Intellectual Property in Vaccine Innovation: Impact of Recent Patent Developments.

This chapter examines the issues on patentability of microorganisms and human genes under the US laws and analyzes their influence on vaccine innovation. The analysis will focus on three aspects, namely, the naturally existing state, unmodified isolated form (i.e., mere extraction from the natural environment), and human-modified/genetically engineered structure. The outcome of the assessment suggests that the impact of the recent US patent jurisprudence on vaccines may differ significantly depending on whether the preparation of a vaccine in question involves natural or man-made DNA material.