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Current Issues in Patentable Subject Matter:
Business Methods, Tax Planning Methods,
and Genetic Materials
John R. Thomas
Visiting Scholar
January 6, 2010
Congressional Research Service
7-5700
www.crs.gov
R40681
CRS Report for Congress
P
repared for Members and Committees of Congress
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Current Issues in Patentable Subject Matter
Summary
Congressional interest in the patent system has grown in recent years, tracking increasing
recognition of the importance of intellectual property to innovative U.S. industries. One of the
areas of interest is the topic of patentable subject matter—that is, the sorts of inventions for which
patents may be obtained. In particular, patents on business methods, tax planning methods, and
genetic materials have proven controversial. Legislation introduced in recent sessions of Congress
would restrict the availability of patents in these fields. None of these bills has yet been enacted.
The patent statute currently provides that patents may be obtained on any invention that is a
process, machine, manufacture, or composition of matter. The range of patentable subject matter
under this provision has been characterized as extremely broad. The courts have nonetheless
concluded that certain subject matter, including abstract ideas, mathematical algorithms, laws of
nature, and mental processes may not be patented no matter how innovative they might be. They
have reasoned that these inventions comprise the fundamental tools of scientific research, and that
allowing them to be privately appropriated might interfere with future advancement.
Business method patents relate to a method of administering, managing, or conducting a business
or organization. Tax planning method patents concern a method of reducing or deferring taxes.
Both types of patents have been traced to the 1998 decision of the Court of Appeals for the
Federal Circuit in State Street Bank, which held that these sorts of methods may be patented if
they comply with other Patent Act standards such as novelty and nonobviousness. The 2008
Federal Circuit opinion in In re Bilski has been viewed by some observers as placing significant
limits on the ability to patent business and tax planning methods, although other experts believe
that the impact of the Bilski opinion is less certain. The United States Supreme Court has
announced that it will review the holding in Bilski.
Patents claiming the products of biotechnology, and in particular genetic materials, have also led
to considerable debate. Genetic material patents cover such technologies as DNA sequences,
amino acid sequences, individual mutations known to cause disease, and testing kits for detecting
genetic mutations. Since the 1980 decision of the Supreme Court in Diamond v. Chakrabarty, the
lower courts and the U.S. Patent and Trademark Office have viewed genetic materials and related
technologies as patentable.
Numerous arguments have been advanced in opposition to patents on business methods, tax
planning methods, and genetic materials. Some commentators believe that business method
patents ultimately discourage competition, that tax strategy patents provide undesirable
innovation incentives, and that patents on genetic materials lead to deleterious effects on
healthcare and medical research. Other experts assert that these concerns are overstated, and
further contend that the patent system provides a powerful incentive for innovation, investment,
and public disclosure of technology across many fields of endeavor.
Several legislative options present themselves. If Congress decides the current rules with respect
to patent eligibility are appropriate, then no action need be taken. Other possibilities include
amendments to the Patent Act either to bar the issuance of patents in particular disciplines, or to
limit the ability to enforce certain kinds of patents. The desire to comply with certain international
agreements, in particular the WTO Agreement on Trade-Related Aspects of Intellectual Property
(TRIPS), may restrict certain legislative alternatives.
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Contents
Introduction ................................................................................................................................ 1
Fundamentals of the Patent System ............................................................................................. 2
Patents on Business and Tax Planning Methods ........................................................................... 3
Business Method Patents....................................................................................................... 4
Tax Planning Method Patents ................................................................................................ 7
In re Bilski ............................................................................................................................ 8
Patents on Genetic Materials ..................................................................................................... 10
Innovation Policy Issues............................................................................................................ 12
Congressional Issues and Options ............................................................................................. 15
Concluding Observations .......................................................................................................... 16
Contacts
Author Contact Information ...................................................................................................... 17
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Introduction
Recent congressional discussion of patent system reform has included consideration of provisions
that would restrict the sorts of inventions for which patents may be obtained. Legislation
introduced in the 111th Congress would prevent the patenting of tax planning methods,1 and one
recent hearing regarding patent reform focused in part upon the propriety of patenting business
methods.2 Legislation has been introduced in previous sessions of Congress that would have
banned patents relating to genetic materials as well.3
Under current law, one of the requirements to obtain a patent is that the invention must consist of
a “process, machine, manufacture, or composition of matter.”4 The courts and the U.S. Patent and
Trademark Office (USPTO) have understood this language to allow an expansive range of
patentable subject matter.5 Patents have therefore been obtained upon diverse inventions,
including living organisms, genetic materials, tax avoidance strategies, insurance methods, and
marketing techniques.6 Some observers believe that recent judicial opinions have narrowed the
extent of patentable subject matter, however.7
The proper scope of patentable subject matter has been the subject of an often impassioned
debate. Among other concerns, critics believe that business method patents are unnecessary to
promote innovation,8 that tax strategy patents conflict with public policy,9 and that patents on
generic materials raise ethical concerns.10 However, other observers believe that the patent system
has served as a fair and effective mechanism for promoting advances in a broad range of
disciplines.11 In their view, arbitrary restrictions upon the patent incentive are inappropriate.12
1 H.R. 1265, § 303; H.R. 2584, §1; S. 506, § 303.
2 U.S. House of Representatives, Committee on the Judiciary, Hearing on H.R. 1260, the “Patent Reform Act of 2009,”
April 30, 2009.
3 See, e.g., The Genomic Research and Accessibility Act, 110th Congress, H.R. 977. This legislation was not enacted.
4 35 U.S.C. § 101 (2006). If an invention is judged to fall within one of these four categories of patentable subject
matter, then it must meet other standards in order to be subject to a patent. In particular, the invention must not have
been obvious to a person of ordinary skill in the art at the time it was made. 35 U.S.C. § 103(a) (2006).
5 See Ryan Hagglund, “Patentability of Human-Animal Chimeras,” 25 Santa Clara Computer & High Technology Law
Journal (2008-2009), 51.
6 See Dana Remus Irwin, “Paradise Lost in the Patent Law? Changing Visions of Technology in the Subject Matter
Inquiry,” 60 Florida Law Review (2008), 775.
7 See Scott D. Locke & William D. Schmidt, “Business Method Patents: The Challenge of Coping with An Ever
Changing Standard of Patentability,” 18 Fordham Intellectual Property, Media and Entertainment Law Journal (2008),
1079.
