When attorneys for Myriad Genetics Inc. appear before a federal appeals court in Washington, D.C., on Monday, they will be facing a new and formidable challenger to their position that human genes can be patented in certain circumstances.
In a brief filed in the appeal of a legal ruling against Myriad, the U.S. Justice Department has made arguments that run counter to long-standing federal practices of granting patents on human genes. It asks the appellate judges to uphold parts of the ruling that overturned several of the Salt Lake City-based company's patents on genes that are related to breast and ovarian cancer.
The decision puts the government at odds with the custom of the Patent and Trademark Office that since about 1987 has granted such patents on genes isolated in laboratories from their place in human DNA, the chemical molecules that control living organisms.
"We acknowledge that this conclusion is contrary to the long-standing practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies, that have in the past sought and obtained patents for isolated genomic DNA," the Justice Department said in the brief. "The district court's judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature."
At stake, according to Myriad, is whether the nation's biotechnology industry can continue nearly a quarter-century practice of obtaining patent protections that allow companies to attract investments and pour money into research for diagnostic tests and treatments of genetically related diseases. The scientists and women who filed suit say ending those patents will result in more research and a wider variety of tests and treatment for those gene-related diseases.
On Monday, the U.S. Court of Appeals for the Federal District is to hear oral arguments in the appeal of the March 2010 decision by U.S. District Judge Robert Sweet of New York. He made the ruling in a lawsuit against Myriad and the University of Utah that was brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of scientists and women who have suffered from breast and ovarian cancer.
The lawsuit challenged 15 parts of seven patents Myriad received in the early 1990s after its scientists and those from the University of Utah and other organizations, including the National Institutes of Health, discovered and isolated two genes. The genes are known as BRCA1 and BRCA2, mutations of which are responsible for most cases of hereditary breast and ovarian cancers.
The lawsuit argued that products of nature such as genes cannot be patented under the law and that Myriad's exclusive control of them has stifled research and harmed women being treated for the diseases or who are seeking genetic tests to see if they carry the mutations.
In its brief, the Justice Department argues that the judge correctly held "that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible."
Justice Department representatives declined requests for interviews about the brief, which also argues part of Sweet's ruling should be overturned. The judge "erroneously cast doubt on the patent-eligibility of a broad range of man-made compositions of matter whose value derives from the information-encoding DNA," the brief says, and that "countless industrial products such as vaccines and genetically modified crops, created with the aid of such molecules are in every meaningful sense the fruits of human ingenuity and thus qualify as 'human-made inventions' eligible for patent protection."
Chris Hansen, the ACLU attorney who will argue the case before the appeals court, said last week he can't predict whether the U.S. government's position will help sway the appellate judges.
"Obviously we're pleased the United States agrees with our major position in the case and we obviously think they're right," he said.
But Kenneth Chahine, a visiting professor of law at the University of Utah who also holds a doctorate in biochemistry and molecular biology, said other factors such as the court's expertise in patent law it hears all patent appeals should play a bigger role in the decision.
"Those judges are steeped in patent laws and hear hundreds of patent cases a year," Chahine said. "So how they view the same facts is going to be the real key."
Myriad Genetics spokeswoman Rebecca Chambers said the company had no comment on the Justice Department's position "but fully believes in the patent- eligibility of isolated genes."
In its brief, the company argues that the appellate court should reverse the lower court's decision, saying those who sued could not prove research had been stifled or that they suffered any harm as a result of the patents. Upholding the decision would mean virtually anyone could challenge any patent, the company said.
It argues that genes on which the patents are based have been separated from their natural environment and are different from native DNA.
"These isolated molecules are man-made chemical compositions, structurally and functionally distinct from any substance found in the human body indeed, in all of nature," Myriad said in asking the justices to overturn Sweet's ruling.
The judge's decision "imperils the entire biotechnology industry," including genetic testing, the development of drugs to treat genetic conditions and even agricultural practices related to plant and animal husbandry, the company said, pointing to the tens of millions of private dollars poured into genetic research as the result of patent protections.
The ACLU's Hansen said the focus also should be on women's health.
"I prefer to think of it as an important case about health and the advance of research about breast cancer in America," he said.
The American Bar Association's intellectual property law section recently sided with Myriad, taking the position that isolated genes should be treated no differently than other materials when patents are under consideration.
Professor Chachine said the ACLU is making more of an ideological argument than a legal one, when it says that even if isolated genes meet the legal requirements for patents they should not be granted as a matter of public policy.
One measure of the importance trade and scientific organizations place on the case is the that 68 individuals and groups have officially declared in interest, from the Asian Communities for Reproductive Justice to the Pharmaceutical Research and Manufacturers of America to the American Medical Association.
The appeals court ruling is expected to be appealed to the U.S. Supreme Court.
firstname.lastname@example.org U.S. Court of Appeals for the Federal District
Randall R. Rader is chief judge of the 16-member court hearing the appeal in the Myriad Genetics patent case. He received a B.A. in English from Brigham Young University in 1974.
The parties who sued Myriad Genetics have asked that Rader not participate in the decision, saying he has attended events where the case was discussed and stated his views before reading briefs or hearing arguments.
It is not clear if Rader will be a member of the panel hearing the case.