. The provisions in these omnibus bills may or
may not be identical to the stand-alone bills summarized in the preceding sections, but the
provisions are typically similar (as noted in the table).
Table 15. Omnibus Drug Pricing Bills with Pharmaceutical IP Provisions in the 116th
Congress
Italics indicate bill passed one house of Congress; underline indicates bill reported or ordered to be reported
out of committee. Caret (^) indicates bill had at least one original cosponsor of a different party than the
sponsor.
Bill No.
Bill Title
OCs
Summary
H.R. 987
Strengthening Health Care
Rep. Blunt
Inter alia, contains provisions similar to
and Lowering Prescription
Rochester
(1) BLOCKING Act; and (2) Protecting Consumer
Drug Costs Act
Rep. Castor
Access to Generic Drugs.
Rep. McBath
Rep. Kildee

270 Id. § 2 (proposed PHSA § 310B(a)(4)(C)).
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Bill No.
Bill Title
OCs
Summary
S. 1895
Lower Health Care Costs
Sen. Alexander
Inter alia, contains provisions similar to
Act^
Sen. Murray
(1) Biologic Patent Transparency Act; (2) Orange
Book Patent Transparency Act; (3) Protecting
Access to Biosimilars Act of 2019; (4) BLOCKING
Act; (5) Ensuring Innovation Act; and (6) Orphan
Drug Clarification.
H.R. 19
Lower Costs, More Cures
Rep. Walden
Inter alia, contains provisions similar to
Act of 2019
(and 111 OCs)
(1) Protecting Consumer Access to Generic Drugs
Act; (2) Orange Book Transparency Act;
(3) Purple Book Continuity Act; (4) Protecting
Access to Biosimilars Act of 2019; (5) BLOCKING
Act; (6) Ensuring Innovation Act; and (7) Orphan
Drug Clarification.
H.R. 1332 Fair Care Act of 2019
Rep. Westerman
Inter alia, contains provisions similar to the
PRICED Act and would reduce terms for serial
orphan-drug regulatory exclusivities.
H.R. 2700 Lowering Prescription
Rep. Burgess
Inter alia, contains provisions similar to
Drug Costs and Extending
(and 29 OCs)
(1) BLOCKING Act; and (2) Protecting Consumer
Community Health
Access to Generic Drugs Act.
Centers and Other Public
Health Priorities Act
H.R. 3947 Competition Prescription
Rep. Meadows
Inter alia, includes provisions similar to the
Act of 20189
Biologic Patent Transparency Act.
H.R. 8527 Fair Care Act of 2020
Rep. Westerman
Inter alia, includes provisions similar to (1) Biologic
Rep. Burchett
Patent Transparency Act; (2) Orange Book
Rep. Smucker
Transparency Act; (3) PRICED Act; (4) Protecting
Rep. Riggleman
Access to Biosimilars Act of 2019; and (5) Ensuring
Innovation Act.
S. 1801
Affordable Medications
Sen. Smith
Inter alia, contains provisions similar to
Act
(and 14 OCs)
(1) Preserve Access to Affordable Generics and
Biosimilars Act; and (2) FAIR Generics Act. Also
limits certain regulatory exclusivities, including
reducing the new biologic exclusivity from 12 to 7
years.
S. 3384
Lowering Prescription
Sen. McSal y
Inter alia, contains provisions similar to the
Drug Prices for America's
Preserve Access to Affordable Generics and
Seniors and Families Act
Biosimilars Act.
of 2020
S. 4796
Fair Care Act of 2020
Sen. Braun
Inter alia, includes provisions similar to (1) Biologic
Patent Transparency Act; (2) Orange Book
Transparency Act; (3) PRICED Act; (4) Protecting
Access to Biosimilars Act of 2019; and (5) Ensuring
Innovation Act.
Source: CRS; congress.gov.

