On April 14, 2022, the U.S. Court of Appeals for the Federal Circuit reversed the PTAB’s determination in IPR2016-01542 that claims of Amgen’s U.S. Patent No. 8,952,138 are obvious. The ’138 patent claims are directed to methods of refolding proteins by “contacting the protein with a refolding buffer comprising a…
On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab). AbbVie’s first action was brought in the Northern District of Illinois on April 27, 2021. We previously…
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its affiliate Hospira for patent infringement of U.S. Patent No. 8,273,707 (“’707 patent”) based on…
We are pleased to present the next webinar relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. Our next webinar, Patent Dance Disclosures: Discovery During the Patent Dance and Beyond,…
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…
On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various court filings. Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…
Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act. The BPCIA—whose legislation certain members of the Big Molecule Watch team were involved in drafting—created an abbreviated regulatory pathway for seeking…
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological products will be “deemed to be a license” as if approved under BLAs as of March…
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 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…