Supreme Court Rules Law of Nature Not Patentable in Mayo v. Prometheus
Claims directed to natural laws of nature must possess additional features that provide "practical assurance" that the process is more than a "drafting effort designed to monopolize the law of nature itself" to be patent eligible subject matter.
In Mayo v. Prometheus, 566 U.S. ___, (2012) the Supreme Court revisited what constitutes patent eligible subject matter under 35 USC §101.
Patent claims must satisfy certain prerequisites, the first being that the claimed invention is patent eligible subject matter. While "all inventions at some level embody, use reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas," "laws of nature, natural phenomena, and abstract ideas are not patentable." While an application of a law of nature or mathematical formula to a structure or process may be patentable, the Court in Mayo held that the claims at issue did not meet such standard.
In Mayo, the Court addressed a claim directed to the natural phenomenon of "relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of [the] drug will prove ineffective or cause harm."
The Court held that the claim was directed to a law of nature (the relationships between concentration in the blood of metabolites and the likelihood that the drug dosage would be harmful or effective) and did not do significantly more than simply describe a natural relation, and was therefore not patent eligible.
Apart from the recitation of the natural law, the claim provided "steps" for applying the law. Addressing the steps and considering whether this transformed the claims into patent eligible subject matter, the Court held that the steps did not, in fact, render the claim patentable. The addition of an "administering" step merely defined "a preexisting audience"; the "determining" step merely referred to methods well known in the art (the specific metabolites were also well known); and the "wherein" clause was simply a reference to the relevant natural law. Adding any of these steps was insufficient to transform the claim into patent eligible subject matter.
Viewing the claim as a combination of steps was also not sufficient – the Court held that the combination was "nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patient." Comparing the claim to Einstein telling someone to apply his equation, E=mc2, the Court was clear in stating that a natural law cannot be transformed into patent eligible subject matter by simply adding the words "apply it."
What you need to know - The Court did not foreclose any and all claims that embody a natural phenomenon (noting that all inventions, to some extent, embody natural law), and provided some substantive guidelines regarding claims referencing natural laws or phenomenon that may be helpful in determining whether or not to file for patent protection on claims comprising a law of nature, particularly diagnostic claims. For example:
- Claims that transform a process into an "inventive application" of a natural law can be patented. That is, other steps added to a natural law—particularly unconventional steps—may transform the process into a patent eligible, inventive application. The question then becomes: do the claims contain previously unknown or unconventional additional steps? If so, this may constitute sufficient transformation under Mayo.
- Claims that add a degree of specificity may tend towards a conclusion that claims embodying an application of natural law are patent eligible subject matter, but adding specificity to a claim is not conclusive. Consider whether such a claim may be so broadly directed to the natural law that it may be contrary to innovation – if so, a court and/or examiner may find the claim not patent eligible, as broadly claiming a natural law.
- Claims to new drugs or new ways of using existing drugs are presumably protectable by patent. The Court clarified this in stating that the claims at issue in Mayo were "[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug…"
- Claims directed to a novel and useful structure created with the aid of knowledge of a scientific truth may constitute patent eligible subject matter. Again, this is so provided the claim does more than simply say "apply the [natural law]."
What you need to do - Thus, in view of the Mayo decision, inventors and applicants should carefully consider the guiding principles set forth in Mayo when determining whether filing for patent protection on inventions related to a natural law is appropriate.