Public Release: 

APC Supports SACGHS' landmark recommendations on DNA patenting exempting caregivers

American Society for Investigative Pathology

PRESS RELEASE: Bethesda, Maryland (October 19, 2009) - The Association of Pathology Chairs joins the Association for Molecular Pathology and other leading professional organizations in their support of draft recommendations just published by the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) on DNA patenting. The Committee met on October 8th and 9th to review its final draft report on gene patents and licensing practices, and took the enlightened step of recommending to the Administration that it promote exempting patient caregivers from infringement liability stemming from patent claims on genes. They recommended that the exemption from liability extend to anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care or in the pursuit of research.

The draft report also calls for enhanced transparency in licensing activities, public access to information about licensing actions, and Federal adoption of efforts to promote broad licensing practices. APC views these recommendations as a call to action for policy-makers to protect all patients from the detrimental effects of gene patents and exclusive licensing practices.

Charles Jennette, MD, President of APC, said, "We see time and again, how gene patenting results in reduced patient access to important molecular testing. This trend has a limiting effect on the advent of personalized medicine. The negative impact on patient care is felt now, but will be much worse as we move into the new era of greater reliance on molecular diagnostics." He added, "Our academic medical center laboratories are leaders in the development of molecular diagnostic tests in the United States. However, clinical laboratories can only develop these important tests when they have access to the broadest base of genomic discoveries. This access grows more critical as modern technology platforms allow for increasingly sophisticated tests that encompass a greater range and diversity of content from the genome."

Earlier this year, APC provided comments to the Secretary's Advisory Committee on Genetics, Health and Society on its Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. At that time, APC expressed its concern that the U.S. Patent & Trademark Office has historically granted broad patents on genomic discoveries, including individual genes, and large numbers of new patent applications are continuously under review. They noted that patent holders and their exclusive licensees have frequently chosen to monopolize molecular testing by restricting other health care providers and facilities from developing or performing tests covered by these patents and licenses. APC believes that molecular testing services constitute vital medical procedures. As such, they should be widely available to promote optimal patient care, medical education, and medical research. The research, development and practice of molecular testing are essential to medical practice, the education of physicians, researchers and health-care professionals, and the continued improvement of the quality of medical care.

APC supports the right to patent intellectual property associated with the invention of new therapeutics, diagnostics, or technology platforms. However, APC opposes patents on a single gene or a sequence of the genome, which is a product of nature and should not be patentable. Gene patents can serve as a disincentive to innovation by denying access to or use of basic genomic information, which in the long run can hurt patients that might benefit from that innovation. Furthermore, exclusive licenses that confine molecular testing to a single provider are detrimental to the public interest by limiting patient access to testing, restricting medical practice and research, impeding the advancement of medical knowledge and enhancement of the public's health through informed clinical decision-making. Most patented discoveries of pathogen or human genes can be effectively translated into molecular tests provided they are licensed on a non-exclusive basis and licenses are easily obtainable, both in financial and practical terms.

Several major scientific and clinical laboratory organizations, including the Association for Molecular Pathology, have adopted public policy statements in opposition to gene patents. In keeping with what other societies have proposed, the Association of Pathology Chairs supports the following recommendations:

  1. The patenting of single genes, sequences of the genome, or correlations between genetic variations and biological states should be discontinued, either as a result of judicial review or through an act of Congress.

  2. Entities, including higher educational and research institutions, that currently hold gene patents, should not grant exclusive licenses to these patents.

  3. To ensure that access to innovative molecular tests remains widely available and affordable to patients, financial terms for test licenses should be reasonable. License agreements should also be free of any terms that limit the number of tests that can be performed by a laboratory. Regulating the technical performance or clinical uses of the test should not be allowed, since laboratory professionals will ensure technical performance and appropriate clinical use. License agreements should likewise be free of terms that inappropriately limit research related to testing or the public dissemination of the resulting research findings.

  4. Physicians, researchers, clinical laboratory directors, patient advocates, government officials, research funding agencies and other stakeholders should work cooperatively to develop alternative models to gene patents and exclusive licenses. These innovative models should increase patient access to health care and achieve greater benefit from the existing body of intellectual property linked to the human genome.

Donald Karcher, MD, Chair of APC's Advocacy Committee, commented, "APC believes these recommendations are in the best interests of the patients we serve and will promote better access to and quality of innovative molecular testing services."

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The Association of Pathology Chairs (APC) is a non-profit society, which serves as the primary voice of LCME-accredited departments of pathology in the US, Canada and Puerto Rico. The mission of the APC is to provide leadership and to advocate for the dynamic discipline of pathology at all levels - academically, professionally, and with related agencies and governments. The APC provides education, training, information resources and networking opportunities for chairs, residency program directors, undergraduate medical education directors and department administrators in its 145 member institutions. For more information, visit www.apcprods.org or call 301-634-7408.

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