The U.S. Supreme Court on Tuesday unanimously declared a company’s patents on a medical-testing process invalid, a decision that could affect the patentability of countless numbers of life-sciences inventions developed at universities and other research institutions.
Patent claims that merely describe natural phenomena are not patent-eligible, the court said, and the diagnostic procedure outlined in the patents at stake in the case “adds nothing to the laws of nature that is not already present when the steps are considered separately.”
The patents in the case, Mayo Collaborative Services v. Prometheus Laboratories Inc. (No. 10-1150), covered a process by which doctors established a drug dosage for patients with Crohn’s disease. The method, which Prometheus licensed from academic researchers in Canada, calls for measuring levels of a naturally occurring byproduct in the bloodstream of the patients as their bodies metabolize the drug.
Physicians’ groups and medical educators, who had contended that the patents threatened doctors’ ability to treat their patients and train future doctors, welcomed the ruling. The patents had “the potential to really inhibit the practice of medicine,” said Michael Watson, executive director of the American College of Medical Genetics.
His group, along with the Association of American Medical Colleges, the American Medical Association, and several other groups of medical professors and educators had called for a rejection of the patents in a friend-of-the-court brief.
“If patent licenses are required for physicians merely to consider newly discovered implications of well-established diagnostic tests and laboratories become indirect infringers merely by educating doctors about those implications, it is hard to imagine how medical diagnostics will continue to serve the goal of quality patient care,” the brief argues.
Another higher-education group took the opposite view, contending in its brief that a rejection of the patents would “adversely affect the entire biomedical field.” In its brief, the Association of University Technology Managers, an organization for people who work for universities and in companies that commercialize academic inventions, argues that “studies designed to identify appropriate amounts of drugs to be administered to a particular subpopulation of patients having a specific ‘biomarker’ profile are costly and time-consuming, and patent protection is often needed to justify the investment in such studies.”
But in the end, it was the arguments of Mayo, an arm of the Mayo Clinic, and of the medical-school groups, that held sway. The court’s opinion, written by Justice Stephen G. Breyer, even quotes from the medical groups’ brief—which warns that a “vast thicket of exclusive rights” could imperil doctors’ use of critical scientific data.
While some patent-law experts and the Biotechnology Industry Organization were quick to paint the decision as a major setback to the burgeoning industry based on “personal medicine,” others were more measured.
“Is patent protection for innovation in personalized medicine dead? No,” said Mandy Wilson Decker, a patent lawyer in Louisville, Ky., who represents universities and others. But she said that the breadth of some patents might be lessened, and noted that researchers will have to figure out “what additional features will be necessary to produce a patent-eligible invention.”
