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Diagnostics firms face new patent claim worries

Nature Biotechnology volume 27, pages 586–587 (2009)Cite this article

An Erratum to this article was published on 01 October 2009

This article has been updated

The recent lawsuit filed against the BRCA1 and BRCA2 breast cancer gene patents has drawn the most attention. The case, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., pits the Bethesda, Maryland–based Association for Molecular Pathology (AMP), which includes patients, some breast cancer activists and laboratories representing over 100,000 researchers, against the US Patent and Trademark Office (USPTO), in Washington, DC, and the patent owners—Myriad Genetics and the University of Utah Research Foundation, both based in Salt Lake City. AMP et al. claim the patents are invalid and, in a surprise twist, that they violate the First Amendment's guarantee of free speech.

The USPTO has ruled that genes are patentable once isolated and purified. “That is just wrong,” says Sandra Park, a staff attorney for the American Civil Liberties Union (ACLU) in Washington, DC—one of the groups arguing against the patents. “We want the patent office to reverse its policy, starting with BRCA1 and 2.” The lawsuit claims the patent gives Myriad a monopoly not just on the genes, but on “fundamental pieces of knowledge” as well. That blocks “free exchange of knowledge and ideas,” which infringes the First Amendment. Parks points out, however, that the lawsuit is strictly about genes. “We have no problems with patents on tests or therapies.”

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  • 08 October 2009

    In the version of this article initially published, on page 587, left column, last paragraph, it states incorrectly that GeneDX holds a patent to certain mutations in the connexin 26 gene related to keratitis-ichthyosis-deafness syndrome. GeneDX does not own that patent. The error has been corrected in the HTML and PDF versions of the article.

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    Malorye Allison

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Allison, M. Diagnostics firms face new patent claim worries. Nat Biotechnol 27, 586–587 (2009). https://doi.org/10.1038/nbt0709-586c

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