The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine…
In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series, which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. Stay tuned for more details, including registration information for upcoming webinars. So…
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…
GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY. According to the complaint, AVREXY and ABRYSVO were approved by the U.S….
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product. Sarepta’s gene therapy product, SRP-9001, was approved this June…
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J. In February 2023, Formycon announced its entry into a global license agreement with Fresenius…
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and “Classification Categories for Certain Supplements under BsUFA III”, respectively. The “Formal Meetings between the FDA and…
Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which is generally directed to methods of manufacturing VEG-F antagonists, including aflibercept. Regeneron’s motion to terminate is based on Regeneron’s filing…
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to…
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept biosimilar to Biocon). Now, post-trial briefing is complete. The parties submitted their responsive briefs on July 24,…