Biologics is part of our work in Life Sciences.
Introduced nearly ten years ago, the Biologics Price Competition and Innovation Act (BPCIA) opened the door for companies to seek U.S. Food and Drug Administration (FDA) approval to manufacture and sell biosimilar or interchangeable versions of brand name biological products. The BPCIA provides reference product sponsors with 12 years of market exclusivity. It also provides a statutory basis for patent litigation between the reference product sponsor and the biosimilar, as patents can provide additional exclusivity for the branded product. Unlike the Hatch-Waxman Act, the BPCIA does not require reference product sponsors to list patents in an Orange Book equivalent. Instead, it defines specific pre-litigation procedures, sometimes called the “patent dance,” that requires identification of relevant patents and each party’s basis for infringement and validity.
Finnegan advises clients on virtually every intellectual property issue related to the complex and evolving area of biologics, including patent prosecution, due diligence investigations, portfolio management, and litigation. Our team comprises experienced life science intellectual property attorneys, who have an in-depth understanding of the complex legal, technical, regulatory, and business issues surrounding these complex molecules, and how those issues impact life science companies.
We help with:
2:23-cv-00094, 2:23-cv-02364, D.N.J., Judges Cecchi, Padin, Wettre
IPR2022-01200, PGR2022-00051, PTAB, Judges Newman, Snedden, Wisz
22-2232, Fed. Cir.
PGR2022-00037, PTAB, Judges Newman, Obermann, Worth
IPR2022-00738, -00739, -00796, PTAB, Judges Cotta, Wisz, Worth
1:21-cv-10954, D. Mass., Judge Burroughs
1:21-cv-02258, 1:21-cv-02899, N.D. Ill., Judge Lee
1:21-cv-01736, 1:23-cv-00554, D. Del., Judge Andrews
Conference
2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities
March 20, 2024
Boston
Webinar
February 15, 2024
Webinar
Webinar
Navigating Your Life Sciences Opposition: Tips for Best Practice When You Are Opposing or Opposed
December 12, 2023
Webinar
Webinar
November 28, 2023
Webinar
Conference
3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
October 10-26, 2023
Virtual
Press Release
Finnegan Continues to Hold Top-Tier LMG Life Sciences 2022 Rankings
September 22, 2022
Press Release
Finnegan Celebrates Two Wins at the 2020 LMG Life Sciences Awards and Top Honors in the Rankings
October 5, 2020
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