Viatris Wins Federal Circuit Court Appeal Upholding District Court Decision Invalidating Biogen's Tecfidera® Patent
On December 1, 2021, Viatris (NASDAQ: VTRS) announced that the U.S. Court of Appeals affirmed a prior ruling that invalidated Biogen's Tecfidera patent for lack of written description. This decision supports Viatris' launch of a generic version of Tecfidera in August 2020, facilitating greater access to multiple sclerosis treatments. CEO Michael Goettler expressed satisfaction with the ruling, highlighting Viatris' commitment to improving patient access to affordable medications.
- U.S. Court of Appeals upheld district court ruling invalidating Biogen's Tecfidera patent.
- Reinforces Viatris' ability to provide a generic version of Tecfidera, enhancing access to affordable treatment.
- None.
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.
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