Whose Genes Are They, Anyway? Myriad Cannot Block Competitors from Selling Breast Cancer Tests

Recently, Lawline faculty Amy Goldsmith updated us on the status of gene patents, including the litigation about the patentability of the breast cancer genes and the ability of Myriad competitors to test for breast cancer biomarkers, which continues in Myriad Genetics, Inc., et al., v. Ambry Genetics Corporation, Case 14-1361 (Fed. Cir. 2014).

Below is a fantastic article written by Amy illuminating the recent US Court of Appeals decision.

Whose genes are they, anyway? Myriad Cannot Block Competitors from Selling Breast Cancer Tests
Amy Goldsmith, Tarter, Krinsky & Drogin LLP

In a unanimous decision dated December 17, 2014, the US Court of Appeals for the Federal Circuit (Judges Dyk, Clevenger and Prost) affirmed the district court’s denial of Myriad’s preliminary injunction motion (to prevent Ambry from marketing the biomarker tests).  Primers, the short, synthetic single-strands of DNA which bind to target sequences of nucleotides, are not patent eligible under Section 101; they are products of nature since they claim the same nucleotide sequence as naturally occurring DNA. The Federal Circuit reversed the district court on the question of the patentability of cDNA, finding that the cDNA primers were not similar to those found patent eligible by the Supreme Court in Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013).

Judge Dyk said: “A DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature. Primers do not have such a different structure and are patent ineligible.”

The district court had also ruled that the method claims were not patent eligible under Section 101. The Federal Circuit agreed, after evaluating Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) in light of Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) and employing the latter’s 2-step test (is there patent eligible subject matter? What else is in the claims?) Identifying the alterations in a gene by comparing the patient’s gene with the wild-type and identifying differences which arise are unpatentable abstract ideas. Interestingly, Judge Dyk noted that “it is antithetical to the patent laws to allow these basic building blocks of scientific research to be monopolized.”

On the question of whether the claims referred to any transformative elements  or inventive step, the Court said “No.” Hybridizing a BRCA gene probe and detecting the hybridization product, or amplifying the BRCA gene and sequencing the amplified nucleic acids, “don’t add ‘enough’ to make the claims as a whole patent eligible.” Indeed, the Court agreed with Ambry that these claims were drawn to routine and conventional steps.

An original goal of the ACLU and researchers in the lawsuit against Myriad, to reduce the price of the breast cancer biomarker test, has now been accomplished. The effect of this and other decisions on the allocation of research dollars by the biotech industry to new genetic tests is yet to be determined.