Tom Irving has some 45 years of experience in intellectual property law. His U.S. pharma practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, reissue, and reexamination. In addition to advising on procuring strong U.S. patents, Tom counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability, supplemental examination, and validity analysis. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations; as lead counsel in numerous AIA post-grant proceedings; and as an expert witness in patent litigation and patent procurement.
Tom’s current practice is heavy on due diligence analysis, as well as AIA post-grant proceedings, including how to evaluate and enhance the strength of U.S. patents in the pharmaceutical space to protect against post-grant challenges. Tom directed the preparation of two highly complex IPRs, which worked out well for the innovative pharma patent owner. Tom also focuses on 35 U.S.C. § 112(f), supplemental examination, and Sanofi v. Watson-type claims, all of which he considers to be under-utilized.
Tom has been extensively involved in counseling, due diligence, prosecution and prelitigation for matters involving major drugs such as Kalydeco®, Orkambi®, Aloxi®, Tecfidera®, Lorcaserin®, Pulmicort®, Respules®, Taxotere®, Eloxatin®, Lantus®, Crestor®, Targretin®, Brilinta®, Halaven®, Allegra®, Apidra®, Epiduo Gel®, Rilutek®, Ramipril®, Jakafi®, Duexis®, Viracept®, KEVEYIS®, and other drugs such as Rimonabant®, VX-661, and HMPL 0004®, in clinical trials prior to FDA approval. He successfully reissued the patent for the low molecular weight heparin drug, Lovenox®, a blockbuster product.
For more than 25 years, Tom served as principal teacher of the Patent Resources Group (PRG) Chemical Patent Practice course, a comprehensive course on U.S. chemical patent law taught twice a year, and he coauthored the multi-volume treatise used in the course. He originated PRG’s Orange Book and Due Diligence courses, which helped prepare patent owners, through effective application drafting and prosecution, to withstand the rigors of AIA’s inter partes review (IPR) and post-grant review (PGR). He presents analyses of U.S. Court of Appeals for the Federal Circuit and Patent Trial and Appeal Board (PTAB) decisions for many state bar association groups and has spoken at numerous national trade and bar association meetings, including the now ubiquitous virtual presentations, such as Intellectual Property Owners Association, American Intellectual Property Law Association (AIPLA), and American Bar Association. Tom has lectured at many law schools in both the United States and China, and at the Patent Office of the State Intellectual Property Office (SIPO) of the People’s Republic of China. He has participated in more than 150 Strafford Webinars on U.S. patent law topics, including several that dealt with 35 U.S.C. § 112(f), Sanofi v. Watson-type claims, supplemental examination, inducement to infringe, claim construction, enablement, written description, claim definiteness, and AIA post-grant proceedings.
