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.

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.

Traditionally, a response to a Final Office Action (“FOA”) issued by the United States Patent and Trademark Office (“USPTO”) often involves filing a Request for Continued Examination (“RCE”) in order for the Examiner to consider further claim amendments.  In 2013, the USPTO launched the After Final Consideration Pilot program 2.0 (“AFCP 2.0”) as an alternative.  The AFCP 2.0 program allows patent applicants to request consideration of an amendment after a FOA without additional fees and grants examiners extra time to review the after-final amendment.  This provides applicants the chance to file after-final amendments without incurring the significant fees associated with an RCE.  The AFCP 2.0 program also provides an opportunity for applicants to have an interview with the Examiner and this increased communication often led to efficient resolution of prosecution. 

The USPTO has just issued an update to its guidance on subject matter eligibility, discussing the application of these guidelines to emerging technologies such as AI-related and AI-assisted inventions.  These guidelines are currently open to public comment until September 16.   

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.