A new Supreme Court ruling has re-examined the criteria for patenting diagnostic tests, which may have a significant impact on personalized medicine. The Court declared two tests patented by Nestlé’s Prometheus Laboratories invalid because the methods contained within them are already recognized and practiced by scientists. The Court dismissed Prometheus’s claim that its steps were patent worthy, instead finding them “obvious.” The Court stated that simply suggesting doctors use a new treatment method does not constitute a patentable invention. The ruling paves the way for the Mayo Clinic to introduce a test similar to the Prometheus test for ensuring the proper dosage of thiopurine. The ruling did not set forth any new regulations on diagnostic test patents but upheld that “laws of nature” cannot be patented. Molecular diagnostic tests account for $4 billion in global annual sales. Drug firms have increased their reliance on diagnostic tests, which can help distinguish which patients are likely to respond to particular treatments.

Source: The Wall Street Journal