Blog Big Molecule Watch August 08, 2019

Federal Circuit Declines to Block Sales of Amgen’s KANJINTI (trastuzumab-anns) Before Resolving Genentech’s Appeal

As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States.  In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending resolution of the appeal and (2) to expedite the appeal process.

Yesterday, a Federal Circuit panel denied both of Genentech’s requests. The panel concluded that Genentech had not established that an injunction pending appeal was warranted under the four factors governing the grant of such injunctions: (1) whether the movant has made a strong showing of likelihood of success on the merits; (2) whether the movant will be irreparably injured ab-sent an injunction; (3) whether issuance of the injunction will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies. The panel also concluded that, although Genentech had self-expedited the filing of its own briefing on the merits of its appeal, Genentech had not shown that Amgen’s time to file its responsive appellate brief (i.e., within 40 days of July 26, 2019) should be shortened.

The post Federal Circuit Declines to Block Sales of Amgen’s KANJINTI (trastuzumab-anns) Before Resolving Genentech’s Appeal appeared first on Big Molecule Watch.