Tag: Ovarian Cancer

In a rare unanimous decision, the US Supreme Court ruled that human genes cannot be patented:

The case, AMP v. Myriad Genetics, revolved around Utah corporation Myriad Genetics’ exclusive patents on the BRCA1 and BRCA2 genes, which, when mutated, lead to a very high risk of breast and ovarian cancer. Because Myriad was the first to identify the BRCA genes, it patented them, charged exorbitant prices for BRCA testing, and then aggressively prevented any other labs from offering the same test. In 2009, a coalition of plaintiffs including the ACLU, Breast Cancer Action and a number of scientific organizations, researchers and patients sued Myriad, claiming that it had no legal right to hold patents on the BRCA genes.

In a majority decision written by Clarence Thomas, the court affirmed the plaintiffs’ claim that because DNA is naturally occurring, it “lie(s) beyond the domain of patent protection.” In so deciding, the court effectively reversed decades worth of policy by the US Patent and Trade Office, which has granted thousands of gene patents, many of which should now be rendered invalid.

The Court refuted Myriad’s claim that because it had put a lot of time and money into locating the gene, that it therefore deserved a patent: “extensive effort alone is insufficient” to make something patent-worthy. Basically, just because you tried really hard doesn’t mean that you deserve a multi-billion dollar legal monopoly.

This is great news for women, men, doctors, scientists and the world in the fight against breast and ovarian cancer. In a New York Times article about the impact of the ruling, other research companies said they would begin offering genetic testing which would bring down the cost and availability of the test, as well as, other tests held by patents:

Some experts say that other genetic tests that are exclusively controlled by a patent holder include the test for spinal muscular atrophy and the test for an inherited form of deafness.

Dr. (Sherri) Bale of GeneDx said the deafness gene also caused a skin disease. Her company is allowed to test for mutations that cause the skin disease, but if it discovers a mutation for hearing loss, it cannot tell the doctor. Instead, a new blood sample has to be drawn and sent to Athena Diagnostics, which controls the testing for the deafness gene. Dr. Bale said the court’s decision should eliminate the need for that arrangement.

It is often said that patents cover 4,000 human genes, or about 20 percent of all human genes, meaning the decision could have a large impact.

Amy Goodman and Juan Gonzalez of Democracy Now, in a discussion of the ruling, were joined by Judge Robert Sweet, the senior federal judge for the Southern District of New York who originally invalidated Myriad Genetics’ patents; Lisbeth Ceriani, one of the plaintiffs in the ACLU lawsuit. In May 2008, she was diagnosed with an aggressive form of breast cancer; and Sandra Park, a senior attorney with the ACLU’s Women’s Rights Project and a lead counsel on the case.

“With the ruling today, we fully expect much better access and much better options for patients, as well as for scientists who want to look at different parts of the genome,” Park says. “They no longer now need to deal with patents on the thousands of genes on our genome when they’re engaging in their scientific work.”