The U.S. Supreme Court reversed the Federal Circuit and held that Prometheus’ patents claiming a method to optimize therapeutic efficacy for the treatment of immune-mediated gastrointestinal disorders were invalid. Mayo Collaborative Services v. Prometheus Laboratories, Inc., __ U.S. __ (2012). [Prometheus] Justice Breyer, writing for a unanimous Supreme Court, held that Prometheus’ patent claims set forth laws of nature, namely the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.  Laws of nature, the Justice noted, are excluded from patentable subject matter.

Basic Tools or Technological Application ?

Justice Breyer began the opinion by focusing on the language of Section 101 of the Patent Act which defines patentable subject matter.  Section 101 recites:

“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.”

There are exceptions to this almost limitless definition — laws of nature, natural phenomena, and abstract ideas are not patentable. For this reason, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity….” citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)).

While phenomena of nature and abstract mental concepts, for example are not patentable because they are the basic tools of scientific and technological work, the applications of a law of nature or mathematical formula to a known structure or process may be patent-eligible.

With this in mind, Justice Breyer framed the issue as whether

“the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws.  We conclude that they have not done so and therefore the processes are not patentable.”

Slip Op. at 3.

That Something Extra

Justice Breyer emphasized that if a law of nature is not patentable, then neither is a process reciting a law, unless that process has additional features that provide practical assurance that the process is more than careful patent claim drafting.  Slip Op. at 8.

In analyzing the claims to determine if they contained additional features to satisfy Section 101, the Court focused on discrete claim elements: the “administering” step, the “determining” step and the “wherein” steps of the claims.

With respect to the “administering” step, the Court determined that this step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopuring drugs. Slip Op. at 9.  The Court stated that one cannot attempt to circumvent the prohibition against patenting abstract ideas by limiting the use of the idea to a particular technological environment.

For the “wherein” clause, the Court interpreted this element to simply tell a doctor about the relevant natural laws, “at most adding a suggestion that he should take those laws into account when treating his patient.” Slip Op. at 9. Thus, these types of clauses tell the relevant audience about those laws and how to use them.

For the “determining” step, this step “tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field” Slip Op. at 10.

Finally, the combination of these steps as an ordered combination did not add anything to the laws of nature that is not already present when the steps are considered separately.

In sum, the Court concluded that the “administering,” determining” and “wherein” claim elements were nothing more than appended conventional steps, specified at a high level of generality, to laws of nature.

Less Conventional, Still Patentable ? 

Many in the industry are studying this decision and its effect on future private investment, especially in the growing personalized medicine industry, is now of great concern. The U.S. Patent Office likely will issue guidelines implementing the Court’s ruling. However, the Court itself provided little guidance as to what moves a medical method from patent-ineligible to patent-eligibility. Indeed, the Court declined to opine on what claim elements would be determinative of patent-eligibility noting that:

 ”We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular application of those laws. The presence here of the basic underlying concern that these patents tie up too much future use of laws of nature simply reinforces our conclusion that the processes described in the patents are not patent eligible, while eliminating any temptation to depart from case law precedent.”