New BPCIA Litigation: Amgen v. Mylan (W.D. Pa.)

by Goodwin

On Friday, Amgen filed a complaint for patent infringement under the BPCIA against yet another developer of a biosimilar of Neulasta® (pegfilgrastim).  Amgen has sued Mylan in the Western District of Pennsylvania for infringement of U.S. Patent Nos. 8,273,707 and 9,643,997, which Amgen alleges “claim methods of purifying proteins used in the manufacture of a biological product.”  The complaint alleges that Mylan’s submission of its aBLA constituted an act of infringement of the ’707 and ’997 patents under 35 U.S.C. § 271(e)(2)(C)(i), and that Mylan’s importation, sale, offer for sale or use of its product, if approved, would constitute an act of infringement under 35 U.S.C. § 271(g).

Amgen’s complaint acknowledges that the parties engaged in the information exchanges of the BPCIA’s patent dance. Amgen alleges that it listed 3 patents—the ’707 and ’997 patents, as well as U.S. Patent No. 8,940,878—pursuant to 42 U.S.C. § 262(l)(3)(A) or (l)(7).  According to Amgen, the parties failed to reach agreement on which patents to litigate in the first wave litigation during their § 262(l)(4)  negotiations, and Amgen and Mylan arrived at litigating the ’707 and ’997 patents in this first wave by exchanging lists pursuant § 262(l)(5).

Amgen also claims that certain actions by Mylan during the patent dance exchanges prejudiced Amgen and/or violated the BPCIA. First, Amgen alleges that Mylan “materially prejudiced and impeded Amgen’s ability to review the Mylan aBLA” by only allowing access to the aBLA through a virtual data room that (a) prohibited Amgen from “saving, copying, annotating, or printing any documents or data,” (b) “was also slow and cumbersome, and lacks fully working hyperlinks,” (c) left Amgen “unable to view many of the documents and data …, including many of the xml, xsl, sas, xpt, jpeg, and txt files,” and (d) “suffered periodic technological failures, preventing Amgen from accessing or viewing the documents and data.”  Second, Amgen states that Mylan “failed to provide ‘other information that describes the process or processes used to manufacture the biological product that is the subject of’ the Mylan aBLA, pursuant to 42 U.S.C. § 262(l)(2)(A).”  Amgen alleges that it requested from Mylan “certain specific categories of documents that [Amgen] believes exist and describe the Defendants’ process for manufacturing the Mylan Pegfilgrastim Product,” but that Mylan has failed to provide such documents despite undertaking to consider Amgen’s request.

This is the fourth patent litigation under the BPCIA regarding a proposed biosimilar of Neulasta®, none of which are yet FDA-approved. (See our most recent BPCIA Litigation Roundup post for additional coverage of the Amgen v. Apotex, Amgen v. Sandoz and Amgen v. Coherus pegfilgrastim suits.)

Although the ’997 patent, which issued just this past May, does not appear to have been previously litigated in any of the prior pegfilgrastim patent suits, the ’707 patent is the sole patent-in-suit in Amgen’s related litigation against Coherus. In July, Coherus moved to stay discovery in that litigation, but withdrew that motion earlier this month.

The ’878 patent, which Amgen and Mylan are not presently litigating pursuant to the patent dance negotiation procedures, is also in-suit in Amgen’s litigations against Sandoz regarding Sandoz’s filgrastim biosimilar (Zarxio®) and pegfilgrastim biosimilar candidate. Pursuant to a recently filed stipulated order, the ’878 patent now appears to be the sole patent-in-suit in those cases.

Stay tuned to Big Molecule Watch for further developments in the new Mylan litigation and the other pegfilgrastim patent litigations.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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