PXE Awareness

Volume 17, Issue 3 November 2011

Gene Patent Ruling Reversed

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By Sarah Roberts

In May 2009, the ACLU and the Public Patent Foundation filed a lawsuit on behalf of twenty plaintiffs including pathologists, geneticists, patients, and health advocacy groups against the U.S. Patent and Trademark Office (USPTO), Myriad Genetics and the University of Utah Research Foundation.  They argued that Myriad’s patents on two genes related to breast and ovarian cancer, BRCA1 and BRCA2, violate the First Amendment and patent law, as genes are “products of nature” which cannot be patented.  Plaintiffs contend that the patents stifle scientific research and genetic testing.  The USPTO has issued thousands of gene patents, resulting in the patenting of 20% of human genes.  In March 2010, Judge Robert Sweet of the District Court for the Southern District of New York ruled that the BRCA1 and BRCA2 patents are invalid.

Myriad appealed to the U.S. Court of Appeals for the Federal Circuit in Washington D.C.  In a reversal of its previous position, the United States government submitted an amicus brief contending that isolated genes without modification, as in the case at hand, are a product of nature, and therefore cannot be patented.  Many organizations, researchers and individuals submitted amicus briefs in support of the plaintiffs, including the March of Dimes and other patient groups, including NAPE (National Association for Pseudoxanthoma Elasticum).

On July 29, 2011, in a 2-1 decision, the appeals court partially reversed the lower court’s ruling. The appeals court ruled that companies can obtain patents on the genes, but invalidated certain patents purporting to claim methods of comparing their genetic sequences.  One of the judges on the panel dissented in part with the decision, writing that patents on the genes
should be invalid.  “Extracting a gene is akin to snapping a leaf from a tree,” wrote Judge William C. Bryson. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”  The next step is to appeal to the United States Supreme Court.  The ACLU and the Public Patent Foundation plan to file their petition by December.

Note:  NAPE’s Board of Directors has submitted its amicus brief to be a party to petition the U.S. Supreme Court.