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Amgen v. Sandoz—The Biosimilars Battle Continues

June 15, 2016

Amgen v. Sandoz—The Biosimilars Battle Continues

June 15, 2016

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“Defendants are piggybacking on the fruits of Plaintiffs’ trailblazing efforts,” Amgen’s complaint alleges in its third suit against Sandoz under the Biologics Price Competition and Innovation Act (BPCIA). N.D. Cal. 3:16-cv-02581, D.I. 1. In this round of BPCIA litigation, Amgen is suing Sandoz and its subsidiaries for infringement of two key patents covering Neulasta®, its biologic product used to treat neutropenia.

Filed in the Northern District of California on May 12, 2016, the complaint states Sandoz’s filing of its abbreviated Biologics License Application (aBLA) constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(C). Amgen, Inc. v. Sandoz, Inc., No. 3:16-cv-02581. The complaint alleges that on November 13, 2015, which was within 20 days after the FDA notified Sandoz that their aBLA had been accepted for review, the parties began exchanging information as required by the BPCIA. This information exchange culminated in the parties’ agreement on April 12, 2016 that U.S. Patent Nos. 8,940,878 and  5,824,784 were properly included in any immediate infringement action that Plaintiffs were to file under 42 U.S.C. § 262(l)(6)(A).  The ‘878 patent covers a method for purifying proteins used in the manufacture of Neulasta® and expires October 8, 2031.  The ‘784 patent, which expired before the complaint was filed but after Sandoz filed its aBLA, covers the biological product, its use, and manufacture.

The complaint alleges that if the FDA approves the aBLA, Sandoz will inevitably infringe the ‘878 patent under §271(g) by making, using, offering to sell, or selling an infringing product within the U.S.  Amgen seeks damages and an injunction.

On May 27, 2016 the Court granted the parties’ stipulated request to relate this case with pending Case No. 3:14-cv-04741-RS (which is the case underlying the Federal Circuit’s first opinion interpreting portions of the BPCIA’s patent dance provisions and notice of commercial marketing.) Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).  The parties stated the two actions are related because (1) the cases concern substantially the same parties, even though the -02581 case is asserted against an additional defendant, Lek Pharmaceuticals, and (2) both cases involve the ’878 patent, and thus concern the same asserted patent filed within two years of each other by the same plaintiff.  Lek Pharmaceuticals allegedly operates as a subsidiary of Sandoz International GmbH and was involved with the submission of its aBLA application seeking approval from the FDA to market and sell the Sandoz pegfilgrastim product. Compl., D.I. 1, at 11. The effect of relating the two cases is that Judge Seeborg will hear both of the Amgen v. Sandoz cases pending in the Northern District of California.

In the earlier case (3:14-cv-04741-RS) concerning Amgen’s Neupogen® and the ’878 patent, Sandoz skipped the BPCIA dance, survived Amgen’s preliminary injunction motion, and launched its biosimiliar at risk 180 days after FDA approval. In this case, Sandoz engaged in the dance. Depending on the decision in Amgen v. Apotex, expected any day, Sandoz may be hoping that its participation in the patent dance provisions in this case will allow it to skip the 180 day notice requirement in order to get its biosimiliar to market more quickly.

We will continue to monitor developments in this case and provide updates.

Authors: Tasha M. Francis, Ph.D., Sarah Jack, Jenny Shmuel, Ph.D.

The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

Blog Authors

Jenny Shmuel, Ph.D. | Principal

Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial. Over the last several...

Sarah Jack
Sarah Jack | Summer Associate

Sarah Jack is a litigation summer associate in the Twin Cities office and currently attends the University of Iowa College of Law.