(Bloomberg News) The U.S. Supreme Court put new limits on the availability of patents for diagnostic medical tests, ruling in favor of the Mayo Clinic in a decision that will shape the growing field of personalized health care.
The justices today said two patents owned by Nestle SA's Prometheus unit are invalid because they cover a natural phenomenon. Prometheus argued that the patents concerned an application of a law of nature, not the law itself.
The case tested the types of medical inventions that are eligible for legal protection. Companies, trade groups and lawyers filed more than two dozen legal briefs, many warning that the court's ruling might have widespread, unintended ramifications. Each side in the case said a defeat might stifle innovation.
Writing for the court, Justice Stephen Breyer pointed to "a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature."
Patent protection is important for companies that are focusing on personalized medicine, including Myriad Genetics Inc. and Novartis AG. The field involves determining whether a patient is genetically susceptible to a particular disease or would be especially responsive to certain medicines.
The dispute divided companies. Verizon Communications Inc., Hewlett Packard Co. and Laboratory Corporation of America backed Mayo, arguing for patent limits. Trade groups for the biotechnology and pharmaceutical industries, along with SAP America Inc., sided with Prometheus.
Stomach Medicine
The patents covered 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.
Prometheus sued two units of the Mayo Clinic, the not-for-profit medical practice based in Rochester, Minnesota. Mayo at one point shipped patient samples to Prometheus and paid the company to perform the test. That relationship ended in 2004, when Mayo created its own test.
Mayo contended 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 lawyers said.
Nothing Added
Breyer agreed with that reasoning, saying, "the steps add nothing of significance to the natural laws themselves."