Scientific Research and the Experimental Use Privilege in Patent Law
CRS Report for Congress
Scientific Research and the
Experimental Use Privilege
in Patent Law
October 28, 2004
John R. Thomas
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress
Scientific Research and the
Experimental Use Privilege in Patent Law
Congress has identified research and development (R&D) as important
contributors to technological progress. The performance of R&D may have
intellectual property ramifications, however. To the extent that researchers use
patented inventions without authorization, they may face infringement liability.
Although the courts recognize an exception to patent infringement known as the
“experimental use privilege,” this judicially created doctrine has been described as
very narrow and rarely applied. In particular, the experimental use privilege applies
only to uses done for amusement, to satisfy idle curiosity or for strictly philosophical
inquiry. This doctrine does not excuse uses that are in keeping with the accused
infringer’s business objectives.
In 2002, the U.S. Court of Appeals for the Federal Circuit applied these
principles in the case of Madey v. Duke University. The court held that the
experimental use privilege does not apply to activities that are “in keeping with the
alleged infringer’s legitimate business” — even though the business of the defendant,
Duke University, was nonprofit research. This ruling has raised concerns among
some representatives of universities and research institutions, who fear that their
basic R&D activities will subject them to patent infringement lawsuits.
Competing views have arisen over the significance of the Madey v. Duke
University case. Some commentators believe that a limited experimental use
privilege may best encourage technological advancement by rewarding successful
researchers with robust patent rights. Others argue that the restricted nature of the
experimental use privilege may in fact limit researcher access to state-of-the-art
technologies and thus discourage further technological development. Still others
assert that this issue is not of great practical importance, as few patent owners will
likely file costly and time-consuming lawsuits against researchers who are not
making commercially important uses of patented inventions.
The judicially created, “common law” experimental use privilege is
complemented by a limited statutory experimental use privilege for patents on
pharmaceuticals, medical devices, and certain other products regulated by the Food
and Drug Administration. This provision, enacted as part of the 1984 Hatch-
Waxman Act, applies to firms seeking to market generic equivalents of brand-name
products. In addition, Congress has enacted other intellectual property legislation
that incorporates provisions shielding researchers from infringement liability.
Should congressional interest continue in this area, a variety of options are
available. If the current scope of the common law experimental use privilege is
deemed to be appropriate, then no action need be taken. Alternatively, Congress
could enact legislation confirming the limited experimental use privilege recognized
in Madey v. Duke University and predecessor cases. Introduction of a broader form
of the experimental use privilege into U.S. patent law is an additional possibility.
The report will be updated if events warrant such action.
Introduction to the Patent System.....................................3
Patent Acquisition and Enforcement...............................4
The Common Law Experimental Use Privilege..........................6
Experimental Use and Innovation Policy............................9
Statutory Experimental Use Privileges................................13
The Hatch-Waxman Act.......................................13
Legislative Issues and Alternatives...................................18
Scientific Research and the
Experimental Use Privilege in Patent Law
Congress has identified research and development (R&D) as important
contributors to technological advance.1 Technological improvements are in turn
acknowledged to be a driving force in the long-term economic expansion of the
United States. The federal government plays a role in funding R&D in the United
States, having appropriated an estimated $126 billion for federal R&D in 2004.2
Legislation has further encouraged technical cooperation among government,
academia, and the private sector during their R&D efforts.3
Although the issue has not commonly arisen, R&D activities may have
intellectual property implications. To the extent that researchers use another’s
patented invention without authorization, they may face liability for patent
infringement. While the courts recognize an exception to patent infringement known
as the “experimental use privilege,”4 this judicially created doctrine has been
described as “very narrow”5 and “only sparingly applied.”6 The experimental use
privilege allows a researcher to use a patented invention without permission from or
compensation to the patent owner. However, such a use must be “merely for
philosophical experiments, or for the purpose of ascertaining the sufficiency of the
[patented invention] to produce its described effects.”7 If the purpose of the research
falls outside these parameters, the “common law” experimental use privilege is
inapplicable, and the researcher may face liability for patent infringement.
1See CRS Report 95-50, The Federal Role in Technology Development, by Wendy H.
2See CRS Issue Brief IB10129, Federal Research and Development Funding: FY2005, by
Michael E. Davey, coordinator.
3See CRS Report RL32076, The Bayh-Dole Act: Selected Issues in Patent Policy and the
Commercialization of Technology, by Wendy H. Schacht; and CRS Report RL32324,
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry
Relationship, by Wendy H. Schacht.
4Janice M. Mueller, “No ‘Dilettante Affair’: Rethinking the Experimental Use Exception to
Patent Infringement for Biomedical Research Tools,” 76 Washington Law Review (2001),
5Michelle Cai, “Madey v. Duke University: Shattering the Myth of Universities’
Experimental Use Defense,” 19 Berkeley Technology Law Journal (2004), 175.
6Douglas v. United States, 181 U.S.P.Q. (BNA) 170, 176 (Ct. Cl. Tr. Div. 1974), aff’d on
other grounds, 184 U.S.P.Q. (BNA) 613 (Ct. Cl. 1975).
7Whittemore v. Cutter, 29 F. Cas. 1120 (C.C. Mass. 1813).
Congress has supplemented this “common law” experimental use privilege with
a statutory research exemption to patent infringement. Introduced as part of the
Hatch-Waxman Act,8 this exemption is limited to patented pharmaceuticals, medical
devices and certain other products regulated by the Food and Drug Administration
(“FDA”). It exempts from patent infringement clinical studies and other activities
performed in order to obtain FDA marketing approval.
Despite relatively limited judicial application of patent law’s experimental use
privilege, vigorous debate on the topic has persisted for many years.9 The 2002
judicial opinion in Madey v. Duke University reinvigorated this discussion.10 Here,
the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) rejected an
experimental use defense to a patent infringement lawsuit against Duke University.
The Federal Circuit held that the experimental use privilege does not apply to
infringing activities that are “in keeping with the alleged infringer’s legitimate
business” — even though Duke University’s “business” consisted of serving as a
nonprofit research institution. Although the experimental use privilege was not
formally eliminated in Madey v. Duke University, some commentators believe that
this infringement exception is so limited that it is practically nonexistent.11 This
decision has in turn raised concerns among some representatives of universities and
research institutions, who fear that their basic research activities will subject them to
patent infringement lawsuits.12
Both supporters and detractors of an expansive experimental use privilege
believe that this doctrine bears upon the fundamental goal of the patent system, the
promotion of innovation. A more narrow exception will result in broader intellectual
property rights. Robust patent rights potentially provide innovators with strong
incentives to invest in research and development.13 On the other hand, an overly
restrictive experimental use exception might conceivably depress technological
advancement by decreasing the ability of researchers to experiment with state-of-the-
art technology.14 Debate over the appropriate scope of the experimental use
exception has been particularly vigorous with respect to patents on cell lines, assays,
8See CRS Report RL30756, Patent Law and Its Application to the Pharmaceutical Industry:
An Examination of the Drug Price Competition and Patent Term Restoration Act of 1984
(“The Hatch-Waxman Act”), by Wendy H. Schacht and John R. Thomas.
