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11th Annual Patent Law Institute


Speaker(s): Angie M. Hankins, Brent K. Yamashita, Brian Hanlon, Craig A. McRobbie, Dana S. Rao, David T. Dutcher, Hon. Timothy J. Goodson, John Cabeca, Jon R. Trembath, Kate Gaudry, Ph.D., Leslie M. Spencer, Matthew Sarboraria, MJ Edwards, Prof. David Hricik, Prof. Mark A. Lemley, Robert Glance, Robert J. Spar, Scott M. Alter, Thomas D. Franklin, Tracy-Gene G. Durkin
Recorded on: Apr. 27, 2017
PLI Program #: 186793

Angie Hankins is the Senior Director of Strategy, Senior Investment and IP Counsel for the Samsung Strategy & Innovation Center (SSIC) in Menlo Park, California.  She also serves as the privacy officer for SSIC.  Ms. Hankins has been practicing law for over 17 years. She is responsible for intellectual property and strategy for SSIC.  Ms. Hankins provides advice on and negotiates technology transactions and investments in early stage companies and disruptive technology.  Ms. Hankins is also responsible for managing the prosecution of patents, trademarks and copyrights for SSIC.

Prior to joining SSIC in 2015, Ms. Hankins was an Intellectual Property partner in the New York office of Stroock & Stroock & Lavan where her practice focused on patent litigation, client counseling, and patent prosecution. She has extensive experience in discovery, motion, trial and appellate practice before the federal courts and the U.S. International Trade Commission (ITC).   While at Stroock, Ms. Hankins also counseled clients on patentability, infringement, copyright and trademark protection.

Ms. Hankins has Juris Doctorate from University of Virginia School of Law and a Bachelors of Engineering in electrical engineering from the Stevens Institute of Technology.  Prior to completing law school and throughout college, Ms. Hankins worked at Bell Communications Research (BELLCORE).  Her responsibilities at BELLCORE included developing software for Asynchronous Digital Subscriber Line III and a test-plan for data link path protection switching.  In addition, Ms. Hankins served as a telecommunications specialist in the U.S. Air Force, where she was the recipient of the John Levitow Award.

Ms. Hankins is a registered patent attorney with the U.S. Patent and Trademark Office, registered in-house counsel in the state of California; and admitted to practice in the states of New Jersey and New York, and before the Supreme Court of the United States, the Court of Appeals for the Federal Circuit, and the Federal District Courts of New Jersey, and the Southern and Eastern Districts of New York.


Brent Yamashita is a partner at DLA Piper LLP (US) in its Silicon Valley Office.  He is a patent litigator and prosecutor, with experience in mobile devices, computer hardware and software, semiconductors, storage systems and devices, communication systems and networking.

Brent has tried numerous patent cases in the ITC and district court and has argued many claim construction hearings.  Brent also prepares and prosecutes patents and has handled numerous inter partes review (IPR) proceedings before the US Patent Office, including appearing as lead counsel at IPR hearings.

Brent has a B.S.E. degree in electrical engineering from Princeton and a J.D. from UC Berkeley and is a registered patent attorney.


Dana Rao is the Vice President of Intellectual Property and Litigation at Adobe Systems. He oversees all aspects of Adobe’s intellectual property and litigation matters, including procuring, licensing, and defending Adobe’s patents, trademarks, and copyrights, and managing all aspects of Adobe’s litigation practice.

Before Adobe, Dana was an Associate General Counsel of Patents at Microsoft Corporation, focusing on their Windows Phone and Xbox patent issues. Dana began his legal career at Fenwick & West, focusing on patent prosecution, licensing, and litigation. Dana received his undergraduate degree from Villanova University in Electrical Engineering, and received his law degree from The George Washington University School of Law, where he graduated Order of the Coif.


Kate Gaudry, Ph.D., is a partner at Kilpatrick Townsend & Stockton LLP. She focuses her practice on patent prosecution and counseling, with an emphasis on software, computer systems, and quantitative biology. Dr. Gaudry also routinely performs statistical analysis of clients’ patent portfolios to identify effective prosecution strategies. Further, Dr. Gaudry regularly empirically evaluates programs and performance of the United States Patent and Trademark Office so as to provide her clients with prosecution recommendations and to advocate for compact and fair examination. Her publications are representative of such efforts.

