Supreme Court Rejects Diagnostic Process Claims as Unpatentable Laws of Nature
By Charlie Stiernberg – Edited by Dorothy Du
Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012)
In a unanimous opinion, the Supreme Court reversed a ruling by the Court of Appeals for the Federal Circuit that had held Prometheus’ claimed invention, a process that helps doctors determine whether a given dosage of thiopurine drugs is too high or low, was patentable subject matter under the “machine or transformation test.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150, slip op. at 4, 7 (U.S. Mar. 20, 2012) (citing Prometheus Labs., Inc. v. Mayo Collaborative Servs., 581 F.3d 1336, 1345–47 (Fed. Cir. 2009)).
In an opinion by Justice Breyer, the Court held Prometheus’ claimed invention was unpatentable under 35 U.S.C. § 101, because it was fundamentally a law of nature. Id. at 24. In so holding, the court reasoned “the steps in the claimed processes (aside from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.” Id. at 4. The Court emphasized that just as a law of nature has long been held unpatentable, so too “is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Id. at 8–9.
SCOTUSblog provides a history of the case, briefs, and other relevant court documents. Patently-O breaks down the opinion in a section-by-section analysis. IPWatchdog criticizes the decision, admonishing that it will kill the medical diagnostics industry. The AMA praises the decision for invalidating patents that inhibit medical treatments. PharmExecBlog argues the decision may be a “harbinger” for the Myriad case now pending before the Court. (more…)