9See Katherine J. Strandburg, “What Does the Public Get? Experimental Use and the Patent
Bargain,” 2004 Wisconsin Law Review 81.
10307 F.3d 1351 (Fed. Cir. 2002).
11See Jennifer Miller, “Sealing the Coffin on Experimental Use,” 2003 Duke Law &
Technology Review (May 7, 2003), 12.
12Lawrence M. Sung & Claire M. Maisano, “Piercing the Academic Veil: Disaffecting the
Common Law Exception to Patent Infringement Liability and the Future of a Bona Fide
Research Use Exemption After Madey v. Duke University,” 9 Journal of Health Care Law
and Policy (2003), 256.
13Jordan P. Karp, “Experimental Use as Patent Infringement: The Impropriety of a Broad
Exception,” 100 Yale Law Journal 2169 (1991).
14Rebecca S. Eisenberg, “Patents and the Progress of Science: Exclusive Rights and
Experimental Use,” 56 University of Chicago Law Review 1017 (1989).
and other “research tools” used primarily for the purpose of conducting
This report will explore the intellectual property laws and policies concerning
the patent law’s experimental use privilege. It begins with a review of patent policy
and procedures. The report then discusses current statutes and judicial precedent
governing the common law experimental use in patent law, as well as the potential
impact of this doctrine upon innovation policy. The report next reviews the statutory
experimental use privilege with respect to the Hatch-Waxman Act and other, more
specialized intellectual property statutes. This report closes with a summary of
congressional issues and alternatives.
Introduction to the Patent System
The goal of the patent system is to promote the production and dissemination
of technological information. Some observers believe that absent a patent system,
individuals and firms would be less likely to engage in research and development.
Without the availability of patent protection, new inventions could be easily copied
by “free riders” who incurred no cost to develop and perfect the technology involved,
and who would therefore be able to undersell the original inventor. The resulting
inability of inventors to capitalize on their inventions would lead to an environment
where too few inventions are made. By providing individuals with exclusive rights
in their inventions for a limited time, the patent system allows inventors to realize the
profits from their inventions.16
Other commentators believe that if the patent system were unavailable,
individuals would maintain their inventions as trade secrets so that competitors could
not exploit them. Trade secrets do not enrich the collective knowledge of society,
however, nor do they discourage others from engaging in duplicative research. The
patent system avoids these inefficiencies by requiring inventors to consent to the
disclosure of their inventions in issued patent instruments.17
Additional explanations for the patent laws have been offered. The Patent Act
may stimulate technological advancement by inducing individuals to “invent around”
patented technology. Issued patent instruments may point the way for others to
develop improvements, exploit new markets or discover new applications for the
15See, e.g., David C. Hoffman, “A Modest Proposal: Toward Improved Access to
Biotechnology Research Tools By Implementing a Broad Experimental Use Exception,” 89
Cornell Law Review (2004), 993.
16Roger E. Schechter & John R. Thomas, Principles of Patent Law § 1.3.1 (Thomson West
17See, e.g., Grant v. Raymond, 31 U.S. 218, 247 (1832).
patented technology.18 Moreover, the patent system may encourage patentees to
commercialize their proprietary technologies during the term of the patent. The
protection provided by a patent’s proprietary rights increases the likelihood a firm
will continue to refine, produce and market the patented technology.19 Finally, the
patent law has been identified as a facilitator of markets. Absent patent rights, an
inventor may have scant tangible assets to sell or license, and even less ability to
police the conduct of a contracting party. By reducing a licensee’s opportunistic
possibilities, the patent system lowers transaction costs and makes technology-based
transactions more feasible.20
The patent system has inspired numerous critics, however. Some detractors
have asserted that the patent system is unnecessary due to market forces that already
suffice to create an optimal level of invention. The desire to gain a lead time
advantage over competitors, as well as the recognition that technologically backward
firms lose out to their rivals, may well provide sufficient inducement to invent
without the need for further incentives.21 Others observe that the inventions that
fueled many dynamic sectors of modern industry, such as biotechnologies and
computer software, arose at a time when patent rights were unavailable or uncertain.22
While these justifications and criticisms have varying degrees of intuitive
appeal, none of them has been empirically validated. No authoritative study
conclusively demonstrates that society obtains more rapid technological development
with patents than it would without them. As a result, the rationales for, and
criticisms of, the patent system remain open to challenge.23
Patent Acquisition and Enforcement
As mandated by the Patent Act of 1952,24 U.S. patent rights do not arise
automatically. Inventors must prepare and submit applications to the U.S. Patent and25
Trademark Office (“USPTO”) if they wish to obtain patent protection. USPTO
18R. Polk Wagner, “Information Wants to Be Free: Intellectual Property and the Mythology
of Control,” 103 Columbia Law Review (2003), 995.
19F. Scott Kieff, “Property Rights and Property Rules for Commercializing Inventions,” 85
Minnesota Law Review (2000), 697.
20See Robert P. Merges, “Intellectual Property and the Costs of Commercial Exchange: A
Review Essay,” 93 Michigan Law Review (1995), 1570.
21See Frederic M. Scherer & David Ross, Industrial Market Structure and Economic
Performance (Rand McNally & Co., 3d ed. 1990).
22See, e.g., Pamela Samuelson, Benson Revisited: The Case Against Patent Protection for
Algorithms and Other Computer Program — Related Inventions, 39 Emory Law Journal
23CRS Report RL31951, Innovation, Intellectual Property, and Industry Standards, by John
24Pub. L. No. 82-593, 66 Stat. 792 (codified at Title 35 United States Code).
2535 U.S.C. § 111 (2000).
officials, known as examiners, then assess whether the application merits the award
of a patent.26 The patent acquisition process is commonly known as “prosecution.”27
In deciding whether to approve a patent application, a USPTO examiner will
consider whether the submitted application fully discloses and distinctly claims the
invention.28 In addition, the application must disclose the “best mode,” or preferred
way, that the applicant knows to practice the invention.29 The examiner will also
determine whether the invention itself fulfills certain substantive standards set by the
patent statute. To be patentable, an invention must be useful, novel and nonobvious.
The requirement of usefulness, or utility, is satisfied if the invention is operable and
provides a tangible benefit.30 To be judged novel, the invention must not be fully
anticipated by a prior patent, publication or other knowledge within the public
domain.31 A nonobvious invention must not have been readily within the ordinary
skills of a competent artisan at the time the invention was made.32
If the USPTO allows the patent to issue, the patent proprietor obtains the right
to exclude others from making, using, selling, offering to sell or importing into the
United States the patented invention.33 The term of the patent is ordinarily set at
twenty years from the date the patent application was filed.34 Patent title therefore
provides inventors with limited periods of exclusivity in which they may practice
their inventions, or license others to do so. The grant of a patent permits the inventor
to receive a return on the expenditure of resources leading to the discovery, often by
charging a higher price than would prevail in a competitive market.
