Justice Dep’t Questions Gene Patents

n March, a federal judge invalidated patents that claimed two genes lined to breast cancer, the BRCA1 and BRCA2 genes. The decision has cast doubt on thousands of gene patents, and may play a significant role in re-shaping the intellectual property landscape. The ACLU and others joined to challenge the validity of the gene patents and argued that since the genes are products of nature, they should not be patentable. Myriad Genetics, the owner of the patents at issue, moved to dismiss the case, claiming that the work necessary to isolate the DNA that comprises the gene, is tranformative and renders the genes patentable.

On Friday, the Justice Department filed an amicus brief urging the courts to hold that genes are products of nature and therefore not patentable subject matter. This filing signals a major policy change within the Obama administration. Insiders suggest that the U.S. Patent Office was “chagrined that the Department of Justice was taking a viewpoint very different from the Patent Office. ” Regardless, the administration’s new policy will have little immediate practical effect because the Patent Office will not start denying or invalidating patents because of pending litigation.

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