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Myriad, ACLU Case Hits Higher Court

By Matt Jones

NEW YORK (GenomeWeb News) – A US federal circuit court heard oral arguments yesterday from Myriad Genetics, the American Civil Liberties Union, and the Department of Justice in a case about gene patenting that could have a wide impact on the genomics and molecular diagnostics business and research fields.

Myriad Genetics on Monday argued in the US Court of Appeals for the Federal Circuit in Washington, DC, that its patent claims on BRCA genes, which it uses in its BRACAnalysis test for predicting individual breast and ovarian cancer risk, are in accord with US patent law.

ACLU lawyers countered by claiming that human genes are a product of nature and cannot be patented — a position that was upheld last year by a judge in a US District Court in New York in the same case, the Association of Molecular Pathologists vs. the US Patent and Trademark Office. (Upon its request, USPTO was relieved from defending the case by the NY court.)

The case landed in the circuit court today after Myriad appealed the ruling of Judge Robert Sweet of the Federal District Court for the Southern District of New York.

While AMP and ACLU's suit is focused on Myriad's patents, it essentially challenges the constitutionality of patenting all genetic sequences on First Amendment grounds — the notion that people have a right to have information about their genes and that patents could block that right.

The Public Patent Foundation (PubPat) joined the ACLU in the suit, and the US Department of Justice's Office of the Solicitor General filed an amicus brief partly supporting the ACLU's position, while Acting Solicitor General Neal Katyal stated the DOJ's position in court yesterday.

In his ruling last year, Judge Sweet effectively decided that Myriad's patent claims on BRCA genes were invalid, stating the company's claims on isolated DNA "[contain] sequences found in nature," which he said are "unpatentable subject matter."

"DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature … [its] existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes," he wrote.

Yesterday, Myriad made the case that their claims are supported by established patent laws and that Judge Sweet's interpretation of the central subject was incorrect.

Myriad holds the view that isolated DNA is "a chemical composition which is not found in the human body, and which has important diagnostic and therapeutic uses that cannot be accomplished with a human's natural or native DNA as found in the body," a company spokesperson told GenomeWeb Daily News in an e-mail Monday.

The firm's technology, the spokesperson stated, is a demonstration of the "handiwork of man," and as such is afforded patent protection for a limited time period under US law.

"The human gene is a product of nature and no more patentable than a human kidney," Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, who argued for the plaintiffs today, said in a statement.

Hansen called Judge Sweet's ruling nullifying human gene patents "a victory for the free flow of ideas and information," and said that removing patent protection for human genes "could lead to important medical and scientific advances."

Myriad sees the question before the court has having nothing to do with the freedom of knowledge. Their spokesperson told GWDN that the key issues in this case are whether isolated DNA and method claims are eligible under Section 101 of the Patent Act, and whether the lower district court had jurisdiction to hear this case to begin with.

PubPat Executive Director Dan Ravicher, who is representing the plaintiffs, sees the issues at stake in more philosophical terms, but he also appeals to US law as the basis for their case.

"Since the beginning, this case wasn't about patent law, it was about the right of women to know what genetic mutations they might have in their own bodies and the right of physicians to help them in doing so," Ravicher said in an ACLU statement yesterday. "Today we asked the Court of Appeals to apply patent law's longstanding prohibition on the patenting of nature to protect these rights from patents that the government now agrees should have never been issued in the first place."

Much of the oral arguments yesterday focused on the issue of the plaintiff's legal standing in the case — whether or not the plaintiffs could show that there have been injuries or negative effects of Myriad's patents.

Hansen argued that the research advocacy groups, including the American College of Medical Genetics and the College of American Pathologists, that have supported the ACLU suit would not have done so if there were not some threat that Myriad might sue to protect its intellectual property.

Hansen told the court yesterday that Myriad's fundamental legal claims about isolated DNA are based on a contradiction within its business model.

"Myriad's entire legal argument here is that the composition of isolated DNA is different than DNA," he said. "Myriad's entire business is built on the proposition that isolated DNA and DNA are identical."

Myriad's attorney argued that the firm has not taken any action to enforce its BRCA patents since 1998. The firm also has said that its intellectual property has not kept women from finding out about their BRCA status.

The firm, which was charging up to $4,000 for its BRCA tests in the past year, according to the Yale Cancer Center Genetic Counseling Program, said that insurance currently covers 90 percent of BRCA testing and that an average co-pay for the test is approximately $100. The company also said it provides financial assistance programs for patients who are uninsured or have high deductibles or limited incomes.

In addition, Myriad claims that its IP hasn't been a hindrance to biomedical progress.

"To date, Myriad has participated in over 100 research programs/studies and more than 8,000 papers have been published relating to BRCA1 and BRCA2 and predisposition testing for hereditary breast and ovarian cancer," the company said. "Therefore, we believe the final outcome of this litigation will not have a material impact on the company's operations."

In addition, the spokesperson said, "Indeterminate of the outcome of this case, Myriad will continue to have a strong suite of 23 patents which offer blocking protection for a number of years."

The Office of the Solicitor General, in an amicus brief, has asked that the circuit court to affirm the district court's conclusion that patent claims covering isolated DNA are invalid, but it also asked for another part of the earlier ruling, which invalidated cDNA for patent protection, to be reversed.

Solicitor General Katyal explained to the court that his office has taken "a very limited position," one that "is not going to undermine the biotechnology industry" or destroy a large number of patents.

"What I think that this court should do is what I think the Supreme Court has repeatedly said; that there is just a cardinal distinction for [Section 101] purposes between products of nature on the one hand and human made invention on the other. And the mere act of isolating a substance doesn't mean that it is a human made invention. For it to be so, lithium would be patentable," Katyal told the court.

It is not clear when a ruling on the case is expected.

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