A federal judge ruled Monday that a lawsuit can move forward against the Patent and Trademark Office and the research company that was awarded exclusive rights to human genes known to detect early signs of breast and ovarian cancer.

The first-of-its-kind lawsuit by the American Civil Liberties Union and the Public Patent Foundation at the Benjamin Cardozo School of Law claims that the patents violate free speech by restricting research.

U.S. District Judge Robert W. Sweet of New York, in ruling that the case may proceed to trial, noted that the litigation might open the door to challenges of a host of other patented genes. About one-fifth of the human genome is covered under patent applications and claims.

Sweet wrote: (.pdf)

The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation and biomedical research. The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.

The case against the patent office and patent-holder Myriad Genetics of Salt Lake City is the first to challenge a patented gene under a civil rights allegation — in this case the First Amendment.

According to the federal lawsuit,filed in the Southern District of New York, the First Amendment is at stake because the patents are so broad they bar scientists from examining and comparing the BRCA1 and BRCA2 genes (.pdf) at the center of the dispute. In short, the patents issued more than a decade ago cover any new scientific methods of looking at these human genes that might be developed by others.

According to the plaintiffs — dozens of patients and researchers — the genes cannot be patented because they exist as naturally occurring products of nature. The suit claims Myriad did not invent, create or in any way construct or engineer the genes. Rather, Myriad located them in nature and described their information content as it exists and functions in nature, the suit claims.

In defense, Myriad argued that, among other things, the lawsuit should be tossed because the plaintiffs have no legal standing to bring the case, even though they were "ready. willing and able to infringe." Myriad also argued that there was no legal basis for the plaintiffs' claims.

The judge disagreed in an 85-page filing.

The judge noted that the plaintiffs contended that patents grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas and basic human knowledge and thought in violation of the First Amendment's protections over freedom of thought.

"The facts alleged in the complaint are plausible, specific and form a sufficient basis for plaintiffs' legal arguments," the judge wrote.

Judge Sweet cautioned, however, that his ruling was at a preliminary stage of litigation, when one side seeks to dismiss a case before more-intense litigation –- and the possible sharing of confidential information –- begins. "The question before the court is not whether a plaintiff will ultimately prevail but whether claimant is entitled to offer evidence to support the claims," Sweet wrote.

The patents at issue give Myriad Genetics a virtual monopoly on such predictive testing for breast and ovarian cancer, according to the suit. Women who fear they may be at an increased risk are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder, which charges about $3,000 per test.

About 10 percent of women with breast cancer are likely to have a mutation inherited from their parents in the genes at issue, according to the suit.

The Patent and Trademark Office first issued a patent for a human gene in 1982 to the Regents of the University of California in connection with a hormone promoting breast development during pregnancy.

Photo: hibiotech

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