Federal Circuit Issues Two Rulings in Biosimilar-Related IPR Appeals

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 Circuit affirmed the PTAB’s final written decisions in IPR2017-00731, -00737, -01121, and -01122 that found claims of Genentech’s U.S. Patent Nos. 7,846,441 and 7,892,549, directed to breast cancer treatment using trastuzumab, to be unpatentable on obviousness grounds. The patents were originally challenged by IPR petitioners Pfizer/Hospira, Samsung Bioepis, and Celltrion, but the USPTO intervened in their stead after each party settled with Genentech. In yesterday’s ruling, the Federal Circuit affirmed the PTAB’s claim construction over Genentech’s appeal, finding that the PTAB correctly construed the terms “in an amount effective to extend the time to disease progression in the human patient” and “an effective amount” in the patents to require a comparison to an untreated patient. Genentech did not challenge the Board’s obviousness conclusion under the that construction. The Federal Circuit also held that the Board did not abuse its discretion in denying Genentech’s motion to amend the claims in one of the IPRs.

Amgen v. Iancu (USPTO), No. 19-2171
On March 24, 2020, the Federal Circuit vacated the PTAB’s final written decision in IPR2016-01542, which found the claims of Amgen’s U.S. Patent No. 8,952,138 to be unpatentable. Apotex had filed the IPR petition during its BPCIA litigation against Amgen regarding Apotex’s filgrastim and pegfilgrastim biosimilars, and the USPTO picked up the reins to defend the PTAB’s decision after Apotex declined to participate in the appeal, having already obtained a favorable judgment of non-infringement of this patent. The Federal Circuit vacated the final written decision and remanded the case to the PTAB in view of the court’s decision in Arthrex, which held that the appointment of Administrative Patent Judges (APJs) to the PTAB violates the Appointments Clause of the Constitution, and the fact that Amgen had raised an Appointments Clause challenge in its opening appellate brief.

A day earlier, on March 23, 2020, the full Federal Circuit declined to rehear the October 31, 2019 panel decision in Arthrex. Four judges concurred in the denial of rehearing, four dissented from denial of rehearing, and four expressed no public view.