On April 8 2016 in Genetic Technologies Ltd v Merial LLC the Federal Circuit upheld the lower court's dismissal of patent infringement claims based on methods of detecting genetic variations. The court held that the claims for analysing DNA for linkage disequilibrium were effectively claiming a law of nature, and thus were patent ineligible.
Genetic Technologies had sued Merial LLC and Bristol-Myers Squibb for infringement of US Patent 5,612,179, which had claims directed to a method of analysing sequences of genomic DNA. The defendants moved to dismiss for failure to state a claim, arguing that the patent claims covered ineligible subject matter under Section 101 of the Patent Act. The district court agreed.
A three-judge panel of the US Court of Appeals for the Federal Circuit unanimously affirmed. The court started by confirming that determining patent eligibility through a motion to dismiss before formal claim construction was appropriate, particularly where there is no claim construction dispute relevant to the Section 101 issue.
The court then applied the Alice/Mayo two-step patent eligibility test. First, the court found that the claims were directed to a patent-ineligible concept (ie, a law of nature). The law of nature was the relationship between the non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences. The court found that the claims were quite similar to the claims that were invalidated in Mayo itself.
Turning to the second step, the court easily found that any additional elements in the claims were insufficient to provide an "inventive concept" necessary to render the claim eligible. The various steps (including "amplifying" genomic DNA with a primer pair, and "analyzing" the amplified DNA) were well known, routine and conventional.
The Genetic Technologies decision joins a long list of other cases demonstrating how the Supreme Court cases of Mayo and Alice are creating sweeping changes in the US patent system.
W Edward Ramage
This article first appeared in IAM. For further information please visit www.iam-media.com.