[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36257-36260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14628]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2021-0032]
Patent Eligibility Jurisprudence Study
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Request for information.
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SUMMARY: At the request of Senators Tillis, Hirono, Cotton, and Coons,
the United States Patent and Trademark Office (USPTO) is undertaking a
study on the current state of patent eligibility jurisprudence in the
United States, and how the current jurisprudence has impacted
investment and innovation, particularly in critical technologies like
quantum computing, artificial intelligence, precision medicine,
diagnostic methods, and pharmaceutical treatments. The USPTO seeks
public input on these matters to assist in preparing the study.
DATES: Comments must be received by September 7, 2021.
ADDRESSES: For reasons of government efficiency, comments must be
submitted through the Federal eRulemaking Portal at
www.regulations.gov. To submit comments via the portal, enter docket
number PTO-P-2021-0032 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 Now!'' 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
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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 contact the USPTO
using the contact information below for special instructions on how to
submit comments by other means.
Submissions of Business Confidential Information: Any submissions
containing business confidential information must be marked
``confidential treatment requested'' and submitted through
www.regulations.gov. Submitters should provide an index listing the
document(s) or information they would like the USPTO to withhold. The
index should identify the confidential document(s) by document
number(s) and document title(s) and should identify the confidential
information by description(s) and relevant page numbers and/or section
numbers within a document. Submitters should also provide a statement
explaining their grounds for requesting non-disclosure of the
information to the public. The USPTO also requests that submitters of
business confidential information include a non-confidential version
(either redacted or summarized) that will be posted on
www.regulations.gov and available for public viewing. In the event that
the submitter cannot provide a non-confidential version of their
submission, the USPTO requests that the submitter post a notice in the
docket stating that they have provided the USPTO with business
confidential information. Should a submitter fail either to docket a
non-confidential version of their submission or to post a notice that
business confidential information has been provided, the USPTO will
note the receipt of the submission on the docket with the submitter's
organization or name (to the degree permitted by law) and the date of
submission.
Anonymous submissions: The USPTO will accept anonymous submissions.
Enter ``N/A'' in the required fields if you wish to remain anonymous.
FOR FURTHER INFORMATION CONTACT: Elizabeth Shaw, USPTO, Office of
Policy and International Affairs, at [email protected] or 571-
272-9300. Please direct media inquiries to the USPTO's Office of the
Chief Communications Officer at 571-272-8400.
SUPPLEMENTARY INFORMATION: In 2016, following the Supreme Court's
decisions in Bilski,1 Mayo,2 Myriad,3
and Alice,4 the USPTO held two public roundtables and
invited written comments from the public on the state of the law of
patent subject matter eligibility and the Court's legal framework for
evaluating eligibility. Notice of Roundtables and Request for Comments
Related to Patent Subject Matter Eligibility, 81 FR 71485 (Oct. 17,
2016). The first roundtable focused on the then-current USPTO
eligibility guidance for patent examiners. Id. at 71487.\5\ The second
roundtable explored the legal contours of patent eligibility, including
the impact of the current law, if/how the law should be revised, and
whether a legislative solution should be sought. Id. at 71486-71487. In
July 2017, the USPTO published a report summarizing patent eligibility
law, public views on the impact of the recent Supreme Court patent
eligibility jurisprudence, and public recommendations for a path
forward. USPTO, Patent Eligible Subject Matter: Report on Views and
Recommendations from the Public (July 2017), available at
www.uspto.gov/sites/default/files/documents/101-Report_FINAL.pdf.
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\1\ Bilski v. Kappos, 561 U.S. 593 (2010).
\2\ Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66 (2012).
\3\ Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569
U.S. 576 (2013).
\4\ Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014).
\5\ The USPTO issued revised patent subject matter eligibility
guidance for examiners in 2019. USPTO, 2019 Revised Patent Subject
Matter Eligibility Guidance, 84 FR 50 (Jan. 7, 2019); USPTO, October
2019 Patent Eligibility Guidance Update, 84 FR 55942-55943 (Oct. 18,
2019). That guidance has since been incorporated into the Manual of
Patent Examining Procedure, sections 2103 to 2106.07(c) (9th ed.,
rev. 10.2019) (June 2020). See www.uspto.gov/PatentEligibility.
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Since 2017, the Federal Circuit has issued numerous decisions
applying the Supreme Court's legal framework in a variety of contexts,
and many petitions for writ of certiorari have been filed. In 2019, the
Supreme Court called for the views of the Solicitor General. HP Inc. v.
Berkheimer, No. 18-415, 139 S. Ct. 860 (Jan. 7, 2019); Hikma Pharms.