Dr. Gaudry’s scientific training spans the fields of biology, mathematics, physics, and computer science. Her experience is particularly strong in applications spanning multiple fields. Dr. Gaudry performed her undergraduate work at Fort Hays State University (magna cum laude), while participating in summer research projects at Los Alamos National Laboratory. Dr. Gaudry then completed her Ph.D. in computational neurobiology at the University of California, San Diego. After working for two years as a patent scientist, she then pursued and completed her J.D. from Harvard Law School (cum laude).

Dr. Gaudry is admitted to the bars in the State of Colorado and in Washington, D.C. She is also a registered patent practitioner at the United States Patent and Trademark Office.


Leslie Spencer, co-chair of the firm's diversity committee, is a partner in the IP litigation practice. She works with clients on intellectual property matters involving software, networking, security, financial technology (“FinTech”) and other emerging technologies. She has over 15 years of experience litigating patent disputes in district courts, including through Markman hearing, trial and appeal to the U.S. Court of Appeals for the Federal Circuit. She is a registered patent attorney, and appears before the Patent Trial and Appeal Board. Leslie also counsels clients regarding IP asset protection, IP transactions and freedom-to-operate opinions.

Prior to practicing law, Leslie worked for financial services and e-commerce companies, and supervised the development of a smart card-based secure transaction system.


Mark Lemley is the William H. Neukom Professor of Law at Stanford Law School and the Director of the Stanford Program in Law, Science and Technology. He teaches intellectual property, computer and internet law, patent law, trademark law, antitrust and remedies. He is the author of seven books (most in multiple editions) and 144 articles on these and related subjects, including the two-volume treatise IP and Antitrust. His works have been cited nearly 200 times by courts, including ten United States Supreme Court opinions and almost 13,000 times in books and law review articles, making him one of the five most cited legal scholars of all time. He has published 9 of the 100 most-cited law review articles of the last twenty years, more than any other scholar and a 2012 empirical study named him the most relevant law professor in the country. His articles have appeared in 22 of the top 25 law reviews and in multiple peer- reviewed and specialty journals. They have been reprinted throughout the world and translated into Chinese, Japanese, Korean, Spanish, Italian and Danish. He has taught intellectual property law to federal and state judges at numerous Federal Judicial Center and ABA programs, has testified seven times before Congress and has filed numerous amicus briefs before the U.S. Supreme Court, the California Supreme Court and the federal circuit courts of appeals.

Mark is a founding partner of Durie Tangri LLP. He litigates and counsels clients in all areas of intellectual property, antitrust, and internet law. He has argued 17 federal appellate cases and numerous district court cases as well as in the California Supreme Court, and represented clients including Comcast, Genentech, DISH Network, Google, Grokster, Guidewire, Hummer Winblad, NetFlix, and the University of Colorado Foundation in over 90 cases in his more than two decades as lawyer.

Mark is a founder and board member of Lex Machina, Inc., a startup company providing data and analytics around IP disputes to law firms, companies, courts and policymakers.

Mark has been named California Lawyer’s Attorney of the Year (2005), Best Lawyers’ San Francisco IP Lawyer of the Year (2010) and a Young Global Leader by the Davos World Economic Forum (2007). In 2009 he received the California State Bar’s inaugural IP Vanguard Award. In 2002 he was chosen as Boalt’s Young Alumnus of the Year. He has been recognized as one of the top 50 litigators in the country under 45 by the American Lawyer (2007), one of the 100 most influential lawyers in the nation by the National Law Journal (2006 and 2013), one of the 10 most admired attorneys in IP (2010) by IP360, one of the 25 most influential people in IP (2010) by the American Lawyer, among other honors. He is a member of the American Law Institute. In 2014 he was inducted by Intellectual Asset Management into the IP Hall of Fame, which honors those who have helped to establish intellectual property as one of the key business assets of the 21st century.

Mark clerked for Judge Dorothy Nelson on the United States Court of Appeals for the Ninth Circuit and has practiced law in Silicon Valley with Brown & Bain and with Fish & Richardson and in San Francisco with Keker & Van Nest. Until January 2000, he was the Marrs McLean Professor of Law at the University of Texas School of Law, and until June 2004 he was the Elizabeth Josselyn Boalt Professor of Law at the Boalt Hall School of Law, University of California at Berkeley. In his spare time, Mark enjoys cooking, travel, yoga and feeding his addiction to video games (at this writing, Dragon Age: Inquisition).


