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Myriad, ACLU Clash over Gene IP in NY Court

NEW YORK (GenomeWeb News) – After two hours of listening to oral arguments today, a judge in a US District Court in New York said that he will wait to make a decision on whether a case on the legality of the patenting of BRCA1 and BRCA2 genes by Myriad Genetics should be decided, or if it should go to trial or be dismissed.

The ramifications of a decision of summary judgment for either Myriad's co-plaintiff the University of Utah Research Foundation, which hold the BRCA patents, or the American Civil Liberties Union, which initiated the lawsuit, were just too serious and the issues too complicated for the judge to make a decision from the bench, Judge Robert Sweet of the US District Court for the Southern District of New York said today.

In the case — Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office, et al — Myriad and the ACLU both had filed motions asking Judge Sweet to issue a summary judgment one way or the other, while the USPTO had asked the court to dismiss the case outright.

The suit, which the ACLU filed in May on behalf of women's health and cancer groups and researchers, claims that the patents on these genes, certain mutations of which are associated with breast and ovarian cancers, are violations of the First Amendment of the Constitution of the United States and of US patent law.

Myriad offers the BRCAnalysis test using these gene mutations to assess risk of breast and ovarian cancers.

The ACLU's patent law claim broadly holds that genes are products of nature, and cannot be patented. The ACLU also argued that patents on genes may hinder innovation because under current law Myriad and UURF would have the right to enforce patent protection against researchers studying or using these genes.

"Allowing patents on genetic material imposes real and severe limits on scientific research, learning, and the free flow of information," ACLU attorney Chris Hansen said in an oral argument. "Patenting human genes is like patenting e=mc2, blood, or air," he argued.

Because of its wide rejection of the practice of human gene patenting in general, the ACLU pointed out in a statement today that the outcome in this case "could have far reaching effects beyond the patents on the BRCA genes."

The defense counsel argued that there are a number of cases that serve as precedents that would offer protection for Myriad's patents.

Defense attorney Brian Poissant, a managing partner at Jones Day, argued today that Myriad's test does not violate the First Amendment and does not hinder research or progress in genomic knowledge or medicine.

He also said that the ACLU argument is another in a line of attacks on biotechnology patenting that warn of the "gruesome parade of horribles" that will happen if companies are given patents over biological phenomena.

He said that the ACLU had "picked" Myriad's technologies to serve as an example of gene patenting, and that if a ruling were as broadly applied here as the ACLU would like then it could "undermine the entire biotechnology sector."

Not only has Myriad's patent position not prohibited research using the BRCA genes, "women would not even know they had BRCA gene if it weren't discovered" under a system that incentivizes patents, Poissant argued.

If Americans don't want to allow patenting of genes, he said, then that is not an issue for the courts. People should "go to Congress and do something about it," he said.

The defense's line today also centered on the issue of DNA isolation. Poissant said that it is at the heart of the case. He argued that the process of applying DNA isolation technologies and PCR amplification to the BRCA genes made their intellectual property fit squarely in line with patent law precedent, and he listed several examples which he said support that assertion.

He also argued that the First Amendment assertions of the plaintiffs are inaccurate, and that if true they would mean that it would be an infringement even to think about the BRCA1 and BRCA2 genes.

Judge Sweet did not say today when he expects to make a decision in the case.