Taking a new legal direction: Genes are not patentable

A judge’s controversial ruling spurs debate

CORRECTION TO THIS ARTICLE: This article refers imprecisely to Universities Allied for Essential Medicines as a “national student organization.” UAEM is a worldwide organization.

The legality of patents on genes is in jeopardy after a judge ruled that genes were ineligible for patents because they involved “laws of nature.” Twenty percent of the human genome is currently patented.

The debate over gene patents has been brought to the fore by the court case American Molecular Pathology, et. al. v. US Patent and Trademark Office case (commonly referred to as the Myriad case) over BRCA1 and BRCA2, two genes that are linked to breast and ovarian cancer. Myriad Genetics, Inc. holds an exclusive license for BRCA1 and BRCA2, but in March of this year, Judge Robert W. Sweet of the United States District Court in Manhattan, invalidated seven patents covering the two genes.

Critics have also worried that the court ruling could hurt licensing practices by universities. However, others support the ruling because they believe gene patents harm academic research and patient access to technologies. The validity of these arguments is the topic of current debate.

Fiona E. Murray, an associate professor at Sloan with a background in chemistry who has been active in the intellectual property policy debate, said in an e-mail that the court ruling is likely to have little, if any, impact on academics.

“In general, academics are not impacted in their ability to do research — there are a variety of cases and examples that suggest that firms don’t sue academics for infringing,” Murray said. “On the other hand, academic patents could be impacted — a high fraction of gene patents have been filed by academia.” Murray suggests that the ruling will have more implications in clinical settings, where activities have been limited by the patents.

The legislative front

There has also been debate about gene patents within the Department of Health and Human Services. In April of 2010, the HHS Secretary’s Advisory Committee on Genetics, Health and Society wrote a report on the implications of gene patent policy for Secretary Kathleen Sebelius. In the report, the committee made a number of recommendations, including one to create exemptions for infringement liability.

The report found that gene patents and licenses have a negative effect on patient access to tests as well as the quality of existing tests. The report also found that gene patents did not result in faster test development. In fact, because not much development is needed to get to a final product, multiple laboratories usually developed tests before patents were granted so that the patent merely serves to narrow the market of already-developed competition. Because government funding is usually used for basic genetics research, the incentives provided by patent rights for private investment in basic genetics research is insignificant and unimportant.

The American Association of Universities, a lobbying group in Washington D.C. that represents the interests of universities, has been in favor of allowing gene patents on the legislative front. In a letter written in May to the NIH, (which is part of HHS), the AAU argued that the advisory committee has not found adequate evidence on the negative or positive impacts of gene patents on patient access. The AAU also argued that the increased regulations in licensing recommended by the committee do not allow for the flexibility that universities need to sign a deal with an industry partner. MIT is a member of the AAU.

Activity in the courts

The patents for BRCA1 and BRCA2 allow Myriad Genetics, Inc. to be the exclusive vendor for a test that looks for mutations in these two genes to determine risk for breast and ovarian cancer. According to the New York Times, the plaintiffs, which include the American Civil Liberties Union, say that the patents kept prices high (at more than $3,000 per test) and prevented women from getting a confirmatory test from another laboratory.

On June 16, Myriad and the University of Utah Research Foundation, who are defendants in the Myriad case, filed for an appeal in the U.S. Court of Appeals for the Federal Circuit.

On October 29, the Department of Justice commented on Judge Sweet’s ruling by filing an amicus (friend of the court) brief saying that the mere isolation of a gene should not be patentable. The DOJ labeled their brief “in support of neither party.” However, because the brief still allowed for the patentability of manipulated DNA, it was not in full agreement with Sweet’s ruling. The appeals court will need to find a balance between the strong stance against gene patents, represented by the lower court’s decision, and a weaker stance that still allows for some types of gene patents, as advocated by the DOJ.

This Wednesday, the Universities Allied for Essential Medicines (UAEM), a national student organization that promotes access to essential medicines has also filed an amicus brief in the Myriad case. It also has a chapter on the MIT campus. UAEM’s brief supports Sweet’s ruling. It argues that the patents increase the costs of research and treatment for genetic diseases.

In the case of genes, not much further research and development is needed to develop technologies. “One reason that [gene patents] are especially onerous” said Karolina Maciag, a medical student in the Harvard-MIT Health Science and Technology program and serving on the executive committee of MIT’s chapter of UAEM, “is that unlike many other academic technologies that are really early stage, if a disease is linked to a gene, that is basically a technology out of the box. You can develop a diagnostic test the next day.”

As is typical of the technology licensing pathway, research linking BRCA1 and BRCA2 to cancer was done in labs at the University of Utah using federal funds from the NIH, and so the university became a patent holder. Utah’s technology transfer office, which is in charge of brokering deals, granted an exclusive license to Myriad. Myriad can then sue infringers to prevent them from using that research.

MIT and its affiliated Broad Institute and Whitehead Institute all conduct research for which gene patents could be filed. Jack H. Turner, the Associate Director of MIT’s Technology Licensing Office, has said that the TLO does not have an opinion on the Myriad case. The TLO also takes care of licensing for the Broad Institute. Carla DeMaria, from the Whitehead Institute’s technology licensing office, was also unavailable to comment on the case.