Can Genes be Patented?

The United States Patent and Trademark Office has issued over 40, 000 patents on sequences of human DNA. Experts estimate that 20% of the human genome is now covered under patents held by academic institutions, private biotechnology companies and the diagnostic development industry.   Last year the American Civil Liberties Union (ACLU) filed suit against Myriad Genetics and the University of Utah on behalf of five cancer patients. Myriad holds exclusive patents on the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancers. The suit was prompted by patients who sought confirmatory testing for their BRCA1 and 2 test results. Myriad exercises exclusive patent rights, so they are the sole provider of BRCA1 and 2 analyses nationwide. The ACLU argued that Myriad’s patents restrict patient access to genetic testing and create a monopoly that limits options and drives up costs. The suit further contends that such patents are contrary to patent law because genes are products of nature. The lawsuit is supported by prominent scientific organizations, including the Association for Molecular Pathology as lead plaintiff, and the College of American Pathologists, the American Society for Clinical Pathology and the American College of Medical Genetics.   On March 29 of this year, New York District Court Judge Robert Sweet ruled against Myriad Genetics, invalidating seven patents related to the two genes. In a carefully rendered decision, Judge Sweet recognized the larger question of whether human genes can be patented even if, as Myriad argued, laboratory techniques are used to extract them from blood or tissues. Judge Sweet wrote, “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes”.   Myriad intends to appeal and the case may ultimately reach the Supreme Court. A final decision will have major implications for both individuals and society. If Myriad’s patents are upheld, most of the human genome will eventually be under patent protection. The availability, timeliness and cost of medical genetic testing would be controlled by large commercial laboratories and the diagnostic industry. Some patent holders would maintain exclusive testing services, such as Myriad does with BRCA1 and 2, and Clinical Data Inc does with long-QT syndrome. Others would develop and exclusively market diagnostic testing products that laboratories must use, whether or not the tests perform to the laboratory’s quality standards. These scenarios currently exist and would proliferate as patent protection expands. The cost of developing tests for multiple genes covered by multiple patents could be prohibitive.   If Judge Sweet’s decision is upheld by higher courts, most gene patents will ultimately be overturned. Patients and physicians would benefit from wider access to less expensive genetic tests. The quality of genetic testing in regulated clinical laboratories would be as good as or better than what is currently available, and inconsistent or questionable results could be confirmed. An unrestricted exchange of scientific information and ideas could produce innovative ways to apply genetic knowledge to the field of medicine. However, biotechnology and diagnostic companies that now base their business plans on gene patents maintain that denial of patent protection would stifle research and development.   The personal, medical and economic aspects of gene patenting will continue to be debated, but the basic question remains – who invented, discovered and owns our genes?
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