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Patent Infringement and Experimental Use
Under the Hatch-Waxman Act: Current Issues
John R. Thomas
Visiting Scholar
February 9, 2012
Congressional Research Service
7-5700
www.crs.gov
R42354
CRS Report for Congress
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epared for Members and Committees of Congress
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Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
Summary
Concerns over the availability of affordable health care has focused national attention upon
patents and other intellectual property rights awarded to pharmaceutical firms. Bills before the
112th Congress propose amendments to the Hatch-Waxman Act, legislation dating from 1984 that
governs intellectual property rights in pharmaceuticals and other regulated products. Recent
rulings from the federal judiciary regarding the Hatch-Waxman Act may be pertinent to
congressional consideration of that statute. Both the judicial holdings, as well as possible
legislative changes to the Hatch-Waxman Act, potentially affect the availability of both brand-
name and generic drugs in the United States.
The Hatch-Waxman Act includes two core provisions that impact the enforcement of patent rights
by brand-name firms against generic pharmaceutical companies. 35 U.S.C. §271(e)(1) creates a
statutory “safe harbor” that exempts firms from claims of patent infringement based on clinical
trials and other acts reasonably related to seeking marketing approval from the Food and Drug
Administration (FDA). Although the explicit wording of that statute does not preclude activities
that occur after the receipt of FDA marketing approval from the “safe harbor,” the courts have
recently held that this infringement exemption applies only to pre-approval activities.
A second provision, 35 U.S.C. §271(e)(2), allows a brand-name drug company to enforce its
patents against a potential generic competitor at such time that the generic firm files an
application—a so-called Abbreviated New Drug Application (ANDA)—with the FDA seeking
marketing approval. Although courts have stated that this litigation may only be based upon
patents identified to the FDA and listed in the so-called “Orange Book,” the express wording of
the statute does not appear to impose this requirement. This issue has yet to be conclusively
resolved in the courts.
Should Congress conclude that the current situation with respect to 35 U.S.C. §271(e) is
satisfactory, no action need be taken. If Congress wishes to intervene, however, then some
options present themselves. Congress could stipulate whether 35 U.S.C. §271(e)(1) applies to acts
that occur following the award of FDA marketing approval or not. Congress could also explicitly
state whether 35 U.S.C. §271(e)(2) establishes a cause of action for infringement of patents that
have not been listed in the Orange Book.
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Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
Contents
Background...................................................................................................................................... 1
Introduction to the Hatch-Waxman Act ........................................................................................... 2
Patent Infringement Dispute Resolution.......................................................................................... 3
The Safe Harbor Provision .............................................................................................................. 4
The Patent Infringement Provision .................................................................................................. 6
Congressional Issues and Options ................................................................................................... 9
Contacts
Author Contact Information............................................................................................................. 9
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Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
Background
The high cost and availability of health care in the United States have motivated the introduction
of bills in the 112th Congress proposing amendments to the Hatch-Waxman Act.1 More formally
known as the Drug Price Competition and Patent Term Restoration Act of 1984,2 the Hatch-
Waxman Act governs intellectual property rights with respect to pharmaceuticals and other
regulated products. This legislation is widely regarding as having a strong impact upon the
availability of both brand-name and generic pharmaceuticals in the United States.3
The Hatch-Waxman Act includes two core provisions addressing the enforcement of
pharmaceutical patents. The first of those, 35 U.S.C. §271(e)(1), creates a statutory “safe harbor”
that exempts firms from claims of patent infringement based on clinical trials and other acts
reasonably related to seeking marketing approval from the Food and Drug Administration
(FDA).4 A second provision, 35 U.S.C. §271(e)(2), allows a brand-name drug company to enforce
its patents against a potential generic competitor at such time that the generic firm files an
application—a so-called Abbreviated New Drug Application (ANDA)—with the FDA seeking
marketing approval. In support of the brand-name firm’s intellectual property rights, the FDA
publishes information pertaining to patents that the brand-name firm identifies to the agency.5 If
the generic firm does not agree to wait until these patents expire before marketing its product,
then the brand-name firm may commence patent infringement litigation immediately.6
Recent judicial developments have involved both provisions. A judgment of the U.S. Court of
Appeals for the Federal Circuit held that the statutory safe harbor was limited to activities
performed prior to the award of FDA approval.7 Because 35 U.S.C. §271(e)(1) does not expressly
restrict its scope to premarketing approval efforts,8 this holding has been the subject of
considerable discussion. As well, brand-name firms have attempted to assert patents against
generic firms that they have not explicitly identified to the FDA. Although the Supreme Court has
suggested that such identification is a predicate for litigation,9 35 U.S.C. §271(e)(2) does not
expressly state as much.10 The courts have yet to rule definitively on this point.
