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Developments in Pharmaceutical and Biotech Patent Law 2019

Speaker(s): Andrew K. Holmes, Ph.D., Benjamin C. Hsing, Bo Han, Daniel L. Reisner, David K. Barr, Jane M. Love, Ph.D., Leslie Fischer, Ph.D., Margaret Bolce Brivanlou, Ph.D., Sanjay K. Murthy, Shilpi A. Banerjee, Ph.D.
Recorded on: Oct. 18, 2019
PLI Program #: 252837

Ben Hsing is an accomplished trial lawyer with significant experience litigating patents across a broad range of technologies, including pharmaceutical compounds and formulations, telecommunication cables, treatment methods, genetically engineered seeds, medical devices, memory chips, light switches, imaging devices, and pet products. Ben has secured favorable results for major pharmaceutical and technology companies in numerous high-profile cases.

Ben regularly calls upon his experience as a patent examiner to provide comprehensive counsel to clients on matters before the U.S. Patent and Trademark Office (USPTO), including post-grant and contested patent office proceedings. He also conducts intellectual property (IP) due diligence investigations in connection with acquisitions and licensing deals. He is deeply involved in his clients’ matters, ensuring that he understands all aspects of their businesses and cases so that he can identify, dissect, and solve potential challenges facing his clients.

Daniel Reisner focuses his practice on intellectual property, with emphasis on biotechnology, pharmaceuticals, medical devices, telecommunications and networking.

Mr. Reisner has represented numerous large and small companies through trial involving companies' most important products including Sanofi, Regeneron, Pfizer, Novartis, Medicalgorithmics, Charter Communications and Amazon.  His experience includes representing plaintiffs and defendants in both jury and bench trials, ANDA litigation and arbitration proceedings, as well as IP due diligence and transactional matters.

David K. Barr concentrates in the areas of patent, trade secret, and unfair competition litigation and counseling. Mr. Barr's experience includes litigation in federal and state courts, appeals to the Federal Circuit Court of Appeals and practice before the US Patent and Trademark Office, including contentious inter partes proceedings. Mr. Barr has been lead trial counsel in many complex Hatch-Waxman and biotech patent infringement cases, and has counseled clients on product development and strategic patent planning. He has extensive experience in intellectual property transactions, including licenses and acquisitions. Mr. Barr has also conducted numerous patent due diligence investigations, and has drafted patent license and related agreements. His patent matters have involved a variety of technologies, including biotechnology, pharmaceuticals, industrial chemistry and biomedical and mechanical devices.

Mr. Barr has authored articles and has lectured on a variety of intellectual property issues. He is a co-author and co-editor of the treatise Pharmaceutical and Biotech Patent Law (Practising Law Institute, 2016).

Mr. Barr received his law degree from the George Washington University Law School, where he was an Associate Editor of the George Washington Journal of International Law and Economics.

Dr. Leslie Fischer, Ph.D., J.D. is a Principal Patent Attorney at Sandoz Inc. in Princeton, NJ.  She focuses on global biosimilar development, including freedom to operate, patent clearance, regulatory exclusivity, contractual negotiations, and due diligences.  Dr. Fischer also teaches mechanical patent claim drafting as an adjunct professor of law at Seton Hall Law School, in Newark, NJ. 

Prior to joining the Novartis Group in 2007, Dr. Fischer was an associate attorney at Fitzpatrick, Cella, Harper and Scinto in New York, during which time she provided detailed opinion work for a broad range of clients, consulted on biotechnology litigation, and performed pharmaceutical and biotechnology patent prosecution.

Dr. Fischer holds a J.D. from Rutgers University, and a Ph.D. in Biochemistry from Thomas Jefferson University in Philadelphia. Her Ph.D. thesis focused on the interaction of Bone Morphogenetic Proteins and Wnts during mouse limb development, with her work appearing in Osteoarthritis and Cartilage, the Journal of Cellular Biochemistry, and the Journal of Biological Chemistry.

Dr. Fischer has appeared as a speaker and panelist in numerous public forums, and for the past seven years, she has also acted as co-chair of American Conference Institute’s “Advanced Summit on Life Sciences Patents" meeting, which is held yearly in New York, NY.

Drew Holmes is currently a Patent Attorney at Novartis Pharmaceuticals Corporation in New Jersey, where he is a member of the Neuroscience/Ophthalmics Team. 

