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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

John Molenda is co-chair of Steptoe's Healthcare & Life Sciences industry team and is based in Steptoe’s New York office. His practice focuses on patent litigation and counseling at the district court and appellate levels, as well as post-grant proceedings before the US Patent and Trademark Office. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, medical devices, computer software, genetically modified plants, polymers, and automotive parts.

Dr. Molenda's practice has recently focused  on the cutting-edge field of biologics litigation, including pre-litigation counseling and strategy concerning application of the Biologics Act to biotherapeutic development programs.  Dr. Molenda is currently coordinating the strategy for a global monoclonal antibody biosimilars program and previously co-led the legal aspects of an EPO biosimilars program. He speaks regularly on current issues impacting the Biologics Act, including appearances for Knowledge Congress, BIOTECanada, and Canaccord Genuity, and moderating webcasts for the Federal Circuit Bar Association.

Dr. Molenda’s appellate practice concentrates on patent appeals before the Federal Circuit, and his experience includes substantial involvement in numerous such appeals. He routinely advises clients on Federal Circuit practice and procedure, and has guest lectured on these topics at Fordham University School of Law. Dr. Molenda is an active member of the Federal Circuit community, and he currently serves as co-chair of the Federal Circuit Bar Association’s Rules Committee. Prior to private practice, he served as a Federal Circuit law clerk with the Honorable Alan D. Lourie.

Dr. Molenda’s district court practice includes all aspects of pre-trial and trial proceedings. He has played substantial roles in several trials, successfully led a court-ordered mediation, participated in numerous Markman-related proceedings, and managed all aspects of discovery. Dr. Molenda speaks regularly about current legal issues in patent litigation, including serving as a co-chair of PLI’s Fundamentals of Patent Litigation 2014 program and moderating webcasts for the FCBA. He has also authored several articles concerning the Federal Circuit’s evolving law of claim construction.

Professional Affiliations

Federal Circuit Bar Association

Co-Chair, Rules Committee (December 2011-October 2014) Co-Chair, Legislation Committee (October 2008-October 2011)

Co-Vice-Chair, Patent Litigation Committee (October 2005-October 2008)

New York Intellectual Property Law Association New York State Bar Association

Noteworthy

FCBA Legislation Committee Individual Leadership Award, 2011 FCBA Legislation Committee Leadership Award, 2011

Areas of Practice

Appellate & Supreme Court

Intellectual Property IP Litigation

Patent

Patent Litigation Patent Office Practice

Education

The University of Michigan Law School, JD, 1998

New York University, Postdoctoral Research, 1995; Biochemistry

Vanderbilt University, PhD, 1994; Chemistry

Vanderbilt University, MS, 1994; Chemistry

Vanderbilt University, 1991; Chemistry and History, cum laude, with Honors in the College of Arts & Science

Bar & Court Admissions

New York

US Supreme Court

US Court of Appeals for the Federal Circuit

US Court of Appeals for the Seventh Circuit

US District Court for the Southern District of New York

US District Court for the Eastern District of New York

US Patent and Trademark Office


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.


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.


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.