Jay Lessler concentrates his practice in domestic and foreign patent procurement, transactions involving intellectual property, client counseling, and patent litigation, primarily in the chemical, pharmaceutical, and computer software arts.
Working closely with inventors and in-house counsel, Jay devises effective strategies to build and protect intellectual property assets, from initial drafting of patent applications to post-grant proceedings. His experience includes:
• all areas of patent prosecution involving domestic and foreign patents
• patent term extension proceedings
• inter partes reviews
• licensing and joint development agreements
• conducting due diligence investigations
• conducting validity and freedom-to-operate studies
• counseling clients in connection with the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act
• preparation of Paragraph IV Notice letters and Offers for Confidential Access pursuant to the Hatch-Waxman Act
• counseling regarding the listability of patents in the FDA Orange Book
He also has significant ANDA and biotech litigation experience.
Jay has been the co-chair of Practising Law Institute’s (“PLI’s”) annual Advanced Patent Prosecution Workshop since 2006. He was also a speaker at PLI’s Patent Boot Camp Workshop from 2002 to 2006, and in 2016 and 2017.
Jay has co-authored numerous chapters on Patent Law and the Hatch-Waxman Act, including the “Generic Drug-Approval Process: Hatch-Waxman Update” chapter in The Pharmaceutical Regulatory Process, Second Edition (edited by I. Berry) (2008), and the "Non-Obviousness, Regulatory Exclusivities for Pharmaceutical Products, Post-Grant Procedures," and "How to Prosecute a Biopharma Patent Application" chapters in Biotechnology And Pharmaceutical Patents (2007) (Aspen).