The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...more
In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit affirmed the district court granting a preliminary injunction based on infringement of U.S. Patent No. 9,353,050 (the product patent), directed to an...more
Torrent Pharmaceuticals (“Torrent”), Apotex Inc., and Mylan Pharmaceuticals filed two inter partes review (“IPR”) petitions in 2014 seeking review of all claims of U.S. Patent 8,324,283 (the “’283 patent”), which is related...more
All nine Supreme Court Justices heard argument on Wednesday, April 26, in Sandoz Inc., v. Amgen Inc. The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (“BPCIA”) made by the...more
5/1/2017
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Biosimilars ,
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Patent Infringement ,
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Pharmaceutical Patents ,
Sandoz v Amgen