On 7 December 2011 the Supreme Court heard oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc., U.S. No. 10-1150, 12/7/2011.
Prometheus sued Mayo for infringing its patent on a diagnostic method for treating Crohn's disease. The claims in this case recite steps for optimising the effect and reducing the toxicity of medicine by “determining” the level of certain metabolites created by taking a particular drug. They state that a level less than about 230 “indicates” a need to increase the medicine, and that a level greater than 400 “indicates” a need to decrease the medicine.
The Federal Circuit found the claims patent eligible in 2009 pre-Bilski and again in 2010 post-Bilski.
Law of nature
Justice Breyer observed that you can't patent a law of nature, but you can patent an application of a law of nature. He asked counsel for Mayo why the administration of a drug and the determining of the resulting level wasn't an application of a law of nature. Mayo answered that the mere observation of a natural result does not add enough for it to be more than a claim to the existence of the natural result.
How much more must be added for the claim to be an “application” of a law of nature, asked Justice Breyer.
A conventional step is not enough, replied Counsel for Mayo. Justice Scalia pointed out that focus on a “conventional step” would be the analysis for finding lack of novelty. Justice Ginsburg asked why Mayo did not challenge patentability in this case under the novelty or nonobvious requirements of the statute.
Leave 101 alone
The Solicitor General, appearing as amicus curiae for the United States, agreed that a mental step may not be patented by tacking on an utterly conventional process for administering drugs and testing their effects.
However, this is an issue of novelty and nonobviousness, he argued, adding that importing these considerations into the Section 101 analysis would be destabilising to the patent system. As stated in Bilski, patent eligibility is a threshold eligibility question, and the test is whether the claim recites a process.
Novelty and Obviousness well settled
The Chief Justice asked why it is beneficial to essentially eliminate Section 101 consideration and fall back on Sections 102 and 103. Counsel for Prometheus explained that issues of novelty and nonobviousness are governed by well-established rules, and that using Section 101 to reject patents where the issue is really novelty and nonobviousness would overlook those important rules.
We await with interest the final decision from the Supreme Court.
Photo courtesy of author Mark Fischer under Creative Commons licence.