Senator Thom Tillis has been busy. He has proposed a new act to clarify patent eligibility doctrine in the United States. This is definitely a relatively broad vision of patent eligibility. Some work on the pricing side of pharmaceuticals/biologics would be helpful if this gets passed. I am wondering if this may get tacked on to another piece of legislation—the timing is interesting. The Press Release states:
U.S. Senator Thom Tillis (R-NC) introduced the Patent
Eligibility Restoration Act of 2022, legislation that will restore patent
eligibility to important inventions across many fields, while also resolving
legitimate concerns over the patenting of mere ideas, the mere discovery of
what already exists in nature, and social and cultural content that everyone
agrees is beyond the scope of the patent system. This bill affirms the basic
principle that the patent system is central to promoting technology-based
innovation.
“I have long said that clear, strong, and predictable patent
rights are imperative to enable investments in the broad array of innovative
technologies that are critical to the economic and global competitiveness of
the United States, and to its national security,” said Senator Tillis. “Unfortunately,
our current Supreme Court’s patent eligibility jurisprudence is undermining
American innovation and allowing foreign adversaries like China to overtake us
in key technology innovations. This legislation, which is the product of almost
four years of consensus driven stakeholder conversations from all interested
parties, maintains the existing statutory categories of eligible subject
matter, which have worked well for over two centuries, and addresses concerns
regarding inappropriate eligibility constraints by enumerating a specific but
extensive list of excluded subject matter. I look forward to continuing to work
with all interested stakeholders on this important matter. Passing patent
eligibility reform remains one of my top legislative priorities during my
second term.”
Background:
Unfortunately, due to a series of Supreme Court decisions,
patent eligibility law in the United States has become confused, constricted,
and unclear in recent years. This has led to inconsistent case decisions,
uncertainty in innovation and investment communities, and unpredictable
business outcomes. This has resulted in a wide range of well-documented
negative impacts.
As of 2021, all 12 judges of the United States Court of
Appeals for the Federal Circuit have lamented the state of the law. Witnesses
and stakeholders from a wide array of industries, fields, interest groups, and
academia have testified and submitted comments confirming the uncertainty and
detailing the detrimental effects of patent eligibility confusion in the United
States. And there is now widespread bipartisan agreement in
Congress and across all recent Administrations that reforms are necessary to
restore the United States to a position of global strength and leadership in
key areas of technology and innovation, such as medical diagnostics,
biotechnology, personalized medicine, artificial intelligence, 5G, and
blockchain.
The proposed legislation states, in part:
SEC. 2. PATENT ELIGIBILITY. (a) IN GENERAL.—Chapter 10 of
title 35, United 8 States Code, is amended— (1) in section 100— (A) in
subsection (b), by striking ‘‘includes a new use of a known process’’ and
inserting ‘‘includes a use, application, or method of manufacture of a known or
naturally-occurring process’’; and (B) by adding at the end the following:
‘‘(k) The term ‘useful’ means, with respect to an invention or discovery, that
the invention or discovery has a specific and practical utility from the
perspective of a person of ordinary skill in the art to which the invention or
discovery pertains.’’;
and (2) by amending section 101 to read as follows: ‘‘§ 101.
Patent eligibility ‘‘(a) IN GENERAL.—Whoever invents or discovers any useful
process, machine, manufacture, or composition of matter, or any useful
improvement thereof, may obtain a patent therefor, subject only to the
exclusions in sub section (b) and to the further conditions and requirements of
this title.
‘‘(b) ELIGIBILITY EXCLUSIONS.— ‘‘(1) IN GENERAL.—Subject to
paragraph (2), a person may not obtain a patent for any of the following, if
claimed as such: ‘‘(A) A mathematical formula, apart from a useful invention or
discovery. ‘‘(B) A process that— ‘‘(i) is a non-technological economic,
financial, business, social, cultural, or artistic process; ‘‘(ii) is a mental
process performed solely in the human mind; or ‘‘(iii) occurs in nature wholly
independent of, and prior to, any human activity. ‘‘(C) An unmodified human
gene, as that gene exists in the human body. ‘‘(D) An unmodified natural
material, as that material exists in nature. ‘‘(2) CONDITIONS.— ‘‘(A) CERTAIN
PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent
for a claimed invention that is a process described in such provision if that
process is embodied in a machine or manufacture, unless that machine or
manufacture is recited in a patent claim without integrating, beyond merely
storing and executing, the steps of the process that the machine or manufacture
perform. ‘‘(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs
(C) and (D) of paragraph (1), a human gene or natural material that is
isolated, purified, enriched, or otherwise altered by human activity, or that
is otherwise employed in a useful invention or discovery, shall not be
considered to be unmodified.
‘‘(c) ELIGIBILITY.— ‘‘(1) IN GENERAL.—In determining whether, under
this section, a claimed invention is eligible for a patent, eligibility shall
be determined— ‘‘(A) by considering the
claimed invention as a whole and without discounting or disregarding any claim
element; and ‘‘(B) without regard to— ‘‘(i) the manner in which the claimed invention
was made; ‘‘(ii) whether a claim element is known, conventional, routine, or
naturally occurring; ‘‘(iii) the state
of the applicable art, as of the date on which the claimed invention is
invented; or ‘‘(iv) any other consideration in section 102, 103, or 112.
‘‘(2) INFRINGEMENT ACTION.— ‘‘(A) IN GENERAL.—In an action
brought for infringement under this title, the court, at any time, may
determine whether an invention or discovery that is a subject of the action is
eligible for a patent under this section, including on motion of a party when
there are no genuine issues of material fact. ‘‘(B) LIMITED DISCOVERY.—With
respect to a determination described in subparagraph (A), the court may
consider limited discovery relevant only to the eligibility described in that subparagraph
before ruling on a motion described in that subparagraph.’’.
