Pharmaceutical Commons
According to an article in First Monday by Arti K. Rai at http://www.firstmonday.org/issues/issue12_6/rai/index.html, pharmaceutical companies have been favourable to the creation of two different types of commons.
Typology
Preventing Anti-Commons
Type One: created with the aim has been to defeat a proliferation of upstream property rights that might threaten an “anti–commons.”
Examples:
"when a proliferation of property rights over upstream research threatened to create a “tragedy of the anti–commons” by imposing significant licensing and royalty burdens on drug development, pharmaceutical firms promoted a number of projects to defeat these patents. One prominent effort involved single nucleotide polymorphism (SNPs), which are single base variations found in the human genome. Individually, and in inherited combinations known as “haplotypes,” SNPs can be used to identify genes important for complex diseases and also to predict responses to therapeutic interventions. Pharmaceutical firms, alarmed by the prospect of biotechnology companies securing large numbers of patents on SNPs, joined together to put SNP information into the public domain. More recently, various pharmaceutical firms and the microarray manufacturer Affymetrix have been involved in patent–defeating data generation projects like the Genome Association Information Network (GAIN). The output of the GAIN project – essentially information about which haplotypes are associated with particular diseases – is being put into the public domain."
Augmenting Knowledge Productivity
Type Two: created with the aim is to solve the daunting research problem of predicting drug safety and efficacy ex ante, before expensive failures in late–stage clinical trials or after the drug has been marketed.
Examples:
"To the extent that pharmaceutical firms can, through collaborative efforts, find standard early biological signs (also known as biomarkers) of a drug’s toxicity, this information could be used by all pharmaceutical firms for a variety of cost–reducing functions, including expediting preclinical drug safety evaluation, providing early indicators of clinical safety, and “trouble–shooting” compounds that fail preclinical drug safety testing. Indeed, to the extent that a particular biomarker test were ultimately approved by the Food and Drug Administration as a reliable indicator of safety, such a test might be considered an industry standard around which all competing firms could converge.
In one of these consortia, the Toxicogenomic Cross–Validation Consortium (TCC), all of the major pharmaceutical firms have committed to sharing internally developed laboratory methods that predict the safety of new treatments. The TCC agreement sets up a commons that relies heavily on a non–profit trusted intermediary, Critical Path, of which the FDA is a founding member. Critical Path (and/or a Director selected by Critical Path) collects membership fees from pharmaceutical firm participants, coordinates the selection of research projects, and manages the flow of any confidential information. Critical Path also owns patent rights to any intellectual property generated. It is obligated to license these patents to all comers on commercially reasonable terms.
While the TCC focuses on tests for safety, the recently formed Biomarkers Consortium aims to encompass research that identifies good biomarkers of both drug safety and efficacy [15]. Like the TCC, the Biomarkers Consortium includes all of the major pharmaceutical firms. In the case of the Biomarkers Consortium, each participant in a particular research project is entitled to a nonexclusive license to all intellectual property created from that project."
More Information
Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, Science, May 1, 1998, at 698.
Ajay Agarwal and Lorenzo Garlappi, “Public Sector Science and the Strategy of the Commons,” at http://www.rotman.utoronto.ca/Ajay.Agrawal/Documents/Agrawal-Garlappi-SoC.pdf
Source
Knowledge Commons: The Case of the Biopharmaceutical Industry by Arti K. Rai First Monday, volume 12, number 6 (June 2007),
URL: http://firstmonday.org/issues/issue12_6/rai/index.html
Projects
GAIN, the Genome Association Information Network. at http://www.fnih.org/GAIN2/home_new.shtml