Drew holds a Bachelor of Science in Microbiology from the University of Miami (Florida) and a Ph.D. in Microbiology and Molecular Genetics from Rutgers University and the University of Medicine & Dentistry of New Jersey. He received his law degree from the Fordham University Law School in New York City and is licensed to practice in New York, Connecticut, New Jersey (special limited license for in-house counsel) and before the United States Patent and Trademark Office.

Prior to joining Novartis, Drew was in private practice at Darby & Darby, P.C., an IP boutique based in New York City, where he handled prosecution, opinion, and litigation matters. His previous experience includes one year as a litigator with Greenberg Traurig in New York, and four years at Fish & Neave, also in New York, where he handled prosecution, opinion, and litigation matters.

At Novartis, Drew has a broad-based intellectual property practice involving litigation, patent counseling and procurement, and transactional matters.  Drew provides patent counseling in the areas of chemistry, biology, biotechnology, biochemistry, molecular biology, immunology, and virology.  Drew also manages Neuroscience due diligence inquiries on behalf of the Legal Intellectual Property Department.

Jane M. Love, Ph.D. is a partner and Chair of the Life Sciences Practice of Gibson, Dunn & Crutcher.  Her practice spans four areas: patent litigation, U.S. Patent Office PTAB proceedings and appeals, strategic patent prosecution advice, and intellectual property diligence in transactions.

Dr. Love has extensive experience in pharmaceutical and biologics patent issues, including Abbreviated New Drug Application (ANDA) litigation, Biologics Price Competition and Innovation Act of 2009 (BPCIA) biosimilar litigation issues, and PTO Inter Partes Reviews under the America Invents Act (AIA).  Dr. Love has coordinated global litigation of patents worldwide.

Dr. Love is experienced in a wide array of life sciences areas such as pharmaceuticals, biologics, biosimilars, antibodies, immunotherapies, genetics, vaccines, protein therapies, blood factors, medical devices, diagnostics, gene therapies, RNA therapies, bioinformatics and nanotechnology.  She is a patent attorney registered to practice before the U.S. Patent and Trademark Office and has prosecuted hundreds of patent applications.

Dr. Love writes and speaks extensively on intellectual property issues.  She is consistently named an “IP Star” by Managing IP.  Dr. Love was named in Legal Media Group’s Expert Guides 2017 Guide to the World’s Leading Women in Business Law for Patents, a “Life Sciences Star” for Intellectual Property by LMG Life Sciences, and a “Life Sciences MVP” by Law360.  She was named one of the “Top 250 Women in IP” by Managing IP in its four most recent lists and was named one of the IP attorneys in the “Top 50 Under 45” list by IP Law & Business in 2008.

Before joining Gibson Dunn, Dr. Love was the Co-Vice Chair of the Intellectual Property Department of Wilmer Hale and associated with that firm in New York since 2001. 

For seven years before that, Dr. Love practiced in an IP boutique law firm in New York.

Dr. Love has a Ph.D. in molecular biology from the University of Pennsylvania.  She also obtained an undergraduate degree in Biology and a minor in English from U. Penn.

Dr. Love conducted post-doctoral research at the University of Pennsylvania and Thomas Jefferson Medical School in Philadelphia. 

She also worked for two years as a post-doctoral fellow at Cornell University Weill Medical College in New York City in molecular biology, pharmacology and cell and developmental biology. 

She served as a Captain in the U.S. Army Reserve Medical Service Corp from 1991 to 1997.

Dr. Love received a Juris Doctor from Fordham University School of Law. 

Peg Brivanlou is a Partner in King & Spalding’s Intellectual Property, Patent, Trademark and Copyright Litigation practice, specializing in patent prosecution, client counseling, due diligence and patent litigation.  Peg represents clients in the biotechnology and pharmaceutical industries, and investment funds in a variety of intellectual property matters.

With a focus on biologics and small molecule therapeutics, Peg counsels clients regarding immunotherapeutics, cell-based assays and therapies, genomics, bioinformatics, vaccines and small molecule pharmaceuticals. She is experienced in developing patent portfolios, particularly relating to biologics, antibody therapeutics and diagnostics. She also conducts patent invalidity, freedom-to-operate analyses and pre-litigation investigations, including for pre-Hatch-Waxman litigation, and strategizes post-grant proceedings.

