On July 9, 2021, the Biden Administration released an “Executive
Order on Promoting Competition in the American Economy” that literally will touch almost every part of the U.S. economy. The Executive Order can be found, here. Concerning SEPs the Executive Order states:
To avoid the potential for anticompetitive extension of
market power beyond the scope of granted patents, and to protect
standard-setting processes from abuse, the Attorney General and the Secretary
of Commerce are encouraged to consider whether to revise their position on the
intersection of the intellectual property and antitrust laws, including by
considering whether to revise the Policy Statement on Remedies for
Standards-Essential Patents Subject to Voluntary F/RAND Commitments issued
jointly by the Department of Justice, the United States Patent and Trademark
Office, and the National Institute of Standards and Technology on December 19,
2019.
The Order further directs the FTC
Chair to consider rulemaking in the following areas:
(i)
unfair data collection and surveillance practices that may damage
competition, consumer autonomy, and consumer privacy;
(ii) unfair
anticompetitive restrictions on third-party repair or self-repair of items,
such as the restrictions imposed by powerful manufacturers that prevent farmers
from repairing their own equipment;
(iii) unfair
anticompetitive conduct or agreements in the prescription drug industries, such
as agreements to delay the market entry of generic drugs or biosimilars;
(iv) unfair
competition in major Internet marketplaces;
. . . and
(vii) any other
unfair industry-specific practices that substantially inhibit competition.
The Order directs the Secretary of
Agriculture to prepare a report concerning IP laws and seeds and other inputs:
to help ensure that the intellectual property system, while
incentivizing innovation, does not also unnecessarily reduce competition in
seed and other input markets beyond that reasonably contemplated by the Patent
Act (see 35 U.S.C. 100 et seq. and 7 U.S.C. 2321 et seq.),
in consultation with the Under Secretary of Commerce for Intellectual Property
and Director of the United States Patent and Trademark Office, submit a report
to the Chair of the White House Competition Council, enumerating and describing
any relevant concerns of the Department of Agriculture and strategies for
addressing those concerns across intellectual property, antitrust, and other
relevant laws.
The Order directs the Secretary
for Health and Human Services to address drug access and pricing:
(iv)
not later than 45 days after the date of this order, submit a report
to the Assistant to the President for Domestic Policy and Director of the
Domestic Policy Council and to the Chair of the White House Competition
Council, with a plan to continue the effort to combat excessive pricing of
prescription drugs and enhance domestic pharmaceutical supply chains, to reduce
the prices paid by the Federal Government for such drugs, and to address the
recurrent problem of price gouging;
(v)
to lower the prices of and improve access to prescription drugs and
biologics, continue to promote generic drug and biosimilar competition, as
contemplated by the Drug Competition Action Plan of 2017 and Biosimilar Action
Plan of 2018 of the Food and Drug Administration (FDA), including by:
(A) continuing to clarify and improve the approval framework for generic
drugs and biosimilars to make generic drug and biosimilar approval more
transparent, efficient, and predictable, including improving and clarifying the
standards for interchangeability of biological products;
(B) as authorized by the Advancing Education on Biosimilars Act of 2021
(Public Law 117-8, 135 Stat. 254, 42 U.S.C. 263-1), supporting biosimilar
product adoption by providing effective educational materials and
communications to improve understanding of biosimilar and interchangeable
products among healthcare providers, patients, and caregivers;
(C) to facilitate the development and approval of biosimilar and
interchangeable products, continuing to update the FDA’s biologics regulations
to clarify existing requirements and procedures related to the review and
submission of Biologics License Applications by advancing the “Biologics
Regulation Modernization” rulemaking (RIN 0910-AI14); and
(D) with the Chair of the FTC, identifying and addressing any efforts to
impede generic drug and biosimilar competition, including but not limited to
false, misleading, or otherwise deceptive statements about generic drug and
biosimilar products and their safety or effectiveness;
(vi)
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, not later than 45 days
after the date of this order, through the Commissioner of Food and Drugs, 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;
(vii) to
support the market entry of lower-cost generic drugs and biosimilars, continue
the implementation of the law widely known as the CREATES Act of 2019 (Public
Law 116-94, 133 Stat. 3130), by:
(A) promptly issuing Covered Product Authorizations (CPAs) to assist
product developers with obtaining brand-drug samples; and
(B) issuing guidance to provide additional information for industry about
CPAs; and
(viii) through the
Administrator of the Centers for Medicare and Medicaid Services, prepare for
Medicare and Medicaid coverage of interchangeable biological products, and
for payment models to support increased utilization of generic drugs and
biosimilars.
The Order directs the Secretary of
Commerce to reconsider proposed regulations concerning technology transfer:
(r) The Secretary of Commerce shall:
(i)
acting through the Director of the National Institute of Standards and Technology
(NIST), consider initiating a rulemaking to require agencies to report to NIST,
on an annual basis, their contractors’ utilization activities, as reported to
the agencies under 35 U.S.C. 202(c)(5);
(ii)
acting through the Director of NIST, consistent with the policies set forth in
section 1 of this order, consider not finalizing any provisions on march-in
rights and product pricing in the proposed rule “Rights to Federally Funded
Inventions and Licensing of Government Owned Inventions,” 86 Fed. Reg. 35 (Jan.
4, 2021);
(iii)
not later than 1 year after the date of this order, in consultation with
the Attorney General and the Chair of the Federal Trade Commission, conduct a
study, including by conducting an open and transparent stakeholder consultation
process, of the mobile application ecosystem, and submit a report to the Chair
of the White House Competition Council, regarding findings and recommendations
for improving competition, reducing barriers to entry, and maximizing user benefit
with respect to the ecosystem.
