Across Canada
By Carmela DeLuca
The U.S. Supreme Court finds “isolated DNA” unpatentable Canary in the mine shaft for personalized medicine patents?
P
ersonalized medicine holds the promise of more individually focused diagnostics, strategies for preventing disease and tailored therapeutic regimens that are more effective and/or have fewer drug side effects – basically smarter medicine. However, as the drama around the legal battle over gene patents culminating in the recent U.S. Supreme Court decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (“AMP v. Myriad”)1 unfolded, it showed that personalized medicine is fraught with contentious moral/ethical and legal, including intellectual property, issues. AMP v. Myriad addressed the debate on gene patents that has been raging in the U.S. for some time. As is well known in the personalized medicine industry, the Supreme Court tried to lay down a bright line test, invalidating claims to naturally occurring “isolated” DNA and affirming the patentability of laboratory made synthetic DNA that is not naturally occurring. But as can sometimes be the case, the bright line distinction, in this instance the distinction between naturally occurring and synthetic DNA, is actually blurry and nuanced. The AMP v. Myriad drama took over four years to wind its way through the courts. The suit was launched in 2009 by the ACLU and the Public Patent Foundation who represented a group of plaintiffs including the Association for Molecular Pathology (AMP) and other medical associations, medical professionals, universities and breast
The plaintiffs claimed that patents on BRCA1 and BRCA2 were unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
cancer patients. The suit took aim at invalidating patents to human genes generally and invalidating Myriad’s patents on two breast cancer susceptibility genes (BRCA1 and BRCA2) more specifically. The plaintiffs claimed that patents on BRCA1 and BRCA2 were unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.” The challenged claims included claims to isolated DNA, methods of detecting germ-line mutations and drug screening. Interestingly claims to vectors comprising BRCA DNA, cells comprising such vectors, DNA primer pair sequences for detecting BRCA mutations and isolated DNA comprising BRCA1 regulatory sequences were not challenged. By way of background, Myriad Genetics was founded in 1991 as a spin-off company from the University of Utah. In August 1994, researchers at Myriad, the University of Utah, the NIH and McGill University published the sequence of the BRCA1 gene and later that year, Myriad and its collaborators filed its first BRCA1 U.S. patent application. Subsequently, Myriad and University of Utah researchers isolated and sequenced the BRCA2 gene and the first U.S. BRCA2 patent application was filed in 1995. In 1996, five years after the company’s inception, Myriad began offering its BRACAnalysis® testing service for hereditary breast and ovarian cancer testing and aggressively guarded its patent position, launching lawsuits against for profit institutions that tried to offer services that infringed of one or more of its patents.2 As a result of its patent position, Myriad became effectively the only commercial provider of BRCA diagnostic testing in the United States.3 Interestingly, Myriad reportedly saw its first profit only in 2012, 17 years and $500 million in development costs later, costs which could presumably be born because of its patent position.4 In a decision that sent shock waves through the personalized medicine industry, the federal district court in New York invalidated all of Myriad’s challenged patent claims. The Federal Circuit then reversed the district court’s rulings on isolated DNA patent claims, holding unanimously that synthetic DNA such as “cDNA”, which is a form of DNA artificially synthesized, is patentable subject matter and holding 2 to 1 that isolated genomic DNA is patentable as well.
Biotechnology Focus / October 2013
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