Last Wednesday we commented on a Delaware decision (Andrews, J.) applying the Federal Circuit’s Mayo analysis to find that a patent on a new dosing regimen for an old drug lacked patentable subject matter under 35 U.S.C. § 101. Alice in Pharma Land. Two days later, the Federal Circuit affirmed another Delaware decision (Stark, J.) that deployed Mayo to crush a patent on a method for detection of a DNA sequence. Genetic Technologies Ltd. v. Merial LLC., 2016 U.S. App. LEXIS 6407 (Fed. Cir. Apr.8, 2016). Expanding on the Mayo reasoning discussed in our earlier post, the court in Merial further clarified the distinction between scientific discovery and patentable invention.
According to the Federal Circuit, Dr. Simons discovered in the 1980’s that certain non-coding regions of human genes are correlated with coding regions within the same genes in a relationship known as “linkage disequilibrium”. Before Simons’ discovery, geneticists were unaware of any function of non-coding regions and referred to them as “junk DNA.” Simons obtained the ‘179 patent based on his discovery, claiming a “method of detecting a coding region of a person’s genome by amplifying and analyzing a linked non-coding region of that person’s genome.” The Court evaluated the section 101 issue under Mayo, and found, first, that the patent was “directed to a natural law – the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.” It then concluded that the steps of “amplifying” and “analyzing” the DNA were well known, routine, and conventional; and hence, did not provide the inventive step necessary to transform Simons’ discovery into a patentable invention. Thus, while the court acknowledged the scientific significance of Simons’ work, this was not enough to justify patent protection commensurate with his discovery.
The court’s careful discussion of Simons’ scientific work in Merial suggests that pharmaceutical litigants might benefit by focusing their discovery efforts on the nature of the inventor’s laboratory research. There is a difference between a scientific discovery and a patentable invention. If the research only recognizes relationships in the human body that are laws of nature, and the patent claims employ only routine method steps in view of that discovery, a strong argument may exist that the patent lacks the inventive step required under section 101.