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US court upholds right of company to patent isolated human genes

A US appeal court has confirmed its decision last year that isolated human genes can be patented.

Biotechnology company Myriad Genetics could, it said, patent two genes linked to breast and ovarian cancer, known as BRCA1 and BRCA2, which it had "isolated" from human DNA strands. However it did not have the right to patent methods of "comparing" or "analyzing" DNA sequences as these did not involve a "transformative" step.

The US Court of Appeals for the District of Columbia had been asked to re-examine the case, originally decided in July last year, by the country's Supreme Court following its own decision that companies could not patent "observations about natural phenomena" in a case involving a blood test developed by Prometheus Laboratories.

Peter Meldrum, head of Myriad, released a statement addressing some "common misconceptions" that the company claimed had appeared in the press relating to gene patents. Its application would not, he said, impede research or result in more expensive cancer testing.

"We are very pleased with the favourable decision the Court rendered today which again confirmed that isolated DNA is patentable," he said. "Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity."

US patent law says that material related to laws of nature cannot be patented. Inventions must also be new, take an inventive step that is not obvious and be useful to industry in order to qualify for patent protection.

In a majority opinion (106-page / 532KB PDF), Circuit Judge Alan Lourie said that although the two isolated genes at issue were "prepared from products of nature", so was "every other composition of matter". In addition, they had been "manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body".

"The remand of this case for reconsideration in light of [the Supreme Court decision] might suggest ... that the composition claims are mere reflections of a law of nature," he said. "Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature ... the isolation here is not a simple separation from extraneous materials, but conversion to a different molecular entity."

Myraid's claims had been challenged by doctors, individuals and various groups including the Association for Molecular Pathology, American College of Medical Genetics and the American Civil Liberties Union (ACLU). ACLU lawyer Chris Hansen told Reuters that the decision was "extremely disappointing" and prevented doctors and scientists from "exchanging their ideas and research freely".

"Human DNA is a natural entity like air or water," he said. "It does not belong to any one company."

Myriad said in a statement that more than 18,000 scientists had to date researched the two genes, publishing more than 9,000 research papers on the subject.

"Myriad has never denied, opposed or impeded any research studies on these, or any other, genes," it said. "The cost of [the company's gene analysis] test is not prohibitive and patient access is extensive ... second opinion testing is available for patients with positive test results in a number of US laboratories, including a large reference laboratory licensed by Myriad in 2001."

Last year CNN reported that Myriad charged $700 for one of its primary tests.

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