WASHINGTON — The Supreme Court heard arguments in a case today brought to them by the Mayo Clinic in which a branch of the Rochester-based hospital challenged the patent on a screening technique from a San Diego medical research company.
Prometheus Laboratories holds two patents on blood tests for determining the optimal dosage of certain types of drugs used to treat autoimmune disorders. In 2004, Mayo announced it had developed its own version of the tests and was planning on using and marketing them. Prometheus sued for patent infringement.
Lawyers for Mayo say its test is more accurate and would help doctors better serve their patients, but they’re unable to use the tests because of the Prometheus patents. Mayo challenged the patents in court, contending Prometheus was attempting to patent a natural occurrence it had simply observed instead of creating something new.
A federal judge originally ruled in favor of Mayo, but that judgment was overturned on appeal. The question before the Supreme Court was whether medical tests based on natural occurrences are patentable under federal law.
At the heart of the case was whether Prometheus’s diagnostic process was novel enough to warrant patent protection. It’s accepted that federal law doesn’t allow patents on natural occurrences alone, so Justice Stephen Breyer pressed the lawyers on what has to be added to such an observation to make it patentable. Breyer said too low a standard would allow someone to patent something as natural as a scientific discovery like, for example, Einstein’s e=mc2.
Mayo’s lawyer, Stephen Shapiro, said Prometheus hadn’t created something worthy of the patent. Rather, the patent was on a natural process alone and it prevented others from improving the practical aspects of it and marketing what they’d discovered. Justice Antonin Scalia suggested a low patenting standard would prevent others from discovering more accurate testing benchmarks than those devised by Prometheus, and Shapiro agreed.
But Prometheus’s lawyer, Richard Bress, said the patent wasn’t simply on the observed aspect of the blood tests. The company’s research had established chemical levels at which doctors should administer more drugs for their patients. In other words, they’d observed a natural process and created an original medical guideline on top of that observation.
Bress likened Prometheus’s patent to those issued on a procedure for using electricity to find metals in the ground. By Mayo’s standard, he said, the one would need to thoroughly instruct miners on where and how to dig in order to win a patent.
More legal analysis on the case can be found here. An opinion isn’t expected until sometime next year.
Devin Henry can be reached at email@example.com. Follow him on Twitter: @dhenry