Matt Sarboraria is Vice President and Associate General Counsel at Oracle Corporation, where he leads the company’s Patent, Trademark and Copyright group.  His team is responsible for developing and implementing strategies and policies for identifying, protecting, and managing the company’s intellectual property.  His practice includes patent prosecution and portfolio management, IP licensing, litigation support, M&A support, and copyright, trademark and brand management.  He is actively involved in IP policy initiatives on Oracle’s behalf.  He serves as a board member or advisor to several IP-focused industry associations.

Prior to his current position, Mr. Sarboraria served as Managing Patent Counsel in Oracle’s Litigation group, where his practice focused on IP disputes and related licensing matters.

Before joining Oracle in 2006, Mr. Sarboraria was in private practice at Weil, Gotshal & Manges LLP, where he focused on IP litigation.  He has litigated cases throughout the country involving a wide variety of technologies, including database, middleware and application software, semiconductors, computer networking, and telecommunications equipment.  He earned his undergraduate degree from U.C. Berkeley and his J.D. from U.C. Berkeley’s Boalt Hall School of Law. 


Professor David Hricik received his undergraduate degree magna cum laude and Phi Beta Kappa from the University of Arizona, where he majored in English.  He received his law degree with honors from Northwestern University School of Law.  He practiced with Baker Botts and small litigation boutiques from 1988 to 2002, litigating cases primarily involving patent infringement, legal malpractice, and general complex commercial matters. 

In 2002, he joined Mercer University School of Law, where he teaches legal ethics, patent law and litigation, federal civil procedure, and other courses.  In 2012-13, he served as law clerk to Chief Judge Randall R. Rader at the Federal Circuit.  He rejoined Mercer and also became Of Counsel to Taylor English Duma, LLP, where he continues to represent clients in patent and complex litigation.

He was elected to the American Law Institute in 2016.  He has authored the only treatise on ethical issues in patent litigation, and co-authored the only treatise on ethical issues in patent prosecution.  In addition to serving leadership positions on ethics committees with the AIPLA and ABA and serving as an expert witness, he has written dozens of articles and given well over 100 presentations on issues at the intersection of ethics and patents.  His articles and testimony have been adopted by both state and federal courts.


Rob Glance is SVP & Senior Company Counsel with Wells Fargo & Company.  He advises Wells Fargo with respect to intellectual property matters, including the development and maintenance of a patent strategy for Wells Fargo.  Mr. Glance advises on all aspects of patent and trade secret matters.  He assists the business units in evaluating their technology with respect to intellectual property best practices.  Additionally, he frequently conducts training and educational sessions on the importance of intellectual property to financial services companies.

Prior to joining Wells Fargo, Mr. Glance was in private practice and was also associate general counsel at Fannie Mae in Washington, DC.  At Fannie Mae, he was responsible for patent and other intellectual property matters.  Mr. Glance is a member of the bars of New York, Minnesota, and Pennsylvania, and he is a registered patent attorney with the U.S. Patent & Trademark Office.  He graduated cum laude with a J.D. from Cornell Law School and has a B.S. in Systems Engineering from the University of Virginia and a Masters in Engineering from the University of Maryland.


Scott Alter is an experienced intellectual property attorney whose practice focuses on software, electronics, internet, telecommunications, cloud computing, medical device, financial, and semiconductor technologies. A skilled global patent strategist, he also has significant expertise in patent eligibility, joint and indirect infringement, and indefiniteness. In every matter he handles, Scott strives to obtain practical results for his clients.

Scott has served as an expert witness in litigation concerning data encryption technology. Before becoming a lawyer, he worked at IBM as a LAN systems developer and computer programmer. Prior to joining the firm, Scott was a partner in the Colorado office of a national IP law firm.


Thomas Franklin focuses his practice on patent prosecution, licensing and intellectual capital management with more than 20 years of experience with intellectual property. He is experienced in intellectual property audits, due diligence and strategic planning processes. Through an IP Asset Management plan, he tailors strategy to business goals, competitive pressures and funding constraints to leverage intangible assets with intellectual property. He uses IP protection to maintain the dominance of large companies or assist smaller enterprises who are vying to dominate. Recognized by Chambers USA, sources noted Mr. Franklin as “a brilliant and intelligent attorney who knows IP law inside out.”

