This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 On March 26, 2020, the Federal…
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected…
We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal Circuit panel (Judges Prost, Wallach, and Bryson) heard argument regarding on Genentech’s appeal. The argument, much like the appellate briefing, focused on the issue…
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. This past week, Hospira filed a petition for rehearing en…
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein purification method IPR appeal Today, the Federal Circuit issued a 2-1 opinion affirming a 2018…
This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…
This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of…
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…
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…
In a precedential decision last week, the U.S. Court of Appeals for the Federal Circuit held that the use of IPR proceedings for patents issued prior to the enactment of the America Invents Act (AIA) was not an unconstitutional taking under the Fifth Amendment to the U.S. Constitution. In that July 30,…