[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

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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

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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

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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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