The American College of Medical Genetics (ACMG) has a long-standing position that genes are products of nature, and as such should not be patentable. ACMG has provided comments to the Secretary's Advisory Committee on Genetics Health and Society (SACGHS) about its views on an ongoing basis.
The recent recommendations of the SACGHS recognize that gene patenting is creating problems both in access to genetic testing and in insuring the quality of genetic testing. Although it has not taken a position for or against the patenting of human genes, SACGHS has sought a middle ground that recognizes both the need to protect investments in therapeutic development as well as the need to provide wide access to high quality genetic testing. They also note the lack of evidence that gene patents have contributed to the development of products for the diagnostic laboratory marketplace.
ACMG applauds the effort that went into evaluating gene patenting and licensing practices and to seek broad public and stakeholder input into the development and review of the SACGHS report. Their comprehensive analysis has led SACGHS to recommend, among other things, that the exemptions from liability for infringement of gene patents afforded to the practice of medicine be extended to gene patents used in diagnostic testing. According to ACMG president, Dr. Bruce Korf, "The practice of gene patenting and exclusive licensing has created monopolies that stifle innovation and limit access, exactly the opposite effects that patents are supposed to promote. The SACGHS report represents a step towards breaking up this logjam."
ACMG welcomes the publication of the SACGHS report and encourages the Executive Branch to pursue the recommendations made through all possible routes. Access to high quality genetic testing should be assured for all Americans.