College of American Pathologists

  Statement to the Secretary’s
  Advisory Committee
  on Genetics, Health and Society


June 26-27, 2006

Submitted by the College of American Pathologists

Good afternoon. My name is Dr. Carol Ann Rauch, I am Medical Director of Microbiology and Chief of Clinical Pathology at Baystate Medical Center. I am here today on behalf of the College of American Pathologists to follow-up on written testimony the College provided to SACGHS prior to your discussion on Gene Patents in March of this year. The College appreciates the opportunity to appear before you today and provide our perspectives on DNA-based patents and licensing practice and their effect on access to quality laboratory tests.

The College of American Pathologists is a national medical specialty society representing more than 16,000 pathologists who practice anatomic pathology and laboratory medicine in laboratories worldwide. The College’s Commission on Laboratory Accreditation is responsible for accrediting more than 6,000 laboratories here and abroad. College members have extensive expertise in providing and directing laboratory services and serve as inspectors in the laboratory accreditation program. The College has been a leader in developing quality improvement programs for laboratories, including programs in molecular pathology and cytogenetics.

We are in the midst of a scientific revolution in genetics that promises extraordinary advances in clinical medicine. As the medical specialists in the diagnosis of disease, College members recognize that genetic testing is an area of growth and change for pathology and medical practice in the decades to come. 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 recent 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.

Physicians and scientists can easily and rapidly translate the fundamental information derived from mapping 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. In fact, College members have received “cease and desist” notification letters from patent holders or exclusive licensees indicating that continued patient testing would be 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.

The College, like SACGHS, was awaiting the completion of the study by the National Academy of Sciences (NAS) Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation and its subsequent recommendations. The College provided testimony to the NAS Committee towards the development of the report. The study recommends 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.

The College and others provided significant information in the development of the NAS study that warrants the need to provide protection for the medical use of genetic information, including for laboratory testing. The NAS report clearly outlines the concerns the committee identified regarding the negative impact of gene patents on medical practice; however, the NAS Committee did not provide recommendations to address the data gathered. We, therefore, ask the SACGHS to carefully review the information provided in the report on the clinical impact of gene patents, consider further investigation of this impact, and develop recommendations for the Secretary of HHS to address the growing negative impact of gene patents on clinical testing in the United States.

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.

Thank you for your time, I am happy to answer any questions.