8 See Leo J. Raskind, “The State Street Bank Decision: The Bad Business of Unlimited Patent Protection for Methods
of Doing Business,” 10 Fordham Intellectual Property, Media & Entertainment Law Journal (1999), 61.
9 See Tinna C. Otero, “Banning Tax Strategy Patents—Should We Listen to the Tax Practitioners?,” 48 Jurimetrics
Journal (2008), 309.
10 See Michele Westhoff, “Gene Patents: Ethical Dilemmas and Possible Solutions,” 20 Health Lawyer no. 4 (2008), 1.
11 See Christopher A. Harkins, “Throwing Judge Bryson’s Curveball: A Pro Patent View of Process Claims as Patent-
Eligible Subject Matter,” 7 John Marshall Review of Intellectual Property Law (2008), 701.
12 See Kevin Schubert, “Should State Street Be Overruled? Continuing Controversy Over Business Method Patents,”
90 Journal of the Patent and Trademark Office Society (2008), 461.
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This report introduces the current debate concerning the appropriate range of patentable subject
matter. It begins by providing an introduction to the patent system. It then reviews the ongoing
discussion concerning the merits of business method and tax planning method patents. The
current controversy concerning patents on genetic materials is then reviewed. The report then
provides a broader discussion of innovation policy concerns that arise as policy makers consider
the appropriate range of patentable subject matter. A summary of congressional issues and options
concludes the report.
Fundamentals of the Patent System
The U.S. Constitution confers upon Congress the power “To promote the Progress of ... useful
Arts, by securing for limited Times to ... Inventors the exclusive Right to their ... Discoveries.”13
In accordance with the Patent Act of 1952,14 an inventor may seek the grant of a patent by
preparing and submitting an application to the USPTO. USPTO officials known as examiners
then determine whether the invention disclosed in the application merits the award of a patent.15
USPTO procedures require examiners to determine whether the invention fulfills certain
substantive standards set by the patent statute. To be patentable, the invention must be novel, or
different, from subject matter disclosed by an earlier patent, publication, or other state-of-the-art
knowledge.16 In addition, an invention is not patentable if “the subject matter as a whole would
have been obvious at the time the invention was made to a person having ordinary skill in the art
to which said subject matter pertains.”17 This requirement of “nonobviousness” prevents the
issuance of patents claiming subject matter that a skilled artisan would have been able to
implement in view of the knowledge of the state of the art.18 The invention must also be useful, a
requirement that is satisfied if the invention is operable and provides a tangible benefit.19
Even if these requirements of novelty, nonobviousness, and utility are met, an invention is not
patentable unless it falls within at least one category of patentable subject matter. According to
section 101 of the Patent Act of 1952, an invention which is a “process, machine, manufacture, or
composition of matter” may be patented.20 The range of patentable subject matter under this
statute has been characterized as “extremely broad.”21 The courts and USPTO have nonetheless
concluded that certain subject matter, including abstract ideas and laws of nature, is not
patentable under section 101.22 This report further discusses this legal standard below.
13 Article I, Section 8, Clause 8.
14 P.L. 82-593, 66 Stat. 792 (codified at Title 35 of the United States Code).
15 35 U.S.C. § 131 (2006).
16 35 U.S.C. § 102 (2006).
17 35 U.S.C. § 103(a) (2006).
18 See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
19 See In re Fischer, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
20 35 U.S.C. § 101 (2006).
21 In re Comiskey, 554 F.3d 967 (Fed. Cir. 2009).
22 See In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc).
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In addition to these substantive requirements, the USPTO examiner will consider whether the
submitted application fully discloses and distinctly claims the invention.23 In particular, the
application must enable persons skilled in the art to make and use the invention without undue
experimentation.24 In addition, the application must disclose the “best mode,” or preferred way,
that the applicant knows to practice the invention.25
If the USPTO allows the patent to issue, its owner obtains the right to exclude others from
making, using, selling, offering to sell, or importing into the United States the patented
invention.26 Those who engage in those acts without the permission of the patentee during the
term of the patent can be held liable for infringement. Adjudicated infringers may be enjoined
from further infringing acts.27 The patent statute also provides for an award of damages “adequate
to compensate for the infringement, but in no event less than a reasonable royalty for the use
made of the invention by the infringer.”28
The maximum term of patent protection is ordinarily set at 20 years from the date the application
is filed.29 At the end of that period, others may employ that invention without regard to the
expired patent.
Patent rights do not enforce themselves. Patent owners who wish to compel others to respect their
rights must commence enforcement proceedings, which most commonly consist of litigation in
the federal courts. Although issued patents enjoy a presumption of validity, accused infringers
may assert that a patent is invalid or unenforceable on a number of grounds. The Court of Appeals
for the Federal Circuit (Federal Circuit) possesses nationwide jurisdiction over most patent
appeals from the district courts.30 The Supreme Court enjoys discretionary authority to review
cases decided by the Federal Circuit.31
Patents on Business and Tax Planning Methods
The Patent Act of 1952 allows a patent to issue upon a “process,” which the statute defines to
mean a “process, art, or method.”32 Process patents claim a series of steps that may be performed
to achieve a specific result. Process patents typically relate to methods of manufacture or use.33 A
process patent may claim a method of making a product, for example, or a method of using a
chemical compound to treat a disease.
23 35 U.S.C. § 112 (2006).
24 See Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1070-71 (Fed. Cir. 2005).
25 See High Concrete Structures, Inc. v. New Enterprise Stone and Lime Co., 377 F.3d 1379, 1382 (Fed. Cir. 2004).
26 35 U.S.C. § 271(a) (2006).
27 35 U.S.C. § 283 (2006). See eBay Inc. v. MercExchange L.L.C., 126 S.Ct. 1837 (2006).
28 35 U.S.C. § 284 (2006).
29 35 U.S.C. § 154(a)(2) (2006). Although the patent term is based upon the filing date, the patentee obtains no
enforceable legal rights until the USPTO allows the application to issue as a granted patent. A number of Patent Act
provisions may modify the basic 20-year term, including examination delays at the USPTO and delays in obtaining
marketing approval for the patented invention from other federal agencies.
30 28 U.S.C. § 1295(a)(1) (2006).
