Sandoz Appeals Ruling It Can't Sue Amgen Over Biosimilar Until FDA Application Filed

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By John T. Aquino  

Dec. 18 --Sandoz Inc. Dec. 13 appealed to the U.S. Court of Appeals for the Federal Circuit a district court's ruling that a biosimilar applicant can't sue a branded company for noninfringement until it files an application with the Food and Drug Administration (Sandoz, Inc. v. Amgen, Inc., Fed. Cir., No. 14-1693, appeal filed 12/13/13).

Sandoz had asked the U.S. District Court for the Northern District of California for declaratory judgments that its biosimilar product wouldn't infringe two patents covering Amgen's rheumatoid arthritis treatment Enbrel (etanercept) and that the patents are invalid and unenforceable.

But the district court Nov. 12 dismissed the litigation, citing the Biologics Price Competition and Innovation Act (BPCIA) requirements governing biosimilar approvals at the FDA (11 PLIR 1363, 11/15/13).

Attorney George Yu, of Schiff Hardin LLP, San Francisco, told Bloomberg BNA in a phone interview Nov. 13 that, to his knowledge, this was the first court decision to interpret the BPCIA, which was passed as part of the Affordable Care Act in 2010 to promote competition in the biosimilars market.

In a Nov. 26 alert on the district court's decision, the law firm Goodwin Procter said, “If this ruling is confirmed it will likely limit the ability of biosimilar developers to bring declaratory judgment actions early in the development process, although U.S. patent office proceedings such as inter partes review and post grant review may be available. This case also highlights the continued importance of patent rights in addition to the market exclusivities afforded to reference biologics under the Biosimilars Act.”

Court Lacked Statutory Authority

According to district court documents, Hoffmann-La Roche, which is based in Nutley, N.J., and Amgen Inc. are the owner and the exclusive licensee, respectively, of U.S. Patent Nos. 8,063,182 and 8,163,522, which are scheduled to expire on Nov. 22, 2028, and April 24, 2029. Amgen, which is based in Thousand Oaks, Calif., asserts that etanercept is covered by these two patents.

In its complaint, Sandoz, which has U.S. offices in Princeton, N.J., and is part of Novartis, indicated that it was in clinical trials and intended to file an FDA application of an etanercept product as a biosimilar to Enbrel. According to Sandoz, it had heavily invested in its etanercept product and wasn't aware of Roche's unpublished application for what became the '182 patent when it began product development in 2004.

Sandoz wrote in its complaint that, throughout the prosecution of the '182 patent, the claims were primarily focused on a protein and method of manufacturing the protein that isn't etanercept, and it wasn't until 15 years later that the prosecution focus shifted to a protein that Amgen claims is etanercept.

In an order authored by Judge Maxine M. Chesney, the court, citing the BPCIA, agreed with Amgen that the litigation was premature because a district court lacks statutory authority to consider a patent dispute involving a biosimilar product until after an application for FDA approval of the product has been filed.

“Specifically, with limited exceptions not applicable here, neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information, 42 U.S.C. §§262(l)(2)-(6),” Chesney wrote.

No Injury Established

In addition, the court wrote, Sandoz didn't establish a real and immediate injury or threat of future injury because Amgen had indicated it never advised Sandoz of its intent to sue and couldn't sue until after Sandoz prepared its FDA application.

Amgen's statement that it defends its patents and Sandoz's allegation that it intends to file an application with the FDA were insufficient to establish an immediate threat or otherwise create a case or controversy, Chesney said.

Sreejit Mohan, head of communications for biopharmaceuticals and oncology injectables for Sandoz International GmbH Industries in Holzkirchen, Germany, told Bloomberg BNA by e-mail Dec. 18 that Sandoz wouldn't issue a comment on the appeal.

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Randy Kubetin at

The appeal filings are at