NYC Healthcare News

Gene patenting policies affect patient access to testing for disease-causing genes: Study

September 06, 2015

The case studies illustrate several ways in which gene patents have the potential to cause harm to patients. The foremost example occurs when patent holders retain exclusive rights or issue exclusive patents, allowing only a single laboratory to perform a certain test??this was the case with the BRCA1/2 patents. "In such circumstances, patient access to testing can suffer??leaving patients without the option of a given genetic test should it be recommended by their provider," Dr. Evans writes. Such exclusive licenses also raise concerns about quality control and the ability to obtain second opinion testing.

The supplement is freely available on the Genetics in Medicine website: geneticsinmedicine. In addition to breast and ovarian cancer, the case studies address gene patents related to colon cancer, Alzheimer's disease, cystic fibrosis, hearing loss, hereditary hemochromatosis, long QT syndrome, spinocerebellar ataxia, Tay-Sachs disease, and Canavan disease.

The case of cystic fibrosis provides a key example that "gene patents and the lure of exclusivity are not needed for the development and wide availability of genetic diagnostic tests," according to Dr. Evans. The laboratories that first cloned the CFTR gene 20 years ago worked to ensure broad licensing, allowing many laboratories to compete in terms of "service, innovation, and quality." Dr. Evans adds that, in all of the case studies, the company that held exclusive intellectual property rights to a gene was not the first to develop a test.

Despite the landmark decision, the debate over gene patents is likely to continue in the years ahead. Patent rules for health-related issues should be different from those for "mere commodities," and benefit to patients should be "the final arbiter of policy," according to Dr. Evans.

SOURCE Genetics in Medicine