Background
Following the Supreme Court’s 2013 decision in AMP v. Myriad Genetics (which invalidated isolated DNA claims but left method claims open), Myriad Genetics and the University of Utah sued Ambry Genetics and other laboratories that began offering BRCA1/BRCA2 genetic testing after Myriad’s composition claims were invalidated. The remaining patent claims included methods of comparing a patient’s BRCA gene sequence with a “wild-type” reference sequence to identify mutations, and methods of growing cells and detecting sequence alterations using specific laboratory techniques.
The district court denied a preliminary injunction, finding the plaintiffs were unlikely to succeed on the merits because the comparison claims were patent-ineligible. The Federal Circuit reviewed this ruling on expedited appeal.
The Court’s Holding
The Federal Circuit affirmed the denial of the preliminary injunction. Applying Mayo and the Alice framework, the court held that Myriad’s “comparing” and “analyzing” sequence method claims were directed to abstract mental processes — the steps of comparing two sequences to identify differences are abstract ideas that can be performed mentally or on paper. The additional steps of obtaining a patient sample and sequencing the BRCA gene were generic and conventional in the field, insufficient to transform the abstract comparison into a patent-eligible method.
The court distinguished claims that required specific laboratory techniques — such as growing transformed cells with particular vectors or using specific probes to detect sequences — as potentially patent-eligible because they required concrete laboratory steps beyond mere comparison of sequences. But the broad “comparing” claims, which covered any method of identifying BRCA mutations by comparing patient sequences to reference sequences, were directed to the abstract idea of comparison without a patent-eligible inventive concept.
Key Takeaways
- Method claims directed to comparing or analyzing genetic sequences to identify mutations are patent-ineligible abstract ideas when the comparison can be performed mentally and the only concrete steps (obtaining a sample, sequencing) are conventional in the field.
- Diagnostic genetic testing patents must claim specific laboratory techniques or methods — not just the abstract concept of comparing a patient’s genetic sequence to a reference sequence — to survive § 101 challenges after Mayo and Alice.
- The Myriad-Ambry dispute illustrated that even after the Supreme Court struck down Myriad’s composition claims on BRCA DNA, method claims covering the same BRCA testing territory were also vulnerable under the Mayo/Alice § 101 framework.
- Patent prosecutors drafting genomic diagnostic claims should focus on specific assay techniques, detection methods, and treatment steps that go beyond the abstract concept of sequence comparison — claims tying genetic findings to specific therapeutic decisions or requiring specific laboratory protocols are better positioned for § 101 survival.
Why It Matters
The Ambry Genetics case — coming in the immediate wake of AMP v. Myriad — effectively ended Myriad’s ability to use its remaining patent claims to block clinical laboratories from offering BRCA testing. The combined effect of the Supreme Court’s 2013 ruling on isolated DNA and the Federal Circuit’s 2014 ruling on comparison method claims opened the BRCA testing market to competition, dramatically reducing the cost of hereditary breast cancer genetic testing and expanding patient access.
The decision had lasting significance for molecular diagnostics patent strategy: it established that the most commercially important claims in genetic diagnostic patents — the broad claims covering any method of comparing a patient’s genetic sequence to identify pathogenic variants — are categorically vulnerable under § 101. This forced the molecular diagnostics industry to rethink patent strategy for genetic tests, focusing on claims tied to specific technical methods rather than broad functional comparison claims.