Patent Reform and Pharmaceuticals: The Key to Lower Drug Prices

Section 112 of the Patent Act stipulates the public disclosure the patentee must provide in order to receive a patent: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, t. [...] The institutional structure of the patent office, the complexity of litigation and the strategic behavior of interested parties have posed challenges to patent quality and innovation while generating an increasing number of legal disputes surrounding the validity of patents. [...] Rising concerns over the high cost of pharmaceuticals led to the passage of the “Drug Price Competition and Patent Term Restoration Act of 1984,” more commonly known as the Hatch-Waxman Act.13 Essentially, this law aimed to inject competition into the pharmaceutical market by opening the market to generic drug manufacturers. [...] In addition to reforms made to the FDA drug-approval process, the legislation also changed patent policy, including the creation of a streamlined process for patent litigation, a safe harbor that allows generics to begin research on generic substitutes prior to a patent’s expiration, and a 180-day period of exclusivity for the first generic to enter the market.14 The goal of these changes was to i. [...] In a recent study of IPR outcomes for pharmaceutical companies, researchers found the results in PTAB hearings to be similar to those in federal courts.59 The review process established by the AIA has become an important While critics often assert that the PTAB acts to aggressively part of the patent system, achieving results similar to other forms of adjudication in a invalidate patents, the data.