Mayo Collaborative Services v. Prometheus Laboratories, Inc. and the Boundaries of Patentability

Posted Thursday, March 29, 2012.

What with all the hoopla surrounding the Supreme Court hearings this week on the Affordable Care Act, it’s timely to comment a bit on its ruling issued last week about patents. For the second time in two years, the Supremes have weighed in on the idea of what kinds of things, exactly, are patentable. And this time (unanimously!) they outlined its limits. http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf

Section 101 of the Patent Act defines patentable material as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Purely laws of nature, natural phenomena, and abstract ideas are not patentable. The definition worked well for many years.

But advances in technology have raised questions about whether things like methods of doing business and the manipulation of genes in organisms fall within the Patent Law. Technologies like these are a big part of innovation in the Pacific Northwest, so the issue of patent protection for them is important to us.

Two Prometheus patents for a method of optimizing a drug therapy were challenged by Mayo. A typical claim in the patents included just two basic steps: administering the drug, and determining the level of metabolites in the patient caused by the administered drug. Mayo argued that Prometheus was merely trying to patent a law of nature. Prometheus argued that the steps were an application of a law of nature, which is patentable.

The Supreme Court sided with Mayo. They reasoned that:

“A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.”

The Supremes rejected the Prometheus claims as a law of nature (i.e. the human response to an administered drug) with the words “apply it.” They held that the patented method step of determining that response added nothing significant to the law of nature.

Innovators in the digital technology and biotechnology arenas should take careful note. Before investing in patent protection for an idea that applies a law of nature, carefully identify how your invention may apply a law of nature. If the “apply” part is new and useful, you have taken the first step toward avoiding the “Prometheus trap.”