Supreme Court Provides Patent Litigators with a Retooled Argument in Prometheus

by Elizabeth Swanson

The United States Supreme Court recently provided litigators with a retooled weapon for invalidating patents in its Mayo Medical Labs et al v Prometheus et al (Supreme Court, 20 March 2012) (“Prometheus”) decision.  35 USC § 101 states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”

Typically, in litigation, patents are invalidated because the claimed matter is not patent-able based on §§ 102 and 103 (anticipation and obviousness, respectively) due to conflicting prior art, not because they are patent-ineligible based on §101.  In fact, §101 is relatively rarely used by courts to invalidate patents.

The patent at issue in Prometheus claimed a patent in a method of finding the optimal level of a drug whose levels varied widely from patient to patient.  The patent claimed the steps of (1) “administering a drug” to a patient and (2) “determining the [resulting metabolite] level”.

The first time that Prometheus was before the Federal Circuit, the Court applied the “machine or transformation test” to the matter and found the patent valid under that test.  The case then went up to the Supreme Court, which determined in June 2010 that the machine or transformation test” was not the sole test available, but that there were other available tests based on the plain language of §101. The case then was remanded to the Federal Circuit, which again found the patent at issue to be valid. When the case arrived before the Supreme Court for a second time in March 2012, the Court issued more language regarding invalidation under §101.

The Supreme Court disagreed with the Federal Circuit:  “The question before us is whether the [patent] claims do significantly more than simply describe these natural relations.  To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?  We believe that the answer to this question is no.”

After examining each of the Prometheus claims individually, the  Supreme Court summarized: “The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations.  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.”

Since Prometheus, there have been several decisions issued in patent cases that draw on or reference Prometheus The district court in Washington, D.C. followed the Prometheus guidelines step for step and invalidated a method patent that used a computer to guide the selection of therapy for patients.  In contrast, the Northern District of California validated a patent, stating that it did not run afoul of §101 because it did “more than recite an abstract idea and say ‘apply it’” (language quoted directly from the Supreme Court’s second Prometheus opinion).

So, litigators take note:  Even if a method patent can be argued to satisfy the “machine or transformation test,” it still may be found invalid and ineligible for patent protection under §101 if the patent does little more than – in the Court’s opinion – restate a natural law.

Elizabeth Swanson’s Century City practice includes all aspects of patent, trademark and copyright prosecution, trade secret management, and also includes infringement matters and litigation.  Ms. Swanson has been practicing only IP law for over 22 years.


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