[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 53963-53965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14164]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-C-2024-0023]
Experimental Use Exception Request for Comments
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice and request for comments.
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SUMMARY: The United States Patent and Trademark Office (USPTO),
Department of Commerce, is interested in collecting the public's views
on the current state of the common law experimental use exception and
whether legislative action should be considered to enact a statutory
experimental use exception.
DATES: Written comments must be received on or before September 26,
2024.
ADDRESSES: For reasons of Government efficiency, comments should be
submitted through the Federal eRulemaking Portal at https://www.regulations.gov. To submit comments via the portal, enter docket
number PTO-C-2024-0023 on the homepage and click ``Search.'' The site
will provide a search results page listing all documents associated
with this docket. Find a reference to this request for information and
click on the ``Comment'' icon, complete the required fields, and enter
or attach your comments. Attachments to electronic comments will be
accepted in Adobe[supreg] portable document format or Microsoft
Word[supreg] format. Because comments will be made available for public
inspection, information that the submitter does not desire to make
public, such as an address or phone number, should not be included.
Visit the Federal eRulemaking Portal (www.regulations.gov) for
additional instructions on providing comments via the portal. If
electronic submission of comments is not feasible due to a lack of
access to a computer and/or the internet, please submit comments by
First-Class Mail or Priority Mail to: Christian Hannon, Senior Patent
Attorney, Mail Stop OPIA, U.S. Patent and Trademark Office, P.O. Box
1450, Alexandria, VA 22313-1450.
FOR FURTHER INFORMATION CONTACT: Christian Hannon, Senior Patent
Attorney, USPTO, Office of Policy and International Affairs (OPIA), at
571-272-7385.
SUPPLEMENTARY INFORMATION: The USPTO is interested in collecting the
public's views on the current state of the common law experimental use
exception and whether legislative action should be considered to enact
a statutory experimental use exception.
Historical Development of the Experimental Use Doctrine
The experimental use defense to a claim of patent infringement was
first introduced in the landmark case Whittemore v. Cutter.\1\ The
Whittemore court approved the instruction to the jury that ``the making
of a machine fit for use, and with a design to use it for profit, was
an infringement'' of a patent right.\2\ In assessing this instruction,
the court reasoned 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.'' \3\
Thus, the court looked to the prospect of profit-making to determine
infringement.\4\
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\1\ Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813)
(Case No. 17,600).
\2\ Prior to the enactment of the Patent Act of 1952, rights
conferred by a patent grant gave a patentee the ``sole and exclusive
right and liberty of making, constructing, using, and vending'' his
or her invention. Without the written consent of the patent holder,
the accused infringing party was required to forfeit and pay damages
to the patentee. See Patent Act of 1790, Ch. 7, sec. 1, 1 Stat. 109-
112 (April 10, 1970).
\3\ Id.; see also Sawin v. Guild, 21 F. Cas. 554, 554 (C.C.D.
Mass. 1813 (No. 12,319)) (stating that Whittemore held that making
must be coupled with intent to use for profit).
\4\ Id.
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Subsequent courts affirmed Whittemore's rationale, finding that
experimentation is not a defense to infringement if it creates a
benefit for the accused infringer.\5\ Thus, in Bonsack Machine v.
Underwood, the court found that experimentation on a patented cigarette
machine was not experimental use when the purpose of the experiment was
to show superior properties of the defendant's competing product.\6\ In
Roche Prod. v. Bolar Pharm. Co., the court found that ``Bolar's
intended `experimental' use is solely for business reasons and not for
amusement, to satisfy idle curiosity, or for strictly philosophical
inquiry.'' \7\ Notably, the Roche court stated that it ``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 insubstantial commercial
purposes.'' \8\ Subsequently, in Embrex v. Service Engineering Corp.,
the court denied an experimental use defense because of the district
court's determination that the defendant performed tests ``expressly
for commercial purposes.'' \9\
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\5\ Bonsack Mach. Co. v. Underwood, 73 F. 206 (C.C.E.D.N.C.
1896) (holding that ``the making of an infringing machine merely as
an experiment is not an actionable infringement, but if it is to be
used for the purpose of selling the patent under which it is made,
it is then to be regarded as use for profit, and a suit will lie for
the infringement'').
\6\ Id.
