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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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FERNANDEZ, Dennis S
Dennis Fernandez has over 20 years’ experience in Silicon Valley and high-tech industry as a patent prosecutor and intellectual property litigator, a venture capitalist, and an engineering manager. He specializes in developing offensive and defensive patent strategies for start-up electronics, software, and biotech companies and their investors. Mr. Fernandez serves as strategic advisor to leading venture capital firms, including Sevin Rosen, Venrock, Charles River Ventures, and Walden International. Some of his clients include Marvell Technology, SiRF Technology, Ayala Corporation, Stanford University, and Northwestern University, as well as various start-up companies acquired by Cisco, Broadcom, Ciena, and Cadence Design Systems. He also serves on the Editorial Board of the Nanotechnology Law & Business Journal, the Board of Directors of the Association of Patent Law Firms, and the Science and Technology Advisory Council. Previously, Dennis served on a consultancy with the United Nations Development Programme on Asian economic development.
Mr. Fernandez also holds several U.S. and international patents in the areas of digital television, sensor networks, and bioinformatics. He has an electrical engineering degree from Northwestern University, a law degree from Suffolk University Law School, and is a Registered U.S. Patent Attorney.
Abstract
The Interface of Patents with the Regulatory Drug Approval Process and How Resulting Interplay Can Affect Market Entry
Abstract:
All biotechnology and pharmaceutical products must be approved by both the U.S. Patent and Trademark Office (PTO) and the U.S. Food and Drug Administration (FDA). To maximize the impact of a product’s market exclusivity, the time spent on getting approval should be minimized. This chapter discusses how the interplay between PTO and FDA applications affect the patent approval process, and by extension the patent term, and how these impact the commercial life of a product.
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