Thomas L. Irving
Tom Irving has more than 40 years of experience in the field of intellectual property law. His practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, and reissue and reexamination. He 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 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 in the pharmaceutical space to protect against post-grant challenges. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations; as counsel in numerous AIA post -grant proceedings; 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 more than 25 years as principal teacher of the Patent Resources Group (PRG) Chemical Patent Practice course, a comprehensive U.S. chemical patent law course taught two times a year, and he coauthors the multi-volume treatise used in the course. In addition, Mr. Irving originated PRG's Orange Book and Due Diligence courses, which help 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 patent decisions for many state bar association groups and has spoken at numerous national bar association meetings 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 50 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 for pharmaceutical matters.
- Accord Healtcare, Inc. v. Helsinn Healthcare, SA. (PTAB). Represented Helsinn in first-ever PGR dealing with pharmaceuticals. Settled prior to institution. Also represented Helsinn in several other IPRs that all settled prior to institution.
- 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 Kalydeco®, Orkambi®, 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, 1993.
- Selected by his peers for inclusion in The Best Lawyers in America, 2005-2016.
- Recognized as a Washington, D.C. "Super Lawyer" in Intellectual Property, Super Lawyers, 2008-2010, 2013-2015.
- Ranked among top U.S. patent lawyers in Legal Media Group's Guide to the World's Leading Patent Law Practitioners since 2011.
- Judicial®, AV-Preeminent®, and AV® rated by Martindale-Hubbell.
- Recognized as a leading patent prosecutor in the D.C. area, 2012-2015; and nationally for post-grant procedures by Intellectual Asset Management, 2015.
- Inducted into the LMG Life Sciences Hall of Fame, 2015; and listed 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 (co-chair, 2008-present); Howard Intellectual Property Program (founding board member, 2015); Howard University School of Law
- Chinese American Biopharmaceutical Society (CABS)
- Coauthor. "Adjusting for the New Normal: Thoughts on Enhancing the Possibilities of Success for the Patent Owner in an AIA Post-Grant Proceeding," Buffalo Intellectual Property Law Review, Dec. 4, 2015.
- Coauthor. "Spotlight on Objective Evidence of Nonobviousness in AIA Post-Grant Proceedings," Buffalo Intellectual Property Law Review, Dec. 4, 2015.
- Coauthor. "Spotlight on Claim Construction Before PTAB," Buffalo Intellectual Property Law Review, Dec. 4, 2015.
- Coauthor. "Very Few Appreciated Just How Bad AIA IPRs Would Be for Patent Owners, Although IPR Denials Have Been, for Patent Owners, a Glimmer of Hope," Buffalo Intellectual Property Law Review, Dec. 4, 2015.
- Coauthor. "Amending Rather than Cancelling Claims in Inter Partes Reviews," Buffalo Intellectual Property Law Review, Dec. 4, 2015.
- Coauthor. "The Latest Unsuccessful Inter Partes Review Petitions," Law360, Oct. 30, 2015.
- Coauthor. "Pre-Institution at PTAB: Obtaining a Denial Is a Patent Owner Win - Part 2: Substantive Bases of Challenge," IPO Law Journal, Oct. 22, 2015.