PITTSBURGH, Dec. 1, 2021 /PRNewswire/
-- Viatris Inc. (NASDAQ: VTRS) today announced that
the United States Court of Appeals
for the Federal Circuit affirmed the June
2020 decision by the U.S. District Court for the Northern
District of West Virginia
invalidating Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514,
for lack of written description. The company launched the first
therapeutically equivalent substitutable generic to Tecfidera in
August 2020.
"We are pleased with the outcome of the Federal Circuit case,
which reinforces our continued commitment to providing the multiple
sclerosis community with access to more affordable treatment
options," said Michael
Goettler, Chief Executive Officer of Viatris. "Bringing
a product like generic Tecfidera to market highlights our
unwavering commitment to removing barriers to patient access,
including challenging unsupportable legal barriers."
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new
kind of healthcare company, empowering people worldwide to live
healthier at every stage of life. We provide access to medicines,
advance sustainable operations, develop innovative solutions and
leverage our collective expertise to connect more people to more
products and services through our one-of-a-kind Global Healthcare
Gateway®. Formed in November
2020, Viatris brings together scientific, manufacturing and
distribution expertise with proven regulatory, medical and
commercial capabilities to deliver high-quality medicines to
patients in more than 165 countries and territories. Viatris'
portfolio comprises more than 1,400 approved molecules across a
wide range of therapeutic areas, spanning both non-communicable and
infectious diseases, including globally recognized brands, complex
generic and branded medicines, a growing portfolio of biosimilars
and a variety of over-the-counter consumer products. With a global
workforce of approximately 38,000, Viatris is headquartered in the
U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at
viatris.com and investor.viatris.com, and connect with us on
Twitter at @ViatrisInc, LinkedIn and YouTube.
Forward-Looking Statements
This press release includes
statements that constitute "forward-looking statements." These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such forward
looking statements may include statements about the outcome and
status of ongoing litigation. Because forward-looking statements
inherently involve risks and uncertainties, actual future results
may differ materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to: the scope, timing and
outcome of any ongoing legal proceedings and the impact of any such
proceedings; that court decisions are not yet final and are subject
to further review, rehearing and appeal, which could result in an
adverse outcome; the potential impact of public health outbreaks,
epidemics and pandemics, including the ongoing challenges and
uncertainties posed by the COVID-19 pandemic; the integration of
Mylan N.V. and Pfizer Inc.'s Upjohn business (the "Upjohn
Business"), which combined to form Viatris (the "Combination") and
the implementation of our global restructuring initiatives being
more difficult, time consuming or costly than expected, or being
unsuccessful; the ability to achieve expected benefits, synergies
and operating efficiencies in connection with the Combination or
its restructuring initiatives within the expected timeframe or at
all; actions and decisions of healthcare and pharmaceutical
regulators; changes in healthcare and pharmaceutical laws and
regulations in the U.S. and abroad; any regulatory, legal or other
impediments to Viatris' ability to bring new products to market,
including but not limited to "at-risk" launches; Viatris' or its
partners' ability to develop, manufacture and commercialize
products; any significant breach of data security or data privacy
or disruptions to our information technology systems; risks
associated with international operations, including our operations
in China; the ability to protect
intellectual property and preserve intellectual property rights;
changes in third-party relationships; the effect of any changes in
Viatris' or its partners' customer and supplier relationships and
customer purchasing patterns; the impacts of competition; changes
in the economic and financial conditions of Viatris or its
partners; uncertainties and matters beyond the control of
management; and the other risks Viatris' filings with the
Securities and Exchange Commission. Viatris routinely uses its
website as a means of disclosing material information to the public
in a broad, non-exclusionary manner for purposes of the SEC's
Regulation Fair Disclosure (Reg FD). Viatris undertakes no
obligation to update these statements for revisions or changes
after the date of this release other than as required by law.
Contacts:
Media:
+1.724.514.1968
Communications@viatris.com
Jennifer Mauer
Head of Global Communications and Corporate Brand
Jennifer.Mauer@viatris.com
Investors:
+1.724.514.1813
InvestorRelations@viatris.com
Bill Szablewski
Head of Capital Markets
William.Szablewski@viatris.com
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SOURCE Viatris Inc.