The Nature of Chemical Non-Obviousness: Functional Approach in Pharmaceutical Context

It is widely accepted that pharmaceutical industry stands among one of the few fields where patent protection is necessary to encourage innovation, with patents taking credit for the discovery and development of valuable new drugs that provide great health benefits to the public. Yet despite these successes, the pharmaceutical industry, along with the patent system for pharmaceuticals, is facing considerable criticism, especially from the perspective of access to drug and proper incentive for R&D. Many solutions are suggested especially from the perspective of implementing legislative or administrative actions. I will focus on, however, the patent law itself, especially the non-obviousness jurisprudence of pharmaceutical patent. In pharmaceutical industry, there are several factors that may cause potential mismatch between technical non-obviousness and pharmaceutical R&D or clinical testing efforts, such as unique regulatory landscapes,recent scientific developments, and changes in innovation patterns. To address this situation, I suggest that, with implementing the FDA’s drug classification system and innovation ranking system, (1) the cost and risk of development and commercialization of invention; and (2) the social value of a drug should be considered as new (or at least supplemental) secondary consideration factors. With above approach,we can achieve wise innovation policy on a case-by-case basis, by fine-tuning tailored degrees of patent protection for different categories of drug products.