Patent rights are not self-enforcing. A patentee bears responsibility for
monitoring its competitors to determine whether they are using the patented invention
or not. Patent proprietors who wish to compel others to observe their intellectual
property rights must usually commence litigation in the federal district courts.35 The
U.S. Court of Appeals for the Federal Circuit possesses exclusive national
jurisdiction over all patent appeals from the district courts,36 while the U.S. Supreme
2635 U.S.C. § 131 (2000).
27John R. Thomas, “On Preparatory Texts and Proprietary Technologies: The Place of
Prosecution Histories in Patent Claim Interpretation,” 47 UCLA Law Review (1999), 183.
2835 U.S.C. § 112 (2000).
3035 U.S.C. § 101 (2000).
3135 U.S.C. § 102 (2000).
3235 U.S.C. § 103 (2000).
3335 U.S.C. § 271(a) (2000).
3435 U.S.C. § 154(a)(2) (2000).
3535 U.S.C. § 281 (2000).
3628 U.S.C. § 1295(a)(1) (2000).
Court possesses discretionary authority to review cases decided by the Federal
The Common Law Experimental Use Privilege
Under the Patent Act of 1952, any individual who makes, uses, sells, offers to
sell, or imports into the United States a patented invention without the authorization
of the patent owner faces liability for infringement.38 Although the Patent Act
authorizes a number of defenses to a charge of patent infringement — such as that
the patented invention does not meet the statutory standards for patentability and was
improvidently awarded a patent by the USPTO39 — the statute does not expressly
authorize a generally applicable experimental use privilege. The federal courts have
nonetheless developed a “common law” experimental use privilege using their
Judicial decisions from the nineteenth century established the scope of the
experimental use privilege. In the first of these opinions, the 1813 case of
Whittemore v. Cutter,40 Justice Joseph Story explained that “it could never have been
the intention of the legislature to punish a man, who constructed such a machine
merely for philosophical experiments, or for the purpose of ascertaining the
sufficiency of the machine to produce its described effects.”41 Later, in Sawin v.
Guild,42 Justice Story explained that an unauthorized manufacture of a patented
invention was not an infringement unless it constituted “making with an intent to use
for profit, and not for the mere purpose of philosophical experiment, or to ascertain
the verity and exactness of the specification.” The 1861 decision in Peppenhausen
v. Falke further explained:
It has been held, and no doubt is now well settled, that an experiment with a
patented article for the sole purpose of gratifying a philosophical taste, or
curiosity, or for mere amusement, is not an infringement of the rights of the43
3728 U.S.C. §1254(1) (2000).
3835 U.S.C. § 271(a) (2000).
3935 U.S.C. § 282 (2000).
4029 F.Cas. 1120 (C.C.D.Mass.1813) (No. 17,600).
4129 F. Cas. at 1121.
4221 F. Cas. 554 (C.C.D. Mass 1813) (No. 12, 391).
4319 F. Cas. 1048, 1049 (C.C.S.D.N.Y. 1861).
This judicial conception of the experimental use privilege has been described
as “crabbed,”44 “narrowly construed”45 and “rarely sustained.”46 As explained in
numerous judicial opinions, the experimental use exception applies only to uses done
for amusement, to satisfy idle curiosity or for strictly philosophical inquiry.47 Any
use that is commercial in nature is not subject to the doctrine.48
The opinion of the Court of Claims in Pitcairn v. United States provides one
example of judicial views concerning the experimental use privilege.49 In that case,
the U.S. government was accused of infringing 59 patents relating to helicopters.
The government contended that various aircraft used only for purposes of testing and
demonstration should be held not to infringe. The court disagreed, explaining:
Defendant urges the court to exclude from compensation any aircraft used by the
defendant for testing, evaluational, demonstrational or experimental purposes.
Use for such purposes is use by or for the Government and is compensable.
Obviously every new helicopter must be tested for lifting ability, for the effect
of vibration on installed equipment, flight speed and range, engine efficiency,
and numerous other factors. Tests, demonstrations, and experiments of such
nature are intended uses of the infringing aircraft manufactured for the defendant
and are in keeping with the legitimate business of the using agency. Experimental50
use is not a defense in the present litigation.
This language further suggests that if the use furthers the user’s “legitimate business”
objectives, even in a tangential way, then it is not experimental.51
A 2002 decision on the experimental use privilege, Madey v. Duke University,52
reflects this narrow sense of the experimental use privilege. Here, Duke University
recruited Dr. John M.J. Madey from Stanford University in order to serve as a
research professor and director of a laser laboratory. A dispute ultimately led to
Madey’s resignation from Duke. After he left the university, Madey brought suit for
44James Boyle, “Foreward: The Opposite of Property,” Law & Contemporary Problems
(Winter/Spring 2003), 27.
45Kevin Sandstrom, “How Much Do We Value Research and Development: Broadening the
Experimental Use Exemption to Patent Infringement in Light of Integra Lifesciences I Ltd.
v. Merck KGaA, 30 William Mitchell Law Review (2004), 1067.
46Rebecca S. Eisenberg, “Proprietary Rights and the Norms of Science in Biotechnology
Research,” 97 Yale L. J. 177, 220 (1987).
47See, e.g., Radio Corp. of America v. Andrea, 15 F.Supp. 685, 30 USPQ 194 (E.D. N.Y.
48See, e.g., Cimotti Unharing Co. Derboklow, 87 F. 997, 999-1000 (C.C.E.D.N.Y. 1898).
49547 F.2d 1106 (Ct. Cl. 1976).
50547 F.2d at 1125-26.
51See also, e.g., Embrex Inc. v. Service Engineering Corp., 216 F.3d 1343 (Fed. Cir. 2000).
52307 F.3d 1351 (Fed. Cir. 2002).
infringement of two patents relating to the operation of specialized equipment used
in the Duke laser laboratory.53
Responding to Madey’s charges of patent infringement, Duke sought to take
advantage of the experimental use privilege. Duke explained that it was a non-profit
educational institution dedicated to teaching, research and the advancement of
knowledge. Duke further argued that it does not undertake research or development
work principally for the purpose of obtaining patents or designing products for the
marketplace. The district court agreed that the experimental use privilege applied
and ruled in favor of Duke.54
On appeal, the Federal Circuit reversed the district court’s experimental use
determination. The Court of Appeals characterized the experimental use privilege
as “very narrow and strictly limited.”55 In particular, the Federal Circuit observed
that the experimental use privilege “does not immunize any conduct that is in
keeping with the alleged infringer’s legitimate business, regardless of commercial
implications.”56 It further explained that:
Major research universities, such as Duke, often sanction and fund research
projects with arguably no commercial application whatsoever. However, these
projects unmistakably further the institution’s legitimate business objectives,
including educating and enlightening students and faculty participating in these
projects. The projects also serve, for example, to increase the status of the57
institution and lure lucrative research grants, students and faculty.
