Biosimilar Litigation Updates

Below is an update on recent developments in several litigations involving biosimilar products.

Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed its opening appeal brief in April, and Sandoz filed its responsive brief in June. On July 23, Amgen filed its reply brief, reiterating its positions that the district court erred in construing the claims of Amgen’s asserted protein purification patent (U.S. Patent No. 8,940,878) and method of treatment patent (U.S. Patent No.6,162,427), which Amgen argues led to incorrect final judgments of non-infringement for each of those patents. The appeal is now fully briefed and should be scheduled for oral argument by early next year.

Sandoz v. AbbVie (adalimumab): As we previously reported, the PTAB denied Sandoz’s petitions to institute IPR on AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using adalimumab.  Sandoz appealed both denials. On July 26, in view of 35 U.S.C. § 314(d) (stating that “[t]he determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable”), the Federal Circuit ordered Sandoz to show cause why the appeals should not be dismissed for lack of jurisdiction.  Sandoz has until August 27, 2018 to submit a response.

Genentech v. Amgen (bevacizumab): As we previously reported, on October 6, 2017, Genentech filed a complaint for patent infringement under the BPCIA against Amgen relating to Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of Avastin®, alleging infringement of 24 patents.  On May 1, 2018, Amgen answered Genentech’s complaint and asserted counterclaims.  On May 22, Genentech moved to dismiss all of Amgen’s counterclaims and strike certain affirmative defenses, including any invalidity theories not expressly stated in Amgen’s BPCIA’s disclosures, and Amgen’s unclean hands and inequitable conduct defenses. Most recently, on July 25, Amgen filed its opposition to Genentech’s motion to dismiss and strike Amgen’s counterclaims and affirmative defenses.  In its opposition, Amgen argued that its counterclaims should not be dismissed on the basis that Amgen violated 42 U.S.C. § 262(l)(2)(A), because (a) nothing in the record suggests that Amgen failed to meet its BPCIA disclosure obligations; (b) even if there was a violation of § 262(l)(2)(A), the remedy was for Genentech to file suit, which it did; and (c) § 262(l)(9)(C), relied on by Genentech, precludes a party from “bringing an action”, not from filing a counterclaim after an action is brought. Amgen further argued that it should be able to raise invalidity theories not expressly stated in its BPCIA disclosures because, among other things, Plaintiffs had the opportunity to supplement their infringement contentions, so Amgen should be afforded a similar opportunity. Finally, Amgen argued that because it had pled all of the elements of inequitable conduct with particularity, and because unclean hands is sufficiently pled by its bare assertion, both defenses were adequately pled.

Genentech v. Amgen (trastuzumab): As we previously reported, on June 21, 2018, Genentech filed a complaint against Amgen asserting infringement of 38 patents under the BPCIA relating to Amgen’s proposed biosimilar of Herceptin® (trastuzumab).  On July 19, Genentech stipulated to dismiss 19 of those patents with prejudice and filed an amended complaint alleging infringement by Amgen of the remaining 17 patents.

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