1 See H.R. 741 (untitled); S. 27 (“Preserve Access to Affordable Generics Act”); S. 373 (“Fair Prescription Drug
Competition Act”); S. 1882 (“FAIR Generics Act”).
2 P.L. 84-417, 98 Stat. 1585 (1984).
3 See, e.g., Michael R. Herman, “The Stay Dilemma: Examining Brand and Generic Incentives for Delaying the
Resolution of Pharmaceutical Patent Litigation,” 111 Columbia Law Review (2011), 1788.
4 See Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).
5 U.S. Department of Health and Human Services, Food and Drug Administration, Electronic Orange Book, Center for
Drug Evaluation and Research, “Approved Drug Products with Therapeutic Evaluations” (available at
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm).
6 21 U.S.C. §355(j)(5)(B)(iii).
7 Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011).
8 35 U.S.C. §271(e)(1) provides in pertinent part:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States ... a
patented invention ... solely for uses reasonably related to the development and submission of
information under a Federal law which regulates the manufacture, use, or sale of drugs or
veterinary biological products.
9 Eli Lilly v. Medtronic, 496 U.S. 661, 678 (1990) (“That is what is achieved by §271(e)(2)-the creation of a highly
artificial act of infringement that consists of submitting an ANDA ... containing the fourth type of certification that is in
error as to whether commercial manufacture, use, or sale of the new drug (none of which, of course, has actually
(continued...)
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Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
This report will discuss current issues with respect to the patent infringement provisions of the
Hatch-Waxman Act. The report begins by laying out the basics of the Hatch-Waxman patent
dispute resolution system. It then describes the recent holding of the Court of Appeals for the
Federal Circuit in Classen Immunotherapies LLC v. Biogen Idec11 that limits the statutory safe
harbor to activities performed prior to FDA approval. Next, the report considers judicial
developments regarding the patent infringement provision of the Hatch-Waxman Act. This report
closes with a review of pertinent legislative issues.
Introduction to the Hatch-Waxman Act
The Hatch-Waxman Act brings together two previously distinct legal regimes, the patent law and
the food and drug law. Under the latter regime, the sponsor of a new drug must demonstrate that
the product is safe and effective in order to obtain FDA approval. This showing typically requires
the drug’s sponsor to conduct both preclinical and clinical investigations.12 In deciding whether to
issue marketing approval or not, the FDA evaluates the test data that the sponsor submits in a so-
called New Drug Application (NDA).
Prior to the enactment of the Hatch-Waxman Act, the federal food and drug law contained no
separate provisions addressing marketing approval for generic versions of drugs that had
previously been approved by the FDA.13 The result was that a would-be generic drug
manufacturer had to file its own NDA in order to sell its product.14 Some generic manufacturers
could rely on published scientific literature demonstrating the safety and efficacy of the drug by
submitting a so-called paper NDA. Because these sorts of studies were not available for all drugs,
however, not all generic firms could file a so-called paper NDA.15 Further, at times the FDA
requested additional studies to address safety and efficacy questions that arose from experience
with the drug following its initial approval.16 Consequently, some generic manufacturers were
forced to prove once more that a particular drug was safe and effective, even though their
products were chemically identical to those of previously approved pharmaceuticals.
(...continued)
occurred) violates the relevant patent.”).
