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Fundamentals of Patent Litigation 2019


Speaker(s): Andrew Kopelman, Betty A. Ryberg, Gary M. Hnath, John J. Molenda, Ph.D., Joseph P. Lavelle, Kirby Lee, Krista M. Rycroft, Megan Raymond, Omar Jabri, Robert P. Lord
Recorded on: Feb. 27, 2019
PLI Program #: 252601

Andrew Kopelman is Medidata’s VP, Assistant General Counsel & Chief Privacy Counsel, and is responsible for managing the company’s domestic and international data privacy matters and intellectual property strategies.

Prior to joining Medidata in 2012, Mr. Kopelman was an associate in the patent group at Jenner & Block, LLP, where he focused on patent litigation and client counseling involving pharmaceutical, computer and mechanical patents. Mr. Kopelman was previously an associate at Frommer, Lawrence & Haug LLP, where he focused on Hatch-Waxman pharmaceutical litigation. He is a registered patent attorney with the USPTO and is Certified Information Privacy Professional (CIPP/US).


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.


Kirby Lee is Assistant Chief Intellectual Property Counsel for Ecolab, where he is responsible for patent and other intellectual property matters, including supporting the needs of NALCO Water business operations in Naperville, Illinois.  Lee also focuses on intellectual property litigation and dispute resolution for the company.

Previously, Lee was a trial attorney at the U.S. Department of Justice in Washington, D.C.  For a decade, he litigated cases in the Intellectual Property Section of the Commercial Litigation Branch.  His recent government service also included a tour of duty in the Executive Office of the President as Senior Policy Advisor to the U.S. Intellectual Property Enforcement Coordinator.

Lee earned a Bachelor of Science degree in chemical engineering from Purdue University and a Juris Doctor from the Indiana University Law School – Indianapolis, where he graduated first in his class.  During law school, Lee served as editor-in-chief of the Indiana Law Review and worked as a patent attorney trainee doing patent prosecution at a major pharmaceutical corporation.

Immediately following law school, Lee served as judicial law clerk to the Hon. Alan D. Lourie at the U.S. Court of Appeals for the Federal Circuit and to the Hon. Marvin J. Garbis at the U.S. District Court for the District of Maryland.  Lee is also a registered patent attorney.


Krista Rycroft is Of Counsel in Quinn Emanuel's New York office.  She has extensive experience in all aspects of patent litigation at the trial and appellate levels for both patentees and defendants.  In addition to her litigation experience, Ms. Rycroft also has extensive experience in client counseling including licensing, due diligence, and validity and freedom-to-operate opinions. Ms. Rycroft has represented clients involved in a variety of complex technologies, including pharmaceuticals, medical devices, biotechnology, telecommunications, and mechanical devices.  Ms. Rycroft has litigated in numerous Federal courts throughout the country, including the District of New Jersey, District of Delaware, Northern District of California, Eastern District of Texas, and District of Massachusetts.  She is admitted to practice in the State of New York, the Court of Appeals for the Federal Circuit, the Court of Appeals for the First Circuit, and various District Courts.


As counsel in the Litigation Department, Megan Raymond focuses on patent infringement matters. Megan has significant experience representing clients in post-grant proceedings before the Patent Trial and Appeal Board (PTAB), and has been involved in over 60 proceedings to date. Megan also has experience litigating in a number of significant patent jurisdictions, including Delaware, Texas, Massachusetts, the U.S. Court of Appeals for the Federal Circuit and the International Trade Commission. Her experience spans the pre-suit investigation stage through trial, appeal and/or settlement. She has argued numerous issues in court that have arisen at the claim construction, pretrial and trial phases of litigation.

Megan has been recognized by The Legal 500 for her patent litigation work. Megan is the vice-chair of the Federal Circuit Bar Association's PTAB committee, the vice-chair of the PTAB Bar Association’s Women’s Committee and the former vice-chair of the PTAB Bar Association’s Programming Committee. In 2017 and 2018, she received the Federal Circuit Bar Association’s Committee Leadership Award. In addition, she is a frequent speaker on developments in patent law, including topics primarily related to the PTAB.

Megan attended college at Harvard University, where she majored in Biochemistry.  Prior to law school, Megan was a research fellow at the National Institutes of Health in the U.S. Food and Drug Administration's Laboratory of Immunoregulation (Center for Biologics, Evaluation, and Research), where she co-authored papers on vaccine design and development.  Megan attended the University of Virginia School of Law for her JD.  Subsequent to law school, she clerked for the Honorable Haldane R. Mayer on the U.S. Court of Appeals for the Federal Circuit.


Betty is a legal leader who enjoys helping companies transform legal and reputational challenges into business opportunities.  She regularly applies her wide-ranging, hands-on legal experience in a wide-variety of matters to achieve results for her clients.  Betty currently serves as member of the West global legal department, head of intellectual property, and lead lawyer for West’s Israel operations.  An accomplishment for which Betty is particularly proud is transforming a breach of a confidentiality agreement into a royalty-bearing license that includes three, seven-figure lump-sum payments. 

Betty joined West in 2016 from Novartis, where she served for eight years as Vice President in its legal function, advising on significant products liability and IP litigation and license and settlement agreements.  She helped devise a global intercompany licensing, patent assignment and cash flow management strategy to optimize potential recovery in patent infringement litigation and corporate taxes.  She created legal/IP strategies under the Biologics Price Competition and Innovation Act of 2009, which created a regulatory pathway for biosimilars.  Betty also was responsible for SOX reporting of litigation matters globally, and the divestment of vaccines, diagnostics and over-the-counter businesses worth over USD 20 bn. 

