title: University opposition to unfettered research: a new bedfellow for biotech?
abstract: This Article examines university opposition to a proposed statutory exemption to infringement liability for basic genetic research and patient care. Gene patenting has allowed patentees to bar basic genetic research, slowing the progress of developing and administering diagnostics and gene-targeting therapeutics. Debates over the merits of gene patents have been heated, most recently leading to an unprecedented invalidation of several broad patents covering all variations and use of two genes linked to breast and ovarian cancers. More important, however (as this ruling was reversed in part), are proposed statutory exemptions to infringement liability. The Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has promulgated an exemption from liability for infringement that occurs in the course of research. This exemption would promote basic research by granting academic scientists unfettered access to genetic material. The proposal does not alter the patentability of gene sequences; it merely restricts patentees from using infringement threats to stop research. Surprisingly, the Association of University Technology Managers (AUTM), an organization responsible for promoting development of university research, opposes such an exemption. The AUTM alleges that the exemption would slow research by reducing the incentive for private firms to invest in upstream discoveries made in university laboratories. Yet the exemption would do the opposite: by opening the doors to research relating to any gene segment, a research exemption would accelerate basic research. Moreover, it would not affect collaboration with private industry: where there is potential to commercialize basic research, biomedical companies would continue to license the rights to university discoveries. Thus, the AUTM's motivations in opposing the proposed research exemption are suspect. They appear to reflect either a misunderstanding of the purpose behind granting property rights to publicly funded university research, or an improper alignment with industry goals.
authors.affiliation: Duke University School of Law & Graduate School, USA.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Record
mesh_terms: D036281:Genetic Research / Q000331:legislation & jurisprudence*; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014495:Universities