10 35 U.S.C. §271(e)(2) provides in pertinent part:
It shall be an act of infringement to submit ... an application ... for a drug ... if the purpose of such
submission is to obtain approval under such Act to engage in the commercial manufacture, use, or
sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in
a patent before the expiration of such patent.
11 659 F.3d 1057 (Fed. Cir. 2011).
12 See G. Lee Skillington & Eric M. Solovy, “The Protection of Test and Other Data Required by Article 39.3 of the
TRIPS Agreement,” 24 Northwestern Journal of International Law and Business (2003), 1.
13 See Alfred B. Engelberg, “Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?,”
39 IDEA: Journal of Law and Technology (1999), 389.
14 See James J. Wheaton, “Generic Competition and Pharmaceutical Innovation: The Drug Price Competition and
Patent Term Restoration Act of 1984,” 34 Catholic University Law Review (1986), 433.
15 See Kristin E. Behrendt, “The Hatch-Waxman Act: Balancing Competing Interest or Survival of the Fittest?,” 57
Food & Drug Law Journal (2002), 247.
16 Id.
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Some commentators believed that the approval of a generic drug was a needlessly costly,
duplicative, and time-consuming process.17 These observers noted that although patents on
important drugs had expired, manufacturers were not moving to introduce generic equivalents for
these products due to the level of resource expenditure required to obtain FDA marketing
approval.18
In response to these concerns, Congress enacted the Hatch-Waxman Act, a statute that has been
described as a “complex and multifaceted compromise between innovative and generic
pharmaceutical companies.”19 Its provisions include a new statutory pathway, the Abbreviated
New Drug Application or ANDA, which expedites the marketing approval process for generic
drugs. An ANDA allows a generic applicant to obtain marketing approval by demonstrating that
the proposed product is bioequivalent to an approved pioneer drug. Unlike brand-name firms,
generic drug companies are not required to undertake costly and time-consuming clinical trials in
order to demonstrate the safety and effectiveness of their products.
Patent Infringement Dispute Resolution
When drafting the Hatch-Waxman Act, Congress recognized that brand-name pharmaceutical
firms may be the proprietors of one or more patents directed towards their products. These patents
might be infringed by a product described by a generic firm’s ANDA in the event that product is
approved by the FDA and sold in the marketplace. The Hatch-Waxman Act therefore established
special procedures for resolving patent disputes in connection with applications for marketing
generic drugs. Reflecting its compromise nature, the legislation both provides an exemption for
patent infringement (for FDA regulatory compliance activities) and creates a new infringing act
(the filing of certain ANDAs by generic firms).
First, the Hatch-Waxman Act established a statutory research exemption to patent infringement.
35 U.S.C. §271(e)(1) applies “solely to uses reasonably related to the development and
submission of information under a Federal law which regulates the manufacture, use, or sale of
drugs or veterinary biological products.” The Supreme Court has observed that although “the
contours of this provision are not exact in every respect, the statutory text makes clear that it
provides a wide berth for the use of patented drugs in activities related to the federal regulatory
process.”20 This statutory “safe harbor” most commonly operates in favor of generic firms who
wish to perform activities, including bioequivalence studies, prior to filing their ANDAs.
The Hatch-Waxman also establishes a new cause of action for infringement. 35 U.S.C. §271(e)(2)
states that each NDA applicant “shall file” a list of patents that the applicant believes would be
17 See, e.g., Justina A. Molzon, “The Generic Drug Approval Process,” 5 Journal of Pharmacy & Law (1996), 275
(“The Act streamlined the approval process by eliminating the need for [generic drug] sponsors to repeat duplicative,
unnecessary, expensive and ethically questionable clinical and animal research to demonstrate the safety and efficacy
of the drug product.”).
18 See Jonathan M. Lave, “Responding to Patent Litigation Settlements: Does the FTC Have It Right Yet?,” 64
University of Pittsburgh Law Review (2002), 201 (“Hatch-Waxman has also increased the generic drug share of
prescription drug volume by almost 130% since its enactment in 1984. Indeed, nearly 100% of the top selling drugs
with expired patents have generic versions available today versus only 35% in 1983.”).
