[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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