Thomas L. Irving
Tom Irving has nearly 40 years of experience in the field of intellectual property law. His practice includes AIA post-grant proceedings, due diligence, counseling, patent prosecution, reissue and reexamination, and patent interferences. He counsels clients on a wide range of chemical and pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability and validity analysis, and litigation. A significant portion of Mr. Irving's current practice is focused on AIA post-grant proceedings, including how to enhance the strength of patents to protect against post-grant challenges. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations, and as an expert witness in patent litigation.
Mr. Irving has been involved in every facet of several U.S. district court litigations, thus enhancing his ability to render advice in due diligence, enforceability, infringement, validity, and patent prosecution areas.
Mr. Irving has served for 25 years as principal teacher of the PRG Chemical Patent Practice course, a comprehensive U.S. chemical patent law course taught three times a year, and he coauthors the multi-volume treatise used in the course. He originated PRG's Orange Book and Due Diligence courses as well as PRG's course taught three times a year to prepare patent owners, through effective application drafting and prosecution, to withstand the rigors of AIA's inter partes review and post grant review. He presents analyses of U.S. Court of Appeals for the Federal Circuit patent decisions for many state bar association groups and is a frequent speaker at national bar association meeting such as the American Intellectual Property Law Association (AIPLA), Intellectual Property Owners Association, and American Bar Association. Mr. Irving has lectured at many law schools in both the United States and China. He also has lectured at the Cold Spring Harbor National Laboratory graduate school, the Patent Office of the State Intellectual Property Office (SIPO) of the People's Republic of China, and has presented nearly 40 Strafford Webinars on patent law topics, including a number that deal with AIA's post-grant proceedings. Outside of the patent law field, he has been involved in public health and safety issues related to the preparation of Citizen Petitions before the FDA.
- Accord Healtcare, Inc. v. Helsinn Healthcare, SA. (PTAB). Represented Helsinn in first-ever PGR dealing with pharmaceuticals. Settled prior to institution.
- N8 Medical v. Colgate-Palmolive Company (D. Utah). Serves as technical advisor in U.S. district court litigation.
- Directed the preparation of two highly complex IPRs for possible use in settling litigation.
- Successfully prosecuted the anti-cancer taxane small molecule interference Chen v. Bouchard, prevailing both at the U.S. Patent and Trademark Office Board and the Federal Circuit.
- Successfully reissued the patent for the low molecular weight heparin drug, Lovenox®, a blockbuster product.
- Extensively involved in counseling, due diligence, prosecution and prelitigation for matters involving major drugs such as Aloxi®, Tecfidera®, Lorcaserin®, Pulmicort®, Respules®, Taxotere®, Eloxatin®, Lantus®, Crestor®, Targretin®, Brilinta®, Halaven®, Allegra®, Apidra®, Epiduo Gel®, Rilutek®, Ramipril®, Duexis®, Viracept®, and other drugs such as Rimonabant® and HMPL 0004®, in clinical trials prior to FDA approval.
- Opened the firm's first European office in Brussels, Belgium, 1993.
- The Best Lawyers in America, 2005-2015.
- Washington, DC "Super Lawyer" in Intellectual Property Litigation, Super Lawyers Magazine, 2008-2010, 2013-2014.
- AV-Preeminent® and AV® rated by Martindale-Hubbell.
- Recognized as a leading patent prosecutor in the D.C. area by Intellectual Asset Management, 2012-2014.
- Listed in LMG Life Sciences as an Intellectual Property: Life Sciences Star, 2012-2014.
- AIPLA (chair, Chemical Practice Committee, 1991; and member, Board of Directors, 1992-1994)
- Institute of Intellectual Property and Social Justice, Howard University School of Law (co-chair, 2008 - present)
- Coauthor. "The Patent Eligibility of Traditional Chinese Medicine in the US: Section 101 Guidelines," China IP News, Feb. 11, 2015.
- Coauthor. "From Allergan to BMS: Are We Forgetting the Lessons of History?" BNA Pharmaceutical Law & Industry Report, July 25, 2014.
- Coauthor. "Comparison of United States AIA First-Inventor-to-File with Chinese First-to-File," University of Dayton Law Review, Winter 2013.
- Coauthor. "America Invents Act Effects on Litigation," IP Litigator, May/June 2013.
- Coauthor. "Top Five Dangers for the AIA Unwary," Landslide, May/June 2013.
- Coauthor. "Claim Construction in U.S. Patent Law," Managing Intellectual Property Chinese Edition, June 2013.
- Coauthor. "Comparison of AIA Post-Grant Review & European Oppositions," Managing Intellectual Property Chinese Edition, March 2013.
- Coauthor. "AIA Post-Grant Review and European Oppositions: Will They Work in Tandem, or Rather Pass Like Ships in the Night?" North Carolina Journal of Law & Technology, Fall 2012.
- Coauthor. "Whither Therasense? " China IP News, May 16, 2012.
- Coauthor. "Highlights of U.S. Patent Law Reform," China IP News, Feb. 8, 2012.