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US judge overturns gene patents

6 April 2010
Appeared in BioNews 552

A US judge has invalidated a genetic testing company's patents on two breast cancer genes. New York District Judge Robert Sweet ruled that BRCA1 and BRCA2 are a 'law of nature' and can't be patented.

The decision, which Myriad Genetics has promised to appeal, could have major ramifications for biotechnology companies.

Richard Gold, from the Centre for Intellectual Property Policy at McGill University in Canada, told the Financial Times: 'If this decision were to be upheld, it would lead to the invalidation of a large number of gene patents - perhaps most - as well as patents over proteins and even some chemicals'.

Myriad Genetics' exclusive patents mean they are the only US Company licensed to sequence the genes BRCA1 and 2, variations in which can raise a women's risk of breast cancer by up to 80 per cent. Upon gaining the patents, they allowed researchers to test anonymous samples. But women who wanted to know their breast cancer risk had to be tested in a lab belonging to Myriad or one of its affiliates at a cost of more than $3,000, according to the New York Times.

The court case pitted Myriad against a coalition of cancer patients, doctors, the College of American Pathologists, the American Civil Liberties Union and the Public Patent Foundation at the Benjamin N. Cardozo School of Law.

They sought to invalidate the patents because patients could not always afford the Myriad test. Patients and healthcare providers had no choice of labs and could not get a second opinion, and researchers could not advise study subjects about their risk.

Myriad Genetics argued that 'isolated DNA molecules' were patent-eligible because they were 'markedly different' in their structural and functional properties from DNA existing in nature. But Judge Sweet said DNA - uniquely among chemical compounds - carries information. And the same information is carried by 'isolated DNA molecules' used for testing and the same genes in-situ.

The judgement shocked some experts. Online law blog, The Genomics Law Report, called it 'radical and astonishing in its sweep', titling its article 'Pigs Fly'. Robert Cook-Deegan, a gene patents expert at Duke University reportedly said: 'It's certainly a bombshell. The blogosphere is pretty shocked at this outcome'.

Some European countries had already challenged Myriad's patent. The UK and several other countries use the company's testing techniques, but don't pay them royalties. France changed its legislation to override the patent, according to the Financial Times.

SOURCES & REFERENCES
After Patent on Genes Is Invalidated, Taking Stock
New York Times |  30 March 2010
Final court judgement (includes a genetics primer)
ACLU |  29 March 2010
Gene patents are the talk of the town following surprise court ruling
Los Angeles Times |  31 March 2010
Gene Ruling Could Have Broad Reach
Wall Street Journal |  31 March 2010
How Gene Patents Harm Innovation
Forbes |  31 March 2010
In Patent Fight, Nature, 1; Company, 0
New York Times |  30 March 2010
Is the DNA patent dead?
Fortune CNN Money |  30 March 2010
Maker of cancer test loses right to DNA patent
FT |  30 March 2010
Who owns your genes?
San Francisco Chronicle |  1 January 1970
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