November 26, 2013

Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act

The first court decision interpreting the Biosimilars Act has arrived, with a federal district court in California finding that a biosimilar application must be filed with the FDA before patent litigation can be initiated. This ruling may have implications on patent strategy for both reference biologics and biosimilar developers.

The first judicial interpretation of the Biologics Price Competition and Innovation Act of 2009 (the “Biosimilars Act”) has finally arrived.  The U.S. District Court for the Northern District of California dismissed a declaratory judgment action brought by Sandoz, Inc. against Amgen, Inc. for lack of subject matter jurisdiction.  Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. 13-cv-02904.

The case concerned Amgen’s biopharmaceutical product Enbrel® (etanercept), a large fusion protein that binds to a regulator of immune response, TNFa, and is approved for autoimmune disorders such as rheumatoid arthritis.  Etanercept has current U.S. sales over $3 billion.

Etanercept was approved in 1998.  Sandoz, in anticipation of the expiration in 2014 of patent rights covering etanercept, began development of its biosimilar product, now in Phase III clinical trials.  Amgen, however, obtained additional, later patents with significantly later expiration dates, based on unpublished patent applications.  Sandoz brought a declaratory judgment action in June 2013 against Amgen seeking a determination that those patents are invalid and not infringed by the Sandoz biosimilar.

The Sandoz v. Amgen ruling involves a provision of the Biosimilars Act, 42 U.S.C. § 262, which provides the FDA with authority to license biological products that are biosimilar to a reference product, and sets specific limitations on the timing of any patent litigation arising from the filing of an application for such license.  The statute provides for a series of mandated exchanges of information between the biosimilar applicant and the reference product sponsor, initiated by FDA acceptance of a biosimilar application.  The exchanged information contemplated by the statute includes a notice of commercial marketing by the biosimilar applicant to the reference sponsor, patent information and the biosimilar application itself.

Since Sandoz has not yet filed its application with the FDA, the court determined that it lacked subject matter jurisdiction under the Biosimilars Act, as the required obligations under 42 U.S.C. § 262 had not been met.  The court also determined that Sandoz has not established a “real and immediate injury or threat of future injury” by Amgen, as required by the Declaratory Judgment Act for jurisdiction, finding that while Sandoz may file a biosimilar application with the FDA in the future, that does not provide the immediacy and reality required for such an action.

This first court ruling provides some initial guidance on how the Biosimilars Act will affect patent rights and regulatory exclusivities for both new, reference biologic therapeutics and for biosimilars.  While we expect this case to be appealed to the Federal Circuit, 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 inter partes review (“IPR”) and post grant review (“PGR”) 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.

Brian Drummond contributed to the preparation of this Alert.