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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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HSU, Justin
Justin Hsu is currently a third year undergraduate Industrial Engineering and Operations Research student at the University of California, Berkeley. Prior to his summer tenure at Fernandez & Associates L.L.P., he was a mechanical engineering intern at Lawrence Berkeley National Laboratory, where he worked on magnetic measurement systems at the Advanced Light Source, a synchrotron radiation facility. His professional and academic interests include intellectual property law, venture capital, stochastic processes, and optimization with applications in finance and operations research. In his spare time, he enjoys football and playing the guitar, among other things. Upon graduation, Justin hopes to attend graduate school and work several years in the Silicon Valley high-tech industry before taking the U.S. patent bar examination.
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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