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Fundamentals of Patent Litigation 2015


Speaker(s): Gary M. Hnath, John J. Molenda, Ph.D., John M. Mola, Joseph P. Lavelle, Lisa M. Ferri, Madison C. Jellins, Sanjeet K. Dutta
Recorded on: May. 29, 2015
PLI Program #: 59221

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.

Patent Litigation

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.

Antitrust

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.


John Mola is Director of PLI’s California Operations and a Senior Program Attorney. He is responsible for  the operation of the California Center and as a Senior Program Attorney, primarily handles patent programs. Prior to joining PLI, John was the Program Department Manager at Continuing Education of the Bar--California (CEB). John also served on the ACLEA Executive Committee for a two-year term. He was an attorney with Rhode Island Legal Services for a number of years was named Executive Director. He was a national advocate in efforts to preserve legal services programs in the early 1980s. During the Carter Administration, John was Director of Legal Training at the Legal Services Corporation in Washington, D.C. where he supervised national professional development activities for legal services lawyers, paralegals and clients. John has a B.A. in History from Franklin and Marshall College; a M.A.T. from Antioch Graduate School of Education; and, a J.D. from the Antioch School of Law, where he was a member of the Founding Class.


Lisa M. Ferri is a partner in Mayer Brown’s Intellectual Property practice and serves as the IP Practice Leader for the New York Office. She focuses her practice on the trial and appeal of patent litigation in the Life Sciences field, including representing innovator companies in cases brought pursuant to the Hatch-Waxman Act.  Lisa serves as lead counsel on behalf of high-profile companies in federal courts across the country, Patent Office inter partes reviews, the International Trade Commission and the Federal Circuit Court of Appeals.  Following enactment of the AIA, Lisa handled one of the first co-pending inter partes reviews and district court litigations relating to the Orange Book listed drug Lexiva® -- which was the first “lead compound” IPR before the PTAB as well.

Lisa is an adjunct professor at Fordham University School of Law where she teaches Patent Litigation.

Lisa was named one of the “Top 250 Women in IP” by Managing Intellectual Property and an “IP Star” and “Life Sciences Star” by the Legal Media Group.  Lisa was nominated in 2014 as "Hatch-Waxman Litigator of the Year" by the LMG Life Sciences Awards. In addition, she has been recognized in the area of patent litigation by the Legal 500. Her recent victory at the Federal Circuit Court of Appeals in Biogen IDEC, Inc. and Genentech v. GlaxoSmithKline, which involved the monoclonal antibody therapy Arzerra®, was shortlisted for "Patent Impact Case of the Year" by the LMG Life Sciences Awards.