Empirical Analysis of Government Regulation of Pharmaceutical Innovation

Talks at Canadian PTO and Industry Canada

I gave two talks on the group's work to the Government of Canada in Ottawa in late 2010 to Industry Canada and the Canadian Intellectual Property Office (CIPO).

Both of talks were well attended, and both audiences provided excellent feedback and comments.

I am grateful to leadership in the Government of Canada for facilitating the talks, particularly individuals in Industry Canada, CIPO, and Health Canada.

Structure-Function Study of Global Pharmaceutical Law

I am pleased to be part of a global consortium of eleven intellectual property law and health policy scholars, economists, and practicing lawyers in nine counties. The group is called the Consortium Study of Global Pharmaceutical Linkage.

The Consortium is spread across nations with established, maturing, and nascent linkage regulations as follows:

• Canada: Ron Bouchard (Manitoba)
• Canada: Aidan Hollis (Calgary)
• Canada: Joel Lexchin (Toronto)
• U.S.: Dan Cahoy (Penn State)
• EU: Bengt Domeij (Uppsala, Sweden)
• EU: Graham Dutfield (Leeds, U.K.)
• Mexico: Juan Louis Serrano (Mexico City)
• Australia: Tom Faunce (ANU)
• China: Paul Jones (Toronto)
• South Korea: Heesob Nam (Seoul)
• India: Feroz Ali Khader (Currently at Duke)

The Consortium includes individuals with litigation experience with pharmaceutical linkage regulations on both sides of the brand-generic divide, scholars in Faculties of Law, Medicine, Health, and Economics, and practicing lawyers working in law firms and Non-Governmental Organizations.

The Consortium is supported in its work by a Key Decision Maker Advisory Board composed of senior members of the judiciary and government in federal and provincial health, industry and intellectual property portfolios.

The goal of our work is to produce and use empirical knowledge relating to the structure and function of different global linkage regimes to assist key decision-makers in global governments and legal systems working with linkage regimes and related intellectual property law and policy.

UPDATE: The first paper from the Consortium has been accepted for publication with the Minnesota Journal of Law, Science & Technology.

The full cite is:

Bouchard, R.A. Cahoy, D., Domeij, B., Dutfield, G., Faunce, T., Hollis, A., Jones, P., Ali Khader, F., Lexchin, J., Nam, H., & Serrano, J.L. "Structure-Function Analysis of Global Pharmaceutical Linkage Regulations." Minnesota Journal of Law, Science & Technology. 12(2): 391-457. 2011.

The article is available on the journal website.

CIHR New Investigator Award

I recently received a New Investigator Salary Award in the amount of $300,000 over a term of five years by the Canadian Institutes for Health Research (CIHR). I was very fortunate, as the application was ranked 4th of 62 applications nationally, with a rating of 4.45/5.00.

The project funded is entitled: "Empirical Analysis of the Effectiveness of Patent Rights as an Incentive for Pharmaceutical Innovation".

Update: A a $50,000 Research Allowance was also provided in conjunction with the New Investigator Award.

IP Osgoode Profile of Pharmaceutical Obviousness Law

Thanks to IP Osgoode for profiling our work in the University of Ottawa Law & Technology Journal on the push-pull between obviousness and inventiveness in pharmaceutical litigation.

A couple paragraphs from the article:

While obviousness and inventiveness are opposite ends of the spectrum of activity leading up to invention, the roof under which they co-inhabit, however uncomfortably, is that of human agency. Notwithstanding the PHOSITA represents at once the metric for the obviousness analysis undertaken by the courts, the class of persons most likely to be actual inventors in reality, and the societal medium through which all pharmaceutical inventions emanate and are vetted, rejected and put into practice, Canadian patent jurisprudence and legal commentary nevertheless stipulates that for an invention to be obvious, no “experimenting or serious thought, or research, whether the research be in the laboratory or amongst literature” can be conducted in the lead-up to invention.

Judicial reasoning underpinning this approach hinges on the current legal fiction of the PHOSITA, who is said to possess not even a “mere scintilla” of inventiveness or creativity. This is true independent of whether the obviousness analysis is couched as an express injunction against testing or the “worth a try” approach to testing or whether the PHOSITA “would have” versus “could have” arrived at the impugned invention. The approach taken by Canadian courts on the issue is highly binary in nature, which contrasts sharply with the spectrum of inventive activity engaged in by both actual patentees or more generally by persons skilled in the art of pharmaceutical research and development.

In order to gain a better understanding of the issue, a social sciences construction of the normative practices of the pharmaceutical PHOSITA was undertaken. This involved evaluating the scientific norms of industrial pharmaceutical research and development, with particular focus on the identity and inventive capacity of the pharmaceutical PHOSITA. Two analytical methods were employed in the analysis: the tacit and focal knowledgebase framework of Polanyi and actor-network theory (ANT) as described by Latour.

The full article can be found on the journal website.

I'm Still Your Baby: Canada's Continuing Support of U.S. Drug Law

Thanks to IP Osgoode for profiling our work on the drug approval-drug patenting linkage published by the Marquette Intellectual Property Review.

The Article is entitled "I'm Still Your Baby: Canada's Continuing Support of U.S. Linkage Regulations for Pharmaceuticals."

A couple of paragraphs from the article:

Canada’s linkage regime for pharmaceuticals was enacted under intense political pressure to harmonize the nation’s intellectual property law with those of other developed nations. The original policy intent of the regulations was two-fold: first, to encourage the development of new and innovative drugs, and second to facilitate the timely market entry of generic drugs. The NOC Regulations were expressly intended to balance the goals and objectives of food and drug law with those of patent law. Prior to the linkage regime coming into force, drug regulation and drug patenting represented distinct goals and policy objectives. Under the terms of the linkage regime, there must be a specific functional nexus between approved drugs and patent protection for those drugs pursuant to the NOC Regulations.

In choosing the words “the development of new and innovative drugs” to be one half of the balance linking patent law to food and drug law, the federal government articulated a clear public policy goal that pioneering drug development is desired in exchange for the unusual protections afforded to the pharmaceutical industry by the linkage regime. In choosing the words “timely market entry of their lower priced generic competitors” the government articulated a second public policy goal of cost savings, triggered by expiry of specific patents on specific drug forms that are no longer new and innovative. Thus the “balance” sought to be effected by the NOC Regulations is not just a qualitative balance between two poles, but also a quantitative balance. The more reward there is on the private side of the ledger, the more there must be on the public side in order to maintain legal equilibrium.

It has now been almost two decades since the regulations were enacted. Given the continuing public debate over high drug prices, the large fraction of research and development carried out by publicly-funded institutions ultimately enveloped within commercialized products, and wide criticism of the failings of the patent system to promote innovation, it is an excellent time to assess whether the NOC Regulations have in fact satisfied the twin policy goals of encouraging new and innovative drug development and the timely market entry of generic drugs.

The full article can be found on the journal website.