31 28 U.S.C. § 1254(1) (2006).
32 35 U.S.C. § 100(b) (2006).
33 See In re Pleuddemann, 910 F.2d 823, 826 (Fed. Cir. 1990).
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Although the statutory term “process” is broad, courts and the USPTO have nonetheless
established certain limits upon the sorts of processes that may be patented. In particular, abstract
ideas, mathematical algorithms, mental processes, and scientific principles have been judged not
to be patentable.34 The Supreme Court has described these sorts of inventions as the “basic tools
of scientific and technological work”35 that should be “free to all men and reserved exclusively to
none.”36 As explained by Supreme Court Justice Stephen Breyer, this rule “reflects a basic
judgment that protection in such cases, despite its potentially positive incentive effects, would too
severely interfere with, or discourage, development and the further spread of future knowledge
itself.”37
In recent years, two controversial categories of process patents have been identified. The first of
these, business method patents, have been defined to include “a method of administering,
managing, or otherwise operating a business or organization, including a technique used in doing
or conducting business.”38 The second, tax strategy patents, have been defined as “a plan,
strategy, technique, or scheme that is designed to reduce, minimize, or defer, or has, when
implemented, the effect of reducing, minimizing, or deferring, a taxpayer’s tax liability.”39 This
report discusses these two sorts of process patents in turn.
Business Method Patents
Prior to 1998, some courts had held that methods of doing business were not patentable subject
matter under § 101 of the Patent Act. For example, the Court of Appeals for the First Circuit held
that:
[A] system for the transaction of business, such, for example, as the cafeteria system for
transacting the restaurant business, or similarly the open-air drive-in system for conducting
the motion picture theatre business, however, novel, useful, or commercially successful is
not patentable apart from the means for making the system practically useful, or carrying it
out.40
The Federal Circuit revisited the issue in 1998, however, and in its well-known decision in State
Street Bank & Trust Co. v. Signature Financial Group held that no business method exclusion
from patentability existed.41 The patent at issue in that case concerned a data-processing system
for implementing an investment structure known as a “Hub and Spoke” system.42 This system
allowed individual mutual funds (“Spokes”) to pool their assets in an investment portfolio
34 See Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. 548 U.S. 124 (2006) (opinion of Justice
Breyer, dissenting from dismissal of writ of certiorari as improvidently granted) (hereinafter “LabCorp.”).
35 Gottschalk v. Benson, 409 U.S. 63, 67 (1972).
36 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948).
37 LabCorp., supra, at 128.
38 Business Method Patent Improvement Act, H.R. 5364, 106th Cong., § 2 (2000). This legislation was not enacted.
39 H.R. 1908, 110th Cong., § 10(b)(2)(A) (2008). In a portion of the definition not quoted above, the legislation
expressly explained that “the use of tax preparation software or other tools used solely to perform or model
mathematical calculations or prepare tax or information returns” was not considered a “tax planning method.” This
legislation was not enacted.
40 Lowe’s Drive-In Theaters, Inc. v. Park-In Theaters, Inc., 174 F.2d 547, 552 (1st Cir. 1949).
41 149 F.3d 1368 (Fed. Cir. 1998).
42 See U.S. Patent No. 5,193,056.
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(“Hub”) organized as a partnership. According to the patent, this investment regime provided the
advantageous combination of economies of scale in administering investments coupled with the
tax advantages of a partnership.43 The patented system purported to allow administrators to
monitor financial information and complete the accounting necessary to maintain this particular
investment structure. In addition, it tracked “all the relevant data determined on a daily basis for
the Hub and each Spoke, so that aggregate year end income, expenses, and capital gain or loss
can be determined for accounting and tax purposes for the Hub and, as a result, for each publicly
traded Spoke.”44
Litigation arose between Signature, the patent owner, and State Street Bank over the latter firm’s
alleged use of the patented invention. Among the defenses offered by State Street Bank was that
the asserted patent claimed subject matter that was not within one of the four categories of
statutory subject matter,45 and hence was invalid. The district court sided with State Street Bank.46
The trial judge explained:
At bottom, the invention is an accounting system for a certain type of financial investment
vehicle claimed as [a] means for performing a series of mathematical functions. Quite
simply, it involves no further physical transformation or reduction than inputting numbers,
calculating numbers, outputting numbers, and storing numbers. The same functions could be
performed, albeit less efficiently, by an accountant armed with pencil, paper, calculator, and
a filing system.47
The trial court further relied upon “the long-established principle that business ‘plans’ and
‘systems’ are not patentable.”48 The court judged that “patenting an accounting system necessary
to carry on a certain type of business is tantamount to a patent on the business itself.”49 Because
the court found that “abstract ideas are not patentable, either as methods of doing business or as
mathematical algorithms,”50 the patent was held to be invalid.
Following an appeal, the Federal Circuit reversed. The court of appeals concluded that the patent
claimed not merely an abstract idea, but rather a programmed machine that produced a “useful,
concrete, and tangible result.”51 Because the invention achieved a useful result, it constituted
patentable subject matter even though its result was expressed numerically.52 The Federal Circuit
further explained that:
Today, we hold that the transformation of data, representing discrete dollar amounts, by a
machine through a series of mathematical calculations into a final share price, constitutes a
practical application of a mathematical algorithm, formula, or calculation, because it
produces “a useful, concrete and tangible result”—a final share price momentarily fixed for
43 149 F.3d at 1370.
44 Id.
45 35 U.S.C. § 101 (2006) (identifying processes, machines, manufactures, and compositions of matter as patentable
subject matter).
46 927 F. Supp. 502 (D. Mass. 1996).
47 Id. at 515.
48 Id.
49 Id. at 516.
50 Id.
51 149 F.3d at 1373.
