On February 11, 2020, in the Genentech v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims. Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…
As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen and Mylan filed a joint status report in which the parties stipulated that Mylan does not infringe the asserted claims of US Patent 8,273,707. On August 21, 2019, after reviewing the…
As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707…
As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®. Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary…
On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate. As we previously reported, on May 8, 2019, a Federal…
On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab). In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures. Pfizer also…
As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita™, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States. As we also reported, Coherus amended its…
On April 11, 2019, in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical Inc., a Hatch-Waxman case concerning the small-molecule drug Zortress® (everolimus), Judge Andrews of the District of Delaware ruled that IPR estoppel could apply on remand to the District Court even after a trial on the issue of invalidity had been…
As we previously reported, Pfizer recently filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. On March…