Viatris Defeats Biogen's Attempt to Revive Tecfidera Patent

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Viatris Inc. (NASDAQ: VTRS) announced a significant legal victory as the U.S. Court of Appeals for the Federal Circuit upheld the invalidity of Biogen's U.S. Patent No. 8,399,514, which covers its multiple sclerosis drug, Tecfidera^®. The court denied Biogen's request to reconsider its earlier ruling, reinforcing that the patent remains invalid. This decision is crucial for Viatris, particularly after its subsidiary, Mylan Pharmaceuticals, launched the first generic equivalent of Tecfidera in August 2020, potentially enhancing market competition and access for patients.

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U.S. Court of Appeals upheld the invalidity of Biogen's Tecfidera patent, allowing greater market access for Viatris.
This ruling supports Mylan's launch of the first generic equivalent of Tecfidera, enhancing Viatris' competitive positioning.

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03/17/2022 - 02:54 PM

Federal Circuit Refuses to Reconsider Decision Invalidating Biogen's Patent Covering its Multiple Sclerosis Product Tecfidera^®

PITTSBURGH, March 17, 2022 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today announced that it is pleased with the decision by the United States Court of Appeals for the Federal Circuit denying Biogen's request that the Court reconsider its prior decision affirming the invalidity of Biogen's U.S. Patent No. 8,399,514, covering Tecfidera^®. Following the Court's denial of Biogen's rehearing petition, the '514 patent remains invalid. Viatris' subsidiary Mylan Pharmaceuticals, Inc. launched the first therapeutically equivalent substitutable generic to Tecfidera in August 2020.

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 portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 37,000, 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 decision by the United States Court of Appeals for the Federal Circuit denying Biogen's request that the Court reconsider its prior decision affirming the invalidity of Biogen's U.S. Patent No. 8,399,514, covering Tecfidera; following the Court's denial of Biogen's rehearing petition, the '514 patent remains invalid; and the outcome 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 potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by the COVID-19 pandemic; that the pending transaction between Viatris and Biocon Biologics Limited, pursuant to which Viatris will contribute its biosimilar products and programs to Biocon Biologics in exchange for cash consideration and a convertible preferred equity interest in Biocon Biologics, may not achieve its intended benefits; 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; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; 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 described in Viatris' filings with the Securities and Exchange Commission (SEC). 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.