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The Ruling: Supreme Court Overturns Prometheus Patents

By Mari Serebrov
Washington Editor

WASHINGTON – In a decision that will have biotechs reviewing their process patents, the Supreme Court Tuesday ruled that Prometheus Laboratories Inc.'s patents for calibrating the proper dosage of thiopurine drugs used to treat autoimmune diseases are not patentable because they involve laws of nature.

The court's unanimous decision in Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. reversed an appellate court ruling that held the personalized medicine-type claims patent-eligible because they cover a "determining" step, which includes the extraction and measurement of metabolite levels from a patient sample. (See BioWorld Today, July 6, 2010.)

The Supreme Court, however, said that step "simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field."

To be patentable, the claims would have to include "additional features that provide practical assurance that the processes are genuine applications of [natural] laws rather than drafting efforts designed to monopolize the correlations" between metabolites in the blood and the dosing of thiopurine drugs for such diseases as Crohn's and ulcerative colitis, according to the opinion written by Justice Stephen Breyer.

In other words, "to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words 'apply it,'" the court said.

The decision by the U.S. Court of Appeals for the Federal Circuit, which it reaffirmed after the Supreme Court's ruling in Bilski v. Kappos, found that Prometheus' claims included a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs. (See BioWorld Today, Dec. 8, 2011.)

But the Supreme Court clarified in its Prometheus ruling that "machine-or-transformation" should be used as a clue rather than a definitive test to determine patentability of method claims. Noting the two-edged sword of patent protection, the high court acknowledged that granting patents could encourage the costly discovery of new laws of nature, which could lead to new diagnostics to be used in personalized medicine. But those laws are "the basic tools of scientific and technological work," Breyer wrote, adding that tying them up with patents would inhibit future innovation.

Recognizing the effect Tuesday's opinion could have on the biopharmaceutical field, the court said it couldn't make an exception for one area. "Patent law's general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another," Breyer wrote.

If biopharma doesn't like the Supreme Court's ruling, the industry needs to take it up with Congress. It's Congress' job to craft "more finely tailored rules where necessary. . . . We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable," Breyer concluded.