Wednesday, March 28, 2012

Big Data: Capstone Law Review Article


On the Social Benefits and Regulatory Preferences for Different Classes of New and Follow-On Drugs

The capstone analysis from the last five years of empirical legal analysis of the intertwining of innovation, intellectual property, food and drug, and pharmaceutical law and policy is now published in both hard and electronic formats.

The quantitative analysis of nearly 4,000 drug approvals, 5,000 drug patents and 130 chemical components for 100 drugs was published earlier in a law review out of Boston University.

Our work fits into the so-called "big data" paradigm. In total we acquired, measured, analyzed, and/or synthesized into a working model over several million pieces of data over the course of five years through several inter-locking studies relating to New and Follow-On Drug Approvals and related WHO Anatomic Therapeutic Classes, Drug Patents, Drug Patent Classifications, Patent Trees, Chemical Components, Patent Register Listings, 2-D Spatiotemporal Product Cluster Models, Innovation Index data, and associated litigation data for Federal Court of Canada, Federal Court of Appeal and Supreme Court of Canada cases.

The qualitative study of the innovative nature and social benefits for the same group of approvals, patents and chemicals, which is the capstone analysis of our group's cumulative research, has been published this week on the site of the Santa Clara Computer and High Technology Law Journal.

The website for the article is: http://www.chtlj.org/volumes/v28

The Santa Clara article was the beneficiary of superb editing and faculty oversight. This was also true of our earlier 2009 Berkeley study. Must be something good in the California air...

Taken as a whole, the work is focused on the social benefits of various classes of new and follow-on drugs and the regulatory preferences for certain types of drugs that appear to be inherent to the current basket of patent law, food and drug law, and linkage law that governs the availability and cost of brand-name and generic medications domestically and globally.

As Ed Levy from UBC pointed out to me the other day, given that the innovation index is focuses on the social benefits of patenting and innovation, it may have relevance to the triple bottom line discussion, also referred to as impact investing.