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Supreme Court rules applicants for biosimilar products may provide notice of marketing before FDA approval

[JURIST] The US Supreme Court [official website] ruled unanimously Monday in Sandoz Inc. v. Amgen Inc. [opinion, PDF] that companies applying to produce biosimilar products do not need to have the approval of the Federal Drug Administration (FDA) [official website] before giving notice of marketing. The case arose from an application filed by a generic drug company, Sandoz Inc., to market a "biosimilar" product to Amgen, Inc.'s [corporate websites] drug, filgrastim, a bone marrow stimulant for cancer patients seeking radiation therapy. The Biologics Price Competition and Innovation [text, PDF] subsection of the Affordable Care Act (ACA) [text, PDF] requires that companies seeking to market biosimilar products must provide notice of plans to do so to their competitors "not later than 180 days before the date of the first commercial marketing of the [biosimilar] product licensed [by the FDA]." Sandoz sent notice to Amgen while their product was still pending FDA approval. The US Court of Appeals for the Federal Circuit held [opinion, PDF] that Sandoz had issued notice too early because the components of the drug, its manufacturing process and its therapeutic uses are still subject to change in order to gain FDA approval. The Supreme Court reversed the Federal Circuit's decision, shortening the marketing time for generic companies.

This is the sixth and final patent case the Supreme Court decided this term. In May the Supreme Court ruled [JURIST report] that restrictions placed on a patented product could not be enforced through an infringement suit because an authorized sale exhausts all rights under the Patent Act [LII materials]. Also in May the Supreme Court ruled [JURIST report] in TC Heartland LLC v. Kraft Foods Group Brands LLC [SCOTUSblog materials] on what constitutes "residence" in the context of patent cases. The Supreme Court has also already agreed to hear two patent cases this coming fall. In Oil States Energy Services v. Greene's Energy Group [docket; cert. petition, PDF], a case from the US Court of Appeals for the Federal Circuit, the court will determine [JURIST report] whether inter partes review, a process used by the Patent and Trademark Office (PTO) to determine the validity of existing patents, violates private property rights, granted by the Constitution, by not using a jury forum. The US Supreme Court also granted certiorari [JURIST report] in SAS Institute Inc. v. Lee on whether third parties can petition the US Patent and Trademark Office (USPTO) to re-review issued claims and, if not patentable, cancel them.

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