Skip to main content

Fundamentals of Patent Litigation 2016


Speaker(s): Colleen Tracy James, Gary M. Hnath, John J. Molenda, Ph.D., Joseph P. Lavelle, Madison C. Jellins, Sanjeet K. Dutta
Recorded on: May. 12, 2016
PLI Program #: 148936

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.


Joseph Lavelle is an experienced patent lawyer, focusing primarily on the preparation and trial of patent infringement cases.

Joseph also has handled a number of successful appeals to the Court of Appeals for the Federal Circuit.

Joseph has more than 25 years of experience litigating patent cases, including many bench and jury trials. He has litigated in most areas of technology, including semiconductors, computers, computer software, telephony, Digital Signal Processing, telematics, waveform encoding, automotive technology, financial services, biotechnology and many others.

In addition to federal district court proceedings, Joseph has tried a number of Section 337 proceedings before the US International Trade Commission (ITC), as well as handled cases before the US Court of Federal Claims and appeals to the Court of Appeals for the Federal Circuit. He also is licensed to practice before the USPTO and has successfully handled interference proceedings

Joseph has vast experience handling litigation and counseling matters at the intersection of competition laws and antitrust laws. He has participated in many of the leading matters in the area of standard setting. Also, he has represented clients in patent-antitrust matters before the FTC and the Antitrust Division of the Department of Justice.


Madison C. Jellins has more than 20 years of experience in patent litigation and strategic counseling for biopharmaceutical and medical device clients and has served as lead counsel in patent cases in district court and at the Federal Circuit. She is a registered patent attorney and has particular expertise in patent and regulatory strategy, including the FDA approval process for small molecules, biologics, biosimilars, and combination products; Hatch-Waxman litigation strategy; and the new biosimilars pathway. Madison also handles appellate matters before the Federal Circuit and frequently lectures on Federal Circuit case law developments and patent/regulatory issues. She clerked for the Hon. Helen W. Nies, former Chief Judge of the Federal Circuit. She is a Lecturer at Santa Clara University School of Law and was recognized as a Northern California Super Lawyer in IP Litigation in 2009-2012. Madison was formerly a partner in the IP Litigation Group of Alston & Bird LLP and a partner in the Patent Litigation Group at Townsend LLP.

Educational Summary

  • J.D., magna cum laude, University of San Francisco
  • Four American Jurisprudence Awards
  • Comment of the Year Award
  • Senior Member, Law Review
  • M.S. Biological Sciences (cancer biology), Stanford University
  • B.A. Zoology (pre-med), University of Washington

Admissions

  • California State Bar
  • U.S. Patent and Trademark Office
  • U.S. Supreme Court
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. Court of Appeals for the Ninth Circuit
  • All California Courts


Sanjeet Dutta is a litigator who handles intellectual property matters in state and federal courts and before the International Trade Commission (ITC).  His focus is on patent litigation, patent prosecution, licensing agreements, and IP diligence and audits.

Mr. Dutta has considerable experience in handling matters related to technology in a variety of areas including mobile devices, location based services, payment systems, geothermal energy, processor architecture, semiconductor memories, semiconductor verification/emulation, semiconductor processing and manufacturing, network routing, caching, compiler design, and storage area networks.


Representing companies in the Life Sciences Industry, Colleen Tracy James focuses her practice on patent infringement litigation, USPTO Patent Trial and Appeal Board proceedings, and other complex intellectual property litigation. She has extensive experience litigating against generic pharmaceutical companies in matters brought under the Hatch-Waxman Act (ANDA litigation) in federal district courts across the US and the Federal Circuit. Many pharmaceutical companies have entrusted Colleen to handle litigations that involve their billion dollar a year products and bet the company cases. Colleen also provides her clients with an array of intellectual property patent services such as freedom to operate opinions and licensing and due diligence advice, among others.

Whether she is handling a high-stakes patent litigation or engaged in IP counseling, due diligence or licensing, Colleen is known for being organized, efficient, cool under pressure and an exceptional communicator. Her skill and dedication in preparing witnesses for depositions has, time and again, allowed her to achieve outcomes that met or exceeded client expectations.

Above all, Colleen puts a premium on listening to her clients and building consensus among stakeholders so that she can craft strategies that respond directly to the client's legal and business needs.

According to Legal 500 US, "Colleen Tracy attracted client praise for her 'overall depth of knowledge, dogged advocacy, and unfailing attentiveness to details of concern to the client.'" Colleen was Recognized as a "Life Science Star" in the 2016 edition of Euromoney’s Legal Media Group (LMG) Life Sciences, and has been recognized as an "IP Star" by Managing Intellectual Property since 2014, she was also recognized as one of the “Top 250 Women in IP” by Managing Intellectual Property in 2016. Colleen was selected as a top intellectual property law practitioner in the 2011-2018 editions of Best Lawyers in America. She was also named a 2013 "Woman Worth Watching" by Profiles in Diversity Journal. Colleen was featured as a rising star by Law360 in 2010 and was named a rising star in intellectual property law in the 2007 edition of Law360.

While in law school, Colleen served as a student law clerk to the Honorable William G. Bassler of the United States District Court for the District of New Jersey.