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Patents prevail in Myriad case
WASHINGTON, D.C.—On July 29, the U.S. Court of Appeals for the Federal Circuit declared that the composition of matter claims covering isolated DNA and cDNA of the BRCA1 and BRCA2 genes—the work of Salt Lake City, Utah-based Myriad Genetics Inc.—are patent-eligible under Section 101 of the U.S. Patent Act. The ruling reverses the decision of the U.S. District Court for the Southern District of New York that the compositions of matter claims for Myriad's BRACAnalysis product were invalid because the isolated DNA was not really different from the DNA in the body.
The case, The Association for Molecular Pathology, et al. v. Myriad Genetics Inc., was filed in May 2009 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.
The contentious two-year-old court battle over patents and genes has been seen as a legal struggle for dominance between nature and biotechnology. The case's outcome has huge ramifications, as 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 plaintiffs state.
This recent decision is seen by some as tipping the scales toward technology, innovation and profits. The case could ultimately be heard before the U.S. Supreme Court.
The justices ruled 2-1 that DNA isolated from the body was eligible for patents because it was "markedly different" in its chemical structure from DNA that exists inside the chromosomes in the body. As a result, the isolated DNA is not simply a product of nature, which would not be eligible for a patent—but a part of the process invented by a company.
The court also ruled that companies can obtain patents on the genes, but cannot patent methods to compare those gene sequences.
"Judicial restraint is particularly important here because an entire industry developed in the decades since the Patent Office first granted patents to isolated DNA," Judge Kimberley A. Moore wrote in the court's majority opinion. "Disturbing the biotechnology industry's settled expectations, now, risks impeding, not promoting, innovation."
"The claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature," added Federal Circuit Judge Alan D. Lourie.
As expected, Myriad Genetics heralded the federal circuit ruling. Peter Meldrum, president and CEO of Myriad Genetics, told news agencies, "We strongly support the court's decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity. Furthermore, we believe this decision is in the best interests of the agriculture, biotechnology and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection."
Myriad has 237 method claims for BRACAnalysis that were not affected by this ruling and remain in full force.
Thousands of human genes have been patented, and some biotechnology executives say such patents are essential for encouraging innovation, Myriad contends.
But the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) contend that the court made the wrong decision. Lining up beside the ACLU were, among others, the American Medical Association, the March of Dimes and the American Society for Human Genetics, which filed friend-of-the-court briefs in support of the challenge to the patents on the BRCA genes. In an unprecedented move, the U.S. Department of Justice filed a brief arguing that many of the gene patents issued by the Patent Office are invalid.
"(The) ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research," says Christopher Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. "Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas."
The ACLU further 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 ACLU and plaintiffs in the case assert it is unethical to patent something that is part of the human body or the natural world, and that the cost of testing might be reduced if companies did not hold testing monopolies.
Myriad, which holds the patents on the genes called BRCA1 and BRCA2 with the University of Utah Research Foundation, charges more than $3,000 for its breast cancer risk test, according to court records.
Many women with a history of those cancers in their families opt to undergo genetic testing to determine if they have the mutations of their BRCA genes that put them at increased risk for these diseases, and help them decide whether to pursue preventive mastectomies or ovary removal, Hansen explains.
"As the dissent from decision explains, pieces of the human genome are not patentable," says Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. "This is because no one 'invents' genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves."
Ravicher notes that even the judges couldn't "agree among themselves." In writing the dissenting opinion, Judge William C. Bryson stated that patents on genes should be invalid.
"Extracting a gene is akin to snapping a leaf from a tree," Bryson wrote. "Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet, prematurely plucking the leaf would not turn it into a human-made invention."
Ravicher says the plaintiffs were considering either asking the entire appellate court to rehear the gene patenting aspects of the case or appealing to the Supreme Court.
"The court has made the wrong decision for women's health," says Sandra Park, staff attorney with the ACLU Women's Rights Project. "No corporation should be able to claim ownership of a woman's own genetic information."