As a result, the Federal Circuit held that the district court had resolved the case based
upon an inappropriately expansive view of the experimental use privilege. It
remanded the litigation back to the district court, with instructions to resolve the
issue in light of the Federal Circuit’s decision.58
Many patent law experts agree that following the Madey v. Duke
University case, colleges, universities and other academic institutions are unlikely to
be able to rely upon the common law experimental use privilege as a defense to a59
charge of patent infringement. Co-authors Lawrence Sung, then a member of the
University of Maryland Law School faculty, and attorney Claire M. Maisano
explained that the “decision in Madey leaves grave doubt that the common law
exemption to patent infringement liability can act as a safe harbor for any academic
53307 F.3d at 1352-53.
54266 F. Supp. 2d 420 (M.D.N.C. 2001).
55307 F.3d at 1361.
56307 F.3d at 1362.
58307 F.3d at 1362-63.
59See Tom Saunders, “Renting Space on the Shoulders of Giants: Madey and the Future of
the Experimental Use Doctrine,” 113 Yale Law Journal (2003), 261 (concluding that Madey
“reformulated the experimental use doctrine and cast considerable doubt on its continued
viability as a defense in patent infringement cases involving universities”).
research effort.”60 Commentator Michelle Cai further opined that “practically any
project conducted by a research university, even one without any commercial
implications, would be in keeping with the university’s legitimate business interests
and hence would not qualify for the experimental use defense.”61
Observers generally agree that Madey v. Duke University either retains, or
perhaps restricts to an even greater degree, the quite limited nature of the common
law experimental use privilege as it might be applied outside of academic settings.62
Attorneys Paul Devinksy and Mark G. Davis concluded that the opinion is consistent
with previous judicial interpretations of the common law experimental use privilege.
As a result the privilege “lives on as a narrow defense to a claim of infringement.”63
Other observers would go further. Ms. Cai states, for example, that the decision “has
essentially destroyed any practical meaning to the experimental use defense.”64
Attorneys Cathryn Campbell and R.V. Lupo are in accord, stating that after Madey
v. Duke University “the Experimental Use Exception would appear to provide little,
if any protection in today’s world.”65
Experimental Use and Innovation Policy
Although the experimental use privilege has been part of the patent law for
many years, the Madey v. Duke University opinion has renewed dialogue over the
propriety and scope of this infringement exemption. Proponents and detractors of a
broad experimental use privilege, as well as those who do not believe the doctrine is
important as a practical matter, have expressed diverse opinions. This report
summarizes these competing views.
Some commentators believe that a broad experimental use privilege is
inappropriate as a matter of technology policy. Under this view, a liberal
experimental allowance would greatly ease the ability of competitors to “design
around” the invention or develop competing technologies. Patent owners in turn
would be less able to appropriate the returns of their investments in research and
development, this account continues, and would therefore be discouraged from
60Sung & Maisano, supra note 10.
61Cai, supra note 5.
62See Michael R. Taylor & Jerry Cayford, “American Patent Policy, Biotechnology, and
African Agriculture: The Case for Policy Change,” 17 Harvard Journal of Law &
Technology (2004), 321 (“In a recent decision, the U.S. Court of Appeals for the Federal
Circuit narrowed the [common law experimental use] exemption to the point of eliminating
it for practical purposes.”).
63Paul Devinksy & Mark G. Davis, “2003 Patent Law Decisions of the Federal Circuit,” 53
American University Law Review (2004), 773, 883.
64Cai, supra note 5.
65Cathryn Campbell & R.V. Lupo, “Exemption to Patent Infringement Under 35 U.S.C.
Section 271(e)(1): Safe Harbor or Storm A-Brewing?,” 5 Sedona Conference Journal
making future investments in research and development.66 As attorney Jordan Karp
concludes: “Rather than spurring increased innovative activity, a broad experimental
use exception would have just the opposite effect.”67
For some observers, a broad experimental use privilege is inappropriate even
when research takes place within an academic research setting. This is because
university research is often not isolated from the private sector, but instead may have
significant commercial implications.68 As stated by two senior officers of the
USPTO, the Madey v. Duke University decision “recognized a basic economic truth
underlying research performed by large universities — it is a business, and
universities derive substantial commercial value from that research.”69
Indeed, some commentators believe that university research is increasingly
likely to have commercial implications. This shift is believed to be due in part to
federal legislation commonly known as the Bayh-Dole Act.70 The Bayh-Dole Act
aims to encourage the commercialization of basic research by allowing universities
and small businesses to procure patents on inventions that result from federally
funded research. Since the passage of the Bayh-Dole Act, many research universities
have developed patent portfolios and garnered significant royalties from intellectual
property licensing.71 Because academic institutions are increasingly benefitted from
the patent system, some observers reason, they should also be held accountable when
they infringe the patents of others.72
In contrast, others believe that the common law experimental use privilege is
overly narrow. They assert that the current scope of this doctrine too greatly restricts
the ability of innovators to “tinker” with the developments of others.73 Under this
view, research may be chilled if scientists cannot experiment upon state-of-the-art
technology free from charges of patent infringement. By limiting the tools with
which researchers can work, these commentators say, the patent system could
ultimately depress, rather than promote innovation.74
66Karp, supra note 13.
68Cai, supra note 5.
69Stephen G. Kunin & Linda S. Therkorn, “Workship on Future Public Policy and Ethical
Issues Facing the Biotechnology Industry,” 86 Journal of the Patent and Trademark Office
Society (2004), 503.
70Act of Dec. 12, 1980, Pub. L. No. 96-517, 94 Stat. 3015.
71See Schacht, supra note 3.
72See Traci Dreher Quigley, “Commercialization of the State University: Why the
Intellectual Property Restoration Act of 2003 Is Necessary,” 152 University of Pennsylvania
Law Review (2004), 2001.
73See Eisenberg, supra note 14.
74See Maureen A. O’Rourke, “Toward a Doctrine of Fair Use in Patent Law,” 100 Columbia
Law Review (2000), 1177.