19 Natalie M. Derzko, “A Local and Comparative Analysis of the Experimental Use Exception—Is Harmonization
Appropriate?,” 44 IDEA: Journal of Law and Technology (2003), 1.
20 Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).
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infringed if a generic drug were marketed prior to the expiration of these patents.21 The FDA then
lists these patents in a publication titled Approved Drug Products with Therapeutic Equivalence
Evaluations, which is more commonly known as the “Orange Book.”22 Would-be manufacturers
of generic drugs must then engage in a specialized certification procedure with respect to Orange
Book-listed patents. An ANDA applicant must state its views with respect to each Orange Book-
listed patent associated with the drug it seeks to market. Four possibilities exist:
(1) that the brand-name firm has not filed any patent information with respect to that drug;
(2) that the patent has already expired;
(3) that the generic company agrees not to market until the date on which the patent will
expire; or
(4) that the patent is invalid or will not be infringed by the manufacture, use or sale of the
drug for which the ANDA is submitted.23
These certifications are respectively termed paragraph I, II, III, and IV certifications.24 An ANDA
application certified under paragraphs I or II is approved immediately after meeting all applicable
regulatory and scientific requirements.25 A generic firm that files an ANDA including a paragraph
III certification must, even after meeting pertinent regulatory and scientific requirements, wait for
approval until the drug’s listed patent expires.26
The filing of an ANDA application with a paragraph IV certification constitutes a “somewhat
artificial” act of patent infringement under the Hatch-Waxman Act.27 The statute requires the
generic applicant to notify the proprietor of the patents that are the subject of a paragraph IV
certification.28 The patent owner may then commence patent infringement litigation against that
applicant.
The Safe Harbor Provision
The scope of 35 U.S.C. §271(e)(1) was recently the subject of a judicial consideration. By its own
terms, this statute does not restrict its infringement safe harbor to activities performed prior to the
award of marketing approval by the FDA.29 In the August 31, 2011, panel opinion in Classen
21 21 U.S.C. §355(b)(1).
22 See, e.g., Jacob S. Wharton, “‘Orange Book’ Listing of Patents Under the Hatch-Waxman Act,” 47 St. Louis
University Law Journal (2003), 1027.
23 21 U.S.C. §355(j)(2)(A)(vii).
24 See Douglas A. Robinson, “Recent Administrative Reforms of the Hatch-Waxman Act: Lower Prices Now In
Exchange for Less Pharmaceutical Innovation Later?,” 81 Washington University Law Quarterly (2003), 829.
25 21 U.S.C. §355(j)(5)(B)(i).
26 21 U.S.C. §355(j)(5)(B)(ii).
27 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 1047 (1990).
28 21 U.S.C. §355(j)(2)(B)(i).
29 35 U.S.C. §271(e)(1) provides in pertinent part:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States ... a
patented invention ... solely for uses reasonably related to the development and submission of
(continued...)
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Immunotherapies LLC v. Biogen Idec,30 the Federal Circuit nonetheless concluded that this statute
was “directed to premarketing approval of generic counterparts before patent expiration.”31 In
view of this holding, activities not associated with the preparation of an NDA or ANDA are not
shielded by the safe harbor, even though they lead to information that must be reported to the
FDA.
The Classen litigation involved three patents directed towards methods of immunization. The
accused infringement consisted in part of the defendants’ participation in studies evaluating
associations between childhood vaccinations and the risk of developing type 1 diabetes.32 The
accused infringers asserted that their participation in studies evaluating risks associated with
different vaccination schedules was reasonably related to their regulatory obligation to review and
report adverse events to the FDA.33 The district court agreed with the defendants and held that
they did not infringe due to the statutory safe harbor.
The Federal Circuit reversed this holding on appeal. The majority sided with the patent owner and
rejected the contention of the accused infringers that they were protected by the 35 U.S.C.
