Federal Court Invalidates Breast Cancer Gene Patent

The American Civil Liberties Union sued the genetic testing company Myriad Genetics over its patents on the BRCA1 and BRCA2 gene variants that are strongly associated with hereditary forms of breast cancer. As the Economist reports:

On March 29th the New York District Court made a ruling that, taken at face value, turns America's approach to the patent protection of genes on its head. A coalition led by the American Civil Liberties Union (ACLU) had challenged the very basis of Myriad's patents. The nub of the case was this question: "Are isolated human genes and the comparison of their sequences patentable things?"

Until now, the answer had been "Yes". But Robert Sweet, the presiding judge, disagreed, at least as far as the BRCA genes are concerned. After weighing up Myriad's arguments, he ruled: "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issues directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter." Mr Sweet reasoned that DNA represents the physical embodiment of biological information, and that such biological information is a natural phenomenon.

As a rule, patents are not granted for rules of nature or naturally occurring phenomena, but the American patent office has allowed genes to be patented if they are isolated and "purified." Perhaps no longer, if this decision is upheld. The ACLU gleefully declared that this ruling "marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes."

GenomeWeb quotes ACLU attorney Chris Hansen as saying:

"Today's ruling is a victory for the free flow of ideas in scientific research. The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

Hansen is making the argument that gene patents have created an anti-commons that is impeding important research. But is that so? I looked into the issue three years ago and could find little empirical support for the …

… concern that the over-proliferation of patents, instead of encouraging innovation, is stifling it. This argument achieved prominence in an influential 1998 article published in Science by two University of Michigan law professors, Michael A. Heller and Rebecca S. Eisenberg. Heller and Eisenberg worried that the privatization of biomedical research "promises to spur private investment but risks creating a tragedy of the anticommons through a proliferation of fragmented and overlapping intellectual property rights."

By "anticommons," they meant a situation in which the existence of a large number of intellectual property rights applicable to a single good or service unduly retards or even prevents its provision. The blockage to innovation would occur because of high transaction costs, the conflicting goals of various intellectual property owners, and cognitive biases in which owners overvalue their own patents, undervalue others' patents, and reject reasonable offers.

As evidence for a biomedical anticommons, analysts regularly cite the high profile case of "probably the most hated diagnostics company," Myriad Genetics.

As evidence against the existence of a research anti-commons, I cited a number of studies by the National Academy of Sciences and I further noted that …

… in 2006, Nature Biotechnology published a review (free registration required) of the academic literature on the existence of a research anticommons. The review concluded that "among academic biomedical researchers in the United States, only one percent report having had to delay a project and none having abandoned a project as a result of others' patents, suggesting that neither anticommons nor restrictions on access were seriously limiting academic research." Worryingly, the review noted there was evidence that secrecy was growing among academic researchers. However, patent issues do not seem to be fueling this secrecy. One study suggested that increased academic research secrecy arises chiefly from concerns about securing scientific priority (scientific competition) and the high cost and effort involved in sharing scientific materials and data.

In 2007, the American Association for the Advancement of Science (AAAS) released a report, International Intellectual Property Experiences: A Report of Four Countries, which surveyed thousands of scientists in the U.S., Germany, the U.K. and Japan to assess their experiences in acquiring, using, or creating intellectual property. The AAAS study found "very little evidence of an 'anticommons problem.'" As Stephen Hansen, the director of the AAAS study, noted in a press release, "All four studies suggest that intellectual property rights had little negative impact on the practice of science."

Perhaps there is newer and better evidence for a research anti-commons. I will look into it again and report back.

In any case, since this federal court ruling will undoubtedly be appealed, it is not the last word on the validity of gene patents. As GenomeWeb reports:

William L. Warren, partner at Sutherland Asbill & Brennan, believes this is a "poor decision that may have negative short-term implications for financing in the biotechnology sector, and hence the development of new diagnostics and therapeutics, until it is overturned by the U.S. Court of Appeals for the Federal Circuit in the next one to two years.

Go here for the Economist's reporting and here for GenomeWeb's.

Disclosure: I am still a member of the ACLU.