Viatris Defeats Biogen’s Try and Revive Tecfidera Patent

Federal Circuit Refuses to Rethink Determination Invalidating Biogen’s Patent Masking its A number of Sclerosis Product Tecfidera®

PITTSBURGH, March 17, 2022 /PRNewswire/ — Viatris Inc. (NASDAQ: VTRS) right now introduced that it’s happy with the choice by america Court docket of Appeals for the Federal Circuit denying Biogen’s request that the Court docket rethink its prior determination affirming the invalidity of Biogen’s U.S. Patent No. 8,399,514, overlaying Tecfidera®.  Following the Court docket’s denial of Biogen’s rehearing petition, the ‘514 patent stays invalid.  Viatris’ subsidiary Mylan Prescribed drugs, Inc. launched the primary therapeutically equal substitutable generic to Tecfidera in August 2020.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a brand new type of healthcare firm, empowering folks worldwide to reside more healthy at each stage of life. We offer entry to medicines, advance sustainable operations, develop modern options and leverage our collective experience to attach extra folks to extra services via our one-of-a-kind World Healthcare Gateway®. Shaped in November 2020, Viatris brings collectively scientific, manufacturing and distribution experience with confirmed regulatory, medical and business capabilities to ship high-quality medicines to sufferers in additional than 165 nations and territories. Viatris’ portfolio contains greater than 1,400 accepted molecules throughout a variety of therapeutic areas, spanning each non-communicable and infectious ailments, together with globally acknowledged manufacturers, advanced generic and branded medicines, a portfolio of biosimilars and a wide range of over-the-counter client merchandise. With a worldwide workforce of roughly 37,000, Viatris is headquartered within the U.S., with international facilities in Pittsburgh, Shanghai and Hyderabad, India. Study extra at viatris.com and investor.viatris.com, and join with us on Twitter at @ViatrisInc, LinkedIn and YouTube

Ahead-Trying Statements
This press launch consists of statements that represent “forward-looking statements.” These statements are made pursuant to the protected harbor provisions of the Non-public Securities Litigation Reform Act of 1995. Such ahead trying statements could embrace statements in regards to the determination by america Court docket of Appeals for the Federal Circuit denying Biogen’s request that the Court docket rethink its prior determination affirming the invalidity of Biogen’s U.S. Patent No. 8,399,514, overlaying Tecfidera; following the Court docket’s denial of Biogen’s rehearing petition, the ‘514 patent stays invalid; and the end result of ongoing litigation. As a result of forward-looking statements inherently contain dangers and uncertainties, precise future outcomes could differ materially from these expressed or implied by such statements. Elements that would trigger or contribute to such variations embrace, however should not restricted to: the potential impression of public well being outbreaks, epidemics and pandemics, together with the continued challenges and uncertainties posed by the COVID-19 pandemic; that the pending transaction between Viatris and Biocon Biologics Restricted, pursuant to which Viatris will contribute its biosimilar merchandise and applications to Biocon Biologics in alternate for money consideration and a convertible most popular fairness curiosity in Biocon Biologics, could not obtain its meant advantages; the mixing of Mylan N.V. and Pfizer Inc.’s Upjohn enterprise (the “Upjohn Enterprise”), which mixed to kind Viatris (the “Mixture”) and the implementation of our international restructuring initiatives being harder, time consuming or pricey than anticipated, or being unsuccessful; the flexibility to attain anticipated advantages, synergies, and working efficiencies in reference to the Mixture or its restructuring initiatives inside the anticipated timeframe or in any respect; actions and selections of healthcare and pharmaceutical regulators; adjustments in healthcare and pharmaceutical legal guidelines and rules within the U.S. and overseas; any regulatory, authorized or different impediments to Viatris’ skill to carry new merchandise to market, together with however not restricted to “at-risk” launches; Viatris’ or its companions’ skill to develop, manufacture, and commercialize merchandise; the scope, timing and final result of any ongoing authorized proceedings, and the impression of any such proceedings; any important breach of knowledge safety or information privateness or disruptions to our info know-how techniques; dangers related to worldwide operations; the flexibility to guard mental property and protect mental property rights; adjustments in third-party relationships; the impact of any adjustments in Viatris’ or its companions’ buyer and provider relationships and buyer buying patterns; the impacts of competitors; adjustments within the financial and monetary situations of Viatris or its companions; uncertainties and issues past the management of administration; and the opposite dangers described in Viatris’ filings with the Securities and Trade Fee (SEC). Viatris routinely makes use of its web site as a method of revealing materials info to the general public in a broad, non-exclusionary method for functions of the SEC’s Regulation Truthful Disclosure (Reg FD). Viatris undertakes no obligation to replace these statements for revisions or adjustments after the date of this launch aside from as required by regulation.

Viatris Logo (PRNewsfoto/Viatris Inc.)

 

SOURCE Viatris Inc.

For additional info: Media: +1.724.514.1968, [email protected]; Jennifer Mauer, Head of World Communications and Company Model, [email protected]; Matt Klein, Senior Director, World Company Communications & Media Relations, [email protected]; Buyers: +1.724.514.1813, [email protected]; Invoice Szablewski, Head of Capital Markets, [email protected]



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