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Appendix A. Drug Pricing and IP Legislation in the
116th Congress
Table A-1 surveys the legislative activity of the 116th Congress relating to drug pricing and
pharmaceutical IP, listing all the bills and laws discussed in this report by bill number, including
information on legislative status and category.
Table A-1. Drug Pricing and IP Legislation in the 116th Congress
Bold indicates bill enacted in law (as part of a different piece of legislation where noted); italics indicate
bill passed one house of Congress; underline indicates bill reported or ordered to be reported out of
committee. Caret (^) indicates bill had at least one original cosponsor of a different party than the
sponsor. Asterisk (*) indicates furthest legislative progress as part of another bill (see Table 1 for details).
Bill No.
Bill Title
OCs
Category
H.R. 19
Lower Costs, More Cures Act of
Rep. Walden
Omnibus Drug Pricing Bil s
2019
(and 111 OCs)
H.R. 465
Prescription Drug Price Relief
Rep. Khanna
Limiting IP Rights Based on Drug Pricing
Act of 2019
(and 14 OCs)
H.R. 938
BLOCKING Act^*
Rep. Schrader
Regulatory Exclusivity Reforms (180-day
Rep. Buddy Carter
First-Generic Exclusivity)
H.R. 987
Strengthening Health Care and
Rep. Blunt
Omnibus Drug Pricing Bil s
Lowering Prescription Drug Costs
Rochester
Act
Rep. Castor
Rep. McBath
Rep. Kildee
H.R. 990
Hatch-Waxman Integrity Act
Rep. Flores
Pharmaceutical Patenting Reforms
(Administrative Patent Challenges)
H.R. 1188
FLAT Prices Act
Rep. Golden
Limiting IP Rights Based on Drug Pricing
(and 5 OCs)
H.R. 1332
Fair Care Act of 2019
Rep. Westerman
Omnibus Drug Pricing Bil s
H.R. 1344
Competitive DRUGS Act of 2019 Rep. Doggett
Pharmaceutical Patenting Reforms
(and 21 OCs)
(“Pay-for-Delay” Settlements)
H.R. 1499
Protecting Consumer Access to
Rep. Rush
Pharmaceutical Patenting Reforms
Generic Drugs Act of 2019*
(“Pay-for-Delay” Settlements)
H.R. 1503
Orange Book Transparency
Rep. Robin Kelly
Pharmaceutical Patenting Reforms
Act
(Patent Transparency)
H.R. 1506
FAIR Generics Act
Rep. Barragán
Regulatory Exclusivity Reforms (180-day
First-Generic Exclusivity)
H.R. 1520
Purple Book Continuity Act*
Rep. Eshoo
Pharmaceutical Patenting Reforms
(Patent Transparency)
H.R. 2011
Protecting Access to
Rep. DeGette
Regulatory Exclusivity Reforms (New
Biosimilars Act of 2019^*
Rep. Reed
Biologic Exclusivity)
Rep. Schrier
Rep. Guthrie
H.R. 2375
Preserve Access to Affordable
Rep. Nadler
Pharmaceutical Patenting Reforms
Generics and Biosimilars Act^
Rep. Col ins
(“Pay-for-Delay” Settlements)
Rep. Cicil ine
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Bill No.
Bill Title
OCs
Category
H.R. 2700
Lowering Prescription Drug
Rep. Burgess
Omnibus Drug Pricing Bil s
Costs and Extending Community
(and 29 OCs)
Health Centers and Other Public
Health Priorities Act
H.R. 3199
TERM Act of 2019^
Rep. Jeffries
Pharmaceutical Patenting Reforms
(and 4 OCs)
(Patent “Evergreening”)
H.R. 3379
PRICED Act^
Rep. Schakowsky
Regulatory Exclusivity Reforms (New
(and 16 OCs)
Biologic Exclusivity)
H.R. 3812
REMEDY Act^
Rep. McKinley
Pharmaceutical Patenting Reforms
Rep. Welch
(Patent “Evergreening”)
H.R. 3947
Competition Prescription Act of
Rep. Meadows
Omnibus Drug Pricing Bil s
20189
H.R. 3991
Affordable Prescriptions for
Rep. Hank Johnson
Pharmaceutical Patenting Reforms
Patients Through Improvements
Rep. Roby
(Patent “Thickets”)
to Patent Litigation Act of 2019^
H.R. 4010
Emergency Access to Insulin Act
Rep. Craig
Regulatory Exclusivity Reforms (New
of 2019
Rep. Phil ips
Biologic Exclusivity)
H.R. 4398
Affordable Prescriptions for
Rep. Cicil ine
Pharmaceutical Patenting Reforms
Patients Through Promoting
(“Product Hopping”)
Competition Act of 2019
H.R. 4640
Affordable Pricing for Taxpayer-
Rep. DeFazio
Government-Supported Innovation
Funded Prescription Drugs Act of
Reforms
2019
H.R. 4712
Fairness in Orphan Drug Exclusivity
Rep. Dean
Regulatory Exclusivity Reforms (Orphan
Act^
Rep. Veasey
Drug Exclusivity)
Rep. Buddy Carter
Rep. McKinley
H.R. 4850
Biologic Patent Transparency
Rep. Spanberger
