On March 29, 2010, US District Judge Robert Sweet of New York ruled the patents held by Myriad Genetics, covering how to detect inherited breast cancer, invalid - citing they "are directed to a law of nature and were therefore improperly granted." Judge Sweet sided with the American Civil Liberties Union, which represented groups including the Association for Molecular Pathology, the American Society for Clinical Pathology, and the American College of Medical Genetics.

Barbara Caulfield, a patent attorney with Dewey & LeBoeuf in Palo Alto, California, called the ruling "ground breaking." Ms. Caulfield, who submitted arguments against the patents on behalf of the March of Dimes, went on to say, "now all naturally occurring gene patents are invalid by the reasoning of this opinion. This is really a sea change for patents in life sciences.”

Myriad Genetics, based in Salt Lake City, said it's patents cover how to sequence the breast cancer genes BRCA1 and BRCA2 and how to look for mutations to determine the relative risk of a woman in developing certain types of breast cancer. Based on the prior research and patented genes, the company makes a widely used blood test for determining a patients risk for hereditary breast cancer.

Judge Sweet said that Myriad simply identified something that occurred in the body, and that the comparisons of DNA sequences are “abstract mental processes” and neither are eligible for patent protection.

“The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent,” Sweet ruled.

Many medical groups celebrating this ruling have claimed that Myriad's tight control over the use of these genes has discouraged other scientists from exploring alternative breast cancer screening options. These groups claim that patents inhibit testing, ultimately limiting a patients option in medical care.

The trade group of biotech companies that supported Myriad in this case, known as the Biotechnology Industry Organization, worry that the challenge to these types of patents may hinder investment in research. Edward Reines of Weil Gotshal in Silicon Valley, who represents biotechnology companies said, "so much of the area of genetic discovery requires people working hard,” he said. “It’s hard to find a genetic solution to a health problem, but it’s easy to copy. You can’t rely on academic curiosity. Motivating incubators around this country is something we want to do."

Most expect the case to be appealed to a court in Washington that specializes in patent law - and most likely to the Supreme Court.

Source: Myriad Loses Ruling Over Breast Cancer-Gene Patents; By Susan Decker and Thom Weidlich

The case is Association for Molecular Pathology v. U.S. Patent and Trademark Office, 09cv4515, U.S. District Court for the District of New York.