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.
For more than 25 years, Mr. Irving has 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; he coauthors the multi-volume treatise used in the course. He 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 trade and bar association meetings such as the Intellectual Property Owners Association, American Intellectual Property Law Association (AIPLA), and American Bar Association. Mr. Irving 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 multiple Strafford Webinars on patent law topics, including several that deal with AIA post-grant proceedings.
- Accord Healthcare, Inc. v. Helsinn Healthcare, S.A. (PTAB). Represented Helsinn in first-ever PGR dealing with pharmaceuticals, which settled prior to institution determination. Represented Helsinn as the patent owner in two PGRs denied by PTAB, and in several IPRs that all settled prior to a determination of 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 USPTO 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.
- Recognized by The Legal 500 U.S. for patent portfolio management and licensing, 2016.
- Recognized by Intellectual Asset Management as a leading patent prosecutor in the D.C. area, 2012-2016; and nationally for post-grant procedures, 2015, 2016.
- Recognized as an "IP Star" in Washington, D.C. by Managing Intellectual Property, 2016.
- Selected by his peers for inclusion in The Best Lawyers in America® since 2005, and for patent law, 2011-2017.
- Recognized as a Washington, D.C. "Super Lawyer" in Intellectual Property, Super Lawyers published by Thomson Reuters, 2008-2010, 2013-2016.
- Judicial®, AV-Preeminent®, and AV® rated by Martindale-Hubbell.
- Inducted into the LMG Life Sciences Hall of Fame, 2015; and listed as an Intellectual Property: Life Sciences Star, 2012-2016.
- 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)
- Coauthor. "Fed. Circ. Provides Cautionary Tale on Markush Claiming," Law360, Feb. 22, 2017.
- Coauthor. "Some Early Trends in Post-Grant Review," Law360, Jan. 31, 2017.
- Coauthor. "In Search of Objective Evidence Success at PTAB," Law360, Aug. 30, 2016.
- 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. "Spotlight on Claim Construction Before PTAB," 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. "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. "The Latest Unsuccessful Inter Partes Review Petitions," Law360, Oct. 30, 2015.
- Coauthor. "Pre-Institution at PTAB: Obtaining a Denial Is a Patent Owner Win," IPO Law Journal, Oct. 22, 2015.