Supreme Court Rejects Key Biotech Patents

In a unanimous opinion today, the U.S. Supreme Court rejected patents behind a diagnostic test sold by Prometheus Laboratories of San Diego, California. The decision was a blow to the biotech company and a victory for a testing lab linked to the Mayo Clinic in Rochester, Minnesota, which has refused to pay royalties to Prometheus.

Mayo had developed its own diagnostic blood test, and Mayo officials argued that although it was similar to the company's, it did not violate the principles of patent law and was medically superior. Mayo drew support in amicus briefs from a number of prominent medical and scientific societies, while Prometheus had support from the Biotechnology Industry Organization and other industry leaders.

The Supreme Court opinion, penned by Justice Stephen Breyer cites basic principles for rejecting the Prometheus patents. According to the court, Prometheus sought to lay claim to processes that are not far removed from natural phenomena; previous court rulings make it clear that natural phenomena are "not patent-eligible." Breyer explained that the court does not want to permit monopolies on the "basic tools of scientific and technological work" because this "might tend to impede innovation more than it would tend to promote it." The court also noted that Prometheus's claims fell short because its invention—a method of monitoring thiopurine drugs in the blood—involved a "well-understood, routine, conventional activity previously engaged in by researchers in the field."

The battle over Prometheus's drug test has been closely watched because it may foreshadow rulings on other high-profile biotech cases, in particular the fight over whether human genes can be patented. The court has been sitting on a request to review the validity of patents on the BRCA1 and BRCA2 genes for breast and ovarian cancer, held by Myriad Genetics of Salt Lake City, Utah. A federal district court in 2010 ruled these claims invalid because they were an attempt to patent nature. That decision went to an appeals court, which partly accepted and partly rejected the Myriad patents. Both sides appealed to the Supreme Court, which has yet to say whether it will hear arguments on the Myriad case.

Patent attorney and blogger Dennis Crouch, in comments published today in his column Patently-O, anticipates that the Supreme Court will send the Myriad case back to the lower court for reconsideration. He also speculates that the lower court "could logically find" that, in light of today's ruling, isolated DNA cited in the Myriad BRCA gene patents is "unpatentable."