52 Id. at 1375.
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recording and reporting purposes and even accepted and relied upon by regulatory authorities
and in subsequent trades.53
The court of appeals then turned to the district court’s business methods rejection, opting to “take
[the] opportunity to lay this ill-conceived exception to rest.”54 The court explained restrictions
upon patents for methods of doing business had not been the law since at least the enactment of
the 1952 Patent Act. The Federal Circuit then concluded that methods of doing business should be
subject to the same patentability analysis as any other sort of process.55
Following State Street Bank, numerous patents that arguably claim business methods have issued
from the USPTO.56 Katherine Strandburg, a member of the faculty of the New York University
School of Law, has characterized business method patents as involving four categories: “(1) ‘back
office’ or administrative operational methods; (2) customer service operational methods; (3)
methods of providing personal or professional service; and (4) intangible ‘products.’”57 Several of
these patents have been the subject of litigation in the federal courts.58
Patents on methods of doing business have attracted controversy. Some observers believe that
such patents are appropriate supporters of the costly research and development efforts that occur
in our service-oriented, information-based economy.59 Others believe that business method
patents are unnecessary to promote innovation and may raise unique concerns over competition.60
A subsequent portion of this report will review this debate.
Congressional reaction to the patenting of business methods has to this point been limited. In
1999, Congress enacted the First Inventor Defense Act as part of the American Inventors
Protection Act.61 That statute provides an earlier inventor of a “method of doing or conducting
business” that was later patented by another to assert a defense to patent infringement in certain
circumstances.
In enacting the First Inventor Defense Act, Congress recognized that some firms may have
operated under the impression that business methods could not be patented prior to the State
Street Bank decision. As a result, they may have maintained their innovative business methods as
trade secrets. Having used these trade secrets in furtherance of their marketplace activities for a
period of time, however, these firms may be unable to obtain a patent upon their business method.
Further, should a competitor later independently invent and patent the same business method, the
trade secret holder would potentially be liable for patent infringement. Following the
53 Id. at 1373.
54 Id. at 1375.
55 Id.
56 See, e.g., John R. Allison & Emerson H. Tiller, “The Business Method Patent Myth,” 18 Berkeley Technology Law
Journal (2003), 987.
57 Katherine J. Strandburg, “What If There Were a Business Method Use Exemption to Patent Infringement?,” 2008
Michigan State Law Review, 245.
58 See, e.g., Nicholas A. Smith, “Business Method Patents and Their Limits: Justifications, History, and the Emergence
of a Claim Construction Jurisprudence,” 9 Michigan Telecommunications & Technology Law Review (2002), 171.
59 Thomas J. Scott, Jr. & Stephen T. Schreiner, “Planning for the Brave New World: Are Business Method Patents
Going to Be Second Class Citizens?,” 19 Intellectual Property & Technology Law Journal no. 6 (2007), 6.
60 Andrew A. Schwartz, “The Patent Office Meets the Poison Pill: Why Legal Methods Cannot Be Patented,” 90
Journal of the Patent and Trademark Office (2008), 194.
61 P.L. 106-113, 113 Stat. 1536 (1999) (codified at 35 U.S.C. § 273(b) (2006)).
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confirmation of the patenting of business methods by the State Street Bank court, the creation of
the first inventor defense was intended to provide a defense to patent infringement in favor of the
first inventor/trade secret holder.62
By stipulating that the first inventor defense applied only to a “method of doing or conducting
business,” Congress arguably recognized the validity of these sorts of patents.63 The First
Inventor Defense Act did not define the term “method of doing or conducting business,” however,
and to date no published judicial opinion addresses the precise scope of this defense.64
Tax Planning Method Patents
Although the State Street Bank opinion rejected a per se rule denying patents on business
methods, the invention claimed by the Signature patent was arguably motivated by a desire to
reduce tax liability.65 In some sense, then, State Street Bank may be seen as the first tax patent
case. Some commentators believe that the “increase in the number of tax strategy patents
requested and approved by the [USPTO] came on the heels” of State Street Bank.66
Generally stated, tax planning method patents may be defined as those that disclose and claim a
system or method for reducing or deferring taxes.67 As of January 6, 2010, the USPTO identified
90 issued patents and 136 published applications under classification number 705/36T.68 As the
USPTO received 485,312 patent applications in 2008, and granted 185,224 patents during that
year, it should be appreciated that tax strategy patents represent a very small share of that
agency’s workload.69 Among the titles of the issued patents are:
• System and method for forecasting tax effects of financial transactions (U.S. Patent No.
7,305,353)
• Method and apparatus for tax efficient investment management (U.S. Patent No. 7,031,937)
• Method and apparatus for tax-efficient investment using both long and short positions (U.S.
Patent No. 6,832,209)
62 See generally David H. Hollander, Jr., “The First Inventor Defense: A Limited Prior User Right Finds Its Way Into
U.S. Patent Law,” 30 American Intellectual Property Law Association Quarterly Journal (2002), 37.
63 See Rochelle Cooper Dreyfuss, “Are Business Method Patents Bad for Business?,” 16 Santa Clara Computer and
High Technology Law Journal (2000), 263.
64 John R. Allison & Starling D. Hunter, “On the Feasibility of Improving Patent Quality One Technology At a Time:
The Case of Business Methods,” 21 Berkeley Technology Law Journal (2006), 729.
65 See, e.g., Paul E. Schaafsma, “A Gathering Storm in the Financial Industry,” 9 Stanford Journal of Law, Business
and Finance (2004), 176.
66 Meyer, supra, at 187.
67 H.R. 1908, 110th Cong., § 10(b)(2)(A) (2008).
68 It should be appreciated that some observers have criticized the USPTO classification system as unreliable. See, e.g.,
John R. Allison and Mark A. Lemley, “The Growing Complexity of the United States Patent System,” 82 Boston
University Law Review (2002), 77. As a result, it is possible that some patents arguably directed towards tax strategies
may presently be classified under different categories.
69 USPTO, U.S. Patent Statistics, Calendar Years 1963-2008 (available at http://www.uspto.gov/web/offices/ac/ido/
oeip/taf/us_stat.pdf).
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• Computerized system and method for optimizing after-tax proceeds (U.S. Patent No.
6,115,697)
Tax planning method patents have resulted in a lively discussion among interested parties. Some
observers, and in particular tax professionals, have found tax planning method patents to be
“ridiculous,”70 “bizarre,”71 and “deeply unsettling.”72 On the other hand, other commentators,
including many patent professionals, believe both that concerns over tax patents are overstated,
and that the patenting of tax strategies may lead to numerous positive consequences. This report
will review this debate below.
