Steven J. Lee

Steven J. Lee, Ph.D.

Dr. Steven J. Lee, co-chair of Kenyon & Kenyon LLP’s Chemical/Life Sciences practice group, has twenty-five years of experience representing companies in intellectual property matters. As an experienced chemist, Dr. Lee is adept at advising companies in the pharmaceutical, biotechnology, chemical and bioinformatics industries on all areas of patents, including litigation, interferences, counseling, and prosecution.

Dr. Lee is recognized by several legal referral guides as being one of the leading life sciences attorneys in the world. Legal 500 describes him as possessing “extensive knowledge of patent litigation in the life sciences sector.” Likewise, Chambers Global quotes his clients as reporting that Dr. Lee is “extremely perceptive” with a “high level of technical expertise.” He is also named one of New York’s Best Lawyers in the patent field. In addition, Dr. Lee is recognized as one of the world’s leading patent litigators by IAM Patent Litigation 250, specifically for his work in the life sciences field where he is known as a “solid performer in generic drug litigation.”

Dr. Lee brings his technical acuity to bear in a wide range of client matters. His patent litigation experience literally extends to products ranging from A to Z: generic versions of Allegra, Augmentin, Claritin, Gemzar, Hytrin, Neurontin, Oxycontin, Paxil, Procardia, Relafen, Sarafem, Seldane, Ticlid, Zantac and Zithromax; brand name pharmaceuticals including Duracef, Kadian, Lovenox, Ortho-Cyclen and Xalatan; as well as monoclonal antibodies for septic shock and against stem cells. Equally adept at representing clients whose innovations involve patents on bioinformatics and alternative methods for drug delivery, Dr. Lee has litigated cases involving DNA synthesis machines and transdermal drug delivery systems.

Dr. Lee’s experience gained while practicing chemistry for eleven years and teaching as an associate professor of Chemistry at Fordham University has enabled him to develop sophisticated litigation strategies for clients engaged in chemical related litigations involving coatings for aluminum cans, paints for automobiles, and striped toothpaste. Dr. Lee also prosecutes patent applications in the chemical and life sciences areas, counsels inventors and patent owners on the scope and validity of their intellectual properties, and advises clients introducing new products and services as to any potential for infringement of the patent rights of others.

Dr. Lee is frequently invited to speak at conferences around the world on topics pertaining to intellectual property law and litigation. He speaks annually at Fordham University’s School of Law Conference on International IP Law and Policy. In addition, he has spoken at American Conference Institute’s Annual Paragraph IV Disputes and Maximizing Pharmaceutical Patent Life Cycles conferences. He has also spoken at a webinar hosted by the Intellectual Property Owners Association; a seminar hosted by the Fordham IP Institute; a seminar focused on “Navigating the Challenges of ANDA Disputes” during the Law360 Expert Insight Series; the New York Biotechnology Association’s Annual Meetings; the Institute for International Research’s Annual Generics Summit; a Pharmaceutical Law 2006 seminar entitled “Across the Product Life Cycle” hosted by the Practicing Law Institute; and GphA’s Annual Policy Conference: The Generic Industry Event of the Season.

Dr. Lee is also a prolific author whose recent publications include an article in Intellectual Asset Management magazine on “Waxman-Hatch Litigation Strategies For Generic And Brand Companies” (2010); the chapter in the ABA’s Patent Litigation Strategies Handbook on “Waxman-Hatch Litigation From the Perspective of the Generic Pharmaceutical Industry” (2010); the chapter in BNA’s International Pharmaceutical Law and Practice, 2nd Ed. (2009) on U.S. patent law; and an article in the Fordham Intellectual Property, Media & Entertainment Law Journal, Vol. XVII, number 4, pages 915-932 (2007) on the U.S. law of obviousness.

Dr. Lee argued the following appeals before the United States Court of Appeals for the Federal Circuit Court:

• Glaxo Wellcome, Inc. v. Impax Laboratories, Inc. 356 F.3d 1348 (Fed. Cir. 2004) – Obtained Federal Circuit affirmance of non-infringement in favor of our client Impax Laboratories.
• Berman v. Housey 291 F.3d 1345 (Fed. Cir. 2002)– In a precedential opinion, a panel of the Federal Circuit unanimously affirmed a decision of the United States Patent and Trademark Office's Board of Patent Appeals and Interferences rejecting an attempt by Genentech to bring an Interference to challenge patents owned by Housey Pharmaceuticals claiming methods of screening for new drugs.
• Smithkline Beecham Corporation v. Copley Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc. 154 F. Supp. 2d 157 (D. Mass 2001), aff’d 45 Fed. Appx. 915, 2002 U.S. App. LEXIS 16594 (Fed. Cir. 2002) – Obtained the Federal Circuit’s affirmance the invalidity of SmithKline Beecham's patent on nabumetone.
• Purdue Pharma v. Faulding, 230 F.3d 1320 (Fed. Cir. 2000) affirming invalidity of Purdue’s patent on extended release morphine

