Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective

Dr. Nari Lee, MIPLC
Prof. Josef Drexl, LL.M. (Berkeley), MIPLC/MPI

Public health, safety, and access to reasonably priced medicine for all members of the public are common policy goals of pharmaceutical regulations. At the same time, research and development costs for pharmaceutical products are high, while once produced they are relatively easy to copy. Economists tell us that pharmaceutical industry suffers from the classic case of public goods under-production problem that calls for the protection of exclusive right of patent. To preserve the incentive to produce, the policies of public health, safety and access to medicine have to be balanced with the protection. However, changing innovation dynamic and the structure of competition in the pharmaceutical industry challenge this. Facing the increased competitions from new entrants and generics in the market and the slow-down of breakthrough research, pharmaceutical firms employ various strategies to extend the profitability of a commercially successful product and to manage life cycle.

By exploring the topic of pharmaceutical innovations, competition and patent law, the project focuses on how the life of a patent and life of innovative products are coordinated in a trilateral context. This research project explores if the balance between the policies (public health, safety, access to medicine) and incentives is now challenged by practices of industry actors' life cycle management strategies, in Europe, US and Japan, highlighting difficulties in harmonizing regulatory practices in this area of law.

Keywords: Patent, Life cycle management, Pharmaceuticals, Patent term extension, Term restoration, SPCs, Data exclusivity, Competition policy.