In the 111th Congress, three bills have been introduced that would stipulate that patents may not
be obtained on methods of tax planning.73 H.R. 1265 and S. 506 define the excluded category of
“tax planning invention[s]” to mean “a plan, strategy, technique, scheme, process, or system that
is designed to reduce, minimize, determine, avoid, or defer, or has, when implemented, the effect
of reducing, minimizing, determining, avoiding, or deferring, a taxpayer’s tax liability or is
designed to facilitate compliance with tax laws, but does not include tax preparation software and
other tools or systems used solely to prepare tax or information returns.”74 H.R. 2584 would
prevent any patent claiming a “tax planning method,” which is defined similarly.75 The legislation
would apply to any application filed at the USPTO on or after the date of enactment.76
In re Bilski
Increasing public scrutiny of business and tax planning method patents in recent years has
corresponded with heightened attention to patent eligibility issues by the USPTO and the courts.
On October 30, 2008, the Federal Circuit issued its opinion in In re Bilski.77 The Bilski appeal
was decided en banc—that is to say, with the participation of all the active judges of the court.
Bilski’s application concerned a method of hedging risk in the field of commodities trading. In
particular, his application claimed the following method:
A method for managing the consumption risk costs of a commodity sold by a commodity
provider at a fixed price comprising the steps of:
initiating a series of transactions between said commodity provider and consumers of said
commodity wherein said consumers purchase said commodity at fixed rate based upon
historical averages, said fixed rate corresponding to a risk position of said consumer;
identifying market participants for said commodity having a counter-risk position to said
consumers; and
70 Editorial, “Pay to Obey,” New York Times (Oct. 31, 2006).
71 David Nolte, “USPTO is Getting It Wrong on Tax Strategy Patents,” (July 20, 2006) (available at
http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=13238).
72 Melone, supra, at 438.
73 H.R. 1265, § 303; H.R. 2584, §1; S. 506, § 303.
74 H.R. 1265, § 303(a); S. 506, § 303(a).
75 H.R. 2584, §1(a).
76 H.R. 1265, § 303(b); H.R. 2584, §1(b); S. 506, § 303(b).
77 545 F.3d 943 (Fed. Cir. 2008) (en banc).
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initiating a series of transactions between said commodity provider and said market
participants at a second fixed rate such that said series of market participant transactions
balances the risk position of said series of consumer transactions.78
The USPTO rejected the application as claiming subject matter that was ineligible for patenting
under section 101.
On appeal, the Federal Circuit characterized the “true issue before us then is whether Applicants
are seeking to claim a fundamental principle (such as an abstract idea) or a mental process.”79
Applying Supreme Court precedent, the Federal Circuit explained:
A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular
machine or apparatus, or (2) it transforms a particular article into a different state or thing.80
Applying this standard, the Federal Circuit concluded that Bilski’s application did not claim
patentable subject matter. The Court of Appeals acknowledged Bilski’s admission that his
claimed invention was not limited to any specific machine or apparatus, and therefore did not
satisfy the first prong of the section 101 inquiry.81 The Federal Circuit also reasoned that the
claimed process did not achieve a physical transformation. According to Chief Judge Michel,
“[p]urported transformations or manipulations simply of public or private legal obligations or
relationships, business risks, or other such abstractions cannot meet the test because they are not
physical objects or substances, and they are not representative of physical objects or
substances.”82 As a result, the decision of the USPTO to deny Bilski’s application was affirmed.
Opinions about the impact of the Bilski opinion vary. Randall Picker, a member of the law faculty
of the University of Chicago, explained that the Federal Circuit “sharply cut back on the
availability of patents for processes” and “substantially stepped back from its prior decision in
State Street Bank, the decision that brought us the business-method patents controversy.”83
Attorneys MJ Edwards and Donald Steinberg are of the view that Bilski has narrowed the range
of processes that may be patented.84 Some experts believe that in view of the Bilski standard,
many patents that the USPTO previously issued would now be judged invalid.85
On the other hand, the Bilski opinion left “to future cases the elaboration of the precise contours
of machine implementation, as well as the answers to particular questions, such as whether or
when recitation of a computer suffices to tie a process claim to a particular machine.”86 As a
result, attorney James Myers explains that future litigation may “focus on what degree of
78 Id. at 949.
79 Id. at 952.
80 Id. at 954.
81 Id. at 962.
82 Id. at 965.
83 Randall Picker, “In re Bilski: The Fed Circuit Tells Inventors to Stuff It,” The University of Chicago: The Law
School Faculty Blog (Oct. 30, 2008).
84 MJ Edwards & Donald Steinberg, “The Implications of Bilski: Patentable Subject Matter in the United States,” 49
IDEA: The Intellectual Property Law Review (2009), 411.
85 See Robert A. Hulse & Robert R. Sachs, “Making Sense of the Revised Machine-or-Transformation Test in In re
Bilski,” 21 Intellectual Property & Technology Law Journal no. 2 (Feb. 2009), at 10.
86 545 F.3d at 962.
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computerized involvement you have to have in order to meet the threshold.”87 Others believe that
the primary impact of the Bilski opinion will be to alter the way patent applications are written.
Patent drafters may be able to present inventions such that they involve “a particular machine or
apparatus” or are transformative in nature. Under this view, the Bilski opinion may not be of great
significance to the patent system.88
On June 1, 2009, the United States Supreme Court granted certiorari in In re Bilski. The Supreme
Court will therefore have the opportunity to review the Federal Circuit’s holding in this case. The
Supreme Court decision can be expected to be issued, at the latest, by July 2010.
Patents on Genetic Materials
Controversy concerning patentable subject matter has not been confined to methods of doing
business and tax planning methods. Patents claiming the products of biotechnology, and in
particular genetic materials, have also led to considerable debate. In recent years, advances in
biotechnology have resulted in a growing body of knowledge concerning the genetic material of
living organisms. In turn, thousands of patents have been granted that assert rights in specific
sequences of deoxyribonucleic acid (DNA)—the nucleic acid that contains the genetic
instructions that all known living organisms use in order to develop and function.89 Other patents
claim related technologies, including individual mutations known to cause disease, testing kits for
detecting genetic mutations, amino acid sequences (proteins), and the use of these proteins as
medicines.90
The liberal availability of patents pertaining to genetic technologies may be traced to the well-
known decision of the U.S. Supreme Court in Diamond v. Chakrabarty.91 That 1980 opinion held
that a genetically engineered microorganism constituted patentable subject matter, qualifying as
both a “composition of matter” or “manufacture” within the meaning of §101 of the Patent Act.92
In so doing, the Supreme Court confirmed the traditional rule that “laws of nature, physical
phenomenon, and abstract ideas have been held not patentable. Thus, a new mineral discovered in
the earth or a new plant found in the wild is not patentable subject matter.” The Court reasoned
that the traditional rule denying patents to “products of nature” was inapplicable to the invention
before it, however. Chief Justice Burger explained:
87 See Nate Raymond, “Patent Bar is Atwitter About the Bilski Decision,” The AmLaw Daily (Oct. 31, 2008) (available
at http://amlawdaily.typepad.com/amlawdaily/2008/10/patent-bar-is-a.html).
