Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN)
applauds the United States Supreme Court’s unanimous opinion1
ending a nearly decade-long patent dispute related to the
Regeneron-invented PCSK9 inhibitor, Praluent® (alirocumab). The
decision affirms the United States Court of Appeals for the Federal
Circuit’s opinion, which held that Amgen’s asserted U.S. PCSK9
patent claims were invalid.
This ruling validates Regeneron’s longstanding
position on this matter and represents an unequivocal win for
America’s innovation economy, its scientists, and researchers. Most
importantly, it is a win for patients who rely on the lifesaving
discoveries made through years of research and investment by the
biopharma community. The justices rejected an attempt to radically
change the longstanding legal standard for patent validity under
the enablement doctrine – a move that would have blocked progress
for entire classes of molecules, deterred innovative competition,
and led to potential increases of drug prices.
“Bringing innovative new therapies to patients is
the core mission of Regeneron, and we were proud to deliver
Praluent as the first FDA approved PCKS9 inhibitor,” said Leonard
S. Schleifer, M.D., Ph.D., Founder and Chief Executive Officer of
Regeneron. “This Supreme Court decision protects access to this
medicine and defends our industry and others against overreaching
patent claims that cover an entire therapeutic category and could
have a chilling effect on bringing life-saving medicines to people
in need.”
“This decision affirms the longstanding law on
enablement and functional claiming, such that you need to enable
the full scope of the claims without unreasonable experimentation,”
said Joseph J. LaRosa, Executive Vice President, General Counsel
and Secretary of Regeneron. “We’re gratified that the Supreme Court
has affirmed the position we have held for nearly ten years that
Amgen’s PCSK9 patents were overly broad and inconsistent with
established case law.”
We thank the Justices for their consideration of
this matter and the many groups, individuals and the U.S.
government who supported our defense of scientific innovation.
About Regeneron Regeneron (NASDAQ:
REGN) is a leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to nine FDA-approved treatments and numerous
product candidates in development, almost all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, pain, hematologic conditions, infectious diseases and
rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For more information, please visit
www.Regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and
Use of Digital MediaThis press release includes
forward-looking statements that involve risks and uncertainties
relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the
“Company”), and actual events or results may differ materially from
these forward-looking statements. Words such as “anticipate,”
“expect,” “intend,” “plan,” “believe,” “seek,” “estimate,”
variations of such words, and similar expressions are intended to
identify such forward-looking statements, although not all
forward-looking statements contain these identifying words. These
statements concern, and these risks and uncertainties include,
among others, risks associated with intellectual property of other
parties and pending or future litigation relating thereto,
including without limitation the patent litigation pertaining to
Praluent® (alirocumab) discussed in this press release (as well as
other patent litigation and related proceedings relating to
Praluent, EYLEA® (aflibercept) Injection, and REGEN-COV®
(casirivimab and imdevimab)), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, the ultimate outcome of any such proceedings
and investigations, and the impact any of the foregoing may have on
Regeneron’s business, prospects, operating results, and financial
condition; the nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”) and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned; the likelihood, timing, and scope
of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates and new indications for Regeneron’s
Products; uncertainty of the utilization, market acceptance, and
commercial success of Regeneron’s Products and Regeneron’s Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on any of
the foregoing or any potential regulatory approval of Regeneron's
Products and Regeneron's Product Candidates; the ability of
Regeneron’s collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron’s Products and Regeneron’s Product Candidates;
the ability of Regeneron to manage supply chains for multiple
products and product candidates; safety issues resulting from the
administration of Regeneron’s Products and Regeneron’s Product
Candidates in patients, including serious complications or side
effects in connection with the use of Regeneron’s Products and
Regeneron’s Product Candidates in clinical trials; determinations
by regulatory and administrative governmental authorities which may
delay or restrict Regeneron’s ability to continue to develop or
commercialize Regeneron’s Products and Regeneron’s Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron’s Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron’s Products from third-party
payers, including private payer healthcare and insurance programs,
health maintenance organizations, pharmacy benefit management
companies, and government programs such as Medicare and Medicaid;
coverage and reimbursement determinations by such payers and new
policies and procedures adopted by such payers; competing drugs and
product candidates that may be superior to, or more cost effective
than, Regeneron’s Products and Regeneron’s Product Candidates; the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; and the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business. A more complete description of these and
other material risks can be found in Regeneron’s filings with
the U.S. Securities and Exchange Commission, including its
Form 10-K for the year ended December 31, 2022 and its Form
10-Q for the quarterly period ended March 31, 2023. Any
forward-looking statements are made based on management’s current
beliefs and judgment, and the reader is cautioned not to rely on
any forward-looking statements made by Regeneron. Regeneron does
not undertake any obligation to update (publicly or otherwise) any
forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations
website and social media outlets to publish important information
about the Company, including information that may be deemed
material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron’s
media and investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Regeneron Media Contact: Alexandra BowieTel: +1
914-847-3407 alexandra.bowie@regeneron.com |
Regeneron Investor Contact: Mark HudsonTel: +1
914-847-3482mark.hudson@regeneron.com |
_____________________1 Amgen v. Sanofi et. al.,
https://www.supremecourt.gov/opinions/22pdf/21-757_k5g1.pdf.
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