Patent Law Weblog
recent posts
- Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits
- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
about
Category: Biosimilars
-
By Andrew Williams — Earlier today, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple types of cancer. This marks the first time that a biosimilar for the treatment of cancer has been approved by the FDA. According to…
-
By Andrew Williams — In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case — can a reference product sponsor use discovery to obtain information from a biosimilar applicant if it…
-
BIO, Biologics, and Biosimilars By Andrew Williams — The 2017 BIO International Convention began earlier this week, but there are still many sessions and forums still to come. Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention. For example, today, we…
-
By Kevin E. Noonan and Andrew Williams — Earlier today, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. The Court described the statute as "a carefully calibrated scheme for…
-
By Andrew Williams — On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa). According to a press release from Pfizer, the committee "recommended approval of the Company's proposed…
-
By Kevin E. Noonan — Yesterday, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. from Sandoz counsel (Deanne E. Maynard), Amgen counsel (Seth P. Waxman), and presenting the opinion of the United States, an Assistant to the Solicitor General, U.S. Department of Justice (Anthony A. Yang). A synopsis of the arguments made by…
-
By Andrew Williams — Earlier today, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. Sandoz was represented by Deanne E. Maynard, and Amgen was represented by Seth P. Waxman. In addition, Anthony A. Yang presented the position of the United States. The Court considered two issues: (1) whether a biosimilar applicant…
-
By Kevin E. Noonan — On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted in 2010 to facilitate the entry of biosimilar drug products into the marketplace. Yesterday's post considered…
-
By Andrew Williams — On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be the Court's first opportunity to consider this statute enacted in 2010 to facilitate the entry…
-
By Kevin E. Noonan — On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Considerations in Demonstrating Interchangeability with a Reference Product, Is long-awaited and addresses a important…
Patent Docs 