In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation

In the latest decision addressing the patentability of Myriad’s BRCA1- and BRCA2-related patents, the U. S. Court of Appeals for the Federal Circuit invalidated a number of Myriad’s composition of matter claims and method claims as directed to patent-ineligible subject matter under 35 U.S.C. § 101.  Specifically, the Federal Circuit found that the composition claims covering DNA primers—short, synthetic, single-stranded DNA molecules that bind to specific nucleotide sequences—were directed to naturally occurring products of nature.  The Court also found that the method claims covering comparison of wild-type DNA sequences to patients’ DNA sequences were directed to the abstract idea of comparing DNA sequences and lacked any inventive concept.  In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366 (Fed. Cir., Dec. 17, 2014) (Dyk, J.).

The Supreme Court previously (2013) ruled that Myriad’s patent claims directed to isolated double-stranded DNA were not patent-eligible subject matter because isolated DNA is a naturally occurring product of nature  (Assoc. for Molecular Pathology v. Myriad Genetics, Inc., see IP Update, Vol. 16, No. 6).  In that case, the Supreme Court also ruled that complementary DNA (“cDNA”)—exon-only double-stranded DNA synthesized from single-stranded mRNA and widely used in cloning—is patent-eligible and found Myriad’s claims directed to cDNA valid.  Myriad’s DNA primer claims and comparing DNA claims were not before the Supreme Court, and so it was not decided whether such claims were patent-eligible.

Shortly after the Supreme Court’s decision, Ambry entered the market for medical kits designed to test for susceptibility to certain types of cancer.  Myriad sued Ambry and requested a preliminary injunction.  Although the district court found that the irreparable harm prong of the analysis favored Myriad and that the equities were in equipoise, it denied Myriad’s request for an injunction because of the “dubious validity” of the asserted patent claims directed to DNA primers and comparing DNA sequences.  Myriad appealed.

With respect to the DNA primer claims, Myriad argued on appeal that synthetic DNA primers are not naturally occurring because single-stranded DNA cannot be found in the human body.  Moreover, Myriad argued that DNA primers have a fundamentally different function than when they are part of the DNA strand.  Relying on the Supreme Court’s Myriad decision, the Federal Circuit rejected Myriad’s arguments and concluded that the fact that primers are synthetic makes no difference since the synthetic primers “are structurally identical to the naturally occurring compositions” and function just like naturally occurring DNA by binding to complementary nucleotide sequences.  And although primers as such cannot be found in the human body, separating DNA “from its surrounding genetic material is not an act of invention.”

With respect to the method claims directed to comparing DNA sequences, Ambry argued that under a straightforward application of the Supreme Court’s 2012 Mayo v. Prometheus decision (IP Update, Vol. 15, No. 3), the method claims simply identify a law of nature (the sequence of the BRCA genes and comparison of wild-type DNA to patient DNA).  The Court declined to determine whether Mayo was directly on point and instead applied the two-step Alice Corp. analysis (IP Update, Vol. 17, No. 7).  In the first step, the Court relied on its 2012 Myriad decision finding that the claim from which the asserted claims depend were directed to the abstract idea “comparing [DNA] sequences and determining the existence of alterations.”  The Court then turned to second prong and asked whether the additional limitations added “‘enough’ to make the claims as a whole patent-eligible.”  The Court concluded that the additional limitations set forth only well-understood and routinized activity and therefore did not add inventive subject matter so as to render the claims patent-eligible.