[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67019-67022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24107]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2022-0037]
Joint USPTO-FDA Collaboration Initiatives; Notice of Public
Listening Session and Request for Comments
AGENCY: United States Patent and Trademark Office, U.S. Department of
Commerce.
ACTION: Notice of public listening session; request for comments.
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SUMMARY: The United States Patent and Trademark Office (USPTO),
Department of Commerce, in collaboration with the United States Food
and Drug Administration (FDA), Department of Health and Human Services,
is announcing a public listening session
[[Page 67020]]
on January 19, 2023, titled ``Listening Session on Joint USPTO-FDA
Collaboration Initiatives.'' The purpose of the listening session is to
seek public comments on proposed initiatives for collaboration between
the agencies to advance President Biden's Executive Order on
``Promoting Competition in the American Economy'' and to promote
greater access to medicines for American families. To assist in
gathering public input, the USPTO and the FDA are announcing the
establishment of a docket to track feedback received through this
notice and a request for comments on these collaborative efforts.
DATES: The public listening session will be held on Thursday, January
19, 2023, from 10 a.m. to 5 p.m. ET. Persons seeking to speak at the
listening session must register by 5 p.m. on January 5, 2023. Persons
seeking to attend, either in person or virtually, but not speak at the
event must register by January 17, 2023. Seating is limited for in-
person attendance. Written comments will be accepted until February 6,
2023.
ADDRESSES:
Public Listening Session
The public listening session will take place in person in the Clara
Barton Auditorium at the USPTO, 600 Dulany Street, Alexandria, VA
22313. The session will also be available via live feed for those
wishing to attend remotely. Registration is required for both in-person
and virtual attendance. Information on registration is available at
www.uspto.gov/initiatives/uspto-fda-collaboration/engagements.
Registrants must indicate whether they are registering as a listen-only
attendee or as a speaker participant.
Requests to participate as a speaker must include:
1. The name of the person desiring to participate;
2. The organization(s) that person represents, if any;
3. Contact information (address, telephone number, and email); and
4. Information on the specific topic(s) of interest to the speaker
(or their organization) and identification of the primary topic of
interest.
Speaking slots are limited; preference will be given to speakers
wishing to address one of the questions raised in this request for
comments. We will attempt to group speakers by topic. Topics and
speakers will be announced a few days prior to the public listening
session. Speakers must attend in person and are required to submit
their remarks for the listening session in advance through the Federal
eRulemaking Portal at www.regulations.gov. We will inform each speaker
in advance of their assigned time slot. If we receive more requests to
speak than time allows and are unable to assign a time slot as
requested, we will invite the requestor to submit written comments.
Time slots will be at least three minutes but may be longer, depending
on the number of speakers registered. A panel of USPTO and FDA
personnel may reserve time to ask questions of particular speakers
after the delivery of a speaker's remarks.
Request for Comments
You may submit written comments as follows. 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-2022-0037 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 comments 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 (PDF) 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 in the comments.
Visit the Federal eRulemaking Portal 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 regarding how to submit comments by mail or by
hand delivery.
FOR FURTHER INFORMATION CONTACT: Linda Horner, Administrative Patent
Judge, USPTO, at 571-272-9797 or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2021, President Biden issued an Executive Order on
``Promoting Competition in the American Economy,'' 86 FR 36987 (July
14, 2021) (Competition E.O.). To advance the Biden Administration's
goals of promoting greater access to medicines for American families
and increasing competition in the marketplace, section 5(p)(vi) of the
Competition E.O. directs the Secretary of Health and Human Services,
``through the Commissioner of Food and Drugs'' and ``not later than 45
days after the date of this order,'' to ``write a letter to the Under
Secretary of Commerce for Intellectual Property and Director of the
United States Patent and Trademark Office enumerating and describing
any relevant concerns of the FDA,'' in order ``to help ensure that the
patent system, while incentivizing innovation, does not also
unjustifiably delay generic drug and biosimilar competition beyond that
reasonably contemplated by applicable law.''
In response to the Competition E.O., on September 10, 2021, the FDA
sent a letter to the USPTO outlining ideas for further engagement with
the USPTO (FDA Letter). On July 6, 2022, the USPTO sent a responsive
letter (USPTO Letter) discussing specific initiatives the USPTO was
exploring to collaborate with the FDA to ensure that our patent system
properly and adequately protects innovation while not unnecessarily
delaying getting generic, biosimilar, and more affordable versions of
pharmaceuticals into the hands of Americans who need them. The letters
are available at www.uspto.gov/initiatives/fda-collaboration.
The FDA-USPTO exchange of letters recognizes that, while the two
agencies have different missions and authorities, we share a commitment
to ensuring our innovation system strikes the appropriate balance--
encouraging meaningful innovation in drug development while supporting
a competitive marketplace that can promote greater access to medicines
for American families.
