The biotechnology industry is reeling after the U.S. Supreme Court unanimously ruled that two medical-testing patents held by San Diego-based Prometheus Laboratories Inc. were invalid.
At issue in the landmark case, Mayo Collaborative Services v. Prometheus, were patents protecting research Prometheus had conducted to develop a diagnostic test that helps doctors screen patients’ blood to determine the proper drug-dosing levels for therapies treating autoimmune diseases.
Justice Stephen Breyer sided with patient advocacy groups, saying the test did little more than observe laws of nature. Patents on so-called “natural phenomena” would potentially “inhibit the development of more refined treatment recommendations,” he said.
But life sciences industry representatives disagree; they say the ruling will hurt innovation because diagnostic companies will be less likely to spend on research and development if they aren’t able to protect their findings.
Biotechnology lawyer Michael J. Shuster, a partner in the intellectual property group of Fenwick & West LLC in San Francisco, said he’s concerned that last week’s ruling will drive investment dollars away from an industry that’s already having a tough time attracting capital.