§271(e)(1) safe harbor. According to Judge Newman, the legislative history of the Hatch-Waxman
Act indicated that Congress intended the safe harbor only to expedite FDA approval of generic
drugs.34 Further, every prior judicial analysis of the statute had addressed activities performed
prior to the award of FDA marketing approval.35 She therefore asserted that “statute does not
apply to information that may be routinely reported to the FDA, long after marketing approval
has been obtained.”36
Judge Moore authored a dissenting opinion that would have applied 35 U.S.C. §271(e)(1) to the
accused infringement. In her view, the statute included no language restricting its scope to pre-
approval activity.37 Further, in her opinion, the legislative history simply did not speak to whether
the statute covered post-approval activity or not.38 She also observed that the Supreme Court had
consistently construed the safe harbor in an expansive manner.39
The holding in Classen was arguably quite significant in terms of determining the impact of
intellectual property law within the health sciences. The majority opinion expressed concerns
about the potential breadth of the Hatch-Waxman Act’s safe harbor provision. Via statute and
regulation, the FDA receives a great deal of information from the pharmaceutical industry at all
stages of the life cycles of particular products. If 35 U.S.C. §271(e)(1) were to apply to post-
(...continued)
information under a Federal law which regulates the manufacture, use, or sale of drugs or
veterinary biological products.
30 659 F.3d 1057 (Fed. Cir. 2011).
31 Id. at 1071.
32 Classen, 381 F.Supp.2d at 455.
33 For example, 21 C.F.R. §600.80 requires “postmarketing reporting of adverse experiences” and 21 C.F.R. §601.70
requires “annual progress reports of postmarketing studies.
34 659 F.3d at 1071.
35 Id.
36 Id. at 1070.
37 Id. at 1083.
38 Id. at 1083-84.
39 Id. at 1083.
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approval activities, then a potentially broad swath of activity could be conducted free of the
patent system. The majority appeared to doubt that Congress intended to limit the value of
pharmaceutical patents to this extent.
On the other hand, the dissenting opinion correctly observes that 35 U.S.C. §271(e)(1) is not
restricted to pre-approval activities through its own wording. The extent to which jurists should
employ legislative histories and their sense of congressional purposes when construing statutes
has been the subject of a longstanding debate that exceeds the scope of this report.40 In terms of
public health policy, the dissenting view would potentially reduce patent barriers to compliance
with FDA regulators. This result would arguably come at the expense of intellectual property
rights and incentives to bring innovative drugs to market, however.
Under the majority view that confines 35 U.S.C. §271(e)(1) to pre-approval activities, the
statutory safe harbor principally acts to regulate the timing of patent litigation. The Hatch-
Waxman Act exempts a generic firm from infringement suits as it prepares its ANDA. Once an
ANDA is filed, however, 35 U.S.C. §271(e)(2) potentially allows a patent infringement lawsuit to
commence. Under the dissenting view, no patent litigation would occur at all with respect to post-
approval activities. This distinction possibly motivated the majority ruling that limited 35 U.S.C.
§271(e)(1) to pre-approval activities despite the statute’s literal wording.
The Patent Infringement Provision
Recent judicial developments have also impacted 35 U.S.C. §271(e)(2), the counterpart to the
safe harbor provision. This provision has traditionally been understood to allow a patent
infringement lawsuit once a generic firm files an ANDA with a paragraph IV certification. For
example, the Supreme Court once described 35 U.S.C. §271(e)(2) as establishing “a highly
artificial act of infringement that consists of submitting an ANDA ... containing the fourth type of
certification that is in error as to whether commercial manufacture, use, or sale of the new drug
(none of which, of course, has actually occurred) violates the relevant patent.”41
The actual text of 35 U.S.C. §271(e)(2) does not seem to require the filing of a paragraph IV
ANDA for a brand-name firm to bring a patent infringement lawsuit, however. That statute states
in pertinent part:
It shall be an act of infringement to submit ... an application ... for a drug ... if the purpose of
such submission is to obtain approval under such Act to engage in the commercial
manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the
use of which is claimed in a patent before the expiration of such patent.
