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Partial victory for biotech sector after gene patent ruling

US Supreme Court decides genes can be patented, if synthetically produced

US Supreme CourtThe highest court in the US has ruled that synthetically created genes can be patented, bringing relief to the biotechnology sector.

The US Supreme Court ruled yesterday afternoon that synthetically produced genetic material can be patented - but it also found that naturally occurring genes cannot be intellectual property, in what could be a blow to some companies. 

This has been seen as a compromise decision, which was reached unanimously by the nine justices, and one that was urged by US President Barack Obama. 

Writing the decision Justice Clarence Thomas ruled that forms of DNA that have been manipulated in the laboratory in a way that alters their natural state, and which are known as complementary DNA (cDNA), can be patented under US law.

But genes that are naturally occurring cannot be patented as they have not been manipulated or changed by a firm: “A naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated,” said Justice Thomas. 

The decision was made in a case brought against US diagnostics firm Myriad, which was thrust into the public's eye last month when Oscar-winning US actress Angelina Jolie announced she had undergone a mastectomy after using the company's $3,000 BRACAnalysis gene test. 

This showed that Ms Jolie had an 87 per cent chance of having BRCA positive breast cancer in her lifetime and a 50 per cent chance of ovarian cancer, the disease which killed her mother at 56. 

Overall victory for Myriad 

Myriad hailed yesterday's vote as a victory as its patents on the BRCA 1 and 2 patents are classed as cDNA. But the company did add that the Court found that five of its claims covering isolated DNA were not patent eligible – although these are not critical patents for the firm. 

In a statement, the firm's chief executive Peter Meldrum said: “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection forward.

“More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs.”

The case had been bought against Myriad by the Association for Molecular Pathology, which was concerned that patenting genes could give firms like Myriad a monopoly on research and raise costs for patients and researchers.

Trying to allay these fears, Meldrum added: “We are collaborating with the medical and scientific communities to improve patient access to genetic testing and facilitate research worldwide. Already, more than 10,000 scientific papers have been published on the BRCA genes, ranking them among the most researched genes in history.

“We are committed to advancing scientific knowledge even further, and Myriad will continue to encourage and support academic research studies conducted on the BRCA genes.

“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 from any of the many laboratories conducting BRCA testing for the purpose of confirming the Myriad test result.”

Myriad's shares initially rose nearly 13 per cent after the news broke yesterday at 2pm, but swiftly dropped after potential rivals such as Quest announced their intentions to market BRCA gene tests.

14th June 2013

From: Research, Sales

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