Another Diagnostic Patent Falls Apart under Ariosa/Mayo

CAFC Decision: Genetic Technologies Ltd. v. Merial LLC, No. 2015-1202 (Fed. Cir. Apr. 8, 2016)

Background: Genetic Technologies Ltd. (GTG) is the owner of U.S. Patent No. 5,612,179 (the ‘179 patent), directed to “junk DNA.” The patent’s basic idea stems from the inventors discovery that non-coding DNA sequences (also referred to as introns or “junk DNA”) tend to be inherited with DNA sequences in coding regions (exons) of certain genes, more than random probability would predict.  The patent provides methods for detecting an allele of a particular gene that are in linkage disequilibrium by amplifying and analyzing non-coding regions known to be linked to the coding region. These methods are helpful because they allow for detection of specific alleles for a variety of purposes, including diagnosis and treatment of genetic disorders and diseases correlated with those alleles. While the specification is not limited to detecting any particular alleles linked to any particular non-coding sequences, it does provide examples of linked alleles known to be diagnostic of inherited diseases.

Issue: Are claims of the ‘179 patent directed to “junk DNA” ineligible subject matter under 35 U.S.C. § 101.

Outcome: The district court held invalid the ‘179 patent on motions to dismiss for claiming a law of nature, without the court performing claim construction. Similarly, on appeal, the Federal Circuit affirmed the district court decision that claims 1-25 and 33-36 of the ‘179 patent are invalid, applying the two-step Mayo/Alice test for assessing patent eligibility and confirmed that claim construction is not a prerequisite for validity determination under § 101.  The Federal Circuit noted that claim 1 of the ‘179 patent “covers essentially all applications, via standard experimental techniques, of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA.”  As in Sequenom v. Ariosa, GTG allegedly pursued claims too broad in scope. The Court further stated that the method claims at issue in Mayo, Sequenom, and here all relate to obtaining newly discovered information about human biology. Had the patent claimed creation or alteration of DNA sequences or identification of novel identification techniques, GTG’s claims may have been allowed.

Prosecution Takeaway: In the context of newly discovered information related to human biology, claiming what was actually reduced to practice may have a better chance of survival under Section 101.

Links to the USPTO’s patent eligibility memo and examples dated May 4, 2016, are included.