Pharmaceutical Patenting Reforms
Act^
Rep. Reed
(Patent Transparency)
Rep. Anthony
Gonzalez
H.R. 4955
Protecting Access to Safe and
Rep. Engel
Regulatory Exclusivity Reforms (New
Effective Medicines Act of 2019^
Rep. Guthrie
Chemical Entity Exclusivity)
Rep. Schrader
Rep. Hudson
H.R. 5133
Affordable Prescriptions for
Rep. Cicil ine
Pharmaceutical Patenting Reforms
Patients Through Promoting
Rep. Col ins
(“Product Hopping”)
Competition Act of 2019^
Rep. Nadler
Rep. Sensenbrenner
H.R. 5501
Affordable Drug Manufacturing
Rep. Schakowsky
Government Production of Generics
Act of 2019
and Biosimilars
H.R. 7113
COVID-19 Emergency
Rep. Schakowsky
Government Production of Generics
Manufacturing Act of 2020
and Biosimilars; COVID-19-Specific Bil s
H.R. 7296
MMAPPP Act of 2020^
Rep. Schakowsky
Government-Supported Innovation
(and 6 OCs)
Reforms; COVID-19-Specific Bil s
H.R. 8527
Fair Care Act of 2020
Rep. Westerman
Omnibus Drug Pricing Bil s
Rep. Burchett
Rep. Smucker
Rep. Riggleman
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Bill No.
Bill Title
OCs
Category
S. 64
Preserve Access to Affordable
Sen. Klobuchar
Pharmaceutical Patenting Reforms
Generics and Biosimilars Act^
Sen. Grassley
(“Pay-for-Delay” Settlements)
S. 102
Prescription Drug Price Relief
Sen. Sanders
Limiting IP Rights Based on Drug Pricing
Act of 2019
(and 5 OCs)
S. 344
Hatch-Waxman Integrity Act of
Sen. Til is
Pharmaceutical Patenting Reforms
2019
(Administrative Patent Challenges)
S. 366
FLAT Prices Act
Sen. Durbin
Limiting IP Rights Based on Drug Pricing
(and 4 OCs)
S. 659
Biologic Patent Transparency
Sen. Col ins
Pharmaceutical Patenting Reforms
Act^
(and 5 OCs)
(Patent Transparency)
S. 1140
Protecting Access to
Sen. Smith
Regulatory Exclusivity Reforms (New
Biosimilars Act of 2019^*
Sen. Cassidy
Biologic Exclusivity)
S. 1209
REMEDY Act^
Sen. Cassidy
Pharmaceutical Patenting Reforms
Sen. Durbin
(Patent “Evergreening”)
S. 1416
Affordable Prescriptions for
Sen. Cornyn
Pharmaceutical Patenting Reforms
Patients Act of 2019^
Sen. Blumenthal
(“Patent Thickets” and “Product
Hopping”)
S. 1617
Second Look at Drug Patents Act Sen. Murray
Pharmaceutical Patenting Reforms
of 2019^
Sen. Cornyn
(Administrative Patent Challenges)
S. 1636
Ensuring Innovation Act^
Sen. Roberts
Regulatory Exclusivity Reforms (New
Sen. Smith
Chemical Entity Exclusivity)
Sen. Cassidy
S. 1801
Affordable Medications Act
Sen. Smith
Omnibus Drug Pricing Bil s
(and 14 OCs)
S. 1895
Lower Health Care Costs Act^
Sen. Alexander
Omnibus Drug Pricing Bil s
Sen. Murray
S. 2004
Emergency Access to Insulin Act
Sen. Smith
Regulatory Exclusivity Reforms (New
of 2019^
Sen. Cramer
Biologic Exclusivity)
S. 2387
We PAID Act^
Sen. Van Hol en
Government-Supported Innovation
Sen. Rick Scott
Reform
S. 3092
Expanding Access to Low Cost
Sen. Smith
Regulatory Exclusivity Reforms (180-day
Generics Act of 2019^
Sen. Braun
First-Generic Exclusivity)
S. 3162
Affordable Drug Manufacturing
Sen. Warren
Government Production of Generic and
Act of 2020
Biosimilars
S. 3166
Prescription Drug Affordability
Sen. Booker
Limiting IP Rights Based on Drug Pricing
and Access Act
Sen. Sanders
Sen. Harris
S. 3271
Fairness in Orphan Drug
Sen. Cassidy
Regulatory Exclusivity Reforms (Orphan
Exclusivity Act^
Sen. Baldwin
Drug Exclusivity)
Sen. Shaheen
S. 3384
Lowering Prescription Drug
Sen. McSal y
Omnibus Drug Pricing Bil s
Prices for America's Seniors and
Families Act of 2020
S. 3630
Facilitating Innovation to Fight
Sen. Sasse
COVID-19-Specific Bil s
Coronavirus Act
S. 3847
COVID-19 Emergency
Sen. Warren
Government Production of Generic and
Manufacturing Act of 2020
Biosimilars; COVID-19-Specific Bil s
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Bill No.
Bill Title
OCs
Category
S. 4253
Second Look at Drug Patents Act Sen. Murray
Pharmaceutical Patenting Reforms
of 2020^
Sen. Cornyn
(Administrative Patent Challenges)
S. 4439
MMAPPP Act of 2020
Sen. Smith
Government-Supported Innovation
(and 4 OCs)
Reforms; COVID-19-Specific Bil s
S. 4796
Fair Care Act of 2020
Sen. Braun
Omnibus Drug Pricing Bil s
Source: CRS; congress.gov.

