Overview
FDA and USPTO have initiated collaboration efforts following the issuance of Executive Order No. 14036, Promoting Competition in the American Economy, encouraging coordination among agencies with overlapping jurisdiction over industries. Earlier this year a joint USPTO-FDA Public Listening Session on Collaboration Initiatives was held to obtain public input on the PTO’s proposed initiatives to foster coordination between the agencies, enhance meaningful innovation in medical product development, and support a competitive marketplace to promote product access and affordability to the public. Panelists will discuss concerns and suggestions raised at this forum and opine on the changing landscape of innovation for industry and progress towards interagency coordination.
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Speakers
Linda E. Horner, Acting Senior Lead Administrative Patent Judge, USPTO
Maarika L. Kimbrell, Partner, Morgan, Lewis & Bockius LLP
George O’Brien, Partner, Mayer Brown LLP
Arti Rai, Elvin R. Latty Professor of Law and Faculty Director, The Center for Innovation Policy, Duke Law
Jay Sitlani, Regulatory Counsel, Office of Regulatory Policy, FDA
Moderated by Brian J. Malkin, Associate General Counsel, TEVA Pharmaceuticals USA, Inc
BRIAN J. MALKIN is an Associate Counsel at Teva Pharmaceutical Industries (“Teva”) where he supports Research and Development (R&D), Regulatory Affairs (RA), Commercial, Quality, and other client groups by counseling on FDA regulatory law and strategy including expedited development pathways, labeling and safety issues, and pre-and post-approval development challenges. Brian serves as a Center of Excellence in regulatory law, including on issues arising under the FDCA, PHSA, BPCIA, PREA, BPCA, the Hatch-Waxman Act, the Orphan Drug Act, the User Fee Acts, and other laws. Brian represents Teva in informal and formal dispute resolution and litigation and develop advocacy strategies, submissions, appeals, and correspondence. Brian sits on R&D project teams across therapeutic areas to advise on legal and regulatory issues and post-approval developments for innovative and biosimilar pharmaceutical products. Brian develops and maintains relationships with health authorities, external facing organizations, trade associations, and pharmaceutical industry counterparts. Brian provides training for RA, R&D, and commercial functions on FDA legal and regulatory issues. Brian has more than 30 years of FDA law and policy experience and over 20 years intellectual property law experience, including 9 years at the FDA (Office of the Commissioner and the Center for Drug Evaluation) and a number of boutique FDA and IP and international law firms in associate and partner capacities, where his practice focused on generic/biosimilar pharmaceutical, innovative/hybrid and biologic products, including medical devices and other FDA-regulated products. Brian has also supported the pharmaceutical and biotechnology community by mentoring pharmaceutical and biotechnology companies (e.g., MassChallenge) and serving as an adjunct professor at a variety of masters and legal programs in addition to being a frequent speaker at professional conferences and training programs. Brian am an Executive Committee member of the New York State Bar Association’s Food, Drug and Cosmetic Law Section and the Co-Chair of the Intellectual Property Community (Section) for the DC Bar Association.
GEORGE A. O’BRIEN is a partner in Mayer Brown’s FDA Regulatory practice, resident in the Washington DC office. He works with life sciences companies of all sizes to assist them in developing and marketing innovative drug and biologicals products. George has deep experience providing regulatory advice to pharmaceutical and biotech companies on lifecycle management issues, including regulatory exclusivities, orphan drug issues, and FDA-facing patent issues.
ARTI RAI, Elvin R. Latty Professor of Law and Faculty Director, The Center for Innovation Policy at Duke Law, is an internationally recognized expert in intellectual property (IP) law, innovation policy, administrative law, and health law. Rai’s extensive research on these subjects has been funded by NIH, NSF, Arnold Ventures, the Kauffman Foundation, the Greenwall Foundation, and the Woodrow Wilson Center. Her numerous publications have appeared in both peer-reviewed journals and law reviews. Peer reviewed journals include Science, the New England Journal of Medicine, JAMA, the Journal of Legal Studies, Nature Biotechnology, and the Journal of Law and the Biosciences. From March to December 2021, Rai served as Senior Advisor on innovation law and policy issues to the Department of Commerce’s Office of General Counsel. She also regularly advises other federal and state agencies as well as Congress on these issues. She is a member of multiple distinguished councils, including the National Academies’ Forum on Drug Discovery, Development, and Translation, the Polaris Advisory Council to the Government Accountability Office, and the American Law Institute. She has also served as a member of the National Advisory Council for Human Genome Research, as a public member of the Administrative Conference of the United States, and on numerous National Academies committees. From 2009-2010, Rai headed the Office of Policy and International Affairs at the U.S. Patent and Trademark Office (USPTO). In that capacity, she led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish the USPTO’s Office of the Chief Economist. Prior to entering academia, Rai clerked in the Northern District of California and was a litigator at Jenner & Block and the Department of Justice. Rai graduated from Harvard College, magna cum laude, with a degree in biochemistry and history (history and science), attended Harvard Medical School for the 1987-1988 academic year, and received her J.D., cum laude, from Harvard Law School in 1991.
JAY SITLANI, JD, is a Senior Regulatory Counsel in the Office of Regulatory Policy in the Center for Drug Evaluation and Research (CDER) at FDA. Jay’s practice during his 14-year FDA tenure has focused on various aspects of the Hatch Waxman amendments to the Food, Drug, and Cosmetic Act, and the Biologics Price Competition and Innovation Act. Prior to FDA, Jay practiced as an attorney in Washington, D.C., where he advised clients on Hatch Waxman and and intellectual property issues as they related to the patentability of inventions in the life sciences. Virtual Learning FAQ
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