\7\ See Roche Prod. v. Bolar Pharm. Co., 733 F.2d 858, 862 (Fed.
Cir. 1984) at 863.
\8\ Id. This holding was effectively superseded by the Drug
Price Competition and Patent Term Restoration Act of 1984 (commonly
referred to as the Hatch-Waxman Act and codified at 35 U.S.C.
271(e)(1)).
\9\ Embrex, Inc. v. Service Engineering Corp., 216 F.3d 1343
(Fed. Cir. 2000) at 1349.
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The U.S. Court of Appeals for the Federal Circuit revisited the
experimental use exception in Madey v. Duke University, finding that
the district court ``erred in applying the experimental use defense.''
\10\ The court explained that its precedent does not immunize ``use
that is in any way
[[Page 53964]]
commercial in nature'' or ``any conduct that is in keeping with the
alleged infringer's legitimate business, regardless of commercial
implications.'' \11\ The court concluded, ``regardless of whether a
particular institution or entity is engaged in an endeavor for
commercial gain, so long as the act is in furtherance of the alleged
infringer's legitimate business and is not solely for amusement, to
satisfy idle curiosity, or for strictly philosophical inquiry, the act
does not qualify for the very narrow and strictly limited experimental
use defense.'' \12\ This ``very narrow and strictly limited
experimental use defense'' \13\ remains the current state of
experimental use exception jurisprudence in the United States.
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\10\ Madey v. Duke University, 307 F.3d 1361 (Fed. Cir. 2002) at
1352.
\11\ Id.
\12\ Id.
\13\ Id.
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A range of views on the propriety and scope of the experimental use
exception arose following Madey.\14\ Some argued that a narrow
exception enhances innovation by rewarding innovators with robust
patent rights, while others noted that restricting researcher access to
patented technologies would impede innovation.\15\
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\14\ John R. Thomas, Scientific Research and the Experimental
Use Privilege in Patent Law, CRS Report No. RL32651 (2004).
Available at: https://sgp.fas.org/crs/RL32651.pdf.
\15\ Id. at 21.
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Previous attempts at codifying the common law experimental use
exception have been unsuccessful. For example, section 402 of title IV
of the Patent Competitiveness and Technological Innovation Act of 1990
(H.R. 5598) proposed a ``research exemption from patent infringement.''
\16\ Additionally, the Genomic Research and Diagnostic Accessibility
Act of 2002 (H.R. 3967) proposed amending title 35 of the United States
Code to ``provide for noninfringing uses of patents on genetic sequence
information for purposes of research and genetic diagnostic testing,
and to require public disclosure of such information in certain patent
applications.'' \17\
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\16\ Patent Competitiveness and Technological Innovation Act of
1990, H.R. 5598, 101st Cong. (1990).
\17\ Genomic Research and Diagnostic Accessibility Act of 2002,
H.R. 3967, 107th Cong. (2002).
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Article 30 of the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) provides World Trade Organization
members the possibility to enact exceptions to patent rights as long as
they ``do not unreasonably conflict with a normal exploitation of the
patent and do not unreasonably prejudice the legitimate interest of the
patent owner, taking account of the legitimate interests of third
parties.'' \18\ The United States has codified a safe harbor provision
for certain infringing uses at 35 U.S.C. 271(e)(1). This ``Bolar''
exemption, as it is known, allows for the experimental use of a
patented invention by parties to collect regulatory approval data for
medical devices or drugs. Other jurisdictions have experimental use
exceptions providing broader flexibility.
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\18\ Agreement on Trade Related Aspects of Intellectual Property
Rights, art. 30, Apr. 15, 1994, Marrakesh Agreement Establishing the
World Trade Organization, Annex 1C, 1869 U.N.T.S. 401 [hereinafter
TRIPS].
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It should be noted that the Plant Variety Protection Act,\19\ which
provides Federal intellectual property rights to developers of new
plant varieties, contains exemptions that allow for others to use the
protected variety in research and for the breeding of new varieties.
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\19\ Public Law 91-577, 84 Stat. 1542.
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Experimental Use in Other Jurisdictions
Europe
Many European nations, including Germany,\20\ the UK,\21\
France,\22\ Spain,\23\ Italy,\24\ Switzerland,\25\ and the Netherlands
\26\ have implemented a statutory experimental use exception for
otherwise infringing uses. Although the precise application of each of
these national exceptions varies based on interpretation in national
courts,\27\ they are each broader than the U.S. common law exception as
they apply to any experimental purpose.
