Analysis of Amgen’s complaint against Sandoz in pegfilgrastim litigation

As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product (a biosimilar of Neulasta®) infringed two of Amgen’s patents under 35 U.S.C. § 271(e)(2)(C).  Amgen also seeks a declaratory judgment that the sale of Sandoz’s pegfilgrastim product will infringe the later-expiring of its two patents under 35 U.S.C. § 271(g).

The two patents-in-suit are U.S. Patent Nos. 5,824,784 and 8,940,878.  The ’784 patent, entitled “N-terminally chemically modified protein compositions and methods,” relates to N-terminally modified G-CSF (and methods of making and using the same) and expired October 20, 2015.  The ’878 patent, entitled “Capture purification processes for proteins expressed in a non-mammalian system,” relates to methods of protein purification and expires on October 8, 2031.

Even though the ’784 patent has already expired, Amgen alleges that the patent is properly asserted in this case because Sandoz submitted its aBLA prior to October 2015 (before the patent expired), and the FDA accepted the aBLA on October 26, 2015. According to Amgen’s complaint, Amgen and Sandoz then engaged in the “Patent Dance,” and agreed that both the ’878 and ’784 patents were properly included in the infringement action, which Amgen subsequently filed.

This is Amgen’s second suit against Sandoz concerning its pegfilgrastim biosimilar. A prior complaint was filed in March in the District of New Jersey.

Stay tuned to the Big Molecule Watch for further analysis of this case as it develops.