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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

Appendix B. Glossary of Acronyms
General Acronyms
ANDA
Abbreviated new drug application
BLA
Biologics license application
BPCIA
Biologics Price Competition and Innovation Act of 2009
FDA
U.S. Food and Drug Administration
FD&C Act
Federal Food, Drug, and Cosmetic Act
FTC
Federal Trade Commission
FTCA
Federal Trade Commission Act of 1974
HHS
U.S. Department of Health and Human Services
IP
Intellectual property
IPR
Inter partes review
NCE
New chemical entity
NDA
New drug application
PPE
Personal protective equipment
PGR
Post-grant review
PHSA
Public Health Service Act
PTO
U.S. Patent and Trademark Office
OCs
Original cosponsors
RLD
Reference listed drug
R&D
Research and development
Acronyms for Legislation in the 116th Congress
ADMA
Affordable Drug Manufacturing Act of 2019
APPA
Affordable Prescriptions for Patients Act of 2019
APTPDA
Affordable Pricing for Taxpayer-Funded Prescription Drugs Act
BLOCKING Act
Bringing Low-cost Options and Competition while Keeping Incentives for
New Generics Act of 2019
CEMA
COVID-19 Emergency Manufacturing Act of 2020
FIFCA
Facilitating Innovation to Fight Coronavirus Act
HWIA
Hatch-Waxman Integrity Act of 2019
MMAPPP Act
Make Medications Affordable by Preventing Price-gouging Act of 2020
OBTA
Orange Book Transparency Act of 2020
ODC
Orphan Drug Clarification
PAAGBA
Preserve Access to Affordable Generics and Biosimilars Act
PABA
Protecting Access to Biosimilars Act of 2019
PBCA
Purple Book Continuity Act of 2020
PBTA
Biologic Patent Transparency Act
PDAAA
Prescription Drug Affordability and Access Act
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Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress

PDPRA
Prescription Drug Price Relief Act of 2019
PRICED Act
Price Relief, Innovation, and Competition for Essential Drugs Act
REMEDY Act
Reforming Evergreening and Manipulation that Extends Drug Years
SLDPA
Second Look at Drugs Patents Act of 2019
TERM Act
Terminating the Extension of Rights Misappropriated Act
We PAID Act
We Protect American Investment in Drugs Act

Author Information

Kevin J. Hickey
Erin H. Ward
Legislative Attorney
Legislative Attorney

Kevin T. Richards

Legislative Attorney

Disclaimer
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