The US Supreme Court’s ruling last year against Myriad Genetics’ patents on BRCA1 and BRCA2 has resulted in a dramatic expansion of genetic breast and ovarian cancer susceptibility testing services. However, the ruling was not the final word on cancer gene patents—or even BRCA patents. Since the Supreme Court’s decision, Myriad has filed new patent-infringement lawsuits against several labs that now offer BRCA testing. Although dire predictions about the Supreme Court’s ruling on the biotech industry and health care have not come to pass, questions remain regarding the sequence-interpreting experience of the new crop of BRCA testing labs and the quality of the public databases on which they rely.
Last June, the US Supreme Court ruled in a 9-0 decision that naturally occurring DNA sequences are a product of nature that are not eligible for patent protection as inventions, regardless of them being isolated in the lab.1 Literally overnight, Myriad’s market exclusivity was history; the company’s BRACAnalysis® suite was no longer the only option for determining whether or not a woman carries the BRCA1 or BRCA2 mutations that increase the risk of breast and ovarian cancers. The mutations account for the majority of hereditary cases of those two malignancies.
Before the ruling, dire warnings were voiced by critics and proponents of gene patents alike. Critics worried that gene patents—particularly those that claimed that not just a given loci but also related oligonucleotides—could stifle research and the development of new genetic diagnostic tests.2,3 Gene patent proponents, on the other hand, warned that a ruling against Myriad could hurt not only that company and its partners but the multibillion dollar biotechnology industry. According to some estimates, at least one-fifth of human genes have been patented, so it seemed plausible that a ruling against Myriad could send shockwaves through the industry, with important implications for future development of clinical gene analysis-based tools.2
“The decision could have the potential to hurt the industry and patients,” said Myriad’s Vice President of Corporate Communications, Ron Rogers. Myriad spent $500 million to develop BRACAnalysis® and make it widely accessible to patients, he said. “Companies aren’t going to make these kinds of capital investments in the future if they can’t be sure they’ll have a return on that investment,” he said.
The Supreme Court ruling was relatively narrow, however, specifically rejecting patent claims for the isolation of naturally occurring DNA sequences but not affecting Myriad’s process-based patents and licenses. The company’s patent applications for RAD51c, for example—another gene associated with breast and ovarian cancers—describe processing and testing methods rather than DNA sequences.4
Myriad argues that its patent claims for BRCA1 and BRCA2 are also “valid and enforceable” on other grounds than the naturally occurring gene sequences, Rogers noted. The company has filed new lawsuits over the BRCA testing process used by Ambry, Quest, and others, which Myriad claims infringe on its patents.
If Myriad prevails in these newer lawsuits, clinicians and patients might well wind up back at square one, with only one lab offering the tests, said Wendy Chung, MD, PhD, director of Clinical Genetics at Columbia University in New York, NY. But she believes that is unlikely to happen.
Meanwhile, other labs continue to offer BRCA testing, “but they are under the shadow of the lawsuits and spending tremendous amounts of money trying to defend themselves,” Dr. Chung explained.