The USPTO announced a proposal today to change the procedures for amending claims in post-grant proceedings. Even though the AIA specifically provides for claim amendments in IPRs, claim amendments have been rare in actual practice. USPTO Director Andrei Iancu stated that the new procedures are being proposed to allow patent…
As we have previously reported, Momenta appealed a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product. On October 1, 2018, Momenta informed the Court of a press release stating that it “has initiated discussions with its collaboration partner, Mylan, to exit its participation…
As we previously reported, following the Federal Circuit’s ruling in St. Regis Mohawk Tribe v. Mylan that “tribal immunity cannot be asserted in IPRs,” Allergan and the Tribe petitioned for rehearing en banc. The petition was first referred to the panel that heard the appeal as a petition for rehearing, and was then…
Abbvie and Fresenius Kabi have announced today that they entered into a worldwide settlement and licensing arrangement resolving all intellectual property-related litigation concerning Fresenius’s MSB11022, a biosimilar candidate of AbbVie’s HUMIRA (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement and license agreements, AbbVie has granted…
Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements…
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to Amgen, two Phase 3 studies confirmed that AMGEVITA showed biosimilarity to adalimumab, showing no clinically meaningful…
Below are some recent announcements from Momenta Pharmaceuticals, Fresenius Kabi, JHL Biotech, and Innovent Biologics regarding their biosimilar pipelines. On October 1, 2018, Momenta Pharmaceuticals announced that it completed a strategic review of its pipeline with the goal of reducing costs of biosimilar development and focusing its resources on its…
On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement agreements, AbbVie is granting to Sandoz a non-exclusive license to…
As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a…
As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed biosimilar of Genentech’s U.S.-licensed rituximab product Rituxan. The hearing included presentations from various speakers from industry,…