With both parties in the gene patent case recently decided by the U.S. Supreme Court declaring victory, the ultimate consequences of the ruling for labs and for biotechnology companies remain unclear. The court ruled on June 13 that isolated DNA cannot be patented, invalidating five Myriad Genetics patents related to BRCA1 and BRCA2 genes. Mutations in these genes confer increased risk of breast and ovarian cancers. However, the court upheld the patent eligibility of so-called complementary DNA (cDNA)—because cDNA is "not naturally occurring."
Within hours of the ruling, Houston-based DNATraits said it would offer BRCA testing for $995, about a third of what Myriad had been charging. Several other commercial and academic labs also promptly announced their intention to launch BRCA testing, including Quest Diagnostics, Bio-Reference Laboratories, Ambry Genetics, the University of Washington, and Montefiore Medical Center.
A Quest spokesperson told CLN the company was very interested in offering BRCA testing. "Based on our initial review of the Court's decision, we expect it will open opportunities for Quest Diagnostics to develop new testing services, including in the area of hereditary breast cancer," said Quest Diagnostic media relations director Wendy Bost. "We now intend to validate and offer a BRCA1 and BRCA2 test service later this year."
The American Civil Liberties Union (ACLU), which lead the suit against Myriad along with the Association for Molecular Pathology (AMP), declared the ruling a victory for patients, some of whom have paid $3,000 or more out-of-pocket when insurers would not cover Myriad's exclusive test. "Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the ACLU Women's Rights Project in a statement. "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." AMP lauded the court's decision as a critical turning point for the future of medicine.
Francis Collins, MD, PhD, director of the National Institutes of Health, also expressed his approval and suggested the decision would be a boon to genomic research. "The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care," he said. "The right to control exclusively the use of a patient's genes could have made it more difficult to access new tests and treatments that rely on novel technologies that can quickly determine the sequence of any of the estimated 20,000 genes in the human genome. Such approaches form the cornerstone of the rapidly emerging field of personalized medicine, in which diagnostic, therapeutic, and preventive strategies can be tailored to each person's unique genetic makeup."
Just how successfully other labs will be able to maneuver around Myriad's other BRCA-related patents remains to be seen. Currently, labs looking to conduct their own testing are focusing on next-generation sequencing, a step ahead of Myriad's proprietary BRACAnalysis test. A spokesperson for the Albert Einstein College of Medicine confirmed that the college's Montefiore Medical Center in Bronx, N.Y., plans to launch BRCA testing by the end of 2013 using Ion Torrent's semiconductor sequencing method. Harry Osterer, MD, a professor of pathology and of genetics at Albert Einstein College of Medicine and director of genetic and genomic testing at Montefiore Medical Center, joined AMP, ACLU, and others as a plaintiff in the lawsuit against Myriad in 2009.
According to Kevin Ellich, a senior research analyst for investment bank Piper Jaffray, both Quest and LabCorp could offer competing BRCA tests. "While it remains unclear how each company will get around [Myriad's] intellectual property or if they will wait for the foundational patents to expire, we believe the decision will allow each company to develop a test. However, it is difficult to know the timing and how meaningful the test could be," Ellich wrote in a note to investors.
For its part, Myriad played down the impact of the ruling, expressing confidence that its hundreds of other, unaffected patents would preserve the company's leading role in BRCA testing. "We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Myriad president and CEO Peter Meldrum in a statement after the ruling.
Even before the Supreme Court ruled on the case, Myriad seemed unconcerned. In a routine May 31 Securities and Exchange Commission filing, the company reminded investors that it held more than 500 claims under 24 patents, as well as proprietary technologies and information not subject to the lawsuit. "Accordingly, we do not believe that this lawsuit will have a material adverse impact on our business, financial position, or results of operations," the report stated.