88 See Stefania Fusco, “Is In re Bilski A Déjà vu?,” Stanford Technology Law Review (Feb. 16, 2009), at *8 (discussing
this view).
89 See Kevin T. Kelly, “Fragging the Patent Frags: Restricting Expressed Sequence Tag Patenting Using the
Enablement-Commensurate-In-Scope-With-the-Claims Requirement,” 17 Texas Intellectual Property Law Journal
(2008), 49.
90 See Eileen M. Kane, “Splitting the Gene: DNA Patents and the Genetic Code,” 71 Tennessee Law Review (2004),
707.
91 447 U.S. 303 (1980).
92 Id. at 308.
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[T]he patentee has produced a new bacterium with markedly different characteristics from
any found in nature and one having the potential for significant utility. His discovery is not
nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.93
As applied to genetic materials, the reasoning of Diamond v. Chakrabarty allows patents to issue
where scientists have isolated these materials from their natural environment or produced through
artificial techniques. As a result, patent claims directed towards DNA typically employ such terms
as “isolated” or “recombinant” in order to reflect these conditions. Notably, this claim language
restricts the scope of patent to isolated or artificially produced substances. As a result, the genes
naturally possessed by humans and other living organisms are not included within the scope of
proprietary rights.94
As with patents claiming business methods and tax strategies, patents pertaining to genetic
materials are controversial.95 Critics have asserted that genetic materials should remain accessible
to all, rather than subject to intellectual property rights, and that such patents may depress
research efforts and have a deleterious impact upon public health.96 Other experts believe these
critiques are overstated or misplaced, however.97 In their view, patent rights in DNA are no more
expansive or worthy of concern than for other sorts of inventions. This report reviews this debate
below.
No legislation has yet been introduced concerning this topic in the 111th Congress. Congress has
previously considered restricting patents relating to genetic materials, however. In the 110th
Congress, Representative Becerra introduced the Genetic Research and Accessibility Act, H.R.
977. That bill would have provided:
Notwithstanding any other provision of law, no patent may be obtained for a nucleotide
sequence, or its functions or correlations, or the naturally occurring products it specifies.98
The proposed amendment would not have applied to a patent issued prior to the date of enactment
of the Genetic Research and Accessibility Act.99 This legislation was not enacted. As well, the
Genomic Research and Diagnostic Disability Act of 2002 was introduced, but not enacted, in the
107th Congress.100 That legislation would have created a research exemption from infringement
for research on genetic sequence information and an infringement exemption for genetic
diagnostic testing.
93 Id. at 310.
94 Roger Schechter & John Thomas, Principles of Patent Law (2d ed. 2004), 33.
95 See CRS Report RS22516, Gene Patents: A Brief Overview of Intellectual Property Issues, by Wendy H. Schacht.
96 Nuffield Council on Bioethics, The Ethics of Patenting DNA—A Discussion Paper (2002).
97 R. Stephen Crespi, “Patenting and Ethics—A Dubious Connection,” 85 Journal of the Patent and Trademark Office
Society (2003), 31.
98 H.R. 977, § 2(a).
99 Id. at § 2(c).
100 H.R. 3967.
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Innovation Policy Issues
The patenting of business methods, tax strategies, genetic materials, and other sorts of post-
industrial technologies has raised controversy. Some observers have expressed concerns that these
sorts of inventions should not be patented, no matter how innovative they might be. They believe
that section 101 of the Patent Act, the provision governing patentable subject matter, should be
interpreted, and if necessary amended, to exclude these sorts of inventions from patenting.101
Others believe that these concerns are overstated. They further assert that the patenting of
inventions of the Information Age, as well as biotechnologies, will be beneficial for innovation
and competition.102 This report reviews some of the primary arguments that have been raised in
this debate.
Proponents of a broad notion of patentable subject matter assert that the patent system has
traditionally offered a powerful incentive for innovation across many industries. For example, the
chemical, electronics, manufacturing, telecommunications, and pharmaceutical industries are
among those that have long sought and enforced patents. In the view of these commentators, the
patent system will readily adapt to new fields of endeavor as well. Further, many inventions of
the 21st century—including business methods and genetic inventions—are as subject to costly
research and development efforts as more traditional technologies. Observers question why the
patent incentive exists in one field of costly research and development and not in another.103
The patent system also provides the benefit of public disclosure. In order to obtain patent rights,
inventors must fully disclose their inventions such that a skilled artisan could practice them
without undue experimentation.104 A patent system that denies protection to entire categories of
inventions may cause inventors to conceal them as trade secrets. In contrast to patenting, trade
secret protection does not result in the disclosure of publicly available information. Taking the
steps necessary to maintain secrecy, such as implementing physical security measures, also
imposes costs that may ultimately be unproductive for society.105
Another argument in favor of a broad notion of patentable subject matter is that distinguishing
patentable and unpatentable inventions may at times prove difficult. For example, the Bilski
opinion left open the “precise contours of machine implementation” needed to determine whether
a particular invention is patentable or not.106 Assessing whether a particular invention is
sufficiently technologically embedded to constitute patentable subject matter may not constitute a
straightforward, routine inquiry. Indeed, this standard may in some cases lead to artful claims
drafting. In view of the Bilski standard, for example, patent lawyers may attempt to make
101 See, e.g., Michael Moulton, “Effecting the Impossible: An Argument Against Tax Strategy Patents,” 81 Southern
California Law Review (2008), 631.