Mr. Franklin's technical experience broadly covers the areas of software, blockchain technology, Internet technology, content delivery, business methods, clean technology, circuit design, imaging arrays, cryptographic design, telecommunications, electronic design tools, wireless communications, networking and telemetry systems.

Prior to entering the field of law, Mr. Franklin spent nine years working in semiconductor fabrication facilities at the Naval Ocean Systems Center and Hughes Aircraft and several more as a senior engineer for Lockheed Martin. At Lockheed, he managed engineering projects involving the design of complex wireless data links, ASIC/FPGA design, digital circuits, satellite transponders, and encrypted data links.

Mr. Franklin has been recognized by Chambers USA in 2016, 2017 and 2018. He was listed by The Best Lawyers in America® in 2018 and the three years immediately preceding for patent law. He was recognized as an “IP Star” in 2015, 2016 and 2017 by Managing Intellectual Propertymagazine. Mr. Franklin is a recipient of the 2016 Client Choice Award USA & Canada from Lexology and the International Law Office. He was recognized as a top patent practitioner in 2017 and the four years immediately preceding by IAM Patent 1000. In 2017 and 2018, Mr. Franklin was listed in the IAM Strategy 300: The World's Leading IP Strategists. He was recognized as a Colorado “Super Lawyer” in 2018 and the four years immediately preceding for intellectual property by Super Lawyers magazine. The San Diego State University Alumni Association recognized and honored him with the 2014 Distinguished Alumni Award from the College of Engineering. Mr. Franklin was named a Lawyer of the Year in 2012 by Law Week Colorado. He was honored along with other Colorado Bar IP Section members, for their successful effort to bring a patent office to Denver. He was the project lead on the team that helped Denver become one of only four cities to land a new U.S. Patent and Trademark Office. He worked countless hours to fulfill his vision of multiple patent offices to improve patent quality through multiple offices that can hire the brightest and best examiners.


As an Intellectual Property litigation attorney with more than 20 years’ experience, Jon is adept in handling complex legal issues and challenging logistics.

He concentrates on patent litigation, devising winning strategies that give his clients competitive advantages in the marketplace. He has established a record of success at both the trial stage and with appeals before the U.S. Court of Appeals for the Federal Circuit, prevailing in all but one of the Federal Circuit appeals he controlled (9:1).

Jon works on behalf of clients in a variety of industries, including telecommunications, software, electronics, manufacturing, and mining. Clients appreciate Jon’s strong analytical skills and his ability to translate elaborate, intricate concepts and technologies into a clear and compelling narrative. Jon also advises businesses on portfolio management and monetization.

Prior to joining the firm, Jon was a partner in the Colorado branch of a noted U.S. patent litigation firm. Earlier in his legal career, he was an associate at a global IP specialty firm and served as a law clerk for the Honorable Randall R. Radar at the Court of Appeals for the Federal Circuit.


As the Regional Director of the West Coast United States Patent and Trademark Office (USPTO), John Cabeca carries out the strategic direction of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, and is responsible for establishing and leading the USPTO's west coast regional office located in Silicon Valley. Focusing on the region and actively engaging with the community, Mr. Cabeca ensures the USPTO’s initiatives and programs are tailored to the region's unique ecosystem of industries and stakeholders.

A veteran of the U.S. Patent and Trademark Office for over 26 years, Mr. Cabeca previously served as the Senior Advisor to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO. In this role, he worked closely across the Agency's leadership to implement the policies and priorities for the USPTO. He began his career at the USPTO as a patent examiner after graduating from Widener University with a bachelor's degree in electrical engineering. Mr. Cabeca became a Supervisory Patent Examiner in 1997 and joined the Senior Executive Service in 2008 serving as a Patent Technology Center Director over the semiconductor and electrical systems technologies.

Mr. Cabeca has dedicated much of his career to the USPTO's outreach and education programs focusing on small businesses, startups and entrepreneurs. Over the years, he served in the Office of Petitions, the Office of Patent Legal Administration, the Office of Governmental Affairs and the Office of the Under Secretary. In 2006, Mr. Cabeca was appointed a Department of Commerce Science and Technology Fellow and served on special assignment to the Executive Office of the President in the United States Trade Representative's Office.  At USTR, he worked with multiple agencies on a variety of international intellectual property rights issues and played an integral role in the Free Trade Agreement negotiations with the Republic of Korea.


