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Mayo’s view is backed by a coalition ofphysicians and health care groups, includingthe American Medical Association. In a jointbrief, the medical establishment argues that“health care will be undermined if conventionalmedical applications of naturally occurringbodily processes can be patented.”DURING ARGUMENTS BEFORE the SupremeCourt on Dec. 7, 2011, Mayo Clinicattorney Stephen M. Shapiro said that barringMayo and others from using tests similarto Prometheus’ would be detrimental topatients’ health.“The problem with the Prometheus patentis its broad preemption of a physicalphenomenon, which prevents others likeMayo Clinic from offering a better metabolitetest with more accurate numbers. Thisis a huge practical problem for patients,”Shapiro said.Several justices also raised questionsabout Prometheus’ diagnostic patentclaims. “This is not a treatment protocol;it’s not a treatment regimen,” Justice ElenaKagan told Prometheus’ attorney, RichardP. Bress. “All you have done is pointed outa set of facts that exist in the world and areclaiming protection for something thatanybody can try to make use of in any way,and you are saying ‘you have to pay us,’ ”she remarked.Bress acknowledged that the lab’s patentsbuild on a known process. “Peopleknew that you could administer thiopurinesfor these particular diseases” andmeasure the resulting metabolites, he said.There have been efforts to “come up withwhat [Prometheus] came up with—a newtreatment method, a new way of calibratingthe right dose for each individual patientbased on their metabolism.”But, Bress explained, the mere fact thatothers had previously combined administrationof thiopurines with measurementof the metabolites in laboratory experimentsdoes not, under the court’s precedents,negate the novelty of Prometheus’use of the same steps as integral parts of asuccessful working treatment method.Rivard says it is not clear exactly wherethe court will draw the line between processesinvolving mere abstract ideas andthose meriting patent protection. But thejustices, he observes, “seem to be wellaware of the need to tread carefully, sinceany significant limitation on patent eligibilityin this area could have a chilling effecton research.”Justice Stephen G. Breyer, for example,expressed skepticism over the patent eligibilityof diagnostic method claims, buthe also took note of the significant investmentsthat companies have made. “Discoveringnatural laws is often a very expensiveprocess,” he said. “There’s lots of investmentto be protected.”If the Supreme Court concludes thatthe Prometheus patents are invalid, someindustry players may encounter challengesin the short term on their patents relatingto diagnostic methods and tests, saysColton, a past chair and current executivecommittee member of the AmericanChemical Society’s Division of Chemistry& the Law.Over the long term, he adds, differentapproaches to drafting patent claims toprotect investments in diagnostic methodsand tests will emerge. ◾Reprinted from C&EN, Jan. 16, 2012AQO\bVSQ]RSb]dWSebVSdWRS]2]e\Z]ORbVSO^^b]OQQSaa(13