Other observers believe that limiting the experimental use privilege with respect
to universities and nonprofit institutes could impede academic research. Some
university-based scientists believe that, unlike some of their counterparts in the
private sector, academic researchers have all but ignored the patent system.75 In order
to avoid patent infringement, universities may have to devote scarce resources to
perform costly patent searches and engage in licensing negotiations with patent
holders. To a greater extent than profit-seeking firms, educational institutions may
find that these obligations weigh heavily on their frequently tight budgets.76
Several legal scholars have suggested that the holding of Madey v. Duke
University raises particular concerns with regard to patented research tools. A
“research tool” is an invention, such as a particular cell line, reagent, or antibody, that
is used exclusively or primarily for the purpose of conducting scientific research.77
Some observers believe that patents are too frequently granted on research tools,
particularly in biotechnology, and that such patents may impede future advancement.
For example, two members of the University of Michigan Law School faculty,
Michael A. Heller and Rebecca S. Eisenberg, have concluded that researchers might
someday need to obtain numerous patent licenses in order to conduct basic research.78
The costs and complications of engaging in numerous patent transactions may
potentially create an “anti-commons”: an environment where resources that could be
committed towards further research and development are inefficiently under-
utilized.79 Under this view, the narrowly cabined experimental use privilege
contemplated in Madey v. Duke University strengthens patents on research tools and
might make research and development more difficult to accomplish.80
Notably, other scholars contest these theories. For example, F. Scott Kieff, a
member of the law faculty of Washington University in St. Louis, asserts that this
scenario is incorrect as a matter of individual incentives.81 Rational patent holders
should always encourage others to research with their technologies, Kieff explains,
so as to increase the number of applications for their inventions and hence their own
profits. Wesley M. Cohen, an academic at the Fuqua School of Business at Duke
University, has also conducted empirical research suggesting that although the “anti-
75John P. Walsh et al., “Working Through the Patent Problem,” 299 Science 1021, 1021
(2003) (“[Research universities] have largely ignored the growing number of patents
covering technology that their scientists use without license and without apology.”).
76Miller, supra note 11.
77Natalie M. Derzko, “In Search of a Compromised Solution to the Problem Arising From
Patenting Biomedical Research Tools,” 20 Santa Clara Computer & High Technology Law
Journal (2004), 347.
78Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The
Anticommons in Biomedical Research, 280 Science 698 (1998).
80Strandburg, supra note 9.
81F. Scott Kieff, “Facilitating Scientific Research: Intellectual Property Rights and the
Norms of Science — A Response to Rai and Eisenberg,” 95 Northwestern Law Review
commons” environment posited by Heller and Eisenberg may be theoretically
possible, to date it has not actually occurred.82
Other commentators believe that “scientists recognize the benefits of sharing
materials freely whenever possible and have developed informal norms to achieve
broad dissemination of research tools.”83 For example, the National Institutes of
Health (“NIH”) has issued “Principles and Guidelines” in order to promote the broad
use of patented research tools in biotechnology. 84 In particular, the NIH encourages
patent proprietors to license their proprietary research tools in such a way as to
minimize restrictions upon their use. Although the Principles and Guidelines
formally apply only to recipients of federal funding, the NIH has urged the entire
biotechnology community to adopt similar policies “so that all biomedical research
and development can be synergistic and accelerated.”85
Finally, a third set of commentators remain agnostic about the propriety of an
experimental use privilege, but believe that this issue is not of great importance for
practical reasons. Patent infringement litigation is widely regarded as costly, time-
consuming and complex.86 There may be insufficient economic justification to
commence litigation against individuals who are not making commercially important
uses of patented inventions. As a result, patent infringement suits may only rarely
be brought against hobbyists, philosophers and noncommercial defendants, regardless
of how narrowly or broadly the experimental use privilege is defined. 87
It is also important to remember that the patent law may, in certain
circumstances, provide researchers with the ability to use products even though they
have been patented by others. One of these principles is known as the “exhaustion”
doctrine. Under this legal rule, once a patent owner has sold a patented product, he
cannot control the use of that particular product. Any patent rights in that specific
physical item are said to have been “exhausted” by this initial sale. Sometimes the
exhaustion principle is termed the “first sale” doctrine.88
82J. Walsh, A. Arora and W.M. Cohen, “The Patenting and Licensing of Research Tools and
Biomedical Innovation,” Mimeo, National Academy of Sciences, October, 2001.
83Heather Hamme Ramirez, “Defending the Privatization of Research Tools: An
Examination of the “Tragedy of the Anticommons” in Biotechnology Research and
Development,” 53 Emory Law Journal (2004), 362.
84Department of Health and Human Services, National Institutes of Health, “Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources,” 64 Fed. Reg. 72,090 (Dec. 23, 1999).
85Id. at 72,090.
86See, e.g., Kimberly A. Moore, “Are District Court Judges Equipped to Resolve Patent
Cases?,” 15 Harvard Journal of Law and Technology (2001), 1.
87Andrew J. Caruso, “The Experimental Use Exception: An Experimentalist’s View,” 14
Albany Journal of Law, Science & Technology (2003), 217.
88CRS Report RL32400, Patents and Drug Importation, by John R. Thomas.
For example, suppose that a pharmaceutical firm wished to analyze a drug
that had been patented by another. That firm might wish to confirm the drug’s
biological activity, identify new medical indications, or compare its pharmacological
profile to those of other compounds. If the firm is able simply to purchase the
patented drug on the open market, then no issues of patent infringement will
ordinarily arise. Any patent on the drug is exhausted once the drug has been sold,
allowing the purchasing firm to use the patented drug as it wishes. The scope of the
experimental use privilege is irrelevant in this scenario.89
On the other hand, suppose that a patented drug is not available for purchase
within the market. In order to experiment with that compound, a pharmaceutical firm
must synthesize it within its own laboratories. This step would be an act of patent
infringement, however, because the right to make a patented invention is exclusive
to the patent owner.90 In this case the experimental use privilege would, at least
theoretically, come into play as a possible defense to patent infringement.
Statutory Experimental Use Privileges
The existence, possible scope and importance of the common law
experimental use privilege in patent law remains the subject of considerable debate.
However, it should be noted that the Patent Act of 1952 includes a limited statutory
experimental use privilege for patents on pharmaceuticals, medical devices, and
certain other products regulated by the Food and Drug Administration (FDA). This
provision, enacted as part of 1984 legislation known as the Hatch-Waxman Act,91
applies to firms seeking to market generic equivalents of brand-name products. In
addition, Congress has enacted other intellectual property legislation that
incorporates provisions shielding researchers from infringement liability. This report
considers these topics in turn.
The Hatch-Waxman Act
The Hatch-Waxman Act for the first time introduced a statutory experimental
use privilege into the patent laws. This privilege applies only to certain products —
notably specific kinds of pharmaceuticals and medical devices — that are regulated
by the FDA. Firms must obtain FDA approval in order to market these products.
Ordinarily the FDA will approve only of those products that have been proven to be
safe and effective through laboratory, animal and clinical investigations.92 Such
89Edward T. Lentz, “Pharmaceutical and Biotechnology Research After Integra and Madey,”
9035 U.S.C. § 271(a) (2000).
91Pub. L. No. 98 — 417, Title II, 98 Stat. 1585 (Sept. 28, 1984).
