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Court Throws Out Prometheus Drug Patent

Supreme Court unanimously agreed that the patents held by the company were invalid because they were based on the laws of nature, which are unpatentable.

WASHINGTON (AP) -- The U.S. Supreme Court unanimously tossed out medical patent claims for Prometheus Laboratories on Tuesday for a test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, a decision that could affect the burgeoning field of personalized medicine.

The justices unanimously agreed that the patents held by the company -- owned by Switzerland-based Nestle — were invalid because they were based on the laws of nature, which are unpatentable.

The patent in question covers a blood test that helps doctors determine the proper dosage for a drug, thiopurine, to treat gastrointestinal and non-gastrointestinal autoimmune illnesses. The patent covers methods of administering thiopurine to a patient and then determining the levels of the drug or the drug's metabolites -- what's left after it breaks down in the body -- in the patient's red blood cells. That observation is used to adjust the amount of medicine needed for that patient.

"The question before us is whether the claims do significantly more than simply describe these natural relations," said Justice Stephen Breyer, who wrote the opinion. "To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural law? We believe the answer to this question is no."

The Mayo Clinic formerly used the Prometheus test, but its doctors announced in 2004 that they had come up with their own test and would put that one on the market. Prometheus sued to stop Mayo, but a federal judge invalidated their original patent.

Natural phenomenon cannot be patented, a lower court judge said. That decision was overturned by the U.S. Court of Appeals for the Federal Circuit, leading Mayo to appeal to the Supreme Court.

"The unanimous decision of the U.S. Supreme Court will enable physicians and other health care providers to offer and use tailored diagnostic tests to benefit patients," said John Noseworthy, president & chief executive officer of the Mayo Clinic.

Personalized medicine is becoming big business in the United States, with companies trying to find the best way to use a person's genetic makeup to help tailor care and find the most effective individualized treatments for cancer and other illnesses.

Officials at Prometheus Laboratories Inc., in San Diego said they were disappointed in the court's ruling. "We believe that strong patent protection is important to encourage the investment of energy and resources to develop lifesaving diagnostic tests and treatment protocols," a company statement said. "Without the availability of patent protection, future healthcare will suffer as companies may opt out of new research and development. This decision will, in our view, encourage imitation, not innovation."

The court's decision could affect other companies fighting for their personal medicine patents in court, said attorney Gerald Flattmann of the law firm Paul Hastings.

"One danger ... will be that courts misapply the decision as broadly requiring the invalidation of any claim that recites a law of nature as one of its steps," Flattman said. "Such misapplication would have a profound negative impact on innovation in the field of personalized medicine and beyond since, of course, all invention is on some level based on the practical application of natural discoveries."

Breyer noted that Albert Einstein would not have been able to patent his discovery of mass-energy equivalence or "by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa.)"

"If a law of nature is not patentable, than neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself," Breyer said.

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