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Breast cancer gene patents ruled invalid
NEW YORK—March 30 saw a ruling by Judge Robert W. Sweet in a New York federal court that parts of patents held by Myriad Genetics covering two breast cancer genes, known as BRCA1 and BRCA2, were invalid.
Analysis of those genes by Myriad is at the core of an expensive test that predicts whether a woman is at a high risk of getting breast or ovarian cancer. The plaintiffs in the case, which included various medical groups and the American Civil Liberties Union (ACLU), said the patents on DNA were illegal and impeded access to such testing.
As the ACLU noted in a news release about the ruling, this "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. The ruling follows a lawsuit brought by a group of patients and scientists represented by the ACLU and the Public Patent Foundation (PUBPAT), a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law."
"[This] ruling is a victory for the free flow of ideas in scientific research," says Chris Hansen, a staff attorney with the ACLU First Amendment Working Group. "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."
"While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," says Peter Meldrum, president and CEO of Myriad Genetics. "More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents."
In this case, Myriad says, the ACLU Plaintiffs sought a declaratory ruling that 15 claims under seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16 patents covering BRACAnalysis which also were not challenged.
"Notwithstanding today's decision, we are extremely proud of what Myriad has been able to accomplish over the years in promoting women's health in the area of hereditary breast and ovarian cancer," Meldrum says. "Countless lives have been saved as a result of our efforts in concert with the healthcare community."
Many in the pharma and biotech industry aside from Myriad also don't agree with the ACLU's view of things, in large part because biotech companies spend billions every year trying to develop new tests and treatments based partly on genes they have isolated and patented. Lack of patent protection could cut into their potential for profit and have a chilling effect on research into gene-based diagnostics and other areas.
However, as the New York Times noted, "While some executives and lawyers who were interviewed on Tuesday disagreed with the judge's legal reasoning, they conceded that the ruling, even in the worst case for them, would take years to have a significant effect."
Eventually, though, it is possible that the ruling, if upheld on appeal, could impact not only diagnostic companies but also biotechs and pharmas that might be pursuing gene- based therapies—although the Times did point out that traditional drug makers might not notice much impact if the ruling holds up, since drugs are often protected by patents on their own chemical composition.
Also, the Times notes, the industry is "already moving to a period of somewhat less dependence on DNA patents for its sustenance. Diagnostic laboratories, for instance, are shifting from testing individual genes to testing multiple genes or even a person's entire genome. When hundreds or thousands of genes are being tested at once, patents on each individual gene can become a hindrance to innovation rather than a spur."
"This is the first time a judge has ruled on gene patents in a conflict about diagnosis," says Robert Cook-Deegan, the director of the Center for Genome Ethics, Law & Policy at Duke University's Duke Institute for Genome Sciences and Policy. "This completely changes the game, at least for now. Judge Sweet reached a decision the opposite of prior cases. One big difference is that this case is about diagnostics, getting information about DNA in a person's cells, and not about using DNA to make drugs."
The ACLU's and PUBPAT's lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes, as well the U.S. Patent and Trademark Office (USPTO), charged that the challenged patents are illegal and restrict both scientific research and patients' access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."
The same day of the patent ruling, the court today granted the USPTO's request that it be released as a defendant in the lawsuit. The court found that it was unnecessary to reach the First Amendment claims against the USPTO because it had already ruled in favor of the plaintiffs.
The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed on May 12 in the U.S. District Court for the Southern District of New York on behalf of breast cancer and women's health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals.
Because the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.
The court recognized the far-reaching impact of the case on medical research and public health. The opinion stated, "…the resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health."
But Sweet also clearly recognized there would be negative blowback on his ruling from the industry and, in a footnote of his 152-page ruling, he discounted fears that invalidating such patents would decimate the industry.