SCOTUS rejects hearing of Apotex v Amgen biosimilar suit

The US Supreme Court declined to hear a biosimilar case between Apotex and Amgen yesterday.

The case centres on biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a treatment for infection in cancer patients.

Amgen sued Apotex under the Biologics Price Competition and Innovation Act of 2009, after Apotex had applied for permission to market its biosimilar.

In July this year, the US Court of Appeals for the Federal Circuit held that companies must always give 180 days’ notification to rival brands before launching their biosimilar product.

Apotex argued that the 180-day notification is not mandatory and may not be enforced by injunction, but the court disagreed, stating that the marketing provision is mandatory and enforceable by an injunction.

In September this year, Apotex filed a petition for a writ of certiorari, asking the Supreme Court two questions.

First, it asked whether the Federal Circuit had erred in holding that biosimilar applicants that make all disclosures necessary must also provide the reference product sponsor with a notice of commercial marketing.

The second question was whether the court had “improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing … until it receives a[n] FDA licence and therefore may not commercially market its biosimilar product for 180 days after receiving its licence”.