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# Court Considering Amgen, Sandoz Cert Petitions
- URL: https://www.fdaweb.com/court-considering-amgen-sandoz-cert-petitions/
- Published: 2016-05-25T12:00:00.000Z
- Updated: 2026-09-14T21:05:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135763

The Supreme Court may decide in June whether to hear Sandoz and/or Amgen’s petitions appealing a Federal Circuit Court of Appeals decision on interpretation of the “notice of commercial marketing” provision of the Biologics Price Competition and Innovation Act (BPCIA). A *Big Molecule Watch* blog [post](http://www.bigmoleculewatch.com/2016/05/23/amgen-v-sandoz-sandozs-opposition-to-amgens-conditional-cross-petition-for-certiorari/?ref=fdaweb.com) from Goodwin Procter says that the Sandoz appeal also asked the high court to consider whether the Federal Circuit erred in creating a private right of action to force a biosimilar applicant to provide timely notice of commercial marketing, and in granting an “extra-statutory” injunction to enforce that right.

Amgen responded to the Sandoz filing and also filed a conditional cross-petition for a writ of certiorari, challenging the Federal Circuit ruling that the BPCIA disclosure provision is not mandatory and that the law provides its own statutorily defined remedies for non-compliance with the “patent dance.” Amgen’s petition was conditional in that it asked the Supreme Court to consider its question only if it decides to hear the Sandoz appeal.

Sandoz has filed an opposition to the Amgen motion, saying that Amgen did not invoke any cause of action under the BPCIA itself or claim any right to an injunction under the federal statute. It said that Amgen had sought to stop Sandoz from launching its biosimilar product under California’s unfair competition law and common law conversion claims.

In its filing, Sandoz said the court should reject the Amgen cross-petition for two reasons: **(1)** the appeals court correctly held that the BPCIA expressly contemplates that an applicant may choose to withhold its application, and choosing an option permitted by the law is therefore not unlawful under California law, and **(2)** the Federal Circuit correctly interpreted California law and the common law of conversion to deny Amgen’s claims and “the necessity of resolving state law questions to reverse the portion of the judgment makes the conditional cross-petition a poor vehicle for review.”