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Federal Court Rules Human Genes Can be Patented

A federal court has ruled that human genes may be patented.

According to The Raw Story, the United States Court of Appeals for the Federal Circuit ruled in Association for Molecular Pathology, et al v. US Patent and Trademark Office, et al. that patenting human genes is possible because DNA extracted from cells does not occur naturally.

The lawsuit  was filed by the Public Patent Foundation and the American Civil Liberties Union (ACLU) on behalf of scientists and other researchers, female patients and cancer survivors against the US Patent and Trademark Office, the Myriad Genetics corporation and the University of Utah Research Foundation. Myriad Genetics and the University of Utah hold the patents on genes known as BRCA1 and BRCA2.

BRCA1 is a ‘caretaker gene’ that produces a protein that repairs DNA. If damaged, BRCA1 cannot function properly and an increased risk of cancer is resultant. The gene was cloned by Myriad in 1994. BRCA2 contains a breast cancer susceptibility protein involved in the repair of chromosomal damage. Both genes are believe to regulate the activity of other genes and are thought to play crucial roles in embryo development.

The lawsuit argued that patents on human genes violate the First Amendment as well as patent law because genes are “products of nature.”

The court found otherwise.

“In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified,” Judge Alan D. Lourie wrote in the majority opinion. “They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.”

Judge William C. Bryson was the lone dissenter in the 2-1 decision. “If sustained, the court’s decision will likely have broad consequences, such as preempting methods for whole-genome sequencing,” he wrote. Judge Bryson argued that “patents are for inventions” and that “a human gene is not an invention.”

There have been thousands of patents granted for human genes by the US Patent and Trademark Office prior to this case. Life itself has been legally patentable since the US Supreme Court’s 1980 Diamond v. Chakrabarty decision, in which the court ruled that genetically modified organisms– in that case oil-eating bacteria– could be patented.

 

 

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