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.
More Legal and Business Bylines From Thomas L. Irving
- Multiple, Serial IPR Filings Doom Reexamination Request - (Posted On Tuesday, October 12, 2021)
- Bad Acts and Actors Never Die; They Simply Lose Their Appeal - (Posted On Friday, October 01, 2021)
- Federal Circuit Crystallizes BMS’ Apixaban District Court Win - (Posted On Monday, September 27, 2021)
- A Look at AIA § 3(n)(2): Part Two of a Two-Part Series on AIA § 3(n) Effective Filing Date Provisions - (Posted On Friday, September 24, 2021)
- Predictably Part 2: Merck Overcomes Obviousness Challenge at the PTAB - (Posted On Wednesday, September 22, 2021)
- Predictably, a Funny Thing Happened on the Way to the PTAB FWD - Part 1: Merck Overcomes Inherent Anticipation Challenge at the PTAB - (Posted On Tuesday, September 21, 2021)
- Testing the Limits of Therasense: Patent Owner’s Decision Not to Appeal Obviousness Holding Created But-for Materiality and Knowledge of Withheld References Established Intent - (Posted On Monday, September 20, 2021)
- None of Us Saw Them Stop the PTA Giveaway - (Posted On Friday, September 17, 2021)
- 10-Year Anniversary of the AIA at the PTAB―Not Your Grandparents’ U.S. Patent Law - (Posted On Thursday, September 16, 2021)
- Part II: The Current State of Precedential Opinions and Denials of Institution at the USPTO Patent Trial and Appeal Board – Advanced Bionics and Section 325(d) Discretionary Denials - (Posted On Wednesday, September 08, 2021)