Supreme Court Limits Some Medical Patents

The Supreme Court ruled last week that Prometheus Laboratories cannot patent a diagnostic method for observing changes in a patient’s body to determine the optimal dosage of a drug used to treat autoimmune disorders. The justices unanimously found that the biotech company’s claims are invalid because the observations made to determine the proper drug dosage are a natural phenomenon, which cannot be patented. “We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid,” Justice Stephen G. Breyer wrote in the Court’s opinion. As a result of this ruling, experts say, some of the thousands of patents issued in the past two decades for diagnostic methods and tests may be challenged. “We are surprised and disappointed in the Court’s decision,” says Hans Sauer, deputy general counsel for the Biotechnology Industry Organization, an industry trade group. “We are concerned that it introduces new and confusing concepts into the traditional body of patent law.” But the American Medical Association, which represents physicians, calls the decision “a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research.”