As we previously reported, a panel of the Federal Circuit in St. Regis Mohawk Tribe v. Mylan held that “tribal immunity cannot be asserted in IPRs.” The Federal Circuit’s decision, if upheld, means that Allergan’s sale and license-back of patents covering its branded product Restasis to the Tribe was ineffective in shielding the…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…
On Friday, in WesternGeco LLC v. ION Geophysical Corp., the Supreme Court held 7-2 that patentees may recover lost foreign profits based on infringement under 35 U.S.C. § 271(f)(2), reversing the Federal Circuit. Justice Thomas, writing for the majority, concluded that even if the presumption against extraterritoriality applied, the award of…
Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….
Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims. Many patents covering biological products contain antibody claims. A major focus of the USPTO memorandum is the Federal Circuit’s decision in Amgen v….
As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written…
The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the…
As we previously reported, on ex parte reexamination, the Examiner rejected all claims of U.S. Patent No. 6,284,471, a patent covering Janssen’s Remicade® (infliximab), as invalid for obviousness-type double patenting (“OTDP”). The USPTO’s Patent Trial and Appeal Board affirmed the rejection and Janssen appealed the PTAB’s decision to the Federal Circuit. …
On January 8, 2018, the Federal Circuit issued its en banc decision in Wi-Fi One, LLC v. Broadcom Corp., No. 2015-1944. The Federal Circuit originally held that due to binding precedent, a time-bar determination under 35 U.S.C. § 315(b) is final and nonappealable under 35 U.S.C. § 314(d). As we reported here,…
As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on…