Association for Molecular Pathology
 

Genetics - AMP Position on Patenting of Genetic Tests
Note: The statement below was developed by representatives from the following organizations: ACLPS, CAP, ACMG, ASHG, NSGC, AMA, ACOG, ASCP and AAMC. Dr. Debra Leonard, past president of AMP and current Chair of the AMP Professional Relations Committee was AMP's representative in these discussions. AMP endorsed this position on November 22, 1999.

Background:
Use of patents and exclusive licenses to limit genetic testing

Many disease-causing genes from humans and their pathogens have been discovered in recent years, and countless more will be discovered in the coming decades. Clinical laboratories develop many of these discoveries into genetic tests and make these tests widely available as clinical services for the public good. In many instances, the United States Government has granted extremely broad patents on genetic discoveries, and large numbers of new patent applications are presently under review. Increasingly, patent holders or their licensees are choosing to monopolize genetic testing by preventing all other health-care providers and facilities from performing tests covered by the patents.

The undersigned organizations believe:

  • Genetic test services are medical procedures. As such, they should be widely available to promote optimal patient care, medical education, and medical research.
  • Most discoveries of pathogen or human disease genes can be effectively translated into genetic tests without recourse to the incentives provided by patents or exclusive license agreements.
  • The use of patents or exorbitant licensing fees to prevent physicians and clinical laboratories from performing genetic tests also limits access to medical care, jeopardizes the quality of medical care, and raises its cost.
  • The research, development and practice of genetic testing in academic medical centers is essential to medical progress, the education of physicians, researchers and health-care professionals, and the continued improvement of the quality of medical care.
  • Exclusive licenses that limit genetic testing to a single provider are detrimental to the public interest by limiting medical education, practice and research, the advancement of medical knowledge, and the enhancement of the public's health.

The undersigned organizations recommend:

  • Physicians, scientists, patients and research funding agencies should oppose patent licensing agreements that inappropriately limit clinical care, the use of medical procedures, medical education, and medical research.
  • Organizations (including universities) that hold patents controlling genetic testing services should not issue exclusive licenses for these patents unless there is a clear and compelling need for exclusivity in order to make the technology available to the public. Such cases are expected to be extremely rare.
  • When patent holders choose to require licenses for use of their technology for genetic testing, such licenses should be nonexclusive and available to any qualified, CLIA-certified high-complexity laboratory on an equal basis.
  • To ensure that testing remains widely available and affordable, 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 or regulate the technical performance or clinical uses of the test. License agreements should likewise be free of terms that inappropriately limit research related to testing or the public dissemination of the resulting research findings.

Bibliography

  1. Association for Molecular Pathology
    Letter to Dr. Francis Collins, November 8, 1998.
  2. Academy of Clinical Laboratory Physicians and Scientists
    Resolution: Exclusive licenses for diagnostic tests. Approved June 3, 1999.
    http://www.pathology.med.umich.edu/aclpsnewJul99/license.htm
  3. American College of Medical Genetics
    Position statement on gene patents and accessibility of gene testing. Approved August 2, 1999.
    http://www.faseb.org/genetics/acmg/pol-34.htm
  4. Tait JF. Exclusive licenses for home-brew genetic tests: some questions and answers. Department of Laboratory Medicine, University of Washington, Seattle, Washington. December 23, 1998.
    http://www.pathology.med.umich.edu/aclpsnewJul99/taitdoc.htm
  5. Merz JF. Disease gene patents: overcoming unethical constraints on clinical laboratory medicine. Clinical Chemistry 1999; 45:324-330.
    http://www.clinchem.org/
  6. Schissel A, Merz JF, Cho MK. Survey confirms fears about licensing of genetic tests. Nature 1999; 402:118


 12/26/2008