As we previously reported, after Amgen obtained FDA-approval for MVASI (bevacizumab-awws), a biosimilar of Genentech’s AVASTIN, Amgen submitted—and the FDA approved—a number of supplements that revised, among other things, manufacturing and labeling information for the product. Genentech subsequently filed a motion in the district court, arguing that the FDA’s approval of these supplements obliged Amgen to provide Genentech with a new notice of commercial marketing under subsection (l)(8)(A) of the BPCIA at least 180 days before commercially launching MVASI in the United States. Thus, Genentech’s motion sought to block Amgen from launching MVASI until Amgen provided a new notice and waited out at least 180 days. As we reported, last month the district court denied Genentech’s motion, after which Amgen began selling MVASI in the United States. Genentech immediately appealed to the Federal Circuit and requested an injunction pending appeal that, if granted, would enjoin Amgen’s commercial sales of MVASI in the United States.
Today, the Federal Circuit denied Genentech’s motion, finding that Genentech had failed to establish that an injunction pending appeal is warranted under the relevant four-factor standard in Rule 8(a)(2) of the Federal Rules of Appellate Procedure. These factors are: (1) whether the movant has made a strong showing of likelihood of success on the merits; (2) whether the movant will be irreparably injured absent 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 Court’s order clarified, however, that the denial of this motion was made “without prejudicing the ultimate disposition of this case.”
As a result of today’s ruling, Amgen can continue selling MVASI in the United States during the pendency of the appeal, unless and until the Federal Circuit ultimately rules in Genentech’s favor on the merits of the appeal and enjoins such sales. The appeal should now proceed to briefing on the merits. Genentech’s opening brief is currently due by September 17, 2019.