Completion of Pharmaceutical Linkage Study

Five years after starting the project, I am pleased to say the group's empirical work on domestic, regional and global pharmaceutical law and regulations is complete.

A few well deserved thank you's:

• To all the students who not only did great work consistently under pressure but also pushed me to grow as a person;

• Special thanks to Monika Sawicka and Jamil Sawani, both now in successful private practice, for their excellent work on drug approvals and drug patents, respectively;

• To my writing partners, nationally and internationally, for making the work better and relevant to a wider audience;

• To the few but brave PIs and Collaborators who wrote grants with me. God bless for your patience and perseverance;

• To the CIHR, AHFMR, Munk Centre for International Studies, University of Toronto, and the University of Alberta for funding my research studies first as a Masters (LLM) and Doctoral (SJD) student in law and later as an Associate Professor;

• To all individual Key Decision-Makers in federal and provincial government and courts of justice for sticking their necks out to support grant-related research in their fields when they were not entirely comfortable doing so;

• To my mentors in law, medicine and medical science for providing excellent role models of what it means to be a scholar and a man;

• To other individuals in scholarship and administration who provided just as valuable examples of what paths not to walk in life;

• To the book, law journal, and blog editors who supported our work by selecting, editing and then publishing it;

• To many people who, on reading the work, went out of their way to contact me and enter into discussions of mutual interest;

• To the 26,000+ individuals who viewed and downloaded papers on BePress and SSRN author sites between 2007-2012;

• To the 24,000+ people who viewed content on this blog;

•  Top ten nations in rank order are: United States, Canada, Indonesia, Germany, Russia, Ukraine, India, United Kingdom, France, and China; and

• To my wonderful family, without whom none of the work would have been possible.

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.