Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab). Genentech asserts that Tanvex’s process for manufacturing TX05 infringes…
In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must now provide patent information to FDA for listing in the Purple Book…
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…