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Your source for expert commentary on IP management issues.
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About
Editor-in-Chief, Anatole Krattiger
Editorial Board
Concept Foundation
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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HUIE, James T
James T. Huie earned his bachelor of arts degree in Molecular and Cell Biology, with an emphasis in Biochemistry, at the University of California, Berkeley. Subsequently, Mr. Huie obtained his law degree at Santa Clara University School of Law. During and after law school, Mr. Huie developed skills in patent prosecution at Fernandez & Associates, LLP. After some time in the patent field, Mr. Huie changed his focus to corporate practice within the venture capital industry. He has practiced in the Silicon Valley at such law firms as Greenberg Traurig, LLP and Wilson, Sonsini, Goodrich & Rosati, PC. Currently an associate at Wilson, Sonsini, Goodrich & Rosati, PC. he represents early-stage and public medical device companies, as well as institutional and venture capital investors, in transactions that involve equity and debt financings, mergers and acquisitions, public offerings, and public filings.
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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