Pharmaceutical Innovation and Patent Law

The pharmaceutical industry is said to be the paradigm model case where the investment costs in research and development justify a strong exclusive patent right, not only as an incentive to innovate but also to coordinate the innovation process. Changing innovation dynamics and the structure of competition in the pharmaceutical industry challenge this. Facing increased competition from new entrants and generics in the market, and the inevitable slow-down of breakthrough research, pharmaceutical firms employ various strategies to extend the life cycle of a commercially successful product, including "patent life cycle management." Notably, firms file a new patent application on related innovative aspects surrounding a successful product (i.e., delivery method, delivery system, formulation as well as selection), and utilize extension of terms for patents.

Speakers and panelists at this conference looked into these two most commonly used means of patent and product life cycle management, how they affect competition and explore their implications for law and policy, in three major patenting jurisdictions – Europe, the United States, and Japan.