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\20\ Patentgesetz [Patent Act], Dec. 16, 1980,
Bundesgesetzblatt, Teil I, [BGBl I] at 4074, as amended Aug. 30,
2021, section 11 No. 2 (Ger.).
\21\ U.K. Patents Act 1977, (1977) art. 60(5)(b), 37 Current Law
1 (Eng.).
\22\ French Code of Intellectual Property, L. 613-5.
\23\ Law 11/1986 of 20 March on Patents. Art. 52(1)(b).
\24\ Industrial Property Code (Legislative Decree No. 30 of
February 10, 2005, as amended up to Law No. 102 of July 24, 2023)
Art. 68(1)(a) (Italy).
\25\ Article 9(e) of the Federal Act on Patents for Inventions,
adopted in 2008.
\26\ Netherlands Patent Act (15 Dec 1994, as amended) Art.
53(3).
\27\ See Hans-Rainer Jaenichen and Johann Pitz, Research
Exemption/Experimental Use in the European Union: Patents Do Not
Block the Progress of Science, Cold Spring Harb. Perspect Med. 2015
Feb (explaining that each law has been interested with distinct
variations). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315916/#FN4.
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Asia
Many countries in Asia have statutory experimental use exceptions.
Article 69.1 of Japan's Patent Law provides a statutory experimental
use exception.\28\ Japanese courts have interpreted this exception to
include a Bolar exemption for certain acts related to submissions for
regulatory approval.\29\ The Japanese Bolar exemption applies to
clinical testing not only for generic drugs, but brand-name drugs as
well.\30\ Similarly, China's Patent Law provides an exception for
infringing uses for anyone that ``uses the relevant patent specially
for the purpose of scientific research and experimentation.'' \31\
Korea's patent law provides that ``[w]orking of [a] patented invention
for the purpose of research or experiments'' is not an
infringement.\32\ Likewise, India's Patent Act provides that a patented
invention may be made or used by any person ``for the purpose merely of
experiment or research including the imparting of instructions to
pupils.'' \33\
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\28\ Tokkyoho [Patent L.], Law No. 121 of Apr. 13, 1959 (Japan),
amended by Act No. 33 of Jun. 9, 2018 (Japan), art. 69(1) (``A
patent right shall not be effective against the working of the
patented invention for experimental or research purposes.'').
\29\ Ono Pharma. Co., Ltd. v. Kyoto Pharmaceutical Industries,
Ltd., Saik[omacr]-Saibansho [Supreme Court] Apr. 4, 1999, 1998(Ju)
153 (holding that clinical trials conducted during the patent term
for the regulatory submission of a generic drug should be considered
as ``working of a patented invention for testing or research'' as
described in Art. 69(1) of the Patent Law and therefore does not
constitute patent infringement).
\30\ See X(individual) v. Amgen K.K.; Chiteki-zaisan
k[omacr]t[omacr]-saiban-sho [Intellectual property high court,
second division] Feb. 9, 2021, 2020 (Ne)10051.
\31\ Patent Law of the People's Republic of China (Dec. 27,
2008), Article 69(4).
\32\ Korea Patent Act (as amended Jan. 27, 2010), Art. 96(1).
\33\ The Patents Act, 1970, Art. 47(3).
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Americas
Canada and many jurisdictions in Latin America have codified
experimental use exceptions. Canadian patent law provides that common
law rights, inter alia, ``in respect of any use, manufacture,
construction or sale of the patented invention solely for the purpose
of experiments that relate to the subject-matter of the patent'' are
unaffected by the statutory Canadian Bolar exception.\34\ Brazil's
patent law statutorily exempts ``acts carried out by unauthorized third
parties for experimental purposes, in connection with scientific or
technological studies or researches'' from patent infringement.\35\
Mexico's industrial property law exempts from patent infringement
liability ``scientific or technological research activities for purely
experimental, testing or teaching purposes.'' \36\ Likewise, the
industrial property law of the Andean Community \37\ grants an
exception for ``acts performed for exclusively experimental purposes on
the subject
[[Page 53965]]
matter of the patented invention'' and ``acts performed solely for the
purposes of teaching or scientific or academic research.'' \38\
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\34\ Canadian Patent Act Art. 55.2(6).
