Dr. Steven J. Lee, Ph.D. has 30 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 in 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. The US Legal 500 describes him as possessing “extensive knowledge of patent litigation in the life sciences sector.” He is also listed as a leading intellectual property law practitioner in the 2014 edition of Chambers & Partners Global.
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 11 years, including 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 has frequently been invited to speak at conferences around the world on topics pertaining to intellectual property law and litigation. He has often spoken at Fordham University’s School of Law Conference on International IP Law and Policy.
He has also spoken at American Conference Institute’s Annual Paragraph IV Disputes and Maximizing Pharmaceutical Patent Life Cycles conferences; 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 argued the following appeals before the U.S. Court of Appeals for the Federal Circuit:
- For Faulding in patent litigation affirming invalidity of Purdue’s patent on extended release morphine. Purdue Pharma v. Faulding, (Fed. Cir.).
- For Housey Pharmaceuticals in a precedential opinion, in which a panel of the Federal Circuit unanimously affirmed a decision of the U.S. Patent and Trademark Office’s Board of Patent Appeals and Interferences. The decision rejected an attempt by Genentech to bring an interference to challenge patents owned by Housey Pharmaceuticals claiming methods of screening for new drugs. Berman v. Housey (Fed. Cir.).
- For Impax Laboratories in patent litigation resulting in Federal Circuit affirmance of non-infringement in favor of client. Glaxo Wellcome v. Impax Laboratories (Fed. Cir.).
- For Teva Pharmaceuticals in patent litigation that obtained the Federal Circuit’s affirmance the invalidity of SmithKline Beecham’s patent on nabumetone. Smithkline Beecham v. Copley Pharmaceutical, et al. (D. Mass, Fed. Cir.).
- Aventis Pharmaceuticals v. Barr Laboratories (Fed. Cir.).
- Glaxo v. Geneva Pharmaceuticals, et al. (D.N.J.).
- Granutec Inc. v. Shalala (4th Cir.).
- Impax Laboratories and Teva Pharmaceuticals in a patent infringement lawsuit involving Fexofenadine Hydrochloride, the generic version of ALLEGRA®. The FDA accepted the ANDA filed by Impax in 2002. 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. Sanofi-Aventis v. Impax Laboratories (D.N.J).
- In re Certain Diltiazem Hydrochloride and Diltiazem Preparations (ITC).
- Johns Hopkins University, et al. v. CellPro (D. Del., Fed. Cir.).
- MMD v. American Cyanamid & Co. (D.N.J.).
- Pfizer in In re Gabapentin Litigation (Fed. Cir.).
- Sicor Pharmaceuticals in a Hatch-Waxman litigation concerning Sicor’s generic equivalent to Eli Lilly’s cancer drug Gemzar®. Eli Lilly’s patent was found to be invalid after trial, and the decision was affirmed on appeal. Eli Lilly and Co. v. Sicor Pharmaceuticals (S.D. Ill.).
- Teva Pharmaceuticals and Yeda Research and Development in consolidated Hatch-Waxman litigations concerning proposed generic equivalents to Teva’s blockbuster multiple sclerosis drug Copaxone®. Following trial, the court ruled that Teva and Yeda’s nine patents in suit were valid, enforceable and infringed by the proposed generic products of defendants Sandoz/Momenta Pharmaceuticals and Mylan/Natco Pharma. Teva Pharmaceuticals USA v. Mylan Pharmaceuticals and Teva Pharmaceuticals USA v. Sandoz (S.D.N.Y.).
- Teva Pharmaceuticals in patent infringement litigation related to an ANDA Teva filed to manufacture and market a generic version of Eli Lilly’s raloxifene hydrochloride formulation, which Lilly markets as Evista®. Eli Lilly and Company v. Teva Pharmaceutical USA (S.D. Ind., Fed. Cir.).
- Teva Pharmaceuticals USA in a patent litigation brought by Cephalon 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. Cephalon, et al. v. Teva Pharmaceuticals USA, et al. (D. Del.).
- JD, Fordham University School of Law, Fordham Law Review, 1983
- PhD, University of Rochester, 1973
- AB, Chemistry, Cornell University, 1969
- New Jersey
- New York
- US Patent and Trademark Office
- US Court of Appeals, Federal Circuit
- US Court of Appeals, Fourth Circuit
- US District Court, District of New Jersey
- US District Court, Eastern District of New York
- US District Court, Southern District of New York
- US Supreme Court
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