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Viatris Inc. 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. 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,
