Angelina Jolie’s decision to undergo a preventive double mastectomy has shone the actress's megawatt starpower on the genetics of cancer and on the difficult decisions that patients, and those with family histories of the disease, face. Yet it also renewed attention on Myriad Genetics (NASDAQ: MYGN), a Salt Lake City-based biotech that developed and markets the test for the BRCA1 and BRCA2 genes linked to breast cancer. Myriad is the only company that provides that key genetic test – and it has maintained that distinction, along with the ability to charge thousands of dollars for the testing, because it holds patents on those BRCA genes.
Those controversial patents – and Myriad Genetics’ ability to profit from them – are at the heart of a legal battle that started in 2009 and is expected to be decided within weeks by the U.S. Supreme Court. At issue in the case, Association for Molecular Pathology v. Myriad Genetics, Inc., is a fundamental question in an age of rapid biotech advances: Can human genes – those sequences of DNA in your body – be patented? The Supreme Court heard arguments in the case on April 15 and is expected to issue its ruling by late June.
The plaintiffs in the case, including the Association for Molecular Pathology (AMP), the American Civil Liberties Union (ACLU), other advocacy groups and patients contend that Myriad should not be allowed to patent the genes because its researchers merely located items found in nature and did not modify them. The plaintiffs also argued that permitting companies to hold such patents has severe implications for science and for patients.
“The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented,” the ACLU argued in a press release this month. “A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.”
The plaintiffs say that Myriad’s monopoly over the genes has made important medical testing more expensive than it would otherwise be. “Myriad's monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results,” the ACLU said in a statement released on the day the Supreme Court heard oral arguments. “It also allows Myriad to prevent researchers from even looking at the genes without first getting permission from Myriad.”
In other words, invalidating Myriad’s patents could help make the screening test available to more women who don’t have the resources of, say, an Angelina Jolie – a concern that the actress herself raised in her op-ed. “It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live,” she wrote. “The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women.”
Myriad Genetics counters that it isolated the genes in question outside their location in our cells and argues that patent protection is necessary to encourage such research and innovation. The company says that it invested some $500 million in developing the genetic test and making it available to the 1 million people who have benefitted from it so far, or some 250,000 a year now. “Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection,” Myriad CEO Peter D. Meldrum said in a statement before the court hearing last month. Over the first three months of 2013, Myriad’s revenue from the BRACAnalysis test totaled $115.4 million, or 74 percent of the company’s total revenue for the period.
Myriad also says that 95 percent of patients in the U.S. have access to the testing through private insurance or other health-care coverage, and that the average out-of-pocket expense to patients is $100. Earlier this year the company heralded clarification from the government that the BRCA testing would be covered for high-risk patients as a preventive service under the Affordable Care Act.
While the Roberts court, with a reputation for being friendly to business, weighs those considerations, the debate will continue – and now, thanks to Jolie, women all across the country may be paying more attention.