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ARTICLE · 29 NOVEMBER 2020

What's Next For U.S. Biosimilar Litigation

Herbert Smith Freehills Kramer LLP
Herbert Smith Freehills Kramer LLP
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Herbert Smith Freehills Kramer LLP

Herbert Smith Freehills Kramer LLP

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Intellectual Property partner Irena Royzman and associate Michael A. Anderson authored a Bloomberg Law article titled "What's Next for U.S. Biosimilar Litigation" on Nov. 20, 2020

United StatesIntellectual Property
Irena Royzman
Irena Royzman
Michael A. Anderson
Michael A. Anderson
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Kramer Levin Naftalis & Frankel LLP attorneys discuss the direction of biosimilar litigation from recent federal court rulings. They also look at trends in patent litigation and what to expect in 2021 and beyond.

The Biologics Price Competition and Innovation Act (BPCIA) turned 10 this year, making it a good time to look at recent litigation trends and assess what's ahead for 2021.

U.S. biosimilar litigation continues to take shape, although most cases have resolved without a decision on the merits. The U.S. Court of Appeals for the Federal Circuit has provided guidance on the requirements for the BPCIA's 180-day notice of commercial marketing and biosimilar injunctions.

Manufacturing patents protecting all aspects of the manufacture of biologics continue to play a central role in biosimilar litigation, as biosimilar makers are obtaining patents to protect their products and gain a competitive edge.

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