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Publications
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12.15.2017Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"UpdatesOn December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit ruled in Amgen Inc. v. Sandoz Inc. that the original sponsors of biologics products cannot invoke state laws to compel applicants that are seeking to market biosimilar products to disclose information about those products under the Biologics Price Competition and Innovation Act (BPCIA).
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04.17.2012Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole in Hatch-Waxman ActUpdatesIn Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the Supreme Court has unanimously held that generic drug manufacturers may invoke the counterclaim provision of the Hatch-Waxman Act.
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03.13.2012FDA Releases Draft Guidelines for Biosimilar Development ApprovalUpdatesOn February 9, 2012, the Food and Drug Administration ("FDA") released draft biosimilar development approval pathway guidelines.
Presentations
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03.05.2020Enhancing Diversity & Inclusion in IP Law and BeyondSpeaking EngagementsSponsorships
FCBA / Washington, D.C.
Life Science Legal Report
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USPTO Requests Comments on PTAB-Decision Review by October 18, 2022
On July 22, 2022, the USPTO released a Request for Comments (RFC) seeking public input on Director review, Precedential Opinion Panel (POP) review, and internal circulation and review of Patent Trial and Appeal Board (PTAB) decisions. As set out in the RFC, “[t]he USPTO has implemented a number of processes that promote the accuracy, consistency,... Continue Reading…
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On February 28, 2022, the Patent Trial and Appeal Board (“PTAB”) issued a decision on priority in an interference proceeding between the Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (collectively, “Broad”) and the Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”), and... Continue Reading…
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Federal Circuit Confirms the Broad Reach of IPR Estoppel
Under 35 U.S.C. § 315(e), inter partes review (IPR) estoppel applies to “any ground that the petitioner raised or reasonably could have raised during that inter partes review.” In 2018, the Federal Circuit held in Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293 (Fed. Cir. 2016), that IPR estoppel does not apply... Continue Reading…
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Real Parties-In-Interest: Guidance On Who Is An RPI-And Who Is Not-In Post-Grant Proceedings
In a recent article, Real Parties In Interest Guidance On Who Is An RPI-And Who Is Not-In Post Grant Proceedings, linked here, Emily Greb and Maria Stubbing offer practical guidance and examine caselaw to clear some of the confusion and frustration practitioners encounter when real parties-in-interest in post-grant review proceedings before the U.S. Patent and Trademark... Continue Reading…