Qualifying Intellectual Property II: A Novel innovation Index for Pharmaceutical Products
Abstract
Governments around the world have become uniformly locked in to the political mandate of innovation, both in developed and developing nations. Innovation is widely accepted to be a fundamental gateway to national and global productivity and prosperity. 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. Importantly, the innovation index rewards innovation both in the new drug approval stream and for follow-on approvals in proportion to the degree of innovation evidenced by the resulting products. Given that policy-makers no longer need to wait for licensing, litigation or prior art citations to occur, the innovation index reported here may allow for regulatory decisions to be made earlier and more rapidly. The index is sufficiently flexible to be used at several stages of the product lifecycle, including during the regulatory approval stage, post-market surveillance stage, and in the context of deciding which patents should be properly listed on the patent register in order to delay generic market entry. The index may also provide regulators to make judgments about which types of patents should be listed on the patent register under linkage laws in an objective and evidence-based manner. Finally, the attribute of flexibility may also lend itself to customization of the index by jurisdictions with analogous food and drug law. Importantly, customization is not limited to qualification of technology in the pharmaceutical sector, but may be used to qualify any indicator, provided that evidentiary requirements for and prioritization of the indicator have been stipulated by regulators.