WASHINGTON, D.C.—On July 29, the U.S. Court of Appeals forthe Federal Circuit declared that the composition of matter claims coveringisolated 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 theU.S. Patent Act. The ruling reverses the decision of the U.S. District Courtfor the Southern District of New York that the compositions of matter claimsfor Myriad's BRACAnalysis product wereinvalid because the isolated DNA was not really different from the DNA in thebody.
The case, The Association for Molecular Pathology, et al.v. Myriad Genetics Inc., was filed in May2009 on behalf of breast cancer and women's health groups, individual women,geneticists and scientific associations representing approximately 150,000researchers, pathologists and laboratory professionals.
The contentious two-year-old court battle over patents andgenes has been seen as a legal struggle for dominance between nature andbiotechnology. The case's outcome has huge ramifications, as approximately 20percent of all human genes are patented, including genes associated withAlzheimer's disease, muscular dystrophy, colon cancer, asthma and many otherillnesses, the plaintiffs state.
This recent decision is seen by some as tipping the scalestoward technology, innovation and profits. The case could ultimately be heardbefore the U.S. Supreme Court.
The justices ruled 2-1 that DNA isolated from the body waseligible for patents because it was "markedly different" in its chemicalstructure 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 eligiblefor a patent—but a part of the process invented by a company.
The court also ruled that companies can obtain patents onthe genes, but cannot patent methods to compare those gene sequences.
"Judicial restraint is particularly important here becausean entire industry developed in the decades since the Patent Office firstgranted patents to isolated DNA," Judge Kimberley A. Moore wrote in the court'smajority opinion. "Disturbing the biotechnology industry's settledexpectations, now, risks impeding, not promoting, innovation."
"The claims cover molecules that are markedly different—havea distinctive chemical identity and nature—from molecules that exist innature," added Federal Circuit Judge Alan D. Lourie.
As expected, Myriad Genetics heralded the federal circuitruling. Peter Meldrum, president and CEO of Myriad Genetics, told newsagencies, "We strongly support the court's decision that isolated DNA andcDNA are patent-eligible material as both are new chemical matter withimportant utilities which can only exist as the product of human ingenuity.Furthermore, we believe this decision is in the best interests of theagriculture, biotechnology and pharmaceutical industries, as well as thehundreds of millions of people whose lives are bettered by the products theseindustries 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 infull force.
Thousands of human genes have been patented, and somebiotechnology executives say such patents are essential for encouraginginnovation, Myriad contends.
But the American Civil Liberties Union (ACLU) and the PublicPatent 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 filedfriend-of-the-court briefs in support of the challenge to the patents on theBRCA genes. In an unprecedented move, the U.S. Department of Justice filed abrief arguing that many of the gene patents issued by the Patent Office areinvalid.
"(The) ruling is a blow to the idea that patent law cannotimpede the free flow of ideas in scientific research," says Christopher Hansen,a staff attorney with the ACLU Speech, Privacy and Technology Project. "HumanDNA is not a manufactured invention, but a natural entity like air or water. Toclaim ownership of genetic information is to unnecessarily block the freeexchange of ideas."
The ACLU further charged that the challenged patents areillegal and restrict both scientific research and patients' access to medicalcare, and that patents on human genes violate the First Amendment and patentlaw because genes are "products of nature."
The ACLU and plaintiffs in the case assert it is unethicalto patent something that is part of the human body or the natural world, andthat the cost of testing might be reduced if companies did not hold testingmonopolies.
Myriad, which holds the patents on the genes called BRCA1and 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 familiesopt to undergo genetic testing to determine if they have the mutations of theirBRCA genes that put them at increased risk for these diseases, and help themdecide whether to pursue preventive mastectomies or ovary removal, Hansenexplains.
"As the dissent from decision explains, pieces of the humangenome are not patentable," says Daniel B. Ravicher, executive director ofPUBPAT 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 bepatented because they are not genes themselves."
Ravicher notes that even the judges couldn't "agree amongthemselves." In writing the dissenting opinion, Judge William C. Bryson statedthat 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 duringautumn. Yet, prematurely plucking the leaf would not turn it into a human-madeinvention."
Ravicher says the plaintiffs were considering either askingthe entire appellate court to rehear the gene patenting aspects of the case orappealing 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. "Nocorporation should be able to claim ownership of a woman's own geneticinformation."