On August 16, 2012, the U.S. Federal Circuit Court of Appeals issued its judgment in Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Myriad) partly overturning the district court’s summary judgment that Myriad’s claims were drawn to patent ineligible subject matter and affirmed Myriad’s right to patent isolated DNA of BRCA1 and BRCA2, two genes linked to breast and ovarian cancer. The lawsuit had alleged that patents on human genes violate the First Amendment and are unpatentable as “products of nature.” 

This is the Federal Circuit’s second decision after the case was remanded back to the Federal Circuit for further consideration in light of the Supreme Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories (Mayo).

On the merits, the Federal Circuit reversed the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules are patent ineligible products of nature under § 101. The court also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to patent ineligible scientific principle. However, they did affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible as such claims include no transformative steps and cover only patent ineligible abstract mental steps.

Regarding the challenged claims to isolated DNAs, the Federal Circuit clearly indicated that whether limited to cDNAs or not (cDNA is a type of artificially produced DNA), isolated DNAs are directed to patent eligible subject matter under § 101 adding “permitting patents on isolated genes does not pre-empt a law of nature. A composition of matter is not a law of nature.” (Myriad, pg. 51)

Importantly for diagnostic method claims, the Federal Circuit reiterated its previous reasoning with respect to the challenged screening claim. The screening claim required in addition to the step of comparing the cells' growth rates, the steps of growing transformed cells, and determining those growth rates. The Federal Circuit relied on the fact that those steps were transformative stating: “Although the Court has held that certain transformative steps are not necessarily sufficient under § 101 if the recited steps only rely on natural laws, we once again even in light of Mayo, arrive at the same conclusion of patent eligibility because at the heart of the claim is a transformed cell, which is made by man, in contrast to a natural material.” (Myriad, pgs. 55 and 56)

The Federal Circuit stated the claim does do more than simply state a law of nature. It applies a law of nature. The Federal Circuit recognized that all activity, whether chemical, biological, or physical, relies on natural laws. However they stated that the challenged claim applies certain steps to transformed cells that are a product of man, not of nature. Performing “operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists. In situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible.” (Myriad, pg. 61)

However, regarding the Myriad claims that include only the step of “comparing” or “analyzing” two gene sequences, the Federal Circuit reiterated such claims fall outside of the scope of § 101 as they claim only abstract mental processes.

The Federal Circuit’s reasoning is clear and informative. “This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: one looks at the first position in a first sequence; determines the nucleotide sequence at that first position; looks at the first position in a second sequence; determines the nucleotide sequence at that first position; determines if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alteration; and repeats the process for the next position… Myriad’s claims do not apply the step of comparing two nucleotide sequences in a process. Rather, the step of comparing two DNA sequences is the entire process that is claimed.” (Myriad, emphasis added; pg. 57)

The Federal Circuit rejected Myriad’s attempt to read into its method claims the additional steps of (1) extracting DNA from a human sample, and (2) sequencing the BRCA DNA molecule, which Myriad had argued necessarily precede the step of comparing nucleotide sequences. The Federal Circuit responded that the “claims themselves, however, do not include either of these steps. The claims do not specify any action prior to the step of 'comparing' or 'analyzing' two sequences; the claims recite just the one step of 'comparing' or 'analyzing.' Moreover, those terms’ plain meaning does not include Myriad’s proposed sample-processing steps; neither comparing nor analyzing means or implies 'extracting' or 'sequencing' DNA or otherwise 'processing' a human sample.”  (Myriad, pg. 58)

The case is instructive for drafting patent eligible biotech process claims and patent claims in general. As first identified in Bilski, incorporating transformative steps is important for patent eligibility. Application of a law of nature in a process is also vital for patent eligibility.

Seemingly in recognition of the importance of patents to the biotech industry, the majority opinion stated that “patents on life saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be the subject to the incentives of exclusive rights” adding that “disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress.” (Myriad, pg. 18)

The case is good news for the biotech industry which has been saddled with uncertainty and difficulties when obtaining patent protection for its biological process inventions. Hopefully the decision ushers in a more consistent approach to determining patent eligibility of biologically related patents both at the U.S. patent office and in the courts.