First Biosimilars Ruling is Out … Industry, Take Heed!

In a decision of first impression, Judge Maxine M. Chesney of the Northern District of California dismissed Sandoz’s declaratory judgment action against Amgen for lack of jurisdiction. Sandoz had brought its suit on June 24, 2013 seeking a ruling that its biosimilar version of Amgen’s patented arthritis drug Enbrel (etanercept) would not infringe and that the patents are invalid. Amgen moved to dismiss the case for lack of subject-matter jurisdiction or, alternatively, to decline to exercise Declaratory Judgment jurisdiction.

Ruling that the 2010 Biosimilars Act requires a biosimilars manufacturer to seek U.S. Food and Drug Administration approval for its biologic version before filing suit, Judge Chesney granted Amgen’s motion to dismiss. The Court noted that a district court lacks statutory authority to consider a patent dispute involving a biosimilar product until after such time as an application for FDA approval of the biosimilar product has been filed, and that a cognizable case or controversy thus did not presently exist.

As we previously reported, the Biosimilars Act, formally known as the Biologics Price Competition and Innovation Act, created an abbreviated approval path for products demonstrated to be interchangeable or “biosimilar” with large-molecule drugs that already have been approved by the FDA. Here, Sandoz has been working on a biosimilar version of Amgen’s approved drug, but has not yet sought FDA approval.

Biosimilars, also known as follow-on biologics, are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA, or controlled gene expression methods. The evolving biosimilars landscape is of great significance to companies in the U.S. and abroad. Gibbons will continue to stay at the forefront of this burgeoning area of law.

Estelle J. Tsevdos, Ph.D. is a Director in the Gibbons Intellectual Property Department.
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