As recognized by the U.S. Food and Drug Administration (FDA), "[b]iological products often represent the cutting edge of biomedical research." While most small-molecule drugs are chemically synthesized and have known structures, most biological products are produced using biotechnological methods and have complex structures that are not easily identified or characterized. Reflective of these complexities, patent law for biological products continues to evolve, with growing numbers of patents for biological products are being prosecuted, challenged in post-grant proceedings before the U.S. Patent and Trademark Office (USPTO), and litigated under the Biologics Price Competition and Innovation Act (BPCIA).
Our panel will discuss the evolving law for biological product patents, including:
- What patent prosecution strategies have been successful for biological product patents?
- How have patents for biological products been challenged in post-grant proceedings before the USPTO?
- What trends have we seen in post-grant challenges of biological product patents?
- What have we learned about the patent dance and infringement from BPCIA litigations to date?
- How have patents for biological products been challenged in BPCIA litigations?
- What is on the horizon for biological product patents?
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Moderator:
Thomas J. Sullivan
Speakers:
Shana K. Cyr, Ph.D.
Mark J. Feldstein, Ph.D.
Date:
Thursday, March 21, 2019
Time:
10:00 a.m. PDT
1:00 p.m. EDT
7:00 p.m. CEST