On December 17, 2014, the Federal Circuit released its decision in the matter of In re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (“In re: BRCA1/2”).  Myriad asserted a set of patent claims that were not part of the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics (“Myriad”).  The BRCA1/2 lawsuit involved four composition of matter claims directed toward DNA primers and two method claims directed to comparisons between wild-type BRCA gene sequences with a patient’s BRCA gene sequence.  The Utah District Court denied Myriad’s motion for preliminary injunction on the basis that the claims were likely drawn to ineligible subject matter. On appeal, the Federal Circuit affirmed the denial of the preliminary injunction and, in addition, invalidated the claims on de novo review as impermissibly claiming natural products and abstract ideas under 35 U.S.C. § 101.

 The Composition Claims – DNA Primer

The composition of matter claims were directed to synthetic primers that contained the same nucleotide sequence as naturally occurring DNA.  The Federal Circuit found these primers patent-ineligible because they are structurally identical to the ends of DNA strands found in nature.  The court emphasized that the Supreme Court in Myriad made clear that “synthetically created compositions that are structurally identical to the naturally occurring compositions” are not patent eligible.  The court rejected Myriad’s argument that the primers have fundamentally different function than when they are part of the DNA strand.  The court reasoned that the primers utilize the innate ability of DNA to bind to itself and relied on Myriad to conclude that a “DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature.”  (Slip Op. at 9)  Because the primers at issue did not have a different structure than DNA sequences found in nature, they were found patent ineligible.

Method Claims – Method of Screening

The method claims were directed to comparisons between the wild-type BRCA gene sequences with a patient’s BRCA gene sequence in order to detect mutations in the sequences associated with increased risk of breast and ovarian cancer.  The Federal Circuit relied on the two step analysis set forth in Alice Corporation Pty. Ltd. v. CLS Bank Int’l (“Alice”): (1) determining whether the claims at issue are directed to a patent-ineligible concept, and if so, (2) whether the remaining elements, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to transform the claims into a patent-eligible application.

The court held that the comparison of wild-type genetic sequences with a subject’s genetic sequence was an unpatentable abstract mental process, under Alice, that could impede future research related to the BRCA genes because it was not restricted to the detection of specific cancers.  In so holding, the Federal Circuit relied on its 2012 decision in Association for Molecular Pathology v. USPTO (the decision that formed the basis of the Supreme Court’s 2013 Myriad opinion), where it held that claims to “an abstract mental process of ‘comparing’ and ‘analyzing’ two gene sequences” were patent ineligible.  (Slip Op. at 14-15)  The court also found that the particular mechanisms for comparison that were claimed were routine and conventional and therefore, failed to transform the claims into a patent-eligible application.

The Federal Circuit’s decision in In re: BRCA1/2 relied on Myriad for its analysis of the composition of matter claims and Alice for the method claims.  However, the court chose to rely on portions of Alice that quote the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs. (“Mayo”).  In Mayo, the Court found that a method claim directed to a diagnostic assay for determining the proper dose of a drug based on a patient’s metabolite levels was drawn to a law of nature and therefore invalid under 35 U.S.C. § 101.  The fact that the Federal Circuit framed its analysis under Alice, even though the court cited portions of Alice which quote Mayo, may be an indication of the court’s willingness to begin applying Alice broadly to patents directed to naturally-derived products or phenomena.

While the Supreme Court in Myriad limited its holding to isolated DNA sequences, the Federal Circuit in In re: BRCA1/2 found that uses and methods of naturally occurring products may also be patent ineligible subject matter.  The Federal Circuit’s In re: BRCA1/2 decision represents a continuing trend of courts’ narrowing the scope of patentable subject matter.