Analysis of those genes by Myriad is at the coreof an expensive test that predicts whether a woman is at a high risk of gettingbreast or ovarian cancer. The plaintiffs in the case, which included variousmedical groups and the American Civil Liberties Union (ACLU), said the patentson DNA were illegal and impeded access to such testing.
As the ACLU noted in a news release about theruling, this "marks the first time a court has found patents on genes unlawfuland calls into question the validity of patents now held on approximately 2,000human genes. The ruling follows a lawsuit brought by a group of patients andscientists represented by the ACLU and the PublicPatent Foundation (PUBPAT), a not-for-profit organization affiliated withBenjamin N. Cardozo School of Law."
"[This] ruling is a victory for the free flow ofideas in scientific research," says Chris Hansen, a staff attorney with theACLU First Amendment Working Group. "The human genome, like the structure ofblood, air or water, was discovered, not created. There is an endless amount ofinformation on genes that begs for further discovery, and gene patents put upunacceptable barriers to the free exchange of ideas."
"While we are disappointed that Judge Sweet did not follow priorjudicial precedent or Congress's intent that the Patent Act be broadlyconstrued and applied, we are very confident that the Court of Appealsfor 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 notbelieve that the final outcome of this litigation will have a materialimpact on Myriad's operations due to the patent protection affordedMyriad by its remaining patents."
In this case, Myriad says, the ACLUPlaintiffs sought a declaratory ruling that 15 claims under seven BRCApatents owned or exclusively licensed to Myriad were invalid andunenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16patents covering BRACAnalysis which also were not challenged.
"Notwithstanding today's decision, we are extremely proud of what Myriad has been ableto accomplish over the years in promoting women's health in the area ofhereditary breast and ovarian cancer," Meldrum says. "Countless liveshave 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'tagree with the ACLU's view of things, in large part because biotech companies spend billions every year tryingto develop new tests and treatments based partly on genes they have isolatedand patented. Lack of patent protection could cut into their potential forprofit and have a chilling effect on research into gene-based diagnostics andother areas.
However, as the New York Times noted, "While someexecutives and lawyers who were interviewed on Tuesday disagreed with thejudge's legal reasoning, they conceded that the ruling, even in the worst casefor them, would take years to have a significant effect."
Eventually, though, it is possible that theruling, if upheld on appeal, could impact not only diagnostic companies butalso biotechs and pharmas that might be pursuing gene-based therapies—although theTimes did point out that traditional drug makers might not notice much impactif the ruling holds up, since drugs are often protected by patents on their ownchemical composition.
Also, the Times notes, the industry is "alreadymoving to a period of somewhat less dependence on DNA patents for itssustenance. Diagnostic laboratories, for instance, are shifting from testingindividual 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 eachindividual gene can become a hindrance to innovation rather than a spur."
"This is the first time a judge has ruled on genepatents in a conflict about diagnosis," says Robert Cook-Deegan, the directorof the Center for Genome Ethics, Law & Policy at Duke University's Duke Institutefor Genome Sciences and Policy. "This completely changes the game, at least fornow. Judge Sweet reached a decision the opposite of prior cases. One bigdifference is that this case is about diagnostics, getting information aboutDNA in a person's cells, and not about using DNA to make drugs."
The ACLU's and PUBPAT's lawsuit against MyriadGenetics and the University of Utah Research Foundation, which hold the patentson the BRCA genes, as well the U.S. Patent and Trademark Office (USPTO),charged that the challenged patents are illegal and restrict both scientificresearch and patients' access to medical care, and that patents on human genesviolate the First Amendment and patent law because genes are "products ofnature."
The same day of the patent ruling, the court todaygranted 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 claimsagainst the USPTO because it had already ruled in favor of the plaintiffs.
The lawsuit, Association for Molecular Pathology, etal. v. U.S. Patent and Trademark Office, et al., was filed on May 12 in theU.S. District Court for the Southern District of New York on behalf of breastcancer and women's health groups, individual women, geneticists and scientificassociations representing approximately 150,000 researchers, pathologists andlaboratory professionals.
Because the ACLU's lawsuit challenges the wholenotion of gene patenting, its outcome could have far-reaching effects beyondthe patents on the BRCA genes. Approximately 20 percent of all human genes arepatented, including genes associated with Alzheimer's disease, musculardystrophy, colon cancer, asthma and many other illnesses.
The court recognized the far-reaching impact ofthe case on medical research and public health. The opinion stated, "…theresolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals,researchers, caregivers, advocacy groups, existing gene patent holders andtheir investors, and those seeking to advance public health."
But Sweet also clearly recognized there would benegative blowback on his ruling from the industry and, in a footnote of his152-page ruling, he discounted fears that invalidating such patents woulddecimate the industry.