Since January 3, 2007 when he retired from the USPTO, Robert (Bob) Spar has been actively providing advice, consultation and training services to the patent bar about patent practices and Office procedures, including, in particular, about recent examination related notices/initiatives, and proposed/final rule changes by the USPTO. He has provided such specialized consultant services via presentations and training workshops, with follow-up e-mails, to patent intellectual property organizations, individual attorneys, patent departments of major corporations and leading patent law firms; and to the patent community in general via presentations at Annual Patent Law conferences and telephonic Hot Topic Briefing webinars for the PLI. He has taught for the PLI in its bar review course, its program on Reissue and Reexamination Strategies and Tactics with Concurrent Litigation, and in its annual PLI programs on prior art/35 USC 102/103.  He also served as an expert witness in patent litigation matters, and provided legal and technical consultation services on reissues, reexamination requests, and patent procedures, practices and issues.

Prior to his retirement on January 3, 2007, Bob had nearly 40 years of service at the USPTO. For the last 11 years, Bob was the Director of the Office of Patent Legal Administration (OPLA, formerly SPLO), under the Deputy Commissioner for Patent Examination Policy. Bob, with OPLA, played a significant and leading role in developing and implementing many major Office rule makings and policy initiatives involving the patent process, and greatly affecting the patent corps and all patent practitioners.

During his tenure in the Office, Bob served in a number of capacities in Patents, holding the titles of Primary Examiner, Supervisory Patent Examiner (SPE), and Special Programs Examiner (SPRE); serving on details to the Solicitor’s Office, the Board of Appeals and Interferences; and in 1978, he was selected for a 1 year Commerce Science and Technology Fellowship to the White House.

He taught extensively at the Patent Academy (including numerous patent examiner initial training (PEIT) sessions, and on 35 U.S.C. 103 – Obviousness); he made many training and informational presentations to examiners, technical support staff, and top patents management; and he made a large number of presentations on proposed, existing and revised PTO practices and policies to state and city patent bar organizations, at conferences of intellectual property organizations, and for the PLI. He helped to create the Form Paragraph manual of the Manual of Patent Examining Procedure (MPEP), and served as its editor for many years.

He received a BME from Rensselaer Polytechnic Institute in 1962, a LLB from University of Baltimore in 1969, is a member of the Maryland Bar, AIPLA (a member of the Rules Sub-Committee), and is admitted to the CAFC.


When a leading consumer products company wanted to establish a world class program to globally protect what has become one of the most iconic designs in the world, it hired Tracy Durkin of Sterne Kessler Goldstein & Fox, an IP law firm based in Washington, DC. Tracy Durkin has a well-earned reputation for excellence in design patent law. In 2015, Intellectual Asset Management noted in their annual "IAM 1000" ranking that Ms. Durkin is "without a doubt the country's leading authority on design patents." Tracy melds nearly 30 years of experience obtaining and enforcing design and utility patents, trademarks, trade dress and copyrights to create unique IP protection strategies to meet her clients' individual needs. 

Recognized as one of the leading prosecution and strategy attorneys in Washington, DC, Tracy is particularly noted for her "smart, responsive, and value-oriented" approach, as well as her "knowledge of design patents, brand development strategies and eliminating copycat consumer products from the marketplace to prevent the devaluation of IP rights” (World Trademark Review 1000, 2014).

In addition to her work before the U.S. Patent & Trademark Office (USPTO), Tracy has served as an expert witness and technical advisor to the court in patent disputes in district court litigation and before the International Trade Commission on the issues of design patents and USPTO practice and procedures.

Tracy has achieved a Martindale AV Preeminent Peer Rating of 5 out of 5, recognition fewer than 5% of women lawyers have achieved, and was recently named to Managing Intellectual Property's "Top 250 Women in IP."

Active in community and bar service, she is a past president of the Women's Bar Association of the District of Columbia and The Women's Bar Association Foundation; she is currently Vice-Chair of the Industrial Design committee of the American Bar Association and has held leadership positions in the American Intellectual Property Law Association and the Intellectual Property Owners association.


