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Clinical Laboratories and Pathology Groups

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Pathologists already find it difficult to obtain gene patent licenses needed to offer multi-gene molecular diagnostic tests

Patents on human genes are a major issue in pathology and clinical laboratory testing. Now a new report based on the study of the positive and negative consequences of gene patenting comes to the conclusion that patents on human genes tend to deter competition in the gene testing market more than they encourage further development of new technologies for measuring the risk of disease.

Medical science is on the brink of mainstreaming genetic discovery into patient care. But patents and exclusive licensing threaten to fragment ownership of the human genome and derail the promise of personalized medicine for everyone, observed James P. Evans, M.D., Ph.D., Clinical Professor of Genetics at the University of North Carolina-Chapel Hill,  in his commentary on a new report from Duke University that focused on the impact of patenting and exclusive licensing of human genes.

Patents on human genes are a major issue in pathology and clinical laboratory testing.

Patents on human genes are a major issue in pathology and clinical laboratory testing.

Case studies looked at the impact of human gene patents on 10 clinical conditions. These included: breast and ovarian cancers, colon cancers, Alzheimer disease, cystic fibrosis, hearing loss, hereditary hemochromatosis, long QT syndrome, spinocerebellar ataxia, Tay-Sachs disease, and Canavan disease. The findings of this research were published in the April issue of the journal, Genetics in Medicine.

Over the last two decades, more than 20% of the human genome, or about 4,000 genes, has been patented to universities, companies and other parties, noted study lead Dr. Robert Cook-Deegan, M.D., Director of Duke’s Institute for Genome Sciences & Policy.  He pointed out that if hundreds or thousands of patents are issued or exclusively licensed: “How will you offer full-gene sequencing without getting sued?”

Patenting human and animal genes has been controversial since the first genetic patent was issued in the 1980s. Opponents argue that genes are products of nature and fall outside the realm of things that can be patented. Proponents contend these intellectual assets attract investors to launch start-up companies. Without patent protection companies could not raise the capital needed to advance discovery, innovation and delivery of genetic-based diagnostic tests and treatments.

The Duke study, which was commissioned by the Secretary’s (Health and Human Services) Advisory Committee on Genetics, Health and Society, suggests, however, that patents and exclusive licensing deter competition in the gene testing market, rather than furthering development of new technologies for measuring risk for disease. Additionally, scientists and researchers interviewed seemed ambivalent about patenting and none of these experts believed that patenting of human genes was a main incentive in fueling the race to trace the genetic origins of diseases. “The races were driven by wanting scientific discovery, prestige and scientific credit, and the ability to secure funding for additional research based on scientific achievement,” reported the researchers.

For example, Cook-Deegan pointed out, “It’s notable that a gene linked to cystic fibrosis is not subject to an exclusive license, yet there is now a vibrant market for tests to identify carriers of the cystic fibrosis gene. This suggests the problem is not patents, per se, but how they are being licensed, particularly by universities.”

Scientists and researchers interviewed during this study also raised another concern. Because patent holders often grant an exclusive license to a single laboratory provider to conduct tests for certain diseases, this restricts the ability for patients and physicians to obtain second opinions. It also raises concerns over quality, since quality assurance would be unavailable in the context of a single lab provider, warned Evans. “Clinicians who are concerned about a certain laboratory have no alternative to choose from,” he said. “This allows the laboratory [holding the patent or proprietary testing license], rather than the patients, to define the terms of testing.”

Furthermore, Evans noted that exclusive licensing could deny some patients access to testing. For instance, if exclusive providers fail to contract with insurers, such as state Medicaid programs, those patients would not have access to genetic tests.

This study came on the heels of a ruling by a U.S. District Court that struck down patents jointly owned by Salt Lake City-based Myriad Genetics and the University of Utah Research Foundation for BRAC1 and BRAC2, the genes linked to breast and ovarian cancers, respectively. Judge Robert W. Sweet ruled that the patents were “improperly granted because they involve a “law of nature.”

He suggested that the notion that isolating a gene makes it patentable is a “‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.” (See Dark Daily, March 31, 2010, Federal Judge Invalidates Myriad’s Patents for BRCA Genes.) If upheld, Judge Sweet’s ruling would set a precedent that may cast doubt on patents for thousands of genes and alter intellectual property law.

Most pathologists and clinical laboratory managers are likely to agree with the findings of this Duke University study on how patents on human genes do more to create monopolies on the clinical laboratory tests that incorporate these genes. With the advent of cheap, fast, and accurate rapid sequencing of the whole human genome, patents on individual genes will be make it challenging, if not impossible, to obtain all the licenses needed by a clinical laboratory to perform multi-gene diagnostic and molecular tests.

Related Information:

Putting Patients Before Patents

Patently Complicated: Case Studies on the Impact of Patenting and Licensing on Clinical Access to Genetic Testing in the United States

Duke Study Says Claims Staked on Genome Could Derail Promise of New Technology

Report finds gene patents prevent competition, don’t promote advancement

Judge Invalidates Human Gene Patent