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Federal judge invalidates patents on human cancer genes

[JURIST] A judge for the US District Court for the Southern District of New York [official website] ruled [opinion, PDF] Monday that patents held on two genes linked to hereditary ovarian and breast cancer are invalid. The ruling was in response to a suit filed [JURIST report] by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) [advocacy websites] on behalf of patients and scientists challenging patents held by Myriad Genetics [corporate website] on the BCRA genes [NCI backgrounder]. Judge Robert Sweet held that, "[b]ecause the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter." The complaint also alleged that the patents were unconstitutional under the First Amendment, Fourteenth Amendment, and Article I [text] of the Constitution, but the court did not address the constitutionality of the patents because the case could be decided under patent law. ACLU staff attorney Chris Hansen hailed the ruling [press release] as a "victory for the free flow of ideas in scientific research," stating:

The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.

Opponents of the ruling contend [NYT report] that restricting patents on human genes will actually decrease the amount of genetic research performed by the public sector because it will no longer be profitable for companies to study human genes. They also say the result of the ruling will be to push genetic research into primarily government-funded institutions such as universities. Monday's ruling is expected to be appealed.

If Monday's ruling stands, it could invalidate patents covering nearly 2,000 human genes. Genetic research companies currently hold patents to approximately 20 percent of the human genetic code. Many of the patented genes are associated with diseases such as Alzheimer's and cancer. The holder of a gene patent can prevent others from studying the gene and can also develop testing for specific genetic mutations, which they can then market without direct competition.

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