102 See, e.g., Lucas Osbron, “Tax Strategy Patents: Why the Tax Community Should Not Exclude the Patent System,”
18 Albany Law Journal of Science and Technology (2008), 325.
103 See, e.g., Christopher A. Harkins, “Throwing Judge Bryson’s Curveball: A Pro Patent View of Process Claims as
Patent-Eligible Subject Matter,” 7 John Marshall Review of Intellectual Property Law (2008), 701.
104 35 U.S.C. § 112 (2006).
105 See Robert G. Bone, “A New Look at Trade Secret Law: Doctrine in Search of Justification,” 86 California Law
Review (1998), 241.
106 See Robert A. Hulse & Robert R. Sachs, “Making Sense of the Revised Machine-or-Transformation Test in In re
Bilski,” 21 Intellectual Property & Technology Law Journal no. 10 (2009), 10.
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software inventions appear to be hard-wired machines. This reaction may ultimately make patents
more difficult to read and interpret.107
Supporters of an expansive patent system also observe that patents have been identified as
facilitators of markets. If inventors lack patent rights, they may have scant tangible assets to sell
or license. In addition, an inventor might otherwise be unable to police the conduct of a
contracting party. Any technology or know-how that has been disclosed to a prospective licensee
might be appropriated without compensation to the inventor. The availability of patent protection
decreases the ability of contracting parties to engage in opportunistic behavior. By lowering such
transaction costs, the patent system may make transactions concerning information goods more
feasible.108 Categorical exclusion of certain sorts of inventions from the patent system may deny
entire industries this potential benefit.
Studies have also indicated that entrepreneurs and small, innovative firms rely more heavily upon
the patent system than larger enterprises. Large firms often possess a number of alternative means
for achieving a proprietary interest in a particular technology. For example, trade secrecy, ready
access to markets, trademark rights, speed of development, and consumer goodwill may to some
degree act as substitutes for the patent system. However, individual inventors and small firms
often do not have these mechanisms at their disposal. As a result, the patent system may enjoy
heightened importance with respect to these enterprises.109
Legal experts also assert that patents do not provide the affirmative right to use the patented
invention, but rather the right to exclude others from doing so. This perspective implies that the
grant of patent neither implies government approval of an invention, nor allows meaningful
control of a technology. As a result, the grant of a patent on, for example, a particular tax strategy,
should not be deemed as an indication that the strategy is legally sound.110 Similarly, disallowing
patents on genetic materials would not necessarily suppress the technology as a general matter.111
Although these and other assertions weigh in favor of an ambitious scope of patentable subject
matter, other observers are less optimistic. Some commentators believe that innovation in areas
such as business methods, tax planning methods, and genetic materials has flourished even
though the availability of patent rights has been uncertain. For example, the American Institute of
Certified Public Accountants [AICPA] asserts that “[p]eople already have substantial incentives to
comply with tax law and lower their taxes.”112 Under this line of reasoning, the patent incentive is
unnecessary to promote a socially optimal level of innovation within these disciplines.
Other observers go further, believing that patents in these areas may not merely be unnecessary,
but also socially detrimental. With respect to business methods, some commentators believe that
these patents are commonly of such broad scope as to “effectively appropriate all possible
107 See Fusco, supra.
108 Paul J. Heald, “Optimal Remedies for Patent Infringement: A Transactional Model,” 45 Houston Law Review
(2008), 1165; Paul J. Heald, “A Transaction Costs Theory of Patent Law,” 66 Ohio State Law Journal (2005), 473.
109 Michael J. Meurer, “Inventors, Entrepreneurs, and Intellectual Property Law,” 45 Houston Law Review (2008),
1201.
110 See, e.g., Osbron, supra.
111 Robert P. Merges, “Intellectual Property in Higher Life Forms: The Patent System and Controversial Technologies,”
47 Maryland Law Review (1998), 1051.
112 AICPA, “Analysis and Legislative Proposals Regarding Patents for Tax Strategies” (February 28, 2007) (available
at http://tax.aicpa.org) (hereinafter “AICPA Analysis”).
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solutions to a particular problem.”113 This extent of proprietary rights may limit the ability of
others to design around the patented invention and ultimately discourage competition.114
With respect to tax strategy patents, some believe that an incentive to develop methods of
lowering one’s taxes is not socially desirable. William A. Drennan, a member of the law faculty at
Southern Illinois University, contrasts the grant of tax strategy patents with recent Treasury
Department Regulations that, in his view, “reduce the economic incentive to create tax
loopholes.”115 Mr. Drennan thus explains:
[O]ne government agency—the Treasury Department—is taking action to discourage
loopholes. In contrast, the Patent Office (at the direction of the Federal Circuit) is providing
a new incentive to create loopholes. Since the Treasury Department is in charge of the sound
administration of the U.S. tax system, the Treasury Department’s views on sound tax policy
should be given greater weight than the view of the Patent Office on this subject.116
Other experts believe that tax strategy patents are inappropriate because they are said to inject
private control over a system of public laws.117 Under this view, a patent may potentially grant
one individual the ability to prevent others from using a new tax provision. In turn, private actors
may affect the ability of federal, state, and local governments to raise revenue, influence taxpayer
behavior, and otherwise achieve the intended purposes of the tax laws.118 These concerns were
voiced by the AICPA in the following way:
Tax strategy patents also preempt Congress’s prerogative to have full legislative control over
tax policy. Congress enacts tax law provisions applicable to various taxpayers and intends
that taxpayers will be able to use them. Tax strategy patents thwart this Congressional intent
by giving tax strategy patent holders the power to decide how select tax law provisions can
be used and who can use them.119
Tax professionals have also expressed concerns over the impact of tax strategy patents upon their
own practices, as well as taxpayers in general. Some observers believe that the burdens of
investigating whether a taxpayer’s planned course of action is covered by a tax strategy patent,
determining whether the patent was providently granted by the USPTO, and potentially
negotiating with the patent proprietor in order to employ the strategy, will be costly and
impractical for many taxpayers.120 Further, because compliance with the tax laws and its self-
assessment system is obligatory for all citizens of the United States, the scope of this burden
could be considerable.121
113 David Kappos et al., “A Technological Contribution Requirement for Patentable Subject Matter: Supreme Court
Precedent and Policy,” 6 Northwestern Journal of Technology and Intellectual Property 152 (2008) at *57.
