Gene patents: the fight drags on
In 1994, the University of Utah, the National Institute of Environmental Health Science (NIEHS), and Myraid Genetics decoded the sequence of the BRCA1 gene and patented it later that year. Identification and patenting of BRCA2 soon followed in 1995. These were not the first genes to be patented. In fact, four years earlier, in 1990, the cystic fibrosis gene was patented.
Why is this important? BRCA1 and BRCA2 (Breast Cancer susceptibility gene 1 & 2) belong to a group of genes knows as tumor suppressors. Women that inherit a harmful mutation of one or both of these genes have a greatly increased lifetime risk of developing breast and/or ovarian cancer (among others). Therefore, in women with increased risk due to family history, genetic testing for mutations in these genes, and subsequent cancer risk management, could save lives.
In the almost 20 years since the genes were patented, Myriad Genomics has been the sole provider of BRCA genetic testing. Their patents, of which they hold many, have prevented the creation of any additional genetic tests for BRCA, and this has stirred a long debate over the legal right to patent a gene. Can a stretch of DNA that occurs naturally in every single body be owned by an individual or a company?
On June 13, 2013, the Supreme Court published their decision on this matter. (The case was officially the Association for Molecular Pathology vs Myriad Genetics.) Their ruling negated the patent held by Myriad by determining that a naturally occurring product (like DNA) cannot be patented. However, they did rule that modifications or manipulations to DNA that are not naturally occurring could be protected under patents.
The hope was that after this ruling, more and cheaper tests would soon be available; and it seemed that this might be the case when two companies, Ambry Genetics Corp and Gene by Gene Ltd, developed new tests. Unfortunately, on July 12, Myriad filed suit against these two companies for patent infringement and effectively halted progress.
On July 12, Congress added an interesting twist to the story and entered the debate. Senator Leahy (D-Vt) wrote a letter to Dr. Francis Collins, the director of the National Institutes of Health (NIH), urging him to consider “march-in rights” in the Bayh-Dole Act. The Bayh-Dole Act allows researchers and universities to patent their research findings to increase the development of products for the public. The “march-in rights” would allow the government, presumably NIH in this case, to award a license to another company that allows them to develop a new BRCA test. According to Mr. Leahy’s letter, “the government can require the patent holder to grant a license [to another company] for the patent on reasonable terms.” Furthermore, “If the patent owner refuses, the government can directly license the patent in limited circumstances, including if it “is necessary to alleviate health or safety needs which are not reasonably satisfied” by the patentee.”
It seems that greater availability and affordability of BRCA testing for women at high risk of developing cancer is a pretty significant “health or safety need”. This brings forward the question of whether the government has the right to issue licenses that break patents. Cheaper tests that potentially save the lives of women are needed, but will this approach finally break the impasse?
This blog does not necessarily reflect the views of AAAS, its Council, Board of Directors, officers, or members. AAAS is not responsible for the accuracy of this material. AAAS has made this material available as a public service, but this does not constitute endorsement by the association.