Gene Patenting Ruling a Victory for Common Sense

Wasserman Schultz tested BRCA2 positive, a gene at the heart of the case

WASHINGTON – Today the United States Supreme Court ruled in the case of Association of Molecular Pathology vs. Myriad Genetics that patents cannot be held on naturally occurring genes. This ruling has broad ramifications for cancer patients, and individuals seeking to learn more about their genetic risk for disease.

“Having gone through the devastating experience of making life-altering decisions based on the results of one test, I believe that the Supreme Court’s decision is a victory for everyone who believes that a company cannot patent parts of our body,” said U.S. Rep. Debbie Wasserman Schultz (FL-23).

“This decision ends this practice, giving patients new options to learn of and verify their genetic risks. Thanks to the Supreme Court, our nation’s research institutions and medical professionals can perform second opinion testing to confirm gene mutations aiding individuals and doctors with more information when making life-altering decisions, as I did, having a double mastectomy and my ovaries removed.”

The unanimous decision struck down patents held by Myriad Genetics Inc. on two genes, BRCA1 and BRCA2, mutations of which are linked to dramatically increased risks of breast and ovarian cancer.

Today’s ruling should bring down the cost of BRCA1 and BRCA2 testing, as other companies will be able to enter the market. Previously, only Myriad Genetics, or companies with a license from Myriad Genetics, could do research and administer a test to see if gene mutations were present.

Wasserman Schultz was tested for the BRCA gene mutations when she was diagnosed with breast cancer and was found to have a mutation in the BRCA-2 gene, making her much more likely to have recurrences of breast cancer and putting her at a high risk of ovarian cancer. Patients with a BRCA mutation have as high as an 85 percent lifetime risk of getting breast cancer and are over 40 times more likely to develop ovarian cancer.

Like many women facing decisions based on BRCA test results, Wasserman Schultz had to make the very personal and life-altering decision to undergo seven surgeries based on one test from one company, without the option of getting a second opinion test.

“Because one company had a patent on the BRCA1 and BRCA2 genes, I was unable to get a second opinion on the test,” said Wasserman Schultz. “Despite the fact that we’re all born with these genes, a private company had patented them. These patents had broad practical ramifications, preventing competition in testing for the gene mutations, second opinion testing, and restricting access to data on testing results for other researchers.”

Legislatively, Wasserman Schultz introduced and passed legislation in 2011 requiring the U.S. Patent and Trademark Office (USPTO) to conduct a study on ways to remove barriers for patients to get access to second opinions on genetic testing. The USPTO has recently completed their work on the study, which should be released this summer. The study results could help provide legislative recommendations for ways to protect patients and doctors seeking second opinions.

“Thanks to today’s Supreme Court decision, I look forward to working with my colleagues to further increase access to health care and genetic information for patients across the country,” Wasserman Schultz said.

Wasserman Schultz will base her follow-up legislation on the Supreme Court ruling today and the recommendations from the USPTO study.