U.S. appellate court will hear human gene patents lawsuit

The U.S. Court of Appeals for the Federal Circuit will hear arguments April 4 in a landmark case centering on whether human genes should be patentable.

Experts say a ruling could significantly impact the health care and biomedical research industries, including the practice of medicine.

The court battle started in 2009, when the Assn. for Molecular Pathology and others sued Myriad Genetics, challenging the validity of Myriad's patents on two genes linked to breast and ovarian cancer. Myriad's sole rights to the genes and its diagnostic analysis leaves women unable to confirm their test results elsewhere, and other women cannot afford Myriad's $3,000 test, according to the suit.

On March 29, 2010, the U.S. District Court for the Southern District of New York invalidated the patents, ruling that they were barred by laws preventing the patentability of natural phenomena. The court also overturned another patent held by Myriad on a testing method that determines a patient's risk for the two cancers. Myriad appealed, and the case is before the appellate court that oversees patent issues.

The company said in a statement that it is confident the appellate court will rule that Myriad's patents are legitimate. "Isolated DNA is a chemical composition which is not found in nature or the human body, and which has important diagnostic and therapeutic uses that cannot be accomplished with a human's natural or native DNA," the company said. "It is these new uses which demonstrate the handiwork of man for which patent protection, for a limited period of time, is afforded."

Others argue that isolating a gene sequence from the body does not make it man-made.

"Your genes are a product of nature," said Mark H. Stoler, MD, past president of the American Society for Clinical Pathology, a co-plaintiff. "You can't patent gold. You shouldn't be able to patent human DNA."

Legal experts say regardless of the ruling, the U.S. Supreme Court probably will decide the case.

Far-reaching impact

Physician organizations and others have weighed in. Amicus briefs have been filed by the Litigation Center of the American Medical Association and the State Medical Societies, the Justice Dept. and various patent law organizations, among others.

In its brief, the Litigation Center urged the appellate court to uphold the lower court's decision invalidating the gene patents. Myriad's exclusive control over the gene sequences precludes improved genetic tests and prevents patients from obtaining second opinions on tests, the brief said.

AMA President Cecil B. Wilson, MD, said physicians should not be restricted in what care they can provide because a part of human biology has been patented. Existing patents cover about 20% of the human genome.

But gene patents promote innovation and lead to more scientific discoveries, said James Crowne, director of legal affairs for the American Intellectual Property Law Assn., which represents lawyers who practice patent and trademark law. "If a scientist hopes to get the necessary funding to exploit his discovery, a patent is essential. That is the only return on his investment," he said.

The driving force for new discoveries is not to obtain patents, said Steven L. Salzberg, a scientist and director of the Center for Bioinformatics and Computational Biology at the University of Maryland.

"No one that I know is motivated by the possibility of a patent," he said. "We're scientists. We're interested in the human body and how it works. We want to find cures for diseases."

A ruling against Myriad would mean scientists and physicians could freely examine genes for research and clinical purposes without worrying about lawsuits for patent infringement, said Chris Hansen, senior staff attorney for the American Civil Liberties Union, which is representing the plaintiffs.

"If we are successful, it will be a major advancement for science and for medicine," he said.