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SALT LAKE CITY (AP) -- A Utah molecular diagnostics firm is asking a federal appeals court to resolve a legal argument about whether the federal government can issue patents for developments connected with naturally occurring genes.
In court documents filed last week in Washington, D.C., Salt Lake City-based Myriad Genetics Inc. focused on company patents it obtained on two human genes linked to an increased risk of breast and ovarian cancer.
Myriad called the suit by 20 researchers, organizations and cancer victims "nominally directed to Myriad," but said it "imperils the entire biotechnology industry" including molecular diagnostics, therapeutic drugs, agricultural applications, animal husbandry.
The publicly traded company wants the U.S. Court of Appeals for the Federal Circuit to overturn a March ruling by U.S. District Court Judge Robert Sweet in New York challenging whether anyone can hold patents on human genes.
Sweet said the company deserved praise for what is "unquestionably a valuable scientific achievement," but not a patent because the "isolated DNA is not markedly different from native DNA as it exists in nature."
But he cited U.S. Supreme Court rulings that purifying a product of nature does not mean it can be patented.
Kenneth Chahine, a visiting professor at the S.J. Quinney College of Law at the University of Utah, told the Salt Lake Tribune he believes the case will probably wind up before the nation's highest court.
The Supreme Court "showed a fair amount of interest in this basic question, which is 'When is something eligible to be patented and when is it so fundamental it cannot be patented?"' Chahine said.
The lawsuit was filed in March 2009 by the American Civil Liberties Union and the Public Patent Foundation against Myriad Genetics, the University of Utah Research Foundation and the U.S. Patent and Trademark Office.
The ACLU and the patent foundation said Myriad's refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancers are prevented from having anyone but Myriad look at the genes in question.
The Salt Lake Tribune reported that Myriad expects support from trade groups with members having a stake in the outcome.
Based partly on pioneering research at the University of Utah and other institutions, Myriad in 1994 and 1995 obtained patents a breast cancer gene. It then went on to develop diagnostic tests that identify mutations that make women more susceptible to breast and ovarian cancer.
Myriad told the court that the U.S. Patent and Trademark Office has issued more than 50,000 patents during the past 29 years related to genes in humans, animals, plants, bacteria and others.
Myriad is challenging whether plaintiffs in the case had standing to sue by showing they were adversely affected by Myriad's actions, and whether the genetic material Myriad contends it isolated was eligible to be patented.
The company also argues its methods can be patented because the result is something substantially different from naturally occurring genes.
(Copyright 2010 by The Associated Press. All Rights Reserved.)
