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Fundamentals of Patent Litigation 2019

 
Author(s): Gary M. Hnath, John J. Molenda
Practice Area: Intellectual Property
Published: Feb 2019
ISBN: 9781402433160
PLI Item #: 252598
CHB Spine #: G1404

Gary Hnath is a Partner in Mayer Brown’s Washington DC office, where he focuses his practice on intellectual property litigation and counseling, including disputes involving patent, trademark and copyright infringement and trade secrets. He has participated in numerous District Court cases, several Federal Circuit appeals, and over 40 investigations at the International Trade Commission under Section 337 of the Tariff Act of 1930, one of the principal forums for litigating intellectual property disputes involving imported articles.

A leading authority in the area of Section 337 litigation, Gary is a former president of the ITC Trial Lawyers Association and Chair of the ITC Committee of the American Intellectual Property Law Association. He has lectured throughout the United States and Asia and written widely on the subject of Section 337 investigations. While working at the ITC, Gary was lead counsel for the government in Certain Concealed Cabinet Hinges, which raised issues of first impression as to what constitutes a “domestic industry” under the 1988 amendments to Section 337. His position on this issue was adopted by the Administrative Law Judge and the Commission in a decision which is still cited as one of the leading cases in the field.

Gary has successfully represented both patent holders and companies accused of infringement in cases involving a variety of technologies, including high-intensity sweeteners; coenzyme Q10; toner cartridges; sleep apnea products; laminated packaging; linear actuators; medical devices for vein harvesting; personal computers; acetic acid; wireless local area networks; ground fault circuit interrupters; agricultural vehicles; multiplexers used in space satellites; gear couplings used in industrial machinery; and neodymium-iron-boron magnets, to name just a few. He was lead counsel for the first company in China to win a Section 337 case after trial at the ITC. His recent notable victories for clients at the ITC include the successful defense of two manufacturers in China accused of infringing four process patents for the manufacture of sucralose. In this high profile case, the Commission found all of the asserted patents not infringed, and one of the patents invalid, after a hotly contested trial.

Gary has also represented numerous clients on a pro bono basis. For example, in a case for a Washington DC public school bus aide fired from her job as a result of an erroneous drug test, Gary was successful in obtaining a ruling that his client’s constitutional rights had been violated and an order reinstating her with back pay. The court’s decision in that case was cited for several years as one of the leading decisions in the US discussing the constitutionality of random drug testing.

In addition to private practice, Gary has served as law clerk to the Honorable Walter E. Black Jr., US District Court for the District of Maryland and a senior trial attorney with the ITC’s Office of Unfair Import Investigations.


John Molenda is co-chair of Steptoe's Healthcare & Life Sciences Industry Practice, is head of the Intellectual Property Practice for the New York office, and has served on the firm's Executive Committee. He focuses on patent litigation at the district court and appellate levels, opinions of counsel, due diligence, and post-grant proceedings, including inter partes reviews (IPRs) and reexaminations. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, genetically modified plants, medical devices, semiconductors, fiber optics, and computer software.

With respect to John’s appellate practice, he litigates regularly in the US Court of Appeals for the Federal Circuit, including briefing, oral argument, and complex motion practice. He has held substantial roles in over 20 Federal Circuit appeals, including arguing one of the first pharmaceutical-related IPR appeals. John is active in the Federal Circuit community, currently serving as a Vice Chair of the Federal Circuit Bar Association’s Bench & Bar Planning Committee. He has previously held leadership roles on the FCBA’s Patent Litigation, Legislation, and Rules Committees. Prior to private practice, he served as a Federal Circuit law clerk for the Honorable Alan D. Lourie.

With respect to his district court and IPR practices, John has served as lead or co-lead counsel in district court litigations across the United States and has played key roles in multiple trials, mediations, and Markman proceedings. At the same time, John routinely counsels clients on the strategic use of IPRs as part of litigation and settlement strategy, and has served as lead counsel in numerous IPR proceedings on behalf of both petitioners and patent owners. John has served as co-chair of PLI’s Fundamentals of Patent Litigation program since 2014 and speaks regularly about current topics and trends in IPR practice.

While John’s work encompasses a wide range of technologies, he has developed a particular expertise in the area of biologics and biosimilars. He currently represents two pharmaceutical companies in a case involving blockbuster biologics to lower cholesterol and is coordinating pre-litigation strategy and counseling for a global biosimilars program involving high-value monoclonal antibody and cytokine products. John has also led biologics teams conducting transaction-related diligence and pre-petition diligence in advance of IPR filings. He speaks frequently on recent developments involving biologics and biosimilars for organizations including ACI, World Congress, Knowledge Group, BIOTECanada, Canaccord Genuity, and the FCBA.