Blood-Test Patents Debated at High Court as Einstein Invoked

U.S. Supreme Court justices grappled with the reach of federal patent law, touching on both fire-building techniques and Albert Einstein’s discoveries during arguments over diagnostic medical tests.

Today’s one-hour session, which centered on a dispute between Nestle SA’s Prometheus unit and the Mayo Clinic, produced few clear answers. The justices sought to draw what proved to be a fine line between natural phenomena, which can’t be patented, and applications of those principles, which can be.

“My question is, ‘What has to be added to a law of nature to make it a patentable process?’” Justice Stephen Breyer told Mayo’s lawyer. “If you put too little in the answer to that question, I believe I can make things like E=mc2 patentable,” he said, referring to Einstein’s formula showing the connection between an object’s mass and its energy.

“And if you put too much in, you are going to wreck your own case,” Breyer said.

He emerged as a pivotal figure. He took part in the case after his wife earlier in the day sold Nestle stock she had previously owned, said Kathy Arberg, the Supreme Court’s spokeswoman.

Breyer learned about that conflict last night, when Prometheus’s lawyers belatedly told the court that the company had been acquired by Nestle in July, Arberg said. Breyer participated in the court’s decision to hear the case in June, about a month after Vevey, Switzerland-based Nestle announced plans to buy Prometheus.

Breyer Shift

Breyer also revealed a substantive shift today, saying he was rethinking a 2006 dissenting opinion he wrote arguing for limits on patents that involve natural phenomena. He said that opinion “lacked an explanation” as to why the invention in that case wasn’t a patentable application of a law of nature.

The Prometheus case is the second at the Supreme Court since 2010 concerning what types of inventions are eligible for legal protection. Companies, trade groups and lawyers have filed more than two dozen legal briefs, many warning that the court’s ruling might have widespread, unintended ramifications. Each side in the case says a defeat might stifle innovation.

The two disputed patents cover a method for determining the proper dosage of thiopurine, a stomach medicine, based on the rate at which particular patients metabolize the drug.

Doctors can use the method, which involves testing blood for metabolites, to maximize effectiveness and limit toxic side effects while treating Crohn’s disease and other inflammatory bowel illnesses.

Monopoly Questioned

Prometheus is suing two units of the Mayo Clinic, the not-for-profit medical practice based in Rochester, Minnesota.

Mayo says the patents would give Prometheus a monopoly over all uses of the natural relationship between the metabolites created by thiopurine and the drug’s impact on the human body. The patents are so broad they would bar doctors familiar with the Prometheus method from even thinking about the connection between metabolite levels and the proper dosage for a patient, Mayo’s lawyer, Stephen Shapiro, told the justices.

That argument drew skepticism from Justice Sonia Sotomayor. “It’s not as broad as you are stating,” she told Shapiro.

Prometheus’s lawyer, Richard Bress, countered that the patents concern concrete applications of scientific principles, which the Supreme Court has long said fall within the scope of the U.S. Patent Act.

Kagan Skeptical

Justice Elena Kagan questioned whether the Prometheus patents were specific enough. The patents say doctors should either increase or decrease the dosage of thiopurine if metabolite levels fall outside a range specified in the patent.

“It’s not a treatment regimen,” she said. “All you have done is pointed out a set of facts that exist in the world.”

The Obama administration is urging the court to take a middle ground. The government says the Prometheus process probably isn’t the type of genuine innovation that would warrant legal protection. At the same time, the administration says the types of methods involved in the case should at least be eligible for patent coverage.

Chief Justice John Roberts questioned the government’s approach, saying it would make instructions for building a fire eligible for patent protection.

“It is easier to throw something out at the threshold level, isn’t it, than to move further down the line?” Roberts asked U.S. Solicitor General Donald Verrilli.

The case may have its greatest impact on the field of personalized medicine, an emerging practice that involves determining whether a patient is genetically susceptible to a particular disease or would be especially responsive to certain treatments. Two companies focusing on that field, Myriad Genetics Inc. and Novartis AG, are backing Prometheus.

The case is Mayo Collaborative Services v. Prometheus Laboratories, 10-1150.

Before it's here, it's on the Bloomberg Terminal. LEARN MORE