92CRS Report RL30989, The U.S. Drug Approval Process: A Primer, by Blanchard Randall
studies can be costly and time-consuming. In some cases, the effort to obtain FDA
marketing approval requires many years to complete.93
Many firms wish to sell drugs or medical devices that are “generic” — that
is to say, equivalent to a product that was first developed and sold under a brand
name by a different company. Prior to Hatch-Waxman Act, generic firms faced two
notable difficulties in getting their products to market. First, generic firms ordinarily
had to conduct the same sort of expensive and lengthy clinical investigations as their
brand-name counterparts in order to obtain FDA marketing approval. This
requirement existed even in circumstances where the generic drug was chemically
identical to a brand-name drug of widely acknowledged safety and effectiveness.94
Second, generic firms had to account for the patents owned by their brand-
name competitors. As of the early 1980’s, legal uncertainty existed as to whether a
generic firm could conduct clinical trials at all if a brand-name firm held patents on
the drug or medical device. As part of the FDA marketing approval process, the
generic firm would need to both make and use the patented drug or device —
activities that under the intellectual property laws are exclusive to the patent
proprietor.95 The result was that a generic firm could be sued for patent infringement
and, at least until the relevant patents expired, enjoined from engaging in the
activities it needed to perform in order to satisfy FDA marketing approval
Some generic drug and medical device firms sought to rely upon the common
law experimental use privilege in this situation. Their position was that activities
performed in order to fulfill FDA marketing approval standards were merely
experimental in nature, and as a result should be exempted from patent
infringement.96 Whether the courts would uphold this argument remained an open
legal question for many years.
Eventually this issue came before the Federal Circuit, which in 1984 issued
its decision in Roche Products, Inc. v. Bolar Pharmaceutical Co.97 Here the Federal
Circuit conclusively held that the common law experimental use privilege did not
shield generic firms engaged in FDA marketing approval activities from charges of
patent infringement. In this case, Roche Products, Inc. (“Roche”) marketed a
prescription sleeping pill under the trademark “Dalmane.” Roche also was the
proprietor of a patent claiming a chemical compound, flurazepam hcl, that was the
93See Shashank Upadhye, “Understanding Patent Infringement Under 35 U.S.C. § 271(e)(1):
The Collisions Between Patent, Medical Device, and Drug Laws,” 17 Santa Clara Computer
& High Technology Law Journal (2000), 1.
94See Janet A. Gongola, “Prescriptions for Change: The Hatch-Waxman Act and New
Legislation to Increase the Availability of Generic Drugs to Consumers,” 36 Indiana Law
Review (2003), 787.
9535 U.S.C. § 271(a) (2000).
96Alfred B. Engelberg, “Special Patent Provisions for Pharmaceuticals: Have They Outlived
Their Usefulness?,” 39 IDEA: Journal of Law and Technology (1999), 389.
97733 F.2d 858 (Fed. Cir. 1984).
active ingredient in Dalmane. Bolar Pharmaceutical Co. (“Bolar”), a manufacturer
of generic drugs, grew interested in marketing a generic equivalent of Dalmane.
Prior to the expiration of Roche’s patent, Bolar obtained a supply of flurazepam hcl
from a foreign manufacturer. It began to form the flurazepam hcl into dosage form
capsules to obtain stability data, dissolution rates, bioequivalency studies and blood
serum studies necessary to obtain marketing approval from the FDA.98
The Federal Circuit concluded Bolar’s activities infringed the Roche patents,
and that the experimental use defense did not apply. The Court of Appeals reasoned:
Bolar’s intended “experimental” use is solely for business reasons and not
for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.
Bolar’s intended use of flurazepam hcl to derive FDA required test data is
thus an infringement of the [Roche] patent. Bolar may intend to perform
“experiments,” but unlicensed experiments conducted with a view to the
adaptation of the patented invention to the experimentor’s business is a
violation of the rights of the patentee to exclude others from using his
patented invention. It is obvious here that it is a misnomer to call the
intended use de minimus. It is no trifle in its economic effect on the parties
even if the quantity used is small. It is not a dilettante affair such as Justice
Story envisioned. We cannot construe the experimental use rule so broadly
as to allow a violation of the patent laws in the guise of “scientific inquiry,”
when that inquiry has definite, cognizable, and not insubstantial99
Congress responded to Roche v. Bolar by enacting the statute commonly
known as the Hatch — Waxman Act. The statute introduced a number of changes
to both the patent law and the food and drug law.100 Among them was an accelerated101
marketing approval process for generic products. In addition, the Hatch-Waxman
Act created a statutory exemption from patent infringement for activities associated
with regulatory marketing approval. As originally enacted and codified in 35 U.S.C.
§ 271(e)(1), the Hatch-Waxman Act exempted from patent infringement “uses
reasonably related to the development and submission of information under a Federal
law which regulates the manufacture, use, or sale of drugs.” Through the Generic
Animal Drug and Patent Term Restoration Act, which became effective on
November 16, 1988, Congress extended this provision to cover regulated veterinary102
drugs and biological products as well.
A number of significant judicial opinions have interpreted the Hatch-Waxman
Act’s experimental use privilege. The U.S. Supreme Court opinion in Eli Lilly and
98733 F.2d at 860.
99733 F.2d at 863.
100See CRS Report RL30756, Patent Law and Its Application to the Pharmaceutical
Industry: An Examination of the Drug Price Competition and Patent Term Restoration Act
of 1984 (“Hatch-Waxman Act”), by Wendy H. Schacht and John R. Thomas.
10121 U.S.C. § 355(j) (2000).
102Pub. L. No. 100-670, 102 Stat. 3971.
Co. v. Medtronic clarified the sorts of products that are covered by this statute.103 In
that case, Eli Lilly, which owned a patent claiming a cardiac defibrillator, filed an
infringement action against Medtronic for its use of a similar device. Medtronic in
turn pointed to 35 U.S.C. § 271(e)(1), arguing that Medtronic’s use of the
defibrillator was reasonably related to obtaining data for FDA approval. Eli Lilly in
turn argued that the wording of 35 U.S.C. § 271(e)(1) — as it was at the time — only
expressly referred to “drugs,” not “medical devices.”104
The Supreme Court sided with Medtronic, concluding that all of the products
eligible for patent term extension under the Hatch-Waxman Act fall within the scope
of the 35 U.S.C. § 271(e)(1) experimental use privilege. Justice Scalia concluded
that the statutory phrase “a Federal law which regulates the manufacture, use, or sale
of drugs” meant the entirety of the Food, Drug and Cosmetic Act, which regulates
drugs but also covers medical devices and other products. As a result of the Eli Lilly
and Co. v. Medtronic holding, 35 U.S.C. § 271(e)(1) extends to a range of subject
matter, including pharmaceuticals, medical devices, food additives, color additives,
and biological products. A generic firm may therefore use these products during the
term of another’s patent without fear of infringement liability, as long as the use is
reasonably related to obtaining data for FDA approval.105
Other noteworthy judicial opinions have considered the nature of the
activities that are exempted by the Hatch-Waxman Act privilege. The leading
decision in Intermedics, Inc. v. Ventritex, Inc. interpreted the statutory exemption
generously.106 According to the Intermedics decision, “[w]here it would have been
reasonable, objectively, for an accused infringer to believe that there was a decent
prospect that the use in question would contribute (relatively directly) to the
generation of information that was likely to be relevant in the processes by which the
FDA would decide to approve the product,”107 then the court should apply the 35
U.S.C. § 271(e)(1) infringement exemption. Following Intermedics, a number of
other decisions have found that the accused infringer’s activities fall within the
statutory experimental use exemption.108
The Hatch-Waxman experimental use privilege is not without limit, however.