Brian E. Hanlon is the Director of the Office of Patent Legal Administration (OPLA) at the United States Patent and Trademark Office (USPTO).  Prior to taking his current position, Mr. Hanlon served as the acting Chief of Staff for Under Secretary of Commerce for Intellectual Property and Director of the USPTO, David J. Kappos, and served as the Director of Strategic Planning and Management Council for Under Secretary and Director Jon W. Dudas and acting Under Secretary and Director John J. Doll.  Prior to his work in the Under Secretary’s Office, Mr. Hanlon was the Deputy Director of OPLA.  Mr. Hanlon was also a shareholder at the law firm of Banner & Witcoff, Ltd. where his practice focused on patent prosecution and client counseling on issues relating to both procurement and enforcement of utility and design patents.  Mr. Hanlon began his career as a patent examiner at the USPTO in former Group 3300, now TC 3700.  He received a Bachelor of Science in Mechanical Engineering with Honors from Worcester Polytechnic Institute, and a J.D., Magna Cum Laude, from the Catholic University of America, Columbus School of Law.  Mr. Hanlon is a member of the Bars of Maryland, the District of Columbia, and the United States Supreme Court.


Craig McRobbie works directly with inventors to prepare patent applications in the areas of biotechnology, biochemistry, organic chemistry, inorganic chemistry, pharmaceutical chemistry and biology. Mr. McRobbie prosecutes patent applications including corresponding with clients and preparing replies to all USPTO correspondence. Mr. McRobbie handles cases before the USPTO Patent Trial and Appeal Board, and prepares patentability, non-infringement, validity and freedom-to-operate opinions.

Mr. McRobbie has experience with PCT and foreign national stage prosecution of patents on behalf of clients and counsels clients on international patent portfolios. He has practiced in the intellectual property field since 1996, specializing in chemistry and biotechnology.

Mr. McRobbie graduated from McMaster University in 1996, after which he obtained a degree from the George Mason University School of Law in 2002 where he was the recipient of the Giles S. Rich Intellectual Property Award. He passed the bar in Virginia in 2003 and is registered to practice before the USPTO. He is involved with the American Bar Association and the American Intellectual Property Law Association. Mr. McRobbie has presented at various venues including the Norwegian Patent Office (Patentstyret), the Swedish Patent Office (PRV), and the PLI Patent Law Institute. He has also taught a course for the Japan Intellectual Property Association (JIPA).


David Dutcher currently serves as Assistant General Counsel, Intellectual Property at Western Digital Corporation, where he leads a patent team of 19 professionals and is responsible for WD’s portfolio of 17,000+ patent assets. David is also an Adjunct Professor at the J. Reuben Clark Law School at Brigham Young University.  Prior to WD's acquisition of SanDisk, David served as Senior Director, IP at SanDisk, and prior to SanDisk's acquisition of Fusion-io, David served as Associate General Counsel and Vice President, Intellectual Property, at Fusion-io.  David joined Fusion-io from Intellectual Ventures, where he served as Head of Prosecution and Asset Management.  Prior to Intellectual Ventures, David was an attorney at Perkins Coie in Seattle.  David received his J.D. degree from Harvard Law School and his bachelor’s degree in mechanical engineering, summa cum laude, from Brigham Young University.


Tim Goodson is an Administrative Patent Judge at the Patent Trial and Appeal Board in the Silicon Valley office. He studied Mechanical Engineering at North Carolina State University and attended law school at the University of North Carolina School of Law. Before joining the PTAB in 2014, Judge Goodson worked as a patent litigator and prosecutor at Knobbe, Martens, Olson & Bear LLP.


As Senior Counsel, Intellectual Property, at Gilead Sciences in Foster City, California. MJ is responsible for developing strategies to support Gilead’s commercial products worldwide, patent drafting and prosecution to support research and development programs, and for patent surveillance / diligence investigations. She has negotiated intellectual property provisions of agreements related to research and clinical collaborations, as well as in-licensing of intellectual property assets. Prior to joining Gilead Sciences in 2012, MJ was Senior Counsel in the Intellectual Property department of WilmerHale in Boston and worked as a scientist at Eli Elly and Company. In her previous work, MJ represented clients in patent litigation in the areas of pharmaceuticals and medical devices, including ANDA litigation.