USA Inc. v. Vanda Pharms. Inc., No. 18-817, 139 S. Ct. 1368 (Mar. 18,
2019). In both cases, the Government argued that the Court's recent
decisions have strayed from earlier precedent and have fostered
uncertainty regarding the patent eligibility standards. Brief for
United States, HP Inc. v. Berkheimer, No. 18-415, 2019 WL 6715368, at
*10-13 (Dec. 6, 2019) (Berkheimer CVSG Brief); Brief for United States,
Hikma Pharms. USA Inc. v. Vanda Pharms. Inc., No. 18-817, 2019 WL
6699397, at *13-21 (Dec. 6, 2019) (Vanda CVSG Brief). While the
Government contended that neither of the cases was an optimal vehicle
to consider those standards, it urged the Court to grant certiorari in
an appropriate case. Berkheimer CVSG Brief at *10, *14, *19; Vanda CVSG
Brief at *8, *22-23. In particular, the Government highlighted the
then-pending certiorari petition in Athena Diagnostics, Inc. v. Mayo
Collaborative Services, LLC, a case involving medical diagnostic
methods in which the Federal Circuit, in denying rehearing en banc,
issued multiple separate opinions asking the Supreme Court for further
guidance in the area. Berkheimer CVSG Brief at *13, *19; Vanda CVSG
Brief at *22-23. Ultimately, the Supreme Court denied writ of
certiorari in all three cases. HP Inc. v. Berkheimer, No. 18-415, 140
S. Ct. 911 (Jan. 13, 2020); Hikma Pharms. USA Inc. v. Vanda Pharms.
Inc., No. 18-817, 140 S. Ct. 911 (Jan. 13, 2020); Athena Diagnostics,
Inc. v. Mayo Collaborative Servs., LLC, No. 19-430, 140 S. Ct. 855
(Jan. 13, 2020).
Last year, after a split panel decision concluding that a method
for manufacturing drive shafts was patent ineligible, the Federal
Circuit again issued a decision denying rehearing en banc that included
multiple separate opinions with differing views on the scope of patent
eligible subject matter. Am. Axle & Mfg., Inc. v. Neapco Holdings LLC,
966 F.3d 1347 (Fed. Cir. 2020). Like the dissenting judge on the panel,
several of the opinions denying rehearing en banc faulted the panel
majority for establishing a new ``nothing more'' test--if the claimed
invention ``clearly invokes a natural law, and nothing more, to
accomplish a desired result''--for patent ineligibility. Id. at 1366
(O'Malley J., dissenting); id. at 1361 (Stoll J., dissenting); id. at
1359 (Newman J., dissenting). American Axle petitioned for writ of
certiorari on December 28, 2020, and the Supreme Court called for the
views of the Solicitor General on May 3, 2021. Am. Axle & Mfg., Inc. v.
Neapco Holdings LLC, No. 20-891, 2021 WL 1725166 (May 3, 2021). The
questions presented in the petition are: (1) What is the appropriate
standard for determining whether a claim is directed to a patent-
ineligible concept under step one of the Alice two-step framework?; and
(2) Is patent eligibility a question of law for the court or a question
of fact for the jury?
On March 5, 2021, Senators Thom Tillis, Mazie Hirono, Tom Cotton,
and Christopher Coons sent a letter to Mr. Drew Hirshfeld, Performing
the functions and duties of the Director of the USPTO, asking that the
USPTO
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publish a request for information on the current state of patent
eligibility jurisprudence in the United States (since the Supreme
Court's decisions in Mayo and Alice), evaluate the responses, and
provide a detailed summary of its findings by March 5, 2022. The
Senators indicated a particular interest in learning how the current
jurisprudence has adversely impacted investment and innovation in
critical technologies like quantum computing, artificial
intelligence,\6\ precision medicine, diagnostic methods, and
pharmaceutical treatments.
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\6\ On October 6, 2020, the USPTO released a report titled
``Public Views on Artificial Intelligence and Intellectual Property
Policy.'' The report takes a comprehensive look at a wide variety of
stakeholder views on the impact of artificial intelligence across
the intellectual property landscape. See generally ``Public Views on
Artificial Intelligence and Intellectual Property Policy,''
available at www.uspto.gov/sites/default/files/documents/USPTO_AI-Report_2020-10-07.pdf.
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Request for Information: To aid in the study that Senators Tillis,
Hirono, Cotton, and Coons requested, the USPTO invites stakeholders to
submit written comments on the questions below. In the questions, the
phrase ``the current state of patent eligibility jurisprudence in the
United States'' should be understood as referring to the body of patent
subject matter eligibility decisions issued by the U.S. Federal
Judiciary.
