My group has completed two substantial empirical studies on innovation in the pharmaceutical sector. The ensuing articles are entitled:
"Qualifying Intellectual Property I: Harmonized Measurement of Drug Approval, Drug Patenting and Chemical Components."
The purpose of this study was to develop a harmonized method to collect, compare and quantify regulatory approval data from multiple cohorts of new and follow-on drugs that encompassed all drug classes enumerated, described and prioritized by domestic drug regulators. A secondary purpose was to go beyond simplified descriptors of new and follow-on drugs in the literature, and to categorize classes of new, line extension and generic approvals according to the nomenclature used by regulators themselves.
"Qualifying Intellectual Property II: A New Innovation Index for Pharmaceutical Products."
To date innovation is measured using almost exclusively using quantitative methods, particularly with regard to patents. However, even though quantitative models are widely considered to be problematic, a model that assesses patent value using qualitative methods has not yet emerged. Here, a qualitative innovation index is reported that may fill some of the gaps in patent valuation. An innovation index for pharmaceuticals is described that provides a measure of patent quality that is specific to pharmaceutical products. The index is based on regulatory preferences and evidentiary requirements for various types of new and follow-on drugs and yields a method that is not only graded incrementally but which reflects the social value of the products being valued.
The Articles are available on the journal websites.
