Earlier today, the Supreme Court released its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the latest highly anticipated installment in the Court’s grappling with biotech patents.   The case concerned a patent on, basically, given a patient a certain kind of drug, measuring the active amount of blood in the patient (this drug is metabolized quite differently by different people), and then determining whether to adjust the dose.   The Court, in a unanimous opinion written by Justice Stephen Breyer, reversed the Court of Appeals for the Federal Circuit and held that patents were invalid as attempts to patent a “natural law,” in this case the natural law relating the amount of the drug in the patient to its effects.

Justice Breyer summarized the Court’s holding as follows:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

The full implications of the opinion are, of course, unclear, including its implications for the pending Myriad Genetics case involving its patents on BRCA 1.   It may be worth noting that by early afternoon Myriad stock had fallen over 4 percent.

The Center for Law and the Biosciences blog hopes to post continuing commentary on this case over the next few days.  Watch this space!

Hank Greely

Click here for more CLB commentary and analysis of the Prometheus decision.