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, 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…
On July 29, Sandoz filed a response to Amgen’s petition for rehearing en banc of the Federal Circuit’s decision affirming summary judgment of non-infringement of Amgen’s U.S. Patent No. 8,940,878 (“the ‘878 patent”). The ‘878 patent concerns a protein purification method that is allegedly used in the manufacture of Amgen’s NEUPOGEN…
As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…
On July 23, 2019, Amgen sued Tanvex BioPharma USA, Inc. and two of its affiliates in the Southern District of California alleging infringement of U.S. Patent No. 9,856,287 under the BPCIA based on Tanvex’s submission of an aBLA for a biosimilar of NEUPOGEN (filgrastim). As relief, Amgen’s complaint requests, among…
As we previously reported, last week the U.S. District Court for the District of Delaware denied Genentech’s motion for a preliminary injunction against Amgen in the BPCIA litigation concerning Amgen’s Kanjinti (trastuzumab-anns). A redacted version of the court’s opinion has now been posted to the public docket. As set forth…
As we previously reported, on July 10, 2019, Genentech filed motions for a temporary restraining order and preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI™ (trastuzumab-anns). Yesterday, the District Court denied Genentech’s motions and lifted the standstill order given during the…
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 June 8, 2019, Fresenius Kabi filed a petition for inter partes review challenging the validity of U.S. Patent No. 9,643,997, entitled “Capture purification processes for proteins expressed in a non-mammalian system.” The challenged claims in the patent, owned by Amgen Inc., relate to processes for purifying recombinant proteins expressed in a…
On May 2, 2019 Coherus BioSciences, Inc. (“Coherus”) announced that it has settled the trade secret action brought by Amgen Inc. (“Amgen”) relating to Amgen’s Neulasta® and Coherus’ Udenyca® products. In March 2017, Amgen filed a complaint alleging a “massive conspiracy” by disloyal former Amgen employees in a “concerted effort…