Unpatentable Drugs and the Standard of Patentability

In this Article, Professor Benjamin N. Roin exposes a significant flaw in the current patent system that, he argues, presents a significant impediment to pharmaceutical innovation: socially valuable drugs often cannot be patented and are therefore unlikely to be developed for public use.  This flaw, according to Roin, is the result of two fundamental requirements for patent protection—novelty and nonobviousness—coupled with the massive R&D costs necessary to develop a new drug in a way that satisfies the FDA's safety and efficacy standards.

Professor Roin begins with a discussion of the necessity of the patent system for innovation in the drug industry: since unpatented drugs are vulnerable to free-riding by generic manufacturers, pharmaceutical companies would usually find it impossible to recoup their R&D investments without the delay in generic competition that a patent provides.  This fact underscores the significance of Roin's assertion that the novelty and nonobviousness requirements render many potentially useful drugs unpatentable.  After providing a detailed account of the various ways in which these two requirements serve to prevent the patentability of many new drugs, Professor Roin offers practical evidence that the patent standards routinely deter private industry from developing promising drug candidates.  Therefore, Roin argues, the current patent system is preventing the development of untold numbers of beneficial drugs, which results in considerable harm to the public.  After considering the relative costs and benefits of two other possible solutions to this dilemma—patent reform and direct government funding of clinical trials—Professor Roin concludes that the best way for Congress to promote the development of unpatentable drugs is through the FDA, by requiring the agency to withhold regulatory approval from generics for long enough to replicate the protection normally provided by patents.