Is a single human gene, isolated from its cell and chromosome, a natural product or a patentable piece of intellectual property? That's the question at the center of a case the Supreme Court could take up Tuesday.
The answer could have wide-reaching implications for the biotechnology sector, which relies on extensive research about genetic niches to create tailored therapies for small groups of people. If the fruits of such research could become essentially open-source, it could make many products a poor deal to develop. The industry believes that a ruling that genes cannot be patented could undermine many existing patents too.
The case, Association of Molecular Pathology v. Myriad Geneticcs, concerns one of the first effective genetic screening tests for cancer. Myriad isolated variations of two genes, BRCA1 and BRCA2, that can raise the risk of breast and ovarian cancer. Women use the tests to determine whether they are likely to develop tumors and many opt for enhanced screening or even prophylactic surgery if they learn they are positive.
Myriad has been protective of its discovery, and has taken legal action against other companies that pursued tests based on the same gene patterns. They have also kept the cost of testing high--the full genetic analysis costs about $3,000, more than some insurance companies are willing to spend.
The challengers in the case want to make their own tests. Myriad, which has patented both the isolated genes and the processes it uses to decode them, says they should have exclusive rights to the genes.
Patent law allows inventors to protect their creations, but the Supreme Court has recognized an exception for "products of nature." That exception means that companies can't patent naturally occurring plants or bacteria, say, though they can patent synthetic copies or genetically modified organisms.
The Court has not yet considered the question of a single gene. A district court in Washington, D.C., found for the plantiffs, saying that the gene was a "product of nature" and therefore unpatentable. But the Federal Circuit Court found for the inventors, ruling that the gene, once removed from the body and unbound from neighboring genetic material, was a discrete product.
The American Civil Liberties Union says Myriad's patent has stopped other companies from researching and testing the patented genes, increasing costs for patients. "We hope that the Supreme Court will take this opportunity to recognize that genes are indeed unpatentable 'products of nature,' and that the only person who can own your genes is you," the ACLU wrote in a blog post.
The Court is expected to announce Tuesday whether it will take the case.