Myriad Genetics Loses Latest Round of BRCA Genetic Testing Litigation at the Federal Circuit

In 2013, the Supreme Court considered whether isolated genes qualified as patentable subject matter in AMP v. Myriad (see here for analysis). That case centered on Myriad Genetics' patent claims to isolated BRCA1 and BRCA2 genes which are used to provide genetic testing to detect an increased genetic susceptibility to developing breast and/or ovarian cancer. The Court rejected the patent claims to the isolated genes, noting that:

[S]eparating that gene from its surrounding genetic material is not an act of invention. 

After the Court’s opinion was issued, several genetic testing companies immediately moved into the marketplace, offering diagnostic genetic testing for mutations in the BRCA1 and BRCA2 genes (Ambry Genetics and others, see here). At that time, Myriad still held other patent claims that had not been challenged in the earlier litigation. Therefore, following the Supreme Court decision, Myriad promptly filed suit against the new entrants, asserting remaining patent claims to DNA primers (short sequences used to amplify/copy a BRCA1/2 sequence) and to testing methods. Myriad sought a preliminary injunction against Ambry Genetics. In University of Utah Research Foundation et al. v. Ambry Genetics, issued earlier this year, a federal district court denied a preliminary injunction to Myriad, basing its decision on a conclusion that Myriad could not show a reasonable likelihood of success on the merits of the litigation because the asserted patent claims were likely not patentable subject matter. Now, on appeal, the Federal Circuit has upheld the denial of the preliminary injunction, in In re BRCA1-And BRCA2-Based Hereditary Cancer Test Patent Litigation, issued last week. With respect to the patent claims to the primers (short DNA strands that initiate the synthesis of a longer DNA molecule, such as a gene) the court stated: 

The primers before us are not distinguishable from the isolated DNA found patent-ineligible in Myriad and are not similar to the cDNA found to be patent-eligible. Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature. 

In this recent litigation, Myriad had also asserted several method claims that captured the basic process of comparing the sequence of a patient’s BRCA1 or BRCA2 genes with a wild-type (normal) DNA sequence of the relevant gene. In its analysis of these claims, the Federal Circuit rejected the claims, not because of a natural phenomenon or law of nature, but rather relying on the “abstract idea” exception to patentable subject matter (this exception most recently discussed by the Supreme Court in Alice Corp. v. CLS earlier this year):

Here, under our earlier decision, the comparisons described in the first paragraphs of claims 7 and 8 are directed to the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations. The methods, directed to identification of alterations of the gene, require merely comparing the patient’s gene with the wild-type and identifying any differences that arise. 

In this second round of litigation over the DNA primers, the Federal Circuit relied on the Supreme Court’s reasoning regarding isolated genes to invalidate the DNA primer claims (the Federal Circuit had initially upheld the patent claims to isolated genes in 2012, only to be reversed by the Supreme Court). With respect to the method claims, the Federal Circuit relied on the abstract ideas exception as it had in its rejection of similar method claims in its 2012 decision preceding the Supreme Court case. This decision is the latest round in Myriad’s attempts to restrict competition in the BRCA1 and BRCA2 genetic testing field through assertion of patent claims, and Myriad has now lost on patent claims to isolated genes, DNA primers, and basic genetic testing methods (only claims to cDNAs were upheld). Ambry hailed the Federal Circuit's decision. Also last week, the United States Patent and Trademark Office (PTO) has issued its 2014 Interim Guidance on Patent Subject Matter Eligibility. This updated guidance follows an unusually high number of Supreme Court cases to examine patentable subject matter in life science, business method and software patents over the last 6-7 years, and the PTO has been publishing its evolving thinking on these issues. The PTO is seeking public comment on the Interim Guidance until March 16, 2015, and it will hold a public forum on these issues in January 2015.