Topic: Panel Discussion on Biosimilars – Latest Intellectual Property and FDA Issues
Speakers: Douglas Carsten, Partner, Wilson Sonsini Goodrich & Rosati
Vicki G. Norton, Ph.D., Partner, Duane Morris,
Michael A. Swit, Senior Director, Legal, Regulatory at Illumina;
Date: Thursday, February 26, 6:00 pm
This was a lively and informative panel discussion focused on Biosimilars, and the latest issues in Intellectual Property law and FDA practice involving them.
Douglas Carsten, Partner, Wilson Sonsini Goodrich & Rosati
Vicki G. Norton, Ph.D., Partner, Duane Morris
Michael A. Swit, Senior Director, Legal, Regulatory at Illumina
Douglas Carsten is a partner in the San Diego office of Wilson Sonsini Goodrich & Rosati, where his practice focuses on complex patent litigation. His practice has involved patent litigation and counseling in a wide variety of technologies, including pharmaceuticals, medical and mechanical devices, biotechnology, and computer technologies. In particular, Doug has extensive experience representing generic drug companies in Hatch-Waxman patent litigation, as well as medical device and biotechnology companies in patent litigation matters. He also has experience in the analysis of patents and counseling clients on patent-related issues.
Vicki G. Norton, Ph.D., practices in the area of intellectual property law with a focus on biotechnology and chemical patent counseling and litigation. She also advises clients on worldwide patent strategy, including identifying patent coverage issues, auditing technology portfolios to assist clients in transactions and venture opportunities and formulating strategic objectives for prosecution. She has handled patent matters in a variety of industries, including biotechnology, biopharmaceuticals and small molecule pharmaceuticals, relating to engineering transgenic plants and cells, biochemistry, methods to screen and make gas-absorbing materials, stem cell technologies, molecular biology, nanotechnology, immunology, combinatorial chemistry, probe amplification assays, diagnostics, nutraceuticals, microbiology, and therapeutic drugs and devices for physical therapy. Dr. Norton has also advised clients on all facets of litigation involving technologies including biopharmaceuticals, transgenic organisms, small molecules and nanotechnology.
Prior to attending law school, Dr. Norton served as a research and teaching assistant at the University of California, Davis, where she conducted research on histone acetylation and chromatin structure for her doctoral thesis.
Dr. Norton is a 1994 graduate of the University of California, Los Angeles School of Law, where she was managing editor of the UCLA Law Review and elected to the Order of the Coif, and a graduate of the University of California, Davis (Ph.D., Biochemistry and Biophysics; B.S., summa cum laude, Biochemistry).
Michael A. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Illumina as its chief regulatory counsel in December 2014, Swit was a special counsel at the global law firm of Duane Morris LLP in its San Diego office. Prior to joining Duane Morris in March 2012, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries.
Mr. Swit’s multi-faceted experience includes serving for three and a half years as corporate vice president and general counsel of Par Pharmaceutical, a major publicly-traded generic drug manufacturer and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. While at Par, he spearheaded Par’s successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including directing a two-day intensive course on FDA regulation of advertising and promotion of the drug and medical device industries. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.
A magna cum laude graduate of Bowdoin College, with high honors in history, Mr. Swit received his law degree from Emory University School of Law.