IP Law Daily, PATENT NEWS: Supreme Court asked to review Federal Circuit’s interpretation of biosimilar drug procedures, (Feb 18, 2016)

By Cheryl Beise, J.D.

Pharmaceutical company Sandoz, Inc. has filed a petition asking the Supreme Court to review a Federal Circuit decision interpreting the abbreviated procedure for obtaining Food and Drug Administration (FDA) approval for marketing biosimilar drug products provided by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The BPCIA establishes an abbreviated pathway for regulatory approval of follow-on biological products that are “highly similar” to a previously approved product (“reference product”). A drug maker that demonstrates the biosimilarity of its product to one which has already received FDA approval may rely on studies and data completed by the reference product producer. A sponsor of an approved reference product (“RPS”) is entitled to up to 12 years of market exclusivity against follow-on products, regardless of patent protection. The statute also provides that the applicant give notice of commercial marketing to the RPS at least 180 days in advance, giving the RPS the opportunity to seek a preliminary injunction based on patents identified in the disclosures, as well as any newly issued or licensed (“non-listed”) patents.

A divided Federal Circuit panel affirmed a district court’s dismissal of Amgen’s state-law claims of unfair competition and conversion against competitor Sandoz because Amgen failed to show that Sandoz unlawfully failed to provide Amgen with information regarding its biosimilar filgrastim product (marketed under the brand name Zarxio®) that was similar to Amgen’s filgrastim product (marketed under the brand name Neupogen®) prior to applying for biosimilar status with the FDA.

The Federal Circuit held that an applicant’s failure to supply the information described in paragraph 262(l)(2) to the RPS was not a violation of the BPCIA. However, the notice requirement of paragraph (l)(8)(A) was mandatory, according to the court. Section 262(l)(8)(A) provides that an applicant shall provide notice to the RPS at least “180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” According to the Federal Circuit, an applicant may give notice of commercial marketing only after it has a licensed product—that is, only after the FDA has licensed the biosimilar product. When Sandoz gave notice to Amgen of its intent to commercial market its biosimilar filgrastim product on July 8, 2014, Sandoz’s product was not yet a “licensed” product. Therefore, Sandoz could not market its biosimilar product until 180 days after the FDA approved Sandoz’s application for all approved uses of Amgen’s Neupogen on March 6, 2015—that is, September 2, 2015. Circuit Judge Raymond T. Chen dissented from the majority’s holding that paragraph (l)(8) was a standalone provision with what amounted to an inherent right to a 180-day injunction against marketing the biosimilar product.

Sandoz’s petition asks, “Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper” (Sandoz, Inc. v. Amgen, Inc., February 16, 2016).

The case is Dkt. No. 15-1039.

Attorneys: Deanne E. Maynard (Morrison & Foerster LLP) for Sandoz Inc.

Companies: Sandoz Inc.; Amgen, Inc.

News: Patent