114 See Alexandra Wilson, “Business Method Patents Gone Wild: Narrowing State Street Bank and Shifting to a
European Perspective,” 12 Journal of Technology Law and Policy (2007), 71.
115 Drennan, supra, at 280.
116 Id.
117 See Richard S. Marshall, “Tax Strategy Patents—Legislative, Judicial and Other Developments,” 48 Tax
Management Memo (2007), 243.
118 Steve Seidenberg, “Taxation Innovation: Patent Office Receives Criticism for Issuing Patents on Tax Strategies,”
Inside Counsel (December 2006).
119 AICPA Analysis, supra, at 5.
120 Gary C. Bubb, “Patented Tax Strategies—Are You Serious?,” Rhode Island Lawyers Weekly (August 20, 2007).
121 Ellen P. Aprill, “Responding to Tax Strategy Patents,” American Bar Association Annual Meeting (August 11,
(continued...)
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Several additional objections have arisen to patenting the inventions of genetic materials. Some
individuals believe that patenting genetic materials devalues the worth and dignity of living
beings. These commentators believe that such patents would allow individuals to obtain an
ownership right in another sentient being. From this perspective, such a patent right is akin to
slavery and morally wrong. Human genetic materials in particular are instead deemed to be the
common heritage of humanity and therefore should be the subject of shared public ownership,
rather than proprietary rights.122
Patents on genetic materials have also been said to lead to possible deleterious effects on
healthcare and research related to healthcare. For example, some patents claim human genes that
indicate susceptibility to a particular disease and diagnostic tests for detecting that gene.
Observers question whether having only one proprietary diagnostic test for a particular disease
lies in the public interest. They also suggest that patent rights over a gene that is linked to a
particular disease might inhibit further research concerning that disease.123
Professors Heller and Eisenberg have also expressed the concern that the “tragedy of the
anticommons” may lead to the underuse of patented genetic resources. In their view, too many
overlapping intellectual property rights with respect to genetic materials may hinder research and
development, and ultimately the exploitation of potential future products. For example, one
enterprise might own a patent on a genomic DNA fragment, another on the corresponding protein,
and yet another on a diagnostic test for a genetic disease. In this circumstance, multiple owners
each have the right to exclude others and no one has an effective privilege of use. Development of
a commercial product in this situation may prove difficult or impossible.124
Additional assertions have been made both in support of a broad scope of patentable subject
matter, as well as in favor of restricting the scope of patenting. Unfortunately, no rigorous
analytical method allows for study of the role the patent system plays in promoting innovation,
investment, and competition. As a result, arguments for and against a broad scope of patentable
subject matter are difficult to quantify. Determining the precise scope of patentable subject matter
therefore remains a matter of legal reasoning, as informed by concerns over innovation and
competition policy.
Congressional Issues and Options
If Congress decides that the current rules with respect to patent eligibility are satisfactory, then no
action need be taken. Should Congress choose to take action, however, a number of options exist.
One possibility is an amendment to section 101 of the Patent Act stipulating that certain subject
matter is not patentable. Legislation introduced in the 111th Congress would take this step with
(...continued)
2007), 7.
122 Nuffield Council on Bioethics, “The Ethics of Patenting DNA: A Discussion Paper,” 22 (2002).
123 Id. at 40.
124 Michael A. Heller and Rebecca S. Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical
Research,” 280 Science (May 1, 1998), 698.
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respect to tax shelters,125 while legislation in the 110th Congress would have done so with respect
to nucleotide sequences.126
Another option is to allow patents on particular inventions to issue, but to limit the remedies
available to proprietors of such patents. The Patent Act currently stipulates that damages and
injunctions are not available for patent infringement caused by “a medical practitioner’s
performance of a medical activity” under certain circumstances.127 This provision could
potentially be amended to include other categories of inventions.
Other legislative responses are also possible. Congress could choose to track USPTO practices
with respect to patents on business methods, tax strategies, or genetic materials. In this respect,
commentators have proposed several reforms, including the hiring of USPTO examiners with
expertise in taxation or other sensitive areas.128 Congress could also encourage continued
cooperation between the USPTO and other federal agencies, such as the IRS, with expertise in
particular disciplines.
If legislation is contemplated, one international agreement that deserves consideration is the
World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property
Rights, commonly known as the TRIPS Agreement.129 As a WTO member, the United States has
committed to “give effect to the provisions of [the TRIPS] Agreement.”130 The TRIPS Agreement
provides that “patents shall be available for any inventions, whether products or processes, in all
fields of technology.”131 It further states that “patents shall be available and patent rights
enjoyable without discrimination as to ... the field of technology.”132 The TRIPS Agreement
additionally stipulates that WTO member states may exclude from patentability certain
inventions, in particular “diagnostic, therapeutic and surgical methods for the treatment of
humans and animals” and “plants and animals other than micro-organisms, and essentially
biological processes for the production of plants and animals other than non-biological and
microbiological processes.”133 Compliance with the TRIPS Agreement may place some limits on
the ability of WTO member states to legislate with respect to patentable subject matter.
Concluding Observations
The topic of patentable subject matter has raised a surprisingly heated debate in many contexts,
including business methods, tax strategies, and genetic materials. Many knowledgeable observers
have voiced strong objections to patents in these fields on a number of grounds. However, other
experts point to the lack of direct evidence that granting patents within these fields has
125 H.R. 1265, § 303; H.R. 2584, §1; S. 506, § 303.
126 Genomic Research and Accessibility Act, H.R. 977, § 2.
127 35 U.S.C. § 287(c) (2006).
128 Aprill, supra, at 21.
129 See Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement
Establishing the World Trade Organization, Annex 1C, art. 66, para. 1, Legal Instruments—Results of the Uruguay
Round vol. 31, 33 I.L.M. 81 (1994).
130 Id. at Art. 1, § 1.
131 Id. at Art. 27(1).
132 Id.
133 Id. at 27(3).
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persistently led to deleterious consequences, and instead believe that they potentially benefit
society. Although the patenting of business methods, tax strategies, and genetic materials has
generally been viewed on an individual basis, the policy issues raised in these debates share many
common themes. Collectively, these debates may promote further inquiry into the sorts of
inventions that may be appropriately patented.
Author Contact Information
John R. Thomas
Visiting Scholar
jrthomas@crs.loc.gov, 7-
0975
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