Whether a cause of action under 35 U.S.C. §271(e)(2) is predicated upon a paragraph IV
certification or not holds notable consequences for the Hatch-Waxman system. If such a
certification is not required, then the filing of an ANDA could lead to charges of infringement for
patents that are not listed in the Orange Book. This state of affairs could potentially limit the
ability of the Orange Book to identify patents that pertain to a particular pharmaceutical and also
40 See, e.g., Antonin Scalia, A Matter of Interpretation: Federal Courts and the Law (Princeton University Press 1998).
41 496 U.S. 661, 678 (1990).
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impact patent enforcement more generally—two factors that may possibly affect the availability
of generic medications.
The litigation in Abraxis Bioscience Inc. v. Navinta LLC42 recently highlighted this issue,
although the court’s disposition of the matter did not conclusively resolve the issue. Abraxis holds
the NDA for Naropin® (ropivacaine), a drug used during surgical anesthesia and for acute pain
management. Navinta subsequently filed an ANDA with the intention of producing a generic
version of this medication. Abraxis had identified only a single patent for listing in the Orange
Book, U.S. Patent No. 4,870,086. The ‘086 patent claims an isomer of ropivacaine hydrochloride
monohydrate. Navinta’s ANDA included a paragraph IV certification to the ‘086 patent.43
Upon receiving notice of Navinta’s paragraph IV ANDA, Abraxis sued Navinta under 35 U.S.C.
§271(e)(2). Abraxis brought suit under the ‘086 patent. But it also alleged infringement of two
other patents: U.S. Patent Nos. 5,670,524 and 5,834,489. Each of these patents addresses methods
of using ropivacaine for the treatment of pain. But neither was listed in the Orange Book at the
time Navinta filed its ANDA.44 Although Navinta argued that the two method patents should be
removed from the litigation, the district court concluded that a lawsuit under 35 U.S.C. §271(e)(2)
was appropriate even though neither one was identified in the Orange Book.45
Navinta appealed this and other rulings to the Federal Circuit. Navinta cited several cases from
the Supreme Court and Federal Circuit that, in its view, held that 35 U.S.C. §271(e)(2) requires a
paragraph IV certification on an Orange Book-listed patent. In response, Abraxis pointed to the
text of 35 U.S.C. §271(e)(2), which does not state such a requirement. Abraxis also asserted that
neither the Supreme Court nor the Federal Circuit has ever directly held that a paragraph IV
certification is a prerequisite to suit under 35 U.S.C. §271(e)(2).
On appeal, the Federal Circuit acknowledged this issue but did not address it. The court of
appeals instead resolved the dispute between Abraxis and Navinta on a different basis. Abraxis
ultimately purchased all three asserted patents from several other firms through a complex series
of transactions. However, at the time it filed suit against Navinta, Abraxis was not the actual
owner of the patents due to a break in the chain of title. Because Abraxis therefore lacked
standing to assert the patents on the date it filed suit, the Federal Circuit ruled that its complaint
should be dismissed.46
This issue may yet be placed before the courts in the future. Because Abraxis currently owns all
three asserted patents, it now possesses the ability to file an infringement suit against Navinta.
Other firms may potentially assert patents that are not listed in the Orange Book under 35 U.S.C.
§271(e)(2) as well.
The scope of 35 U.S.C. §271(e)(2) potentially holds important consequences for the Hatch-
Waxman system. The Orange Book essentially serves as a patent clearinghouse that allows
generic firms to identify the intellectual property rights that protect brand-name pharmaceuticals.
To assist in this role, the Hatch-Waxman Act requires NDA applicants to identify appropriate
42 625 F.3d 1359 (Fed. Cir. 2010).
43 625 F.3d at 1360-61.
44 Id. at 1361-62.
45 Id. at 1362-63.
46 Id. at 1365.
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patents that the FDA subsequently places in the Orange Book.47 Although the statute offers
certain advantages to identifying relevant patents,48 it establishes no fine or other penalty if a
brand-name firm fails to do so. The ability of brand-name firms to assert unlisted patents under
35 U.S.C. §271(e)(2) may further decrease their incentives to comply with this statutory
obligation.