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. Additionally, if you are a patent owner or
inventor, please include the number of U.S. and foreign patent
applications you have filed; the number of U.S. and foreign patents you
hold; the number of patents you have licensed or sold; and the number
of patent cases you have been involved in since the Supreme Court's
decision in Bilski in 2010.
Commenters need not respond to every question and may provide
relevant information even if not responsive to a particular question.
Topics for Public Comment
Section I--Observations and Experiences
1. Please explain how the current state of patent eligibility
jurisprudence affects the conduct of business in your technology
area(s). Please identify the technology area(s) in your response.
2. Please explain what impacts, if any, you have experienced as a
result of the current state of patent eligibility jurisprudence in the
United States. Please include impacts on as many of the following areas
as you can, identifying concrete examples and supporting facts when
possible:
a. Patent prosecution strategy and portfolio management;
b. patent enforcement and litigation;
c. patent counseling and opinions;
d. research and development;
e. employment;
f. procurement;
g. marketing;
h. ability to obtain financing from investors or financial
institutions;
i. investment strategy;
j. licensing of patents and patent applications;
k. product development;
l. sales, including downstream and upstream sales;
m. innovation; and
n. competition.
3. Please explain how the current state of patent eligibility
jurisprudence in the United States impacts particular technological
fields, including investment and innovation in any of the following
technological areas:
a. Quantum computing;
b. artificial intelligence;
c. precision medicine;
d. diagnostic methods;
e. pharmaceutical treatments; and
f. other computer-related inventions (e.g., software, business
methods, computer security, databases and data structures, computer
networking, and graphical user interfaces).
4. Please explain how your experiences with the application of
subject matter eligibility requirements in other jurisdictions,
including China, Japan, Korea, and Europe, differ from your experiences
in the United States.
5. Please identify instances where you have been denied patent
protection for an invention in the United States solely on the basis of
patent subject matter ineligibility, but obtained protection for the
same invention in a foreign jurisdiction, or vice versa. Please provide
specific examples, such as the technology(ies) and jurisdiction(s)
involved, and the reason the invention was held ineligible in the
United States or other jurisdiction.
6. Please explain whether the state of patent eligibility
jurisprudence in the United States has caused you to modify or shift
investment, research and development activities, or jobs from the
United States to other jurisdictions, or to the United States from
other jurisdictions. If so, please identify the relevant modifications
and their associated impacts.
7. Please explain whether the state of patent eligibility
jurisprudence in the United States has caused you to change business
strategies for protecting your intellectual property (e.g., shifting
from patents to trade secrets, or vice versa). If so, please identify
the changes and their associated impacts.
8. Please explain whether you have changed your behavior with
regard to filing, purchasing, licensing, selling, or maintaining patent
applications and patents in the United States as a result of the
current state of patent eligibility jurisprudence in the United States.
If so, please describe how you changed your behavior.
9. Please explain how, in your experience, the status of patent
eligibility jurisprudence in the United States has affected any
litigation for patent infringement in the United States in which you
been involved as a party, as legal counsel, or as another participant
(e.g., an expert witness). For example, please explain whether this
jurisprudence has affected the cost or duration of such litigation, the
ability to defend against claims of patent infringement, the certainty/
uncertainty of litigation outcomes, or the likelihood of settlement.
Section II--Impact of Subject Matter Eligibility on the General
Marketplace
10. Please identify how the current state of patent eligibility
jurisprudence in the United States impacts the global strength of U.S.
intellectual property.
11. Please identify how the current state of patent eligibility
jurisprudence in the United States impacts the U.S. economy as a whole.
12. Please identify how the current state of subject matter
eligibility jurisprudence in the United States impacts the global
strength of U.S. intellectual property and the U.S. economy in any of
the following areas:
a. Quantum computing;
b. artificial intelligence;
c. precision medicine;
d. diagnostic methods;
e. pharmaceutical treatments; and
f. other computer-related inventions (e.g., software, business
methods,
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computer security, databases and data structures, computer networking,
and graphical user interfaces).
In responding to this question, please provide concrete examples
and supporting facts when possible.
13. Please identify how the current state of patent eligibility
jurisprudence in the United States affects the public. For example,
does the jurisprudence affect, either positively or negatively, the
availability, effectiveness, or cost of personalized medicine,
diagnostics, pharmaceutical treatments, software, or computer-
implemented inventions?
Andrew Hirshfeld,
Commissioner for Patents, Performing the Functions and Duties of the
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2021-14628 Filed 7-8-21; 8:45 am]
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