The US Supreme Court has granted petitions for certiorari in Amgen v. Sandoz confirming that the Court will examine the operation of the “patent dance” regime under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as well as clarifying when notice of commercial marketing can be given. Biosimilar boffins and patent pedants will be (justifiably) excited.

Who Dances with Patents?

The BPCIA established an abbreviated pathway for regulatory approval of follow-on biological products that are “highly similar” to a previously approved product. Rather than submitting its own extensive clinical data, the regime allows an applicant to submit information to show that its product is biosimilar to a previously approved product. The BPCIA also established a patent dispute resolution regime, amending the US Code to create a statutory “act of infringement”. This allows the owner of an originator biological to sue for infringement based on the making of the biosimilar application prior to any approval by the FDA and prior to any marketing of the biological product.

The BPCIA also established an elaborate information exchange regime between the biosimilar applicant and originator to resolve patent disputes, a regime that has been described as the “patent dance”. The first step of this dance requires the biosimilar applicant to grant the originator confidential access to its (the applicant’s) product information within 20 days of the FDA accepting the application for review.

The BPCIA also requires the applicant to give notice of commercial marketing to the originator at least 180 days prior to commercial marketing (to allow the originator time to seek an injunction to prevent commercial launch).

What happened?

Amgen has marketed filgrastim under the brand name Neupogen since 1991.

Sandoz filed a biosimilar application in May 2014 and was then notified on 7 July 2014 that the FDA had accepted its application for review. The next day Sandoz notified Amgen of its application and said it intended to launch its biosimilar immediately upon FDA approval. Through subsequent correspondence, Sandoz told Amgen that it didn’t want to dance with its opponent: it had opted not to provide Amgen with its biosimilar application or manufacturing information.

Amgen

Upset at not being asked to dance by Sandoz, Amgen sued Sandoz claiming that Sandoz had breached the BPCIA and infringed Amgen’s patents for filgrastim. The alleged breaches of the BPCIA resulted from Sandoz’s failure to disclose the required information and its premature (and therefore ineffective) notice of commercial marketing before FDA approval of its biosimilar. Sandoz counterclaimed that its interpretation of the BPCIA was valid and alleged that Amgen’s patent was invalid. The District Court ruled that Sandoz was entitled to elect not to provide information to Amgen under the provisions of the BPCIA (subject to the Act’s consequences) and that Sandoz could give notice of commercial approval under the Act prior to receiving FDA approval.

Amgen appealed to the Federal Circuit Court of Appeals. There were two key issues on appeal:

  1. Whether a biosimilar applicant may elect not to disclose its application and manufacturing information, subject only to the consequences set out in the Act.
  2. Whether a biosimilar applicant may satisfy its obligation to give notice of commercial marketing under the Act by doing so before the FDA approves its product and whether such notice is mandatory.

The Court of Appeals found for Sandoz on the first issue: an applicant can elect not to disclose its application and manufacturing information. The consequence of electing not to disclose the information is that the applicant faces immediate infringement action from the originator.

The Court found for Amgen on the second issue: notice of commercial marketing may be given only after FDA approval of the biosimilar product. The Court also found that notice of commercial marketing is mandatory if the applicant opts out of the information disclosure regime for which the Act provides (that is, chooses not to do the “patent dance”).

What happens now?

Following the Court of Appeals’ decision, Sandoz filed a petition for a writ of certiorari, requesting that the Supreme Court review the Court of Appeals’ interpretation of the BPCIA’s notice of commercial marketing provision. Amgen opposed Sandoz’s petition and followed with a conditional cross-petition for certiorari, challenging the Court of Appeals’ finding that the information disclosure regime for which the Act provides is optional. On 7 December 2016, the Solicitor General filed a brief recommending that both the certiorari petition and cross-petition be granted (as well as siding with Sandoz on the merits of both). On 13 January the Supreme Court granted both petitions for certiorari.

We will report back following the last dance in the Supreme Court, likely to take place later this year.