Throw the biotech baby out with the bath water?

U.S. Department of Justice files precedent-setting amicus curiae brief in landmark DNA patent case

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WASHINGTON D.C.—As the landmark lawsuit, Association of Molecular Pathology v. U.S. Patent and Trademark Office, winds its way towards the U.S. Federal Circuit Court on appeal, a flurry of amicus curiae briefs have flown in for both sides—including a precedent-setting filing by the U.S. Department of Justice (DOJ) "in support of neither party."

The DOJ's brief—in contending that the human genes linked to breast and ovarian cancer, BRCA1 and BRCA2, should not be eligible for patents because they are "part of nature"—appear to be more on the side of the American Civil Liberties Union (ACLU) rather than Utah-based Myriad Genetics.

A three-judge federal district court panel is likely to hear the district court appeal by Spring, and could take up to one year to issue its ruling, according to Jackie Wright Bonilla, partner in Washington D.C.-based Foley & Lardner LLP, who has filed an amicus curiae brief for Myriad. The highly publicized case is expected to ultimately land in the hands of the U.S. Supreme Court.

The final decision will have wide-ranging ramifications for the future of human gene patents and the biotech industry.

The case began when several women with histories of breast cancer in their families wanted the diagnostic tests at Myriad, but could not afford the $3,000 cost and did not have insurance coverage. Several doctors' groups, the ACLU and the Public Patent Foundation then filed a lawsuit in 2009, seeking to invalidate patents on two genes related to breast cancer and owned by Myriad.

On March 29, 2010, Judge Robert W. Sweet of the Southern District of New York granted partial summary judgment, ruling that the claims of several patents on BRCA1 were invalid. Three months later, Myriad appealed, and more than a dozen amicus curiae briefs followed. The ACLU also has about a dozen amicus curiae briefs in support of its position.

Now that the DOJ has weighed in with its amicus curiae brief, legal pundits are predicting a patent Armageddon, of sorts. The brief posits that the district court erroneously cast doubt on the patent eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA.

"Such compositions—e.g., cDNAs, vectors, recombinant plasmids and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as 'human-made inventions' eligible for patent protection under Section 101," the brief states.

The DOJ acknowledges its amicus curiae brief has stirred up a pot of controversy, but places much of the blame on the district court.

"We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA," the DOJ brief states. "The district court's judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature."

Edward Reines, a patent attorney who represents biotechnology companies, says, "It's major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long."

The U.S. Patent and Trademark Office has sided with the proponents and has issued thousands of patents on genes of various organisms, including on an estimated 20 percent of human genes. But in its brief, the government says it now believes the mere isolation of a gene, without further alteration or manipulation, does not change its nature.

Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina, refers to the government's brief as "a bit of a landmark, kind of a line in the sand."

According to Bonilla, "some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief."

The DOJ argues that the district court got it wrong in certain important respects, she says.

 "As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter," Bonilla states. "Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water."

That said, the DOJ "may cut off a hand of the biotech baby, with its contention that 'isolated DNA,' comprising a sequence from genomic DNA as it exists in a body, does not constitute patentable subject matter," Bonilla says.

The DOJ brief also argues that the "chemical structure of native human genes is a product of nature," even when that structure is "isolated" from its natural environment.

"This position presents a slippery slope of considerable concern to those involved in biotech innovation," Bonilla says. "For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules."

Such DNA molecules are by definition of their existence in an isolated form, "human-made" inventions that simply do not exist without human intervention, Bonilla argues.

"Then how does one successfully distinguish what is really 'human-made?'" Bonilla asks. "The DOJ's position has sweeping implications, even if they're not as debilitating as the district court opinion."

The Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social or economic considerations, she says.

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