Genetic Technologies Limited (GTG) has filed sued against both LabCorp and 23andMe, alleging infringement on US patent # 7,615,342 (‘342), which, according to the complaint “…relates to methods for analyzing the ACTN3 gene to predict athletic performance.”
The suit was filed just six days after GTG filed suit against Genelex for patent infringement. That suit revolves around a separate patent (# 5,162,179) for a molecular technique that “…comprises amplifying genomic DNA with a primer pair that spans an intron sequence and defines a DNA sequence in genetic linkage with an allele to be detected.”
Mr. Howard Coleman, the CEO of Genelex, had this to say about that suit:
Apologies for not getting back to you sooner. Not much of a story here. First, the allegations that the loci in question infringe the GTL patent are tenuous. They’re in non-coding regions, but are not used to identify alleles in coding regions as required by the patent. In addition the amount of revenue involved is trivial as these cases go, barely into six figures. As a result we’re in settlement talks that will hopefully be completed in the next few weeks.
Now back to the present lawsuit. GTG’s complaint describes the patent in question:
The present invention concerns novel methods of selecting or matching a sport or sporting event to an individual (e.g. a sprint/power sport or an endurance sport) and predicting athletic performance, the methods involving assessing ACTN3 genotype. In alternative embodiments, training regimens may be optimally designed for athletes by assessing the ACTN3 genotypes. Certain embodiments concern combining the assessment of the ACTN3 genotype with other known fitness related genes to better assess the athletic potential of an individual. In addition, the genotypic analysis of the ACTN3 gene may be combined with physiological tests, physical measurements and/or psychological assessments to more optimally design a training regimen for an individual athlete.
Unlike the ‘179 patent, which expired on March 9, 2010, the ‘342 patent was only issued on November 10, 2009, which means it is still in force.
According to GTG’s complaint, LabCorp performs ACTN3 testing through the National Genetics Institute (NGI), one of LabCorp’s Centers of Excellence, using genetic material supplied by patients via testing kits. Patients apparently purchase these testing kits through 23andMe, which include instructions to send the kits to NGI.
GTG seeks reasonable royalties plus interest due it from the patent infringement and for LabCorp and 23andMe to be compelled to cease infringing on the ‘342 patent.
The full GTG v. LabCorp complaint is here (GTG v. Labcorp).
What makes this patent infringement suit different from the one against Genelex is this one appears to be focused on a patent involving genetic derangements of a particular gene as opposed to a laboratory technique used to study a gene.
It is possible the patent itself could get challenged, in light of a relatively recent Supreme Court ruling in the Mayo v. Prometheus case.
In that ruling, which I posted about a few months ago (a la CAP STATLINE), the US Supreme Court invalidated patents held by Prometheus Laboratories because, according to the CAP, “…the patent claims at issue effectively claim the underlying laws of nature themselves and were therefore invalid.”
There is another very important case involving this same issue of whether a gene itself can be patented-the Myriad Genetics case-for which the Supreme Court just granted cert (agreed to hear). I anxiously await oral arguments on that one.