Before joining Novartis, Betty worked in private practice for over twelve years, including eight as an associate for Kaye Scholer, LLP, where she litigated dozens of pharmaceutical, biotech, medical device, scientific equipment and software patent infringement, copyright infringement and breach of contract cases, and conducted numerous M&A due diligences.  Betty bolsters this large law firm and big Biopharma experience with a solid foundation as an associate at a small IP boutique learning patent and trademark preparation and prosecution.  Upon graduating from law school, Betty worked for a year managing discovery in Superfund cases.  Combined with her in-house experience, Betty has tried nearly 40 patent infringement and products liability cases, including cross-examining a key expert, prepared, taken or defended nearly 50 depositions in various jurisdictions across the United States and in London, and drafted dozens of legal briefs and asset sale/purchase and license agreements. 

Before becoming a lawyer, Betty worked as an engineer for 3M, where she oversaw two specialty film production lines and helped develop a production process for Thinsulate® film.  She also worked as an engineer for Pitney Bowes, where she was responsible for selecting all new elastomers for a new high-speed inking system and an inventor on four patents.  While working fulltime for Pitney Bowes, Betty earned her J.D. from Quinnipiac University in nearby Bridgeport, Connecticut.  Betty also earned a Bachelor of Chemical Engineering from Auburn University.  Betty is admitted to practice law in Pennsylvania, D.C., New York, and Connecticut and is a registered U.S. Patent Attorney.

Betty lives in an old stone farmhouse on historic Horseshoe Trail in Chester Springs, Pennsylvania, with her husband, Phil Grant, and their two boys, Rodger and Nathanael.


Omar is the Global Director in the Intellectual Property department at Apotex, a Canadian pharmaceutical company which distributes drugs in over 115 countries around the globe.  Omar advises Apotex on all day-to-day matters relating to generic drug approval, including pre-submission diligence, including patent analysis, and oversight of external counsel involved in litigations over Apotex’s drug products. Omar is also Lead Attorney for Apobiologix, Apotex’s biologics and biosimilars division.

Prior to joining Apotex, Omar was a litigation associate at Gilbert’s LLP in Toronto.  Omar began his career in the New York offices of two large US firms.  As a litigation associate, Omar participated in all aspects of a patent infringement case including trial.

Omar graduated from the University of Toronto with a Hon. B.Sc. (2000) and received law degrees from the University of Ottawa (2004) and Harvard Law School (2006).  Omar is admitted to practice in Ontario and New York State.


With almost 20 years of patent prosecution experience under his belt, Robert Lord relies on a wealth of sound legal and business-savvy approaches to solving client’s IP issues. Robert’s practice focuses on patent prosecution, portfolio management, due diligence, client counseling, licensing, and ITC/Federal Court litigation in the fields of software engineering, business methods, and computer engineering. 

From a technology standpoint, Robert has experience handling IP matters requiring technical competence ranging from front-end graphical user interfaces to massively parallel processing cycle-based systems for circuit design.  As a software developer prior to practicing law, he worked on programming projects for the IRS, Federal Reserve Bank of Dallas, Baylor University, Southwestern Publishing/Dryden Press, and Apple Computer.

Mr. Lord is in charge of the firm’s prosecution practice and manages over 3,000 active IP matters (patent, trademark, and copyright) for numerous medium-to-large companies, while still being intimately involved in daily patent prosecution matters. Mr. Lord is frequently requested to lecture at seminars and hold presentations regarding various IP subject of high interest to the IP community and hi-tech leaders around the world.  As a result, he is a member of the Texas Bar College recognizing his commitment to continuing legal education.

Bar Admissions

- State Bar of Texas (1994)

- U.S. Patent and Trademark Office (2000)

- U.S. District Court:  Southern District of Texas; Northern District of Texas; Eastern District of Texas;

- Western District of Texas; U.S. Court of Appeal for the Federal Circuit

Education

- Baylor University School of Law; J.D. (1994)

- Baylor University; B.A. Computer Science (1991)

Representative Presentations

- “Patent Prosecution for Litigators,” Practicing Law Institute - New York City, New York (2013-2018)

- “Acquiring and Polishing your Intellectual Property” Xuzhou, China (2018)

- “Legal Masterminds: Startup Bootcamp”, San Francisco Bay Area, California (2018)

- “Litigation & Licensing,” Ningbo and Suzhou, China; Taipei, Taiwan (2017)

- “Section 337 Proceedings at the U.S. International Trade Commission,” Hangzhou, China (2012)

- “The Litigation Process in the U.S. — How did I get here? Can I get out? Is there a way to avoid it altogether?,” Nanjing, Beijing, Ningbo, and Suzhou, China (2012)

Representative Contentious Matters

- RW IP Holdings, LLC v. Standard Innovation Corp., et. al. Civil Action No. 17-cv-12060-DJC

- Dicon Fiberoptics v. Preciseley Technologies (NDCA 3:15-cv-01362)

- Prosper Funding v. Prosper Capital, et al, (EDMO 4:15-cv-01408)

- Certain Kinesiotherapy Devices and Components Thereof, ITC Inv. 337-TA-823

- IPR2014-00148 and IPR2014-00907 (Petitioner)

- IPR2015-01739, IPR2015-01740, IPR2015-01741, IPR2015-01742, and IPR2015-01743 (Patent Owner)