On the other hand, 35 U.S.C. §271(e)(2) was designed to allow brand-name and generic firms to
resolve their patent disputes in a prompt manner. Unlike most patent infringement lawsuits, which
focus on a commercially available product, Hatch-Waxman litigation commences before the
generic drug is publicly available and even before the FDA has approved the generic drug for
marketing. This “head start” may allow the lawsuit to be resolved in a timelier manner. Under this
system, litigation involving all pertinent patents—including ones not listed in the Orange Book—
might best serve the goals of both the intellectual property and public health systems.
In this respect, it should be appreciated that the Hatch-Waxman Act states particular requirements
for the sorts of patents that are appropriately listed in the Orange Book. The statute provides that
an NDA applicant must identify to the FDA:
any patent which claims the drug for which the applicant submitted the application or which
claims a method of using such drug and with respect to which a claim of patent infringement
could reasonably be asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug.49
Stated differently, the statute establishes two requirements for an Orange Book listing. First, the
patent must claim a drug, or a method of using a drug, for which the applicant submitted the
NDA. Second, the patent proprietor could reasonably assert a claim of infringement of that patent
against a proposed generic version of the drug.50
Due to this two-part standard, merely because a patent cannot be listed in the Orange Book does
not mean that the patent could not be successfully enforced against an unauthorized competitor.
Patents claiming methods of manufacture, chemical intermediates, and product packaging are
among those that may not be listed, even though they may possibly be infringed.51 In such cases,
exclusion from the Orange Book would not prevent the patent proprietor from bringing suit at
such time the generic product was marketed.52 Allowing litigation under 35 U.S.C. §271(e)(2) for
unlisted patents would fulfill the policy goal of prompt resolution of pharmaceutical patent
disputes—but also potentially place more intellectual property barriers to generic competition.
47 21 U.S.C. §355(b)(1).
48 In particular, the FDA grant of marketing approval of a generic version of the patented drug may be delayed by 30
months. 21 U.S.C. §355(j)(5)(B)(iii).
49 21 U.S.C. §355(b)(1).
50 John R. Thomas, Pharmaceutical Patent Law 404 (2d ed. Bureau of National Affairs 2010).
51 See Department of Health and Human Services, Food and Drug Admin., Applications for FDA Approval to Market a
New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of
Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 68
Fed. Reg. 36,676 (June 18, 2003).
52 See aaiPharma, Inc. v. Thompson, 296 F.3d 227, 241 n.7, 63 USPQ2d 1670, 1679 n.7 (4th Cir. 2002) (noting that the
owner of an unlisted patent “can still pursue patent infringement suits against generic manufacturers.”).
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Congressional Issues and Options
Should Congress conclude that the current situation with respect to 35 U.S.C. §271(e) is
satisfactory, no action need be taken. If Congress wishes to intervene, however, then some
options present themselves. Congress could stipulate whether 35 U.S.C. §271(e)(1) applies to acts
that occur following the award of FDA marketing approval or not. Congress could also explicitly
state whether 35 U.S.C. §271(e)(2) establishes a cause of action for infringement of patents that
have not been listed in the Orange Book and therefore were not the subject of a paragraph IV
certification.
Recent interpretational disputes with respect to 35 U.S.C. §271(e) have drawn attention to
potential distinctions between traditional Hatch-Waxman Act practice and the arguably broader
wording of that statute. The courts commonly resolve these questions using traditional legal
methods of statutory interpretation. But their rulings may significantly impact the two policy
goals of the Hatch-Waxman Act: the preservation of incentives to develop innovative
medications and the promotion of generic competition. Those who view the availability of new
cures and the cost of health care as pressing issues of national importance would do well to track
future judicial interpretation of these core Hatch-Waxman Act provisions.
Author Contact Information
John R. Thomas
Visiting Scholar
jrthomas@crs.loc.gov, 7-0975
Congressional Research Service
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