Federal court hearings continued Tuesday on a lawsuit that could transform biotechnology in the United States by eliminating gene patents.

The case hinges around the claims of Utah-based Myriad Genetics on BRCA1 and BRCA2, a pair of genes closely linked to breast and ovarian cancer. Myriad "owns" the genes, and says its patents make it possible to profit on diagnostic tests. The company argues that if you remove the patents, the tests — indeed, commercial biotechnology as we know it — will vanish.

A coalition of civil rights, research and women's health groups is fighting the patents. They argue that Myriad's claims stifle innovation by discouraging researchers from looking at the genes, which are still not fully understood, and say Myriad's monopoly limits women's health choices. More broadly, the claims set a precedent for other gene patents, which now cover about one-fifth of the human genome.

"Allowing patents on genetic material imposes real and severe limits on scientific research, learning and the free flow of information," said Chris Hansen, an attorney with the America Civil Liberties Union, in a press release.

At Tuesday's hearing, defense attorney Brian Poissant insisted that "'women would not even know they had BRCA gene if it weren't discovered' under a system that incentivizes patents," reported GenomeWeb Daily News.

But much of the scientific community rejects Myriad's case. Roughly 150,000 researchers are represented by associations that have filed court briefs supporting the plaintiffs. Among them are the American Medical Association, American Society of Human Genetics and March of Dimes.

In his recent book, The Language of Life: DNA and the Revolution in Personalized Medicine, National Institutes of Health director Francis Collins also argued against broad gene patents.

"The information contained in our shared instruction book is so fundamental, and requires so much further research to understand its utility, that patenting it at the earliest stage is like putting up a whole lot of unnecessary toll booths on the road to discovery,” he wrote.

In May, the court rejected Myriad's request that the case be thrown out without a trial. During Tuesday's hearing, the plaintiffs asked to be declared victorious without a trial. A decision is expected to take several months.

If the court rules against Myriad, patents involving genes and other biological products won't be eliminated altogether. Instead, claims will need to be made on specific types of tests or modifications, rather than the discovery of something that exists in nature. The ACLU likened Myriad's claim to that of someone who patents gold after panning a few nuggets from a stream.

A case memo filed by the plaintiffs called Myriad's prediction of industry doom "pure hyperbole." They cited a 1931 Supreme Court decision that struck down the American Fruit Company's claimed ownership of fresh fruit.

"To be sure, the fruit industry survived," wrote the plaintiffs.

*For full documentation of the case, see "Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al." *

Image: ynse/Flickr

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