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Supreme Court to reconsider Myriad’s gene patents

The Supreme Court has agreed to review an appellate court’s 2-1 ruling upholding Myriad Genetics’ patents on two human genes associated with hereditary breast and ovarian cancer.

The 30 November move was celebrated by a group of geneticists, patients, and scientific organisations that filed a law suit in 2010, charging that the BRCA 1 and BRCA 2 gene patents are unconstitutional and invalid.

In July 2011 the appeals court ruled that companies can patent genes but cannot patent methods to compare those gene sequences. Now the Supreme Court will reconsider whether Myriad’s “composition of matter” claims covering isolated DNA of these two genes are patent-eligible under current US patent law.

The case is the first to challenge whether human genes can be patented, according to the American Civil Liberties Union (ACLU), which filed the original lawsuit against Myriad, together with the Public Patent Foundation (PUBPAT). That complaint charged that the challenged patents are unlawful because genes are “products of nature” and restrict both scientific research and patients’ access to medical care.

“Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test that has helped close to one million people learn about their hereditary cancer risk,” said Peter Meldrum, Myriad Genetics’ president and CEO.

He said the company has devoted more than 17 years and $500 million to develop the BRACAnalysis test in question, and that health economic studies have concluded that Myriad’s genetic tests are fairly priced.

But ACLU and PUBPAT applauded the Supreme Court’s review. Daniel Ravicher, PUBPAT’s executive director, argued that Myriad did not invent human genes and has no right to claim ownership of them just because they “removed them from the body”.

Ravicher added: “The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup.”

The ACLU’s Chris Hansen said it’s “wrong” to think that something naturally occurring like DNA can be patented by a single company that “limits scientific research and the free exchange of ideas”.

If the Supreme Court were to rule against human gene patents, then universities, laboratories and biotechnology companies could develop and even patent tests, drugs, and other inventions based on genetic information and sequencing without fear of being accused of patent infringement, according to ACLU.

The group also said such a legal outcome would mean that no single laboratory could use its patents to control most of the data about a gene.