The Impacts of Enhanced Drug-Patent Examination

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OTHER PROJECT INFORMATION – Project Summary/Abstract THE IMPACTS OF ENHANCED DRUG-PATENT EXAMINATION The legal patentability requirements are designed to respect the balance between patient access to existing longevity-improving drugs and incentivizing their existence in the first place. However, the patent system may fail to achieve this balance if it does not provide patent examiners with the resources—mainly, time—needed to apply these patentability standards. Given the legal presumption of validity of incoming patent applications, insufficient examination time may lead to concerns that the U.S. Patent and Trademark Office (PTO) will issue patents on non-novel or obvious innovations, a result which may unnecessarily inhibit patient access and thereby compromise patient outcomes. Patent quality concerns of this nature have been particularly paramount in the case of “secondary” patents—i.e., patents on subsidiary drug features such as on routes of administration. Given that secondary patent applications are often filed years after the issuance of the active- ingredient patent, they have the potential to meaningfully extend the effective patent lives of given drug products, potentially limiting access on the margin to clinically valuable drugs. In this project, we propose to investigate the full extent to which secondary patenting practices may be extending effective patent lives of FDA-approved drugs. Further, drawing on certain PTO reforms and features, we will investigate the impacts of increasing examination time on drug-patent examination quality. In particular, we will address four aims:  Compiling, reviewing and coding data from both the PTO and the FDA, we will build a database of small-molecule drug patents associated with FDA-approved drug products from the mid-1980s to the present, containing various information associated with each such patent, including information (if any) on claims associated with secondary drug features.  We will similarly build a database of large-molecule drug patents, though this effort will likely require a deeper and more extensive review of raw PTO materials given the lack of a congressionally mandated list of biologics-related patents associated with FDA-approvals.  Using these data and employing various quasi-experimental approaches, we will estimate the relationship between the examination time allotted to examiners and the likelihood that the patents they issue meet the legal patentability requirements.  Drawing on the results from Aim #3, we will run simulation exercises to assess the degree to which an increase in examination time will shorten the effective patent lives of approved FDA drug products and thereafter draw on various estimated moments from the generic-entry literature to estimate the resulting effects on increased/accelerated patient access to approved medications.