In 2013 the U.S. Supreme Court issued a mixed ruling rejecting 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.
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 United States. 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 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 was patent eligible. Myriad will no longer be the sole option for patients desiring BRCA testing and other medical professionals are free to remove the genes for diagnostic testing. The Court’s ruling upholding synthetic DNA, or cDNA, leaves unanswered questions regarding the impact of patents on synthetic DNA or whether cDNA meets other standards of patentability. The Court also left unanswered which applications of new knowledge about the BRCA1 and BRCA2 genes are patent eligible.
Almost immediately after the Court’s ruling, several laboratories announced they would begin offering BRCA genetic testing at a fraction of the cost that Myriad had been charging. Myriad moved for a preliminary injunction preventing these new tests, invoking different patents than those that had been decided in the earlier ruling. AARP filed a new round of friend-of-the-court briefs arguing that the new patent claims are invalid as decided by the Supreme Court, that a preliminary injunction would violate both patent law and first amendment protections (by granting Myriad exclusive right over a body of knowledge).
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.
Five other district court patent cases on the same or similar issues have been transferred to the Utah District Court to be coordinated or consolidated with Univ. of Utah Research Found. v. Ambry Genetics under the collective case name BRCA1 and BRCA2 Based Hereditary Cancer Test Patent Litigation. An additional three cases are expected to be transferred in the future. The case Univ. of Utah Research Found. v. Gene by Gene was dismissed after the parties reached a settlement agreement.