Insights

Washington, D.C. – January 4, 2016: Crowell & Moring LLP is pleased to announce that it has elected nine attorneys to the firm's partnership, effective January 1, 2016. The firm has also promoted 15 associates to the position of counsel. The new partners and counsel have been promoted from within the ranks of the firm's Washington, D.C., New York, and Orange County offices, and underscore the firm's commitment to its Antitrust, Health Care, Insurance/Reinsurance, Government Contracts, Advertising & Product Risk Management, Mass Tort, Product, and Consumer Litigation, International Trade, Aviation, Administrative Law & Regulatory, and Intellectual Property Groups.

Washington, D.C. - October 1, 2015: Crowell & Moring represented Apotex in successfully challenging the validity of U.S. Patent No. 8,324,283 before the U.S. Patent and Trademark Office Patent Trial and Appeals Board (PTAB). Apotex, along with generic pharmaceutical companies Torrent Pharmaceuticals and Mylan Pharmaceuticals, petitioned the PTAB to invalidate the '283 patent related to oral formulations for the administration of the multiple sclerosis drug fingolimod, marketed by Novartis as Gilenya®. As a result, all claims of the '283 patent were found invalid by PTAB.

On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision about Patent Term Extensions (PTEs) under the Hatch-Waxman Act for reissue patents. In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254), the Court confirmed that the PTE provision under 35 U.S.C. § 156 refers to the original patent’s issue date, not the reissue patent’s issue date. Thus, the issue date of the original patent should be used when calculating the extension period.

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

Before leaving for an extended recess period ahead of the November general election, Congress left unfinished several proposals with ramifications for generic and biosimilar drug competition. This client alert summarizes some of that legislation and possible next steps in the “lame duck” period before the end of the year.

Endless articles, commentary, and blog entries have been rattling the cage about the brave new world of the metaverse and the unprecedented legal issues that may arise and, in some cases, that have already arisen.

Partner Deborah Yellin and Senior Counsel Dr. Mary Anne Schofield, will be presenting "Biosimilar Biological Products" as part of the Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation course in Washington, D.C., October 1-2. The two-day course explores the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Attendees will also gain a comprehensive understanding of the various administrative agencies that impact these industries. 

This is a joint program between the Pauline Newman IP American Inn of Court and the Hon. William C. Conner American Inn of Court.