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Supreme Court Tosses Myriad's Isolated DNA Patent Claims

myriad_june_14_2013.jpg

By Mari Serebrov
Washington Editor

In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible.

However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created.

In striking down Myriad's isolated DNA claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake City diagnostics company "found an important and useful gene, but groundbreaking, innovative or even brilliant discovery does not by itself satisfy the §101 inquiry" of the Patent Act, which renders laws of nature, natural phenomena and abstract ideas ineligible for patent protection.

Myriad's claims detailed an extensive process of the discovery of the genes, "but extensive effort alone is insufficient to satisfy §101's demands," the court said.

Rather than expressing its claims in terms of chemical composition or relying on the chemical changes that result from the isolation of a specific DNA segment, Myriad focused the claims on the genetic information encoded in the genes, mutations of which can significantly increase the risk of breast and ovarian cancers.

Reversal

The opinion, written by Justice Clarence Thomas, overturned the U.S. Court of Appeals for the Federal Circuit. In two separate split decisions, the Federal Circuit had determined that isolated DNA was patent eligible because it is a "non-naturally occurring composition of matter." (See BioWorld Today, April 5, 2011, and Aug. 17, 2012.)

The appellate court was forced to give Myriad a second look after the Supreme Court sent it back with orders to reconsider it in light of the high court's decision in Mayo Collective Services v. Prometheus Laboratories Inc., which involved method claims on applying a law of nature. (See BioWorld Today, March 21, 2012, and March 27, 2012.)

In arguing before the Supreme Court in April, Myriad pointed out the Patent and Trademark Office's (PTO) 31 years of precedence in granting patents for isolated DNA. But in its opinion, the Supreme Court noted that Congress hasn't endorsed that precedence and the government itself pushed for the new line drawn by the court. (See BioWorld Today, April 16, 2013.)

The justices paid no heed to the fact that the government's argument, which carved out the middle road between isolated and cDNA, was a fairly recent reversal not endorsed by the PTO. The government's changed stance turned Myriad into a political case from the beginning, with much of the public dialogue focusing on access to medical care rather than patent law, Ron Eisenstein, a partner and co-practice group leader with Nixon Peabody's patent group, told BioWorld Today.

Impact of Myriad

The decision "will have an impact . . . because it puts a lot of old patents that people have relied on in doubt," Eisenstein said. But that impact won't be as significant as it would have been a number of years ago because many of the patents that could be affected are either expiring soon or already have expired, he added.

While the disputed Myriad claims would have expired in two years, the company's diagnostic BRCAnalysis continues to be protected by other unchallenged patents.

As for other patents already awarded, the Supreme Court's decision "is likely to have the greatest impact on diagnostic/genetic screening patents similar to those at issue in Myriad," said Courtenay Brinckerhoff, a partner at Foley & Lardner.

"We're back to another level of uncertainty" for diagnostics, she told BioWorld Today, noting the uncertainties already caused by the court's ruling last year in Prometheus, which struck down method claims on natural correlations between metabolites in the blood and the dosing of thiopurine drugs for such diseases as Crohn's and ulcerative colitis. (See BioWorld Today, March 21, 2012.)

In the future, the uncertainty could extend to other newly discovered "isolated" compounds, "such as medicinal compounds isolated from plants, beneficial proteins isolated from human or animal sources and beneficial microorganisms isolated from soil or the deep sea," she added.

Regardless of the limitations imposed by the court's recent decisions, "many commercially valuable ways to claim products related to human genes and genetic technology . . . are perfectly sound in light of Myriad," Mary Sylvia, a patent attorney with Baker & Hostetler LLP, told BioWorld Today.

Since some claims will be invalidated under the new ruling, she advised biotechs to review their patent portfolios with a focused analysis of the claims in comparison with the products and product development.

Brinckerhoff recommended protecting inventions and discoveries from a variety of angles, such as finding a synthetic construct that will meet the new Myriad test and method claims that will withstand Prometheus.

Another concern raised by the Supreme Court decision is that the ruling, coming on the heels of Prometheus, will embolden groups advocating to end patents in general. The logic used by the American Civil Liberties Union, which argued the case for the Association of Molecular Pathology, could be used against patents for any products, Eisenstein said. Isolated DNA was just the lowest hanging fruit.

To prevent further erosion of its intellectual property rights, the biotech industry needs to engage in more effective public relations on the societal value of its patents. "They can't just say, 'We got a decision that we can live with,'" Eisenstein said. Otherwise, other patents will be endangered in the future, he added.

As it is, the court's decision is likely to result in more patent litigation as industry and patent opponents test the boundaries of isolated vs. complementary DNA.

Calling it a "perfunctory decision," Mark Janis, director of the Center for Intellectual Property Research at the Indiana University Maurer School of Law, said it "does virtually nothing to illuminate the broader questions about how to distinguish between ineligible product of nature and eligible inventions derived from natural products."