What if one company was granted complete control over a gene contained in the human body? What if mutations in that gene could increase the risk of certain cancers by an average of 65%, yet the company could price a test for such mutations at more than $3,000?1
That was the reality for many women with a strong family history of breast cancer—including actress Angelina Jolie, who recently brought the issue into the public eye by announcing she had a preventive double mastectomy because she carried the BRCA1 gene mutation—until the Supreme Court ruled last week that human genes cannot be patented.
This ruling brought Myriad Genetics Inc.’s three-decade-long patent on the BRCA gene crashing to the ground while, at the same time, other companies rushed in to pick up the pieces with high hopes of potentially improving oncology practices and access to care.
In what may be a field-changing decision, Justice Clarence Thomas decided that Myriad’s claim—that the DNA it isolated for its breast and ovarian cancer tests were patentable—was in violation of patent rules because laws of nature, natural phenomena, and abstract ideas are not patentable.
“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, a lawyer for the American Civil Liberties Union Women’s Rights Project. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.”
So what does this mean for the practice of oncology?
1. Lower Cost, More Options for BRCA Gene Testing
Just hours after the patent for the BRCA gene was removed, one company—DNATraits, part of Houston-based Gene By Gene, Ltd.—stepped in to offer BRCA testing for $995, less than one third of the current price. Quest Diagnostics Inc. also said it would start selling these genetic tests later this year.
Lower-priced tests have the potential to help countless women who live in fear of developing cancer but could not justify the high price tag previously associated with testing. More at-risk women can now be tested, too; according to a 2012 study, 348,000 women in the United States carry at least one of the BRCA genes, but less than 50,000 have been identified through testing.2
2. Increased BRCA Research
With the previous patent in place, scientists were legally very limited in conducting research on the connection between cancer and BRCA genes. Now, the doors are wide open with the potential to uncover even more information about this topic.
3. Certain Patents Still Prevail
The ruling was only a partial victory to the oncology world: the Supreme Court also ruled that cDNA, a synthetically produced genetic material made by scientists, could be patented. This will likely continue to limit the use of cDNA in cancer research, such as a cDNA microarray to analyze cancer gene expression.
4. Interest in Preventive Mastectomies
Greater access to BRCA testing, coupled with Angelina Jolie’s endorsement of preventative mastectomies for women who carry the BRCA gene mutation, may encourage more women to inquire about whether they need to be tested and, furthermore, to ask about similar surgeries if they are found to have the gene and are appropriate candidates.
The long-term implications of this ruling will emerge with time, but for now, more equal access to BRCA testing is a major step towards eliminating healthcare disparities in the breast cancer arena in the foreseeable future.
1. Hereditary Breast Ovarian Cancer Syndrome (BRCA1 / BRCA2). Stanford Medicine Cancer Institute. http://cancer.stanford.edu/information/geneticsAndCancer/types/herbocs.html. Accessed June 24, 2013.
2. Drohan B, Roche CA, Cusack JC Jr, et al. Hereditary breast and ovarian cancer and other hereditary syndromes: using technology to identify carriers. Ann Surg Oncol. 2012;19(6):1732-1737.