October 30, 2007
The College of American Pathologists, representing more than 16,000 physicians who practice clinical and/or anatomic pathology appreciates the opportunity to submit comments to the House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property regarding an issue of critical importance to pathologists and the patients they serve—access to genetic testing.
Our member pathologists practice in community hospitals, independent clinical laboratories, academic medical centers and federal and state health facilities.
Pathologists play an integral role in health care as physicians who obtain and interpret data as the result of examination of tissues, blood, and other body fluids for diagnosis and patient care. The mission of the College is to represent the interests of patients, the public, and pathologists by fostering excellence in the practice of pathology and laboratory medicine worldwide.
The current scientific revolution in genetics promises extraordinary advances in clinical medicine. As the medical specialists in the diagnosis of disease, pathologists recognize that genetic testing is an area of growth and change for pathology and medical practice now and in the decades to come. The research, development, and practice of genetic testing in academic and other medical centers is essential to medical progress, the training of physicians, researchers and health-care professionals, and the continued improvement of the quality of medical care. Most discoveries of human or pathogen genes can be effectively translated into gene-based diagnostic test services without the incentives provided by patents or exclusive license agreements.
Pathologists therefore have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve.
Gene patents pose a serious threat to medical advancement, medical education, and patient care. When patents are granted, subsequent exclusive license agreements, excessive licensing fees, and other restrictive licensing conditions prevent physicians and laboratories from providing genetic-based clinical testing services. As a consequence, patient access to care is limited, quality of patient care is jeopardized, clinical observations as the basis for new discoveries are compromised, and training of health care providers is restricted.
Throughout history, medical discoveries have progressed from the discovery of basic anatomy to histology and cytology—none of which are patented—to the more recent discovery of genes. The trend of using patents to monopolize gene-based testing services is a radical departure from historical precedent in clinical laboratories, and it works against the goal of making these procedures widely accessible and affordable for the public. Especially troubling is the fact that under patent protection, the increasing understanding of the utility of the test, as well as the underlying disease processes, also becomes proprietary, thereby imposing a profound change in how the profession and the public acquire knowledge about these rapidly evolving tests, the diseases diagnosed by the tests and their clinical utility.
The patent system in the United States generally encourages entrepreneurs to make new discoveries and to benefit directly from making their efforts broadly accessible. Limitations in how this patent system is applied to patents of genes compromises medical progress and access to new gene-based tests. The patent system should be reexamined to ensure the public interest in improving healthcare decisions based on gene-based tests and access to those tests.
Physicians and scientists can easily and rapidly translate the fundamental genetic information derived from sequencing the human genome into diagnostic genetic tests and use these tests for patient care. Because information about gene sequences is so fundamental to understanding specific diseases, patent holders can essentially gain ownership of diseases through patents. Exclusive or restrictive license agreements on gene-based tests have been used to prevent physicians and clinical laboratories from performing genetic tests as diagnostic medical procedures. Patients suffer because diagnostic test services are less readily and affordably accessible.
Medical education and research related to laboratory testing also are threatened. The National Academy of Sciences Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation last year recommended in a report that policy-makers take appropriate steps to prevent the increasingly complex web of intellectual property protections from impeding potential breakthroughs in genomic and proteomic research. The report suggests several approaches to improving public access to patented inventions. Specifically, it recommends that Congress consider legislation to exempt research on certain aspects of patented technologies or inventions from patent-infringement liability, with the goal of promoting scientific discovery. The report also recommends that owners of the patented technology behind certain gene-based diagnostic tests should establish procedures that allow other clinicians to validate test results. If these patent holders do not take this step voluntarily, the report suggests that Congress consider, in the interest of public health, whether work to validate such results should be shielded from liability. This sole clinically-focused recommendation falls short, however, in recommending specific protections for physicians and other providers of clinical laboratory services against gene patent infringement enforcement. The College has supported policy recommendations and advocated for legislation in Congress that would extend certain protections to laboratory physicians.
In 1996, Congress recognized that medical procedure patents might impede the advancement of medicine, curtail academic access, place unreasonable limits on the research community, and interfere with medical education and the quality of care provided to the patient. As a result, in October 1996, legislation was signed into law (Frist-Ganske Amendment, 35 USC Sec. 287) that permanently precludes the filing of infringement suits against physicians and other medical practitioners for the performance of “medical activities” that would otherwise violate patents on medical or surgical procedures. A “medical activity” is broadly defined to include the performance of a medical or surgical procedure on a human body, organ or cadaver or on an animal used in medical research. However, the Act does not explicitly affect enforcement of biotechnology patents or extend to clinical laboratory services. With the advent of new and innovative approaches to gene based diagnostic testing, and the promise of enhanced and expanded diagnostic testing, laboratory services and clinicians should have the same protection from patent infringement as other medical providers and procedures.
Because of this oversight, medical practitioners who perform tests to diagnose genetic disease have received “cease and desist” notification letters from gene patent holder’s indicating that continued patient testing would be a patent infringement. Examples of diseases where testing has been halted due to patent enforcement include breast cancer, Alzheimer disease, Canavan disease, and Charcot-Marie-Tooth disease. To address this issue, the Frist-Ganske law should be amended to protect clinical laboratory medical practitioners from patent infringement - just as other medical providers are protected. This would ensure that gene based diagnostic test services, which are part of medical practice and increasingly important, can be performed without fear of reprisal for the benefit of patient care, medical training, and medical research. Additionally, the College supports H.R. 977, the Genomic Research and Accessibility Act, introduced by Congressman Xavier Becerra (D-CA) and Congressman Dave Weldon (R-FL) that would prohibit patents from being obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.
In summary, we are facing the unprecedented situation in which a single patent owner can prevent physicians throughout the country from performing diagnostic procedures that use certain gene-based tests. This sets an extraordinary and dangerous precedent for patients and all of medicine, and strays from the constitutional and social purpose of the patent system to promote progress. Therefore, the College believes that current practices in the patenting and licensing of genetic sequences must be reexamined to ensure that gene based diagnostic tests are widely available and affordable for the greatest public benefit.