Myriad held patents on two human genes in which mutations are known to be linked with higher risk of breast and ovarian cancers. The company's opponents celebrated the court's ruling to “free the genes” by invalidating five Myriad patents on specific techniques used to isolate cancer-causing genes, allowing women to get second opinions on test results and clearing the way for wide-open research on other genes and diseases.
“This decision really remedies a wrong,” said Karuna Jaggar, executive director of Breast Cancer Action, a San Francisco-based advocacy group that was among numerous organizations that sued Myriad to overturn the gene patents. “It is a discovery, not an invention. And discoveries are not patentable.”
Myriad emphasized to investors on Thursday that the ruling left in place 24 patents “conferring strong patent protection” for its breast-cancer gene test, BRACAnalysis.
“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,” Myriad President and CEO Peter Meldrum, said in a written statement. “While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients' rights to seek second opinion tests.”
Myriad was sued by the Association for Molecular Pathology and other organizations that claimed the company had no right to exercise zealous protection of its patent on two strands of DNA that expose women to higher risk of breast and ovarian cancers, known as BRCA1 and BRCA2. The company claimed its patent gave it the right to exclusively isolate the cancer-causing genes and create BRCA cDNA.
In an 18-page opinion dense with genetic science and patent law, the high court ruled Thursday morning that the company cannot hold a valid patent on the right to isolate a naturally occurring human gene, even if it used groundbreaking scientific techniques to discover it. However, the cDNA is a product of laboratory science involving the creation of a new string of molecules that can be used exclusively by the company, the court ruled.
For about 15 years, Myriad has been selling an expensive test based on the genes that determines whether stricken women have variants of the disease susceptible to drugs that target those mutations. The company had argued that patent protection is necessary to conduct research and bring new products to market.
Most insurers have opted to cover the Myriad test, which costs $3,340—a price that has doubled in the past 15 years, even though a supplementary test developed to look for additional mutations in 2006 costs $700 and is covered by most insurance plans.
Movie star Angelina Jolie drew a frenzy of attention to the science when she publicized her decision to undergo a preventive double mastectomy based on a positive result from the test.
Not all patented genes are subject to the same level of intellectual property skirmishes.
The Huntington's disease gene is patented, but patients who have the symptoms of the disease can take a single genetic test that costs between $300 and $500 to learn whether they carry the gene for the rare genetic disease. Because there is no patent enforcement, there are at least 50 laboratories in the U.S. offering to test for the gene, which is the likely reason for its relatively low cost.
