Promoting Innovation in the Pharmaceutical Industry by Expanding the FDA’s Regulatory Powers to Grant Market Exclusivity
Brian Bernard Eller
University of California, Davis - School of Law
December 19, 2010
UC Davis Legal Studies Research Paper
Under the Patent Act, a patent grants the patent holder the right to exclude others from making, using, offering, or selling the patented invention for twenty years after the patent filing date in exchange for the inventor’s disclosure on how to make and use the invention. Under 35 U.S.C. §102(a), if an invention is described in a publication anywhere in the world before the invention by an applicant for the patent, the applicant is not entitled to that patent. Likewise, under 35 U.S.C. § 102(b), if an invention is described in a publication, without the inventor having first filed a patent application prior to such publication within one year of inventing the invention, then such an invention is unpatentable. Similarly, under 35 U.S.C. §102(f) no person is entitled to a patent if that person did not invent the subject matter sought to be patented. The effect of 35 U.S.C. §§ 102(a), (b), and (f) is that an academic article that describes a promising new drug or pharmaceutical treatment cannot be patented, if the inventors decides not to file an application within the one year statutory period. Thus, there are likely many promising new drugs and pharmaceutical treatments, which are unpatentable. Unfortunately, these drugs and treatments are not being developed because they require significant investment in time and money and there is no guarantee of market exclusivity. My research focuses on a way to rectify this dilemma created by the patent system by utilizing the FDA’s power to grant market exclusivity.
Number of Pages in PDF File: 35
Keywords: Orphan Drug Act, Hatch-Waxman Act, 35 U.S.C. §102, Pharmaceutical, Innovation, Intellectual Property, Abbreviated New Drug Application (ANDA) Process, Public Domain
Date posted: March 21, 2011 ; Last revised: January 3, 2015
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