In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a biosimilar applicant declines to provide its application and manufacturing information, the patent owner’s exclusive remedy under federal law is to bring a declaratory judgment action for patent infringement. The Court left open for now whether a patent owner may have additional remedies under state law. Second, the Court held that a biosimilar applicant may provide its mandatory 180-day notice of commercial marketing at any time and need not wait until FDA has approved its application...
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