By Denise W. DeFranco of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
The decision in Mayo v. Prometheus is sure to be a close one, perhaps even a 5-4 decision, like many other Supreme Court's decisions concerning patent eligibility under section 101 of the patent statute. The outcome of the case will probably turn on two fundamental issues about which the justices wrestled throughout the oral argument.
1) After recognizing the "hornbook law" that a law of nature is not eligible for patent protection, but that the application of a law of nature is, Justice Breyer inquired as to how much needs to be added to a claim to transform it from an unpatentable law of nature to a patent-eligible application of a law of nature. Justice Breyer and others seemed concerned that Prometheus's patent claim simply recites an "observation" of a law of nature, which may not be enough. In response, Prometheus's counsel argued that Prometheus's claims include limitations beyond the mere observation of the natural phenomenon, namely that a particular drug be administered to a patient and that the level of metabolites in the patient's bloodstream be measured. The Supreme Court's decision may ultimately turn on whether limitations like those are adequate to transform a law of nature into an application of a law of nature.
2) Many of the justices wrestled with the question of whether an analysis under section 101 of the patent statute should involve at least a "quick peek" at the issues of novelty and non-obviousness under section 102 and 103, respectively. Mayo's counsel argued that the Supreme Court took such a quick peek in the Bilski case and that such a quick peek is appropriate to provide some measure of protection to the medical community from overbroad patents. In response to an observation by Justice Kennedy that its "hard to resist the temptation to peek," the Solicitor General stated that "taking up the temptation to import a look into novelty and nonobviousness in the 101 inquiry [would] be very destabilizing." He further added that the Court in Bilski made clear that patent eligibility under section 101 is a threshold test that turns simply on "whether there is a process."
As in the Bilski case, the justices — across the board — seemed leery of the patentability of Prometheus's claim. In Bilski, though, both the U.S. Patent & Trademark Office ("PTO") and the U.S. Court of Appeals for the Federal Circuit had already concluded that the claims were patent ineligible under section 101. Here, both the PTO and the Federal Circuit found the claims patent eligible. Perhaps that difference will weigh on the minds of some of the justices as they determine whether their leeriness in fact arises not from issues of eligibility under section 101 but patentability under sections 102 and 103.
Denise W. DeFranco is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. She has been representing companies in patent infringement litigation in both trial and appellate courts for almost two decades. She can be reached at firstname.lastname@example.org or 617.452.1670.