In addition, Peg represents clients on the intellectual property aspects of a wide range of transactions, from technology transfer and out-licensing to multi-million-dollar asset purchases and financings. She conducts due diligence, and negotiates licensing and purchase agreements as well as disclosure documents in connection with public and private financings.

Peg is ranked in the 2019 IAM Patent 1000 Guide and is listed an IP Star in the 2018 and 2019 rankings of Managing Intellectual Property.

Sanjay K. Murthy is a partner in the Intellectual Property practice in the Chicago office of Banner Witcoff and a nationally recognized trial attorney with over 20 years of experience representing life science and technology companies in US District Courts, before the Patent Trial and Appeal Board, and in Section 337 investigations in the US International Trade Commission (ITC).  He has been identified as a leading practitioner by IAM Patent 1000, The Legal 500 and as a “Patent Star” by Managing Intellectual Property. He has also been recognized by The American Lawyer and Crain’s Chicago Business for his victories.

Sanjay has worked on a wide array of life science related technologies, such as pharmaceuticals, methods for manufacturing recombinant proteins, CAR-T and stem cells, and medical devices.  He has represented a number of leading pharmaceutical and medical device companies, such as GSK, Galvani Bioelectronics, Takeda, Boehringer Ingelheim, and Baxter, among others.

Sanjay received an LLM in intellectual property law from The George Washington University Law School, a J.D. from California Western School of Law, where he was a dean’s full-tuition scholarship recipient, and a B.S., Biology with a minor in Chemistry from Loyola University.

Shilpi Banerjee serves as Associate General Counsel and Chief Intellectual Property Counsel of Memorial Sloan Kettering Cancer Center (MSK). Her practice includes oversight of patent prosecution, agreements related to the research enterprise at MSK, including sponsored laboratory research and clinical research, as well as transactional, licensing and litigation matters related to MSK intellectual property.

Prior to joining MSK in 2013, Shilpi served as Counsel and Chair, Research and Education Practice Group, of the Cleveland Clinic, where her practice included counseling the Clinic’s technology commercialization and corporate venturing arm, supervising and advising on intellectual property matters, negotiating patent licenses and other IP agreements, as well as executing agreements related to the research enterprise. Before that, Shilpi spent several years in private practice at Ropes and Gray LLP (formerly Fish & Neave), and at Sidley Austin LLP, where her practice focused on prosection of biotechnology and pharmaceutical patents, and biopharma patent litigation.

Shilpi received a J.D. from Stanford Law School and a Ph.D. from the Department of Microbiology and Molecular Biology at the Tufts University School of Medicine, and is licensed to practice before the USPTO.  Shilpi’s scientific experience prior to law school included stints as Research Associate at Case Western Reserve University, and as Research Fellow at Caltech.  Her graduate and postdoctoral research focused on molecular and developmental neurobiology.

Bo Han is Senior Counsel of Intellectual Property (IP) at Bristol-Myers Squibb Company (BMS), a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.  As part of BMS’s biologics patent practice group, she handles the full scope of global biopharmaceutical patent issues, including strategically building and managing BMS’s biologics patent portfolio; counseling on patentability, validity, infringement, and freedom to operate issues; IP due diligence; IP-related transactional work; and patent enforcement.

Prior to joining BMS, Ms. Han practiced IP law for 8 years at WilmerHale LLP in Boston, MA.  She developed expertise in comprehensive global patent strategies and in strategic enforcement of patent rights for biopharmaceutical companies.  While in private practice, she was recognized as a “Massachusetts Super Lawyers’ Rising Star” in IP Law for three consecutive years.  Ms. Han has served as Biotechnology Committee Co-Chair, Patent Practice Committee Co-Chair, and Activities & Public Relations Chair of the Boston Patent Law Association.  As part of her pro bono practice, she has successfully represented political asylum clients in front of the U.S. Citizenship & Immigration Services.

Ms. Han obtained her J.D. from the New York University School of Law.  At NYU School of Law, she served as the Executive Editor of the NYU Journal of Legislation and Public Policy, and received the Walter J. Derenberg Prize for excellence in intellectual property law.  She obtained a B.S. in Biology, with highest honors and highest distinction, from the University of North Carolina at Chapel Hill, where she was a William Richardson Davie Scholar and a member of Phi Beta Kappa.  She recently obtained her Credential of Readiness Certificate on business fundamentals, with honors, from Harvard Business School Online.  She has also obtained a Certificate of Achievement in Immunology from HMX Fundamentals (Harvard Medical School online learning platform).