Supreme Court Rejects Patent Protections for Certain Diagnostic Tests
On Tuesday, the Supreme Court ruled that screening tests that help physicians determine dosages, treatment options or a person's risk of acquiring a certain disease are not eligible for patent protection, Reuters reports (Bartz/Vicini, Reuters, 3/20).
The lawsuit -- filed by Prometheus Laboratories against Mayo Clinic -- alleges that Mayo infringed on Prometheus' two patents for a test to help physicians determine drug dosages for individuals with Crohn's disease.
Mayo sought to offer its own version of the test, arguing that Prometheus was improperly granted exclusive rights (California Healthline, 12/8/11).
The high court also overturned a previous federal appeals court decision that allowed patent claims by Prometheus to stand (Kendall et al., Wall Street Journal, 3/20). The justices agreed that the claims were invalid because they were based on the laws of nature, which are not eligible for patents, the AP/San Francisco Chronicle reports (Holland, AP/San Francisco Chronicle, 3/20).
Justice Stephen Breyer, who authored the opinion, wrote that natural laws are unpatentable whether they stand alone or in connection with processes that involve "well-understood, routine, conventional activity." Breyer added that an inventor needs to do more than "recite a law of nature and then add the instruction 'apply the law'" to claim patent protection.
Prometheus, Mayo Respond to Ruling
Prometheus said that the Supreme Court's decision "will, in our view, encourage imitation, not innovation," adding, "Without the availability of patent protection, future health care will suffer as companies may opt out of new research and development."
James Rogers -- the lawyer representing Mayo -- said the decision will "be a benefit for patient care, spur innovation in the field and allow access to good quality diagnostic tests" (Liptak, New York Times, 3/20).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.