Intellectual Property Rights in Genetics and Genomics
The purpose of this RFA is to encourage the study of the role of laws and policies regarding intellectual property rights to genetics and genomics research and development, and the effect of such laws and policies on progress in these fields and on commercialization, drug development, health care delivery, and the public health.
Since its inception, the Human Genome Project has attempted to follow a policy of free and open access to genetic and genomic data e.g., National Human Genome Research institute (NHGRI) Policy Regarding Intellectual Property of Human Genomic Sequence (April 9, 1996), http://www.genome.gov/ 10000926; NHGRI Policy on Human Genomic Sequence Data (Dec. 21, 2000), http://www. genome.gov/10000910. The National institutes of Health (NIH) policy recognizes the appropriateness of intellectual property protections for discoveries that are associated with useful products, but promotes the free dissemination of research tools whenever possible, especially when the prospect of commercial gain is remote (Report of the National Institutes of Health (NIH) Working Group on Research Tools, http:// www.nih.gov/news/researchtoolsl).
Over the past three decades, however, many patents have been granted on gene sequences and other types of basic information derived from genetic sequence. For some, this has generated apprehension that gene patents are being granted too broadly or freely, especially for foundational tools. The concern is that the too-liberal issuance of such patent rights, especially when coupled with exclusive licensing practices, will result in the imposition of reach-through restrictions or excessive fees, and inhibit investigators from conducting additional research with these tools. This, it is feared, will ultimately be to the detriment of advances in medical research and to public health.
In January 2001, partly in response to a letter from the NIH urging the implementation of stricter criteria for the issuance of biotechnology patents, the U.S. Patent and Trademark Office revised its guidelines to patent examiners regarding patents on DNA sequence and sequence-derived intellectual property, effectively "raising the bar" on utility standards in this area [U.S. Patent and Trademark Office, Utility Examination Guidelines, Fed Reg 66(4) (January 5, 2001)]. However, questions remain about whether this revision raised the "bar" high enough to serve the public interest. An example of the potential problem is the recent acquisition and aggressive pursuit by Genetic Technologies Limited (GTG), an Australian company, of exceptionally broad global patent protection covering the use of information to derive risks of disease in all non-coding regions of the genome [see Nature (2003) 423:105]. While this is perhaps an extreme example (and the validity of GTG's patents has not yet been tested in the courts), other controversial cases can also be cited (e.g., the Myriad Genetics BRCA1 patent, the University of Miami Canavan disease patent, the CCR5 HIV co-receptor gene patent). Such cases are increasingly leading genetics and genomics researchers, business entities, health care providers, and consumers to question how the balance between providing intellectual property protection and fostering biomedical innovation can best be attained.
Issues regarding the appropriate scope of protection for intellectual property rights in genetics and genomics research and development will only increase in complexity as progress in these fields continues. For example, large-scale proteomics efforts [such as protein biomarker discovery projects, the NIGMS Protein Structure Initiative (http://www.nigms.nih.gov/psi/) and initiatives to characterize protein-protein interactions] will generate new types of potentially patentable information, and with this information, new intellectual property challenges. Such challenges will also arise in several areas of research being emphasized under the new NIH Roadmap Initiative (http://nihroadmap. …