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Rolling Back Patent Power?

Three days ago the ambient uncertainty level of the American patent system was amplified by no less than two orders of magnitude. In his Association for Molecular Pathology et al.v. USPTO et al. opinion, Judge Robert Sweet of the United States District Court, Southern District of New York, ruled that BRCA-1 and BRCA-2 genes useful as indicators of ovarian and breast cancer are products of nature, and that their isolation from their natural contexts is insufficient to render them patentable subject matter. Judge Sweet also determined that methods for comparing the genes were “abstract mental processes,” and therefore also unpatentable [opinion, page 4].

The ruling is certainly a blow to the holder of the patents contested in the suit, Myriad Genetics, but the decision’s fall-out is of significantly broader import.

Consider: close to 20% of human genes are claimed by US patents, according to a recent study [70].

Individuals and enterprises who before March 31, 2010 believed the patents they held in that fifth of the human genome valid, are now at sea, legally speaking. The phones of intellectual prpoerty firms specializing in biotech advisement and litigation have been ringing non-stop since Sweet’s word hit the street, I’m sure.

Equally as interesting and noteworthy as this sharp uncertainty spike is the science policy debate serving as this patent fight’s ground. On one side, we have the classic Mertonian sociology of science view. My friend and colleague, Dr. Jennifer Kennell, a genetics researcher and assistant professor in the Biology Department at Vassar College, encapsulated this position perfectly in a recent email exchange of ours, so I quote instead of paraphrasing her:

As a scientist I found the stories of other researchers being driven away from studying the BRCA genes very compelling. [A]s researchers, we rely on collaborations and open communication of results to drive forward our studies and foster innovation. Myriad’s stance was extreme and stifled both basic research into BRCA1/2 gene function as well as applied research into the design of diagnostic tests. I understand that patents have been very important for the success of biotechnology and I acknowledge that this is a very complicated issue. But I am not convinced that our country should allow the patenting of genes or abstract ideas concerning the connection between mutation in genes and disease. With potential negative impacts of gene patenting on both basic research and public health, there is just too much at stake.

The opposing position, as Kennel acknowledges, believes that patents and other forms of intellectual property are necessary forms of innovation induction —carrots for scientists and other creators— and that in their absence, rates of creativity would suffer. A critique of intellectual property theory gaining steam in some circles argues that this incentive argument is empirically unfounded and should be tested. Judge Sweet’s decision, if it survives an appeal to the CAFC and, possibly, the Supreme Court (yes: I think it’s that big a deal), may turn out to be a fascinating experimental test of intellectual property’s fundamental dogma.

This opinion is required reading, but you’ll have to ‘ffeine up first… way, way up: at 152 pages, Judge Sweet’s decision is longer than Ursule Molinaro‘s (1993) Fat Skeletons, the very fine novel I finished reading last week.

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