On November 6th, Goodwin’s Elaine Blais and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal developments affecting validity…
The FDA announced today that it has approved Sandoz’s biosimilar Hyrimoz (adalimumab-adaz). The FDA had previously approved adalimumab biosimilars from Amgen and Boehringer Ingelheim. Sandoz’s global settlement with AbbVie regarding Hyrimoz provides Sandoz with a U.S. entry date of September 30, 2023, whereas Amgen is permitted an earlier U.S. launch,…
As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding the claims of AbbVie’s U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 unpatentable for obviousness in view of…
On September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar. As we previously reported, prior to the start of trial, the Court had entered a stipulation of infringement of certain asserted claims of U.S. Patent No. 8,063,182 (“the ‘182 patent”)…
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…