The United States is a global leader in the development of drugs
and biologics due to its strong patent system, and the USPTO Letter
describes ongoing efforts to further promote robust and reliable patent
rights across all technologies. Robust and reliable patents are needed
to incentivize and protect the immense research and development
investment that is essential to bringing life-saving and life-altering
products to market. Patent rights can spur the collaboration necessary
for quick and speedy drug and biological product development. Congress
also enacted laws to establish approval pathways for generic and
biosimilar medicines, and these laws set forth patent dispute
resolution mechanisms in the drug and biologic innovation space to
encourage generic and biosimilar manufacturers to timely resolve patent
issues in order to enter the market to increase competition.
The FDA Letter highlights the FDA's commitment to facilitating
increased drug competition through its abbreviated pathways for the
approval
[[Page 67021]]
of generic drugs and biosimilars, which play a foundational role in
ensuring access to high-quality, safe, effective, and affordable
medicines for American patients. The FDA has a ministerial role with
regard to the patent listing provisions of the Federal Food, Drug, and
Cosmetic Act. New drug application sponsors are statutorily required to
submit certain patent information for listing, and the FDA is
statutorily required to publish that information, which it does in
Approved Drug Products with Therapeutic Equivalence Evaluations (the
Orange Book). Orange Book-listed patents may impact the timing of
generic approval. In addition, under section 351(l) of the Public
Health Service Act, if a reference product sponsor (i.e., biologics
license application holder) provides a list of patents to a biosimilar
applicant within the context of patent litigation, then the FDA is
statutorily required to publish that patent list. The FDA publishes
such lists in the Purple Book Database of Licensed Biological Products
(the Purple Book).
To further the objectives of the Competition E.O., the letters the
FDA and the USPTO exchanged outline a number of initiatives to execute
the President's agenda, with a focus on areas in which the agencies'
functions overlap. The initiatives for collaboration with the FDA, as
discussed in paragraph 1 of the USPTO Letter, are reproduced below.
1. Enhance collaboration with other agencies on key technology
areas, including pharmaceuticals and biologics. The USPTO will seek to
create formal mechanisms to collaborate with other agencies such as the
Food and Drug Administration (FDA).\1\ Specifically, the USPTO will:
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\1\ Although these initiatives focus mostly on collaboration
with the FDA, the USPTO is interested in exploring further
interagency collaborations.
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a. Continue discussions with the FDA on this topic and the
initiatives outlined here and work collaboratively on these and other
initiatives.
b. Explore joint USPTO-FDA public engagement through listening
sessions, dissemination of a Request for Comments and other procedures
for collecting broader stakeholder input.
c. Provide examiners with training, in collaboration with the FDA,
on publicly available FDA resources that can be utilized in prior art
searches and on the state of the art in the pharmaceutical and
biopharma areas and provide resources to the FDA to support its work on
matters influenced by patent law and policy.
d. Explore consistency in representations made to the USPTO and the
FDA. The USPTO will work with the FDA to evaluate consistency in
representations to the USPTO (made both during prosecution of patent
applications and in America Invents Act (AIA) and other post-issuance
proceedings) and the FDA. The USPTO is also exploring initiatives to
require patent applicants to provide relevant information to the USPTO
that has been submitted to other agencies and to remind patent
applicants of their disclosure obligations and the ramifications of
failing to disclose required information at the USPTO.\2\ The USPTO
will explore with the FDA whether other avenues exist to determine
whether patent applicants have submitted inconsistent statements
between the agencies.
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\2\ On July 29, 2022, the USPTO published a Federal Register
Notice clarifying the duty of disclosure and the duty of reasonable
inquiry, including as to materials or statements material to
patentability, or statements made to the USPTO that are inconsistent
with statements submitted to the FDA and other Government agencies.
See Duties of Disclosure and Reasonable Inquiry During Examination,
Reexamination, and Reissue, and for Proceedings Before the Patent
Trial and Appeal Board, 87 FR 45764.
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e. Engage in greater FDA collaboration in AIA proceedings. In
addition to improving the robustness and reliability of patents that
are granted in the first place, the USPTO will work with the FDA on
processes and procedures for (1) notifying the FDA of AIA proceeding
filings on any Orange Book-listed patents and/or Purple Book-listed
patents, and (2) potentially sharing more information between the
agencies. The USPTO will also work with the FDA to assess why there
have been so few filings of AIA proceedings on Orange Book-listed
patents and biologic patents and why the number of AIA filings for
pharmaceutical patents has generally declined.\3\
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\3\ Orange Book patent/biologic patent study update through June
2021, available at www.uspto.gov/sites/default/files/documents/PTABOBbiologicpatentstudy8.10.2021draftupdatedthruJune2021.pdf.
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f. Revisit patent term extension practice, required under 35 U.S.C.
156 due to the product being subject to an FDA regulatory review
period. Though a recent report found that the USPTO accurately and
fairly grants patent term extensions based on FDA regulatory review
periods, the USPTO will collaborate with the FDA to determine if there
are any areas for improvement through information sharing or otherwise.