A 2003 Federal Circuit decision, Integra Lifesciences, I, Ltd. v. Merck,109 held that
the 35 U.S.C. § 271(e)(1) experimental use exemption did not apply under the facts
before the court. Here, Integra sued Merck for infringement of several patents
103496 U.S. 661 (1990).
104496 U.S. at 665-66.
105See Patricia Nussle, “Eli Lilly & Co. v. Medtronic Inc.: A Case of Statutory
Interpretation,” 54 Ohio State Law Journal (1992), 645.
106775 F.Supp. 1269 (N.D. Cal. 1991), aff’d, 991 F.2d 808 (Fed.Cir.1993).
107775 F. Supp. at 1280.
108See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir. 1997); Glaxo, Inc. v.
Novopharm, Ltd.,110 F.3d 1562 (Fed. Cir.1997); Amgen, Inc. v. Hoechst Marion Roussel,
Inc., 3 F.Supp.2d 104 (D. Mass.1998).
109331 F.3d 860 (Fed. Cir. 2003).
relating to compounds thought to eliminate tumor growth and for treating a variety
of other diseases. In turn, Merck asserted 35 U.S.C. § 271(e)(1) as a defense. The
district court held that the Scripps-Merck activity did not fall under the 35 U.S.C. §
The Federal Circuit affirmed the district court on appeal. The Federal Circuit
observed that Merck’s experiments did not supply information for submission to the
FDA. Rather, Merck conducted these experiments in order to determine which of
several compounds was the best drug candidate to subject to future testing.111 The
court then reasoned that such activities were not conducted “solely for purposes
reasonably related to the development and submission of information under federal
law,” as the statutory exemption required. Rather, they were early-stage, exploratory
experiments performed merely to identify promising pharmaceutical compounds.112
The Integra Lifesciences decision makes clear that the 35 U.S.C. § 271(e)(1)
exemption does not apply to all exploratory research, but is instead a “narrowly
tailored” exemption intended to have a “de minimis impact on the patentee’s right to
Although the Hatch-Waxman Act awards limited experimental use privileges
with respect to patents on certain drugs, medical devices, and other products
regulated by the FDA, the Patent Act of 1952 does not provide for a more broadly
oriented experimental use privilege. However, Congress has enacted a number of
specialized intellectual property statutes that expressly incorporate a more
comprehensive experimental use doctrine. For example, the Plant Variety Protection
Act allows the Department of Agriculture to issue plant variety certificates on
sexually reproducible plants.114 These certificates provide their owner with the
exclusive right to “exclude others from selling the variety, or offering it for sale, or
reproducing it, importing, or exporting it, or using it in producing (as distinguished
from developing) a hybrid or different variety therefrom.”115 The statute does include
a research exemption, however, stipulating that “[t]he use and reproduction of a
protected variety for plant breeding or other bona fide research shall not constitute
an infringement of the protection provided under this chapter.”116
110Integra Lifesciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (S.D. Cal. 1999).
111331 F.3d at 863.
112331 F.3d at 866.
113331 F.3d at 867.
114Pub. L. No. 91-577, 84 Stat. 1542 (1970) (codified at 7 U.S.C. §§ 2321-2583). See CRS
Report RL31568, Plants, Patents and Seed Innovation in the Agricultural Industry, by John
1157 U.S.C. § 2483(a).
1167 U.S.C. § 2544 (2000).
Another specialized intellectual property statute, the Semiconductor Chip
Protection Act of 1984,117 allows individuals to claim exclusive rights in “mask
works” — circuitry designs used on a computer or other semiconductor chip.118 It is
an act of infringement either to reproduce these mask works, or to sell or import a
semiconductor chip embodying a protected mask work.119 However, this legislation
expressly exempts those individuals who “reproduce the mask work solely for the
purpose of teaching, analyzing, or evaluating the concepts or techniques embodied
in the mask work or the circuitry, logic flow, or organization of components used in
the mask work.”120
A third example is provided by the Vessel Hull Design Protection Act.121
This legislation, which allows designers of an original boat hull to register their
designs with the federal government, incorporates an experimental use privilege
similar to that of the Semiconductor Chip Protection Act. Under the Vessel Hull
Design Protection Act, individuals who make, use, sell or import the protected design
without the authorization of the registered design owner may be subject to
infringement liability.122 Yet the statute expressly exempts from infringement those
uses “solely for the purpose of teaching, analyzing, or evaluating the appearance,
concepts, or techniques embodied in the design, or the function of the useful article
embodying the design.”123
Legislative Issues and Alternatives
Should congressional interest continue in this area, a variety of options are
available. If the current scope of the common law experimental use privilege is
deemed to be appropriate, then no action need be taken. Alternatively, Congress
could enact legislation confirming the narrowly cabined view of the experimental use
privilege as set forth in Madey v. Duke University and predecessor cases.
If reform of the experimental use privilege is deemed prudent, however,
another possibility is the introduction of some additional form of the experimental
use privilege into the Patent Act of 1952. This infringement exemption could
supplement or replace the narrow experimental use privilege introduced by the
Hatch-Waxman Act. One option is to incorporate a generally applicable privilege of
the sort contemplated by the proposed, but unenacted Patent Competitiveness and
117Pub. L. No. 98-620, 98 Stat. 3347.
11817 U.S.C. § 901 (2000).
11917 U.S.C. § 905 (2000).
12017 U.S.C. § 906(a)(1) (2000). See Lee Hsu, “Reverse Engineering Under the
Semiconductor Chip Protection Act: Complications for Standard of Infringement,” 5 Albany
Law Journal of Science and Technology (1996), 249.
121Pub. L. No.105-304 , 112 Stat. 2905.
12217 U.S.C. § 1308 (2000).
12317 U.S.C. § 1309(g) (2000). The Digital Millennium Copyright Act provides another
example of a statutory experimental use privilege. See 17 U.S.C. § 1201 (2000).