\35\ Brazil Patent Law No. 9,279 of May 14, 1996; Art. 43(2).
\36\ Mexico Industrial Property Law (as amended June 28, 2010),
Art. 22(I).
\37\ The Andean Community of Nations is made up of Bolivia,
Colombia, Ecuador, and Peru.
\38\ Andean Community Decision No. 486 of Sept. 14, 2000,
Section 53(b) and (c).
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Scope of Interest
The USPTO is interested in collecting the public's views on the
impact of the experimental use exception in all technology areas. For
example, one technology area for which greater clarity around the
experimental use exception may be of interest is the agricultural
industry. In March 2023, the U.S. Department of Agriculture (USDA)
issued a report, prepared in consultation with the USPTO, on promoting
fair competition and innovation in regards to seeds and other
agricultural inputs.\39\ In that report, the USDA and the USPTO both
committed to evaluating ``new proposals for incentivizing and
protecting innovation in the seed and agricultural-related space,
including the addition of research or breeders' exemptions for U.S.
utility patents.'' \40\ This work is consistent with the call in the
President's 2021 Executive Order on Promoting Competition in the
American Economy. The views submitted in response to this notice will
help in conducting this evaluation, as well as evaluating the impact of
the experimental use exception in other technology areas.
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\39\ Agric. Mktg. Serv., U.S. Dep't Agric., More and Better
Choices for Farmers: Promoting Fair Competition and Innovation in
Seeds and Other Agricultural Inputs, at 6 (2023).
\40\ Id. at 6 (2023).
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Questions for Public Comment
When responding to the questions, please identify yourself and your
interest in the U.S. patent system. If applicable, please indicate
whether you fall within one or more of the following categories:
(1) Inventors, patent owners, or investors (e.g., venture capital,
investment bank, fund, etc.);
(2) licensees or users of patented technology;
(3) entities that represent inventors or patent owners (e.g., law
firms);
(4) recipients of demand letters concerning alleged patent
infringement or accused infringers in a patent lawsuit;
(5) entities that represent accused infringers;
(6) government agencies or officials;
(7) academic or research institutions;
(8) intellectual property organizations or associations; and
(9) nonprofit organizations or advocacy groups.
Commenters need not respond to every question and may provide
relevant information even if not responsive to a particular question.
Unless otherwise specified, the questions are in reference to the U.S.
and/or to U.S. laws and regulations. The questions should not be
interpreted as an indication that the USPTO has taken a position on or
is predisposed to any particular views. The USPTO welcomes comments
from the public on any issues that are relevant to this topic, and is
particularly interested in answers to the following questions:
1. Please explain how the current state of U.S. experimental use
exception jurisprudence impacts investment and/or research and
development in any field of technology, including, but not limited to:
(a) quantum computing; (b) artificial intelligence; (c) other computer-
related inventions; (d) agriculture; (e) life sciences (including
prescription drugs and medical devices); and (f) climate-mitigation
technologies.
2. Do you believe there are any technologies that are negatively
affected by the current state of experimental use exception
jurisprudence in the United States? If yes, please identify which
technologies and explain how you believe they are affected.
3. Please explain what impact, if any, a statutory experimental use
exception would have on the innovation and commercialization of new
technologies including with respect to: (a) research and development;
(b) ability to obtain funding; (c) investment strategy; (d) licensing
of patents and patent applications; (e) product development; (f) sales,
including downstream and upstream sales; (g) competition; and (h)
patent enforcement and litigation.
4. Has the current state of experimental use exception
jurisprudence impacted decisions you have made with respect to filing,
purchasing, licensing, selling, or maintaining patent applications and
patents in the United States? If yes, please explain how.
5. Please explain whether you believe the United States should
adopt a statutory experimental use exception. In doing so, please
identify your reasons, including by providing evidence and data to
support your views.
6. Please explain how a statutory experimental use exception, if
any, should be defined. Please include specific limitations and
restrictions you believe would be needed to ensure that patent rights
are preserved.
7. Please identify public policy reasons in support of maintaining
the status quo or changing the experimental use exception in the United
States.
8. Please provide any additional recommendations on how best to
enhance and facilitate experimental research on patented inventions in
the United States.
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2024-14164 Filed 6-27-24; 8:45 am]
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