The USPTO also is exploring ways to facilitate public access to
information on patent term extension applications and grants.
g. Work with the FDA to understand how else the agencies'
authorities and responsibilities overlap, such as exploring the
policies surrounding the use of ``skinny labels,'' the connection
between method of use patents and associated use codes, and the
patenting of risk evaluation and mitigation strategies that the FDA
requires for certain medications with serious safety concerns. Where
the agencies' functions overlap, the USPTO will work with FDA to
optimize information sharing and policy within our respective
frameworks and legal restrictions.
h. Remain open to discussing with the FDA, other agencies, the
Administration, and stakeholders the FDA's concerns over practices
referred to as ``patent thickets,'' ``evergreening,'' and ``product
hopping.''
In this notice of public listening session and request for
comments, the USPTO and the FDA seek public comments on the proposed
initiatives outlined in the USPTO Letter (1(a)-1(h)) reproduced
above.\4\
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\4\ The USPTO is also working in parallel on the other proposed
initiatives described in the USPTO Letter that are not the focus of
this listening session and request for comments. See, e.g., Request
for Comments on Initiatives Ensuring Robust and Reliable Patents, 87
FR 60130 (October 4, 2022).
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II. Purpose and Scope of the Listening Session and Request for Comments
The purpose of this listening session and request for comments is
to obtain public input on areas for USPTO-FDA collaboration and
engagement. We are seeking feedback from a broad group of stakeholders,
including, but not limited to, patients and their caregivers, patient
advocates, representatives from regulated industry, including companies
that sell branded medicines, generics drugs and biosimilars, healthcare
organizations, payors and insurers, academic institutions, public
interest groups, and the general public.
To facilitate stakeholder feedback on the initiatives listed above,
we provide the questions below. These questions are not meant to be
exhaustive. We encourage interested stakeholders to address these and/
or other related issues and to submit research and data that inform
their comments on these topics. Commenters are welcome to respond to
any or all of the questions and are encouraged to indicate which
questions their comments address.
1. What publicly available FDA resources should be included when
training USPTO patent examiners on tools they can use to assess the
patentability of claimed inventions?
2. What mechanisms could assist patent examiners in determining
[[Page 67022]]
whether patent applicants or patent owners have submitted inconsistent
statements to the USPTO and the FDA? Please explain whether such
mechanisms present confidentiality concerns and, if so, how those
concerns could be addressed.
3. What are the opportunities and challenges related to the use of
AIA proceedings to address the patentability of claims in
pharmaceutical and biotechnological patents, including with respect to
how such proceedings may intersect with Hatch-Waxman paragraph IV
disputes and the Biologics Price Competition and Innovation Act
``patent dance'' framework that biosimilar applicants and reference
product sponsors use to address any patent infringement concerns?
4. How can the USPTO and the FDA reinforce their collaboration and
information exchange in relation to determining whether a patent
qualifies for a patent term extension (PTE) and the length of any
extension under 35 U.S.C. 156, as described in the Manual of Patent
Examining Procedure Sec. 2756? Identify any specific areas for
improvement in the effectiveness of the current USPTO-FDA process for
adjudicating applications for PTE and in the opportunity for public
comment on such applications.
5. The FDA already publishes PTE applications on
www.regulations.gov, and the USPTO publishes PTE applications on its
Patent Center portal (https://patentcenter.uspto.gov/), which replaced
the Public Patent Application Information Retrieval (PAIR) system. The
USPTO also recently provided centralized access to a listing of PTE
applications filed during the last five years at www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156. This
list includes the patent application number, patent number, link to the
electronic file wrapper in Patent Center, PTE application filing date,
and trade name identified in the PTE application. The status of each
PTE application, including disposition, may be determined by reviewing
the electronic file wrapper in Patent Center. What additional
information would be useful to include on this web page?
6. What policy considerations or concerns should the USPTO and the
FDA explore as they relate to method of use patents and, as applicable,
associated FDA use codes, including with respect to generic drug,
505(b)(2), and biosimilar applicants who do not seek approval for
(i.e., who seek to carve out from their labeling) information related
to a patent-protected method of use (sometimes described as ``skinny
labeling'')?
7. What policy considerations or concerns should the USPTO and the
FDA explore in relation to the patenting of risk evaluation and
mitigation strategies associated with certain FDA-approved products?
What other types of patent claims associated with FDA-regulated
products raise policy considerations or concerns for the USPTO and the
FDA to evaluate?
8. Apart from, or in conjunction with, the initiatives set forth in
the USPTO Letter, what other steps could the USPTO and the FDA take
collaboratively to address concerns about the potential misuse of
patents to improperly delay competition or to promote greater
availability of generic versions of scarce drugs that are no longer
covered by patents?
9. What additional input on any of the initiatives listed in the
USPTO Letter (1(a)-1(h)), or any other related suggestions for USPTO-
FDA collaboration, should the agencies consider?
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2022-24107 Filed 11-4-22; 8:45 am]
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