January 12, 2001
Patent and Trademark Office Issues Final Guidelines
The U.S. Patent and Trademark Office (PTO) has finalized guidelines that will affect the award of patents on DNA sequences, including human genes. The PTO published two sets of revised and final guidelines in the Jan. 5 Federal Register [66 FR 1092 and 66 FR 1099]. Patent examiners will employ these guidelines in their review of applications for patents on "compositions of matter," including DNA sequences. The first set of guidelines addresses the utility requirement for patents. The second set addresses the "written description" requirement, to establish that patent applicants are actually in possession of the claimed invention.
The revised utility guidelines require that applicants demonstrate a "specific, substantial, and credible" utility for their invention, a heightened standard from the merely "credible" utility formerly required. Many biomedical researchers had been concerned that the original standard was too lax, and would allow, for example, for patents on expressed sequence tags (ESTs) based merely on their usefulness as biochemical probes (a very general use, not specific to ESTs).
The broader concern of many researchers is that genes, gene fragments, single nucleotide polymorphisms (SNPs), and volumes of other genetic information would become subject to patent rights before the scientific and medical value of that information has been fully or openly ascertained. Thus, scientists discovering a critical role for a gene in the treatment or detection of human disease could also learn that use of that information is subject to control by one or more patent holders (who may have made no prior contribution to the discovery itself). The counter argument, especially prevalent within the biotechnology industry and the PTO itself, is that patent protection on genetic sequences provides individual researchers and firms the incentive to invest substantial funding into further exploration and development of the genome. Absent such protection, proponents argue, progress in developing new drugs and diagnostics would be greatly retarded.
The AAMC and other biomedical research advocates have commended the PTO for using a heightened utility standard. However, the AAMC expressed in a comment letter to the PTO on March 16, 2000, its concerns that that the new guidelines do not go far enough. For example, they would accept claims of utility for human genes based solely on homological description with similar genes of other species.
Although the PTO has implemented the new guidelines, it remains to be seen if the PTO's interpretation of patent law will be upheld in federal court. It is widely reported that a test case for the new guidelines is being prepared and will shortly go to trial.
Information: Steve Heinig, AAMC Division of Biomedical and Health Sciences Research, 202-828-0488.
