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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.
