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Patent Ruling Dismays Biotech

Supreme Court limits personalized medicine claims

by Glenn Hess
April 2, 2012 | A version of this story appeared in Volume 90, Issue 14

Credit: Shutterstock
The Supreme Court ruled Prometheus’ patents are invalid because they cover “well-understood, routine, conventional activity.”
U.S. Supreme Court building in Washington, D.C.
Credit: Shutterstock
The Supreme Court ruled Prometheus’ patents are invalid because they cover “well-understood, routine, conventional activity.”

The Supreme Court’s ruling last month, striking down two patents for a diagnostic test that helps doctors set drug dosages for patients with certain diseases, is being hailed by doctors and other medical professionals as a victory for patients.

But the justices’ unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories has alarmed the biotechnology industry, which fears the decision will hurt the emerging field of personalized medicine (C&EN, Jan. 16, page 26).

Also called targeted therapy, personalized medicine entails the use of a patient’s genetic information to select medicines and treatments that precisely match the needs of the individual.

Prometheus, a San Diego-based biotech firm that is now part of Switzerland’s Nestlé Health Science, obtained patents on a medical invention—a blood test that helps doctors determine optimal drug dosages for patients with gastrointestinal disorders such as Crohn’s disease and other autoimmune ailments. The legal dispute began in 2004 when Prometheus filed a patent infringement lawsuit against Mayo after Mayo tried to market a similar test. In March 2008, the U.S. District Court for the Southern District of California invalidated the patents, finding that Prometheus’ invention was no more than “a natural body process … preexisting in the patient population.”

The U.S. Court of Appeals for the Federal Circuit reversed that ruling in September 2009, saying the claims are patent-eligible because they describe a specific method for improving the treatment of certain diseases through a series of concrete and transformative steps.

After that decision was appealed to the Supreme Court, the justices concluded that Prometheus had attempted to patent laws of nature that could not be made exclusive. “Upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries,” Justice Stephen G. Breyer wrote in the Court’s 24-page opinion.

The American Medical Association (AMA), the nation’s largest physician group, welcomes the ruling. Robert M. Wah, chair of AMA’s Board of Trustees, says the verdict is “a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research.”

Had the Court found the patents to be valid, Wah contends that physicians would have encountered a “vast thicket of exclusive rights” that would prevent them from considering all relevant scientific information when reviewing diagnostic test results.

But the Biotechnology Industry Organization, an industry trade group, finds the decision disappointing. “We are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement,” says Hans Sauer, the group’s deputy general counsel for intellectual property (IP).

The industry is troubled that the Court’s opinion “fails to appropriately recognize” the importance of personalized medicine and the research and investment incentives needed to develop new individualized therapies for untreated diseases, Sauer says.

In the decision, the justices acknowledge the competing interests of securing patent rights to reward significant investment on one hand and the ability to freely conduct research on the other, notes Paul M. Rivard, a patent attorney in the Washington, D.C., office of Banner & Witcoff, an IP law firm. “But they essentially punted on this issue, leaving it up to Congress to fashion any special rules for personalized medicine,” he says.

With a more challenging legal environment for patents broadly directed to diagnostic methods, investors in personalized medicine “may revisit the value proposition for investments already made and may curtail or redirect future investments in new projects,” says Kendrew H. Colton, a partner at Chicago-based IP law firm Fitch, Even, Tabin & Flannery.

The Supreme Court’s decision will “significantly impact how patent applications in the field of personalized medicine are drafted, and the scope of protection that may eventually be obtained,” Colton adds.

Patent applicants in this area “probably will need to identify and claim more specific protocols to avoid being found to preempt a law of nature,” Rivard says.

Additionally, the thousands of patents issued for diagnostic tests in the past two decades could be affected by the Court’s ruling. “The decision may expose broadly drafted diagnostic method patents to increased legal risk,” Colton says. Over time, he adds, the challenges will be tempered by a new generation of patents drafted in the aftermath of the high court’s decision.


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