In 2013, the U.S. Supreme Court rejected a patent giving Myriad the exclusive right to test and isolate breast and ovarian cancer genes while leaving unanswered questions regarding patenting of synthetically created genes. As the fallout from this ruling continues to reverberate, AARP successfully urged a federal court to refuse to halt sales of alternative diagnostic tests.
Myriad Genetics held exclusive patents on two human genes (BRCA1 and BRCA2) that relate to a person’s predisposition to developing breast and ovarian cancer. Because of those patents, Myriad was the only provider of BRCA genetic testing in the U.S. Myriad prohibited other labs and medical professionals from conducting tests on BRCA1 and BRCA2 genes, limiting the ability to get second opinions and keeping the price of these tests high — about $3,000 to $4,000.
A woman’s risk of developing breast and/or ovarian cancer is greatly increased if she inherits a BRCA1 or BRCA2 mutation. Individuals whose families have a history of cancer can benefit by a genetic blood test to determine if they have the mutation, and early detection opens several options including preemptive surgery.
A coalition of nonprofit organizations, scientists, professors, genetic counselors, and individuals at high risk for hereditary breast and ovarian cancer challenged Myriad’s patents, arguing that human genes and DNA molecules are natural phenomena that are not the kind of “discovery” covered by patent laws. AARP Foundation Litigation attorneys filed AARP’s friend-of-the-court briefs (five in all) pointing out that patent law did not envision patenting natural phenomena and that such patents stifle scientific research for cures, elevate the already high cost of genetic testing, and limit patient access to potentially life-saving tests.
The Supreme Court unanimously ruled that discovering a human gene and removing (isolating) the gene from the human body was not patent eligible but that creating a synthetic version of the gene might be patent eligible. After the Court decision was announced, five laboratories announced they would begin offering BRCA testing to patients giving patients an option for a second opinion and less expensive diagnostic tests. The Court’s ruling did leave unanswered questions regarding the impact of patents on synthetic DNA or whether DNA meets other standards of patentability.
In an attempt to hold onto its monopoly Myriad took legal action against some, but not all competitors and moved for a preliminary injunction preventing these new tests, invoking different patents than those that had been decided in the earlier ruling. AARP joined with the ACLU, the Public Patent Foundation, Breast Cancer Action and the Association for Molecular Pathology and filed a new friend-of-the-court brief arguing that the new patent claims are invalid as decided by the Supreme Court and that a preliminary injunction would violate both patent law and first amendment protections
On March 10, 2014, a federal district court rejected Myriad’s motion to enjoin sales of Ambry’s competitive cancer-testing test while the litigation is pending. The court found that Myriad had not shown the substantial likelihood of success on the merits that an injunction requires, a very favorable signal in the ongoing litigation. Although the case is not over, the decision allows patients to choose other genetic testing providers.
What’s at Stake
This case will impact the cost and availability of genetic tests. Genetic diagnostic tests can determine how a patient will respond to a specific drug or a patient’s risk for developing a number of diseases.
Myriad sought an immediate appeal of the preliminary injunction decision. University of Utah Research Foundation v. Ambry Genetics is pending in the Federal Circuit Court of Appeals.