As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses. On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated motion papers on the public docket. In its supporting brief, Genentech argues that the court should dismiss and strike all 29 of Amgen’s counterclaims for declaratory judgment of invalidity, non-infringement and/or unenforceability, as well as all or portions of Amgen’s third (invalidity), fourteenth (unclean hands) and fifteenth (inequitable conduct) affirmative defenses. More particularly, Genentech asserts:
- Subsection (l)(9)(C) of the BPCIA forecloses Amgen’s counterclaims for declaratory judgment because Amgen allegedly did not comply with its patent dance disclosure requirement under subsection (l)(2)(A);
- Amgen’s invalidity counterclaims allegedly exceed the scope of Amgen’s detailed statements under subsection (l)(3)(B) during the patent dance, which Genentech contends is improper under the BPCIA;
- Amgen’s inequitable conduct and unclean hands allegations are deficient as a matter of law; and
- The court lacks subject matter jurisdiction over two of Amgen’s counterclaims that seek to invalidate patents that Genentech has not asserted because there is no continuing case or controversy with respect to those patents.
Amgen’s opposition brief is due July 3, 2018.