Technological Innovation Act of 1990. H.R. 5598 was introduced before the 101st
Congress on September 12, 1990. Section 402 of that bill provided:
It shall not be an act of infringement to make or use a patented invention
solely for research or experimentation purposes unless the patented
invention has a primary purpose of research or experimentation. If the
patented invention has a primary purpose of research or experimentation,
it shall not be an act of infringement to manufacture or use such invention
to study, evaluate, or characterize such invention or to create a product
outside the scope of the patent covering such invention.
H.R. 5598 was reported by the House Judiciary Committee on October 26, 1990.
Other intellectual property statutes, including the Plant Variety Protection Act,
Semiconductor Chip Protection Act, and the Vessel Hull Design Protection Act, also
provide examples of the manner in which a generally applicable statutory
experimental use privilege could be drafted.
A more limited statutory experimental use privilege presents another law
reform option. Such a privilege might be limited to patented inventions that arise in
particular technological fields, in the fashion of the proposed, but unenacted
Genomic Research and Diagnostic Accessibility Act of 2002. H.R. 3967 would have
exempted from patent infringement the use of genetic sequence information for
purposes of research. In addition, this bill would have limited the remedies that the
owner of a patent on genetic diagnostic testing could obtain during infringement
litigation. Following its introduction in the 107th Congress on March 14, 2002, H.R.
3967 was referred to the Subcommittee on Courts, the Internet and Intellectual
Property on May 6, 2002, but no further action was taken.
Another possibility would be to limit the experimental use privilege to
patented research tools, in whatever technological field they might arise. Yet another
option is to grant an experimental use privilege in favor of universities or non-profit
research institutions, but retain the current law of experimental use with respect to
Consideration of any sort of statutory reform with respect to experimental use
privilege should take into account the Agreement on Trade-Related Aspects of
Intellectual Property Rights.124 The United States is a signatory to the so-called
“TRIPS Agreement,” which is a component of the international agreements that form
the World Trade Organization (WTO). The TRIPS Agreement in part requires its
signatories to grant patent owners the right to exclude others from making, using,
offering for sale, selling, or importing a patented invention.125 Further, under Article
27 of the TRIPS Agreement, such rights must be “enjoyable without discrimination
as to the place of invention, the field of technology and whether products are
imported or locally produced.”
124Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994,
Annex 1C, 33 I.L.M. 1197 (1994) (“TRIPS Agreement”).
125TRIPS Agreement, Article 27(1).
The TRIPS Agreement does allow member states to limit patent rights under
certain circumstances, however. As stated in Article 30 of the TRIPS Agreement:
Members may provide limited exceptions to the exclusive rights conferred
by a patent, provided that such exceptions do not unreasonably conflict
with a normal exploitation of the patent and do not unreasonably prejudice
the legitimate interests of the patent owner, taking account of the legitimate
interests of third parties.
Article 30 presumably allows its signatories to provide for a generally applicable
experimental use privilege. Many WTO members, including Germany,126 Japan127
and the United Kingdom,128 already incorporate such a privilege into their patent
statutes. However, a more limited form of the experimental use privilege may raise
concerns under the non-discrimination provision of Article 27. To the extent that the
experimental use privilege is available for some sorts of inventions and not others,
it may conflict with the Article 27 obligation not to discriminate as to the “field of
technology” in which a patentable invention arises.129
Finally, the experimental use privilege need not be an all-or-nothing
proposition. Another option is to grant researchers the ability to experiment with the
patented inventions of others — provided they compensate the patent holder at a
specified royalty rate. This regime would effectively amount to a “compulsory
license” available to researchers.130 Janice Mueller, a member of the faculty of the
University of Pittsburgh Law School, posits that this approach would ensure “a
royalty award of sufficient amount to maintain incentives for the development and
patenting of new research tools, yet [alleviate] the access restrictions and up-front
126German Patent Act, Article 11, § 2. See Klinische Versuche (Clinical Trials) II (Case X
ZR 68/94), Federal Supreme Court of Germany, BGHZ 135, 217,  R.P.C. 423.
127Japanese Patent Act § 69(1), available at [http://www.jpo.go.jp/shoukaie/patent.htm].
128United Kingdom Patent Act, 1977, ch. 37, § 60(5)(b) (Eng.), reprinted in U.K. Patent
Office, Manual of Patent Practice (1999), available at [http://www.patent.gov.uk/-
patent/reference/mpp/s60_71.pdf] (providing a defense to infringement for actions “done
for experimental purposes relating to the subject-matter of the invention”).
129Notably, a Canadian law modeled after the Hatch-Waxman Act was challenged before a
WTO tribunal on precisely this ground. The WTO dispute resolution panel upheld the
Canadian experimental use privilege based upon the particular circumstances created by the
marketing approval and patenting procedures. See Canada — Patent Protection of
Pharmaceutical Products, WTO Panel Report, WT/DS114/R (Mar. 17, 2000). Some
commentators believe that Article 30 was “certainly interpreted narrowly by the WTO
Panel.” See Sol Picciotto, “Private Rights vs. Public Interests in the TRIPS Agreement,” 97
American Society of International Law Proceedings (April 2-5 2003), 167. Whether other
narrowly tailored experimental use privileges would survive scrutiny under the TRIPS
Agreement remains uncertain.
130See CRS Report RL31132, Multinational Patent Acquisition and Enforcement: Public
Policy Challenges and Opportunities for Innovative Firms, by John R. Thomas.
costs currently associated with acquisition and use of many proprietary research
In weighing this approach to the experimental use issue, it is also important
to note that the TRIPS Agreement places some restrictions upon the ability of WTO
members to grant compulsory licenses. Article 31, which is among the more detailed
provisions in the TRIPS Agreement, in part requires that each application for a
compulsory license be considered on its individual merits; that the proposed user
must have made efforts to obtain a license from the patent owner; and that the legal
validity of such a license be subject to review by the courts or other independent
authority.132 Deliberations over a “compulsory license” approach to the experimental
use privilege may wish to account for these obligations.
Whether the patent law’s experimental use privilege should be retained as a
narrowly confined doctrine of limited availability, or expanded to encompass
additional experimental activities, technologies, and researchers, continues to be the
subject of active discussion in the scientific and legal communities. A limited
experimental use privilege may best encourage technological advancement by
rewarding successful researchers with patent rights that are not easily circumvented.
However, some commentators believe that the circumscribed nature of the
experimental use privilege may in fact restrict researcher access to state-of-the-art
technologies and thus discourage further technological development. Although the
courts have relied upon existing law in order to reach their decisions in particular
cases, whether a narrow experimental use privilege most appropriately serves the
contemporary scientific research community remains open to policy debate
131See Mueller, supra note 4.
132Schechter & Thomas, supra note 16 , at § 12.6.