Additional Matters:

• In re Gabapentin Litigation, 503 F.3d 1254 (Fed. Cir. 2007)
• Glaxo v. Geneva Pharmaceuticals et al., 45USPQ2D 1702 (D.N.J. 1997)
• Granutec Inc. v. Shalala, 139 F.3d 889, 46USPQ2d 1398 (4th Cir. 1997)

His representative litigation experience includes:

• Sanofi-Aventis v. Impax Laboratories (D.N.J) – Represented client Impax Laboratories in a patent infringement lawsuit involving Fexofenadine Hydrochloride, the generic version of Allegra. The FDA accepted the ANDA filed by Impax in 2002. Also represented Teva Pharmaceuticals in this case. In early 2006, the Court denied Sanofi-Aventis's motion for a preliminary injunction, thereby allowing Teva to remain on the market with a generic version of ALLEGRA®. The market for Allegra was $1.5 billion at the time Teva launched its product. Teva settled with Sanofi-Aventis in late 2008. In 2011, Sanofi-Aventis and Impax reached a settlement agreement.
• Teva Pharmaceuticals USA v. Mylan Pharmaceuticals, Inc. and Natco Pharma Ltd.; Teva Pharmaceuticals USA v. Sandoz (S.D.N.Y.) – Counsel for Teva Pharmaceuticals and Yeda in high-profile patent infringement litigations involving Teva's largest selling product, multiple sclerosis drug Copaxone®. A bench trial commenced in the Southern District of New York in September 2011 and a decision is pending.
• Cephalon Inc. et al. v. Teva Pharmaceuticals USA Inc. et al. (D. Del.) – Represented Teva Pharmaceuticals USA, Inc. in a patent litigation brought by Cephalon Inc. in the District of Delaware involving Teva's generic version of Nuvigil®, a drug used to treat excessive sleepiness caused by narcolepsy. Cephalon dropped the suit with respect to three asserted patents, resolving one of several cases the company filed in a multidistrict litigation concerning the narcolepsy drug.
• Eli Lilly and Company v. Teva Pharmaceutical USA, Inc. 657 F. Supp. 2d 967 (S.D. Ind. 2009) – Represented Teva Pharmaceuticals in patent infringement litigation in the Southern District of Indiana and at the Federal Circuit related to an Abbreviated New Drug Application (ANDA) Teva filed to manufacture and market a generic version of Eli Lilly’s raloxifene hydrochloride formulation, which Lilly markets as Evista®.
• Aventis Pharmaceuticals, Inc. and AMR Technology v. Teva Pharmaceuticals, USA, Inc. and Amino Chemicals (D.N.J) – Represented Teva Pharmaceuticals in these litigations brought by Sanofi-Aventis in the New Jersey District Court on Sanofi-Aventis's Allegra® antihistamine product. In early 2006, The Court denied Sanofi-Aventis's motion for a preliminary injunction, thereby allowing Teva to remain on the market with a generic version of Allegra®. The market for Allegra® was $1.5 billion at the time Teva launched its product. Teva, Aventis and AMR settled the ongoing litigations between them concerning Allegra® in late 2008.

Additional Matters:

• Eli Lilly and Co. v. Sicor Pharmaceuticals, Inc. et al., 705 F. Supp. 2d 971 (S.D.Ind. 2010)
• Aventis Pharmaceuticals, Inc. v. Barr Laboratories, Inc., 411 F. Supp. 2d 490 (2006)
• In re Gabapentin Litigation, 407 F.Supp. 2d 607 (2005), 393 F. Supp. 2d 278 (2005)
• SmithKline Beecham v. Teva Pharmaceuticals (consolidated as In re ‘639 Litigation), (D. Mass 2001)
• Purdue Pharma LP et ano. v. Faulding Inc., 48 F. Supp. 2d 420 (D. Del. 1999), affirmed 56 U.S.P.Q.2d 1481, 2000 WL 1582737 (Fed. Cir. 2000)
• Johns Hopkins University, Baxter Intern. and Becton Dickinson v. CellPro, 894 F. Supp. 819 (D. Del.); 160 F.R.D. 30, 34 USPQ2d 1276 (D. Del. 1995); 931 F. Supp. 303 (1996); 99 F.3d 1159, 1996 WL 597805 (Fed. Cir. 1996)
• In re Certain Diltiazem Hydrochloride and Diltiazem Preparations, Inv. 337-TA-349, 1995 ITC LEXIS 253
• MMD v. American Cyanamid & Co., 36 USPQ2d 1036 (D.N.J. 1994); 1994 U.S. Dist. LEXIS 11495 (D.N.J. 1994)