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Ken Turchi
IU Maurer School of Law

Last modified: Tuesday, December 6, 2011

Supreme Court patent case invites risk of further confusion: IU Maurer School of Law expert

Dec. 6, 2011

BLOOMINGTON, Ind. -- A case set for oral argument before the U.S. Supreme Court on Wednesday, Dec. 7, presents the court with the challenge of deciding whether medical diagnostic processes should be eligible to be considered for patent protection. According to an Indiana University Maurer School of Law professor familiar with it, the case may have important implications for many areas of technology.

In Mayo Collaborative Services v. Prometheus Laboratories Inc., the court will hear arguments on whether methods relating to the treatment of Crohn's disease patients with thiopurine drugs are among the types of subject matter that may receive patent protection. The drugs are converted into metabolites in a patient's blood, and by ascertaining the level of metabolites, the doctor can adjust the dosage of the drug.

"Mayo, the patent challenger, argues that the methods simply reflect a natural process, and that if the patent is upheld, other health care providers would be pre-empted from developing diagnostic techniques that are also based on the natural process," said Mark D. Janis, a professor at the Maurer School of Law. "Prometheus argues that there's nothing natural about administering a synthetic drug to the body, or about assessing the chemical changes in the blood that come about when that drug is administered."

The Supreme Court has previously ruled that natural phenomena and abstract ideas aren't eligible for patent protection. "That general principle is well-accepted," Janis said, "but the court has never managed to explain how to determine whether something is too 'natural' or too 'abstract,' and I question whether it's really feasible to craft a reliable legal test for doing so."

In 2010, in Bilski v. Kappos, the court heard a case involving the patent eligibility of a method for hedging risk in commodities trading. The court ruled that the claimed method was not eligible subject matter because it was abstract, but, according to Janis, the court shed little light on what "abstract" meant, setting the stage for the Mayo case.

Janis expressed no opinion about which side should prevail in the case, but he worries that a ruling restricting the eligibility of diagnostic process claims may have unintended consequences for patent disputes in many areas of technology.

"Eligibility is only one of several patentability requirements, and it's the most clumsy of all of them," he said. "The real risk here is that the court will attempt to use the eligibility requirement to do the work of fine-tuning the patent system, rather than relying on other patentability doctrines that test whether an invention is actually new and not obvious."

Eligibility rules are clumsy because "they often require courts to ponder the imponderable," Janis said. "We shouldn't put courts to the task of determining what nature is in order to decide a threshold question of patent eligibility." Eligibility rules also frequently generate hair-splitting debates over the precise form in which the claims are drafted.

Janis is the Robert A. Lucas Chair of Law at the Maurer School of Law and director of the school's Center for Intellectual Property Research. He is available to comment on Mayo and other patent-related cases and can be reached at 812-855-1205 or