On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the views of the United States.” While this will delay any Supreme Court review of the Federal Circuit’s first decision interpreting the patent dance provisions of the Biologics Price Competition and Innovation Act (BPCIA), it could give the Court an opportunity to consolidate its consideration of the biosimilar statute with other biosimilar cases making their way through the courts.
These articles discuss some of the issues raised to date in biosimilar patent disputes surrounding Neupogen®, Nuelasta® and Remicade®:
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Neupogen®: The Sandoz petition for certiorari
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Neupogen®:The Amgen opposition and conditional cross-petition for certiorari
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Nuelasta®: The district court decision in Amgen v. Apotex (argued at the Federal Circuit April 4, 2016)