World Congress

for freedom of scientific research

Are gene patents eligible? A comment.

08/29/2011

A recent ruling by the United States Court of Appeals for the Federal Circuit has reversed a lower court’s decision that Myriad Genetics’ composition of matter claims covering isolated DNA molecules were patent-ineligible products of nature “since the molecules as claimed do not exist in nature”.
According to a press release by the American Civil Liberties Union who brought the lawsuit against Myriad, which holds the patents on the genes, the challenged patents are illegal and restrict both scientific research and patients’ access to medical care, and patents on human genes violate the First Amendment and patent law because genes are "products of nature". The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is critical in helping these women decide on a plan of treatment or prevention, including increased surveillance, preventive mastectomies or ovary removal, while according to ACLU “Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests”.
The federal court did for certain reform the crucial section of the former ruling, nonetheless the decision has been challenged from many aspects. Even the United States Department of Justice had filed a brief arguing that many of the gene patents issued by the Patent Office are invalid. Moreover a dissent was in part filed (by Circuit Judge Bryson).
Bryson’s dissent analogizes the full BRCA gene to a slab of marble found in the earth as distinct from the sculpture carved into it, which the dissent indicates would be worthy of intellectual property protection. It suggests that this may well be one of those instances in which too much patent protection can impede rather than promote the Progress of Science and useful Arts. Quoting Circuit Judge Bryson: “Although my colleagues believe our analysis of the legal question in this case should be influenced by purported expectations of the inventing community based on the PTO’s past practice of issuing patents on human genes, that is in effect to give the PTO lawmaking authority that Congress has not accorded it. There is no collective right of adverse possession to intellectual property, and we should not create such a right. Our role is to interpret the law that Congress has written in accordance with the governing precedents. I would do so and would affirm the district court’s rulings as to the BRCA gene and BRCA gene segment claims” (see 2010-1406, Appeal from the United States District Court for the Southern District of New York in Case No. 09-CV-4515, Senior Judge Robert W. Sweet, decided: July 29, 2011).
Finally ACLU declared its intention to recur to the Supreme Court, so we may conclude that nothing has been decided yet.
Last news from the battlefield on patents and biotechnology report that a “lawsuit that threatened scientists who use mouse models in Alzheimer’s research has been dismissed” (source Nature.com). Jackson Laboratory of Bar Harbor Maine, and other institutes and companies, had been accused by the Alzheimer’s Institute of America (AIA) in Kansas City, Kansas, to have infringed on patents covering a genetic mutation that causes early-onset Alzheimer’s disease. Once more a governmental institution, the U.S. National Institutes of Health in Bethesda, Maryland, intervened on the Jackson Lab's behalf leading to the dismissal of the suit against it.

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