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Genetic Technologies Limited v. Laboratory Corporation of America Holdings

United States District Court, D. Delaware

September 3, 2014



CHRISTOPHER J. BURKE, Magistrate Judge.

Presently pending before the Court is Defendants Laboratory Corporation of America Holdings ("LabCorp Holdings"), Laboratory Corporation of America ("LabCorp America") (collectively, "LabCorp") and 23andMe, Inc.'s ("23andMe") (collectively, "Defendants") motion to dismiss for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure (the "Motion"). (D.I. 9) Defendants argue that Plaintiff Genetic Technologies Limited's ("Plaintiff") U.S. Patent No. 7, 615, 342 (the "'342 Patent") is directed to non-patent-eligible subject matter under 35 U.S.C. § 101 ("Section 101"). For the reasons that follow, the Court recommends that Defendants' Motion be GRANTED as to asserted claim 1 of the '342 Patent.


A. Factual Background

Plaintiff is an Australian corporation and is the owner of the '342 Patent by assignment. (D.I. 1 at ¶¶ 1, 10) The '342 Patent, entitled "ACTN3 Genotype Screen for Athletic Performance, " was issued on November 10, 2009. ('342 Patent at 1)[1]

The specification of the '342 Patent explains that certain genotypes are associated with physiological traits that may contribute to or reduce performance in an elite athlete. (Id., col. 1:61-63) In the "Background of the Invention" section, the patent explains that the invention relates to "methods for selecting or matching a sport or sporting event to an individual... to increase their chances of success, optimizing the training programs of individuals, and for predicting the athletic performance of individuals[, ]" based on the identification of"specific gene(s) or alterations in the gene(s) that correlate with potential athletic performance." (Id., col. 1:16-23)

More specifically, the specification describes how "a-actinins play a role in thin filament organization and the interaction between the sarcomere cytoskeleton and the muscle membrane[, ]" and that a-actinins further play "a role in the regulation of myofiber differentiation and/or contraction." (Id., col. 2:27-38) The specification further points out the apparent functional redundancy of the a-actinin-2 gene ("ACTN2") and the a-actinin-3 gene ("ACTN3"), and asserts the hypothesis "that [ACTN2] is able to compensate for the absence of [ACTN3] in type 2 (fast) fibers in humans." (Id., col. 2:54-67) Despite this apparent functional redundancy, genotype screens of elite athletes-in particular, sprinters, swimmers and cyclists-have showed "a very low frequency of homozygosity for the ACTN3 premature stop codon 577X mutation" as compared to the general Australian Caucasian population. (Id., col. 3:3-10) The genotype screens also demonstrated that the frequency of the 577XX genotype was relatively higher in Caucasian elite endurance athletes. (Id., col. 3: 13-15) Thus, the specification explains that screening procedures for these genotypes may provide assistance in selecting young individuals with potential for elite performance in sprint-type and endurance sports. (Id., col. 3:10-19)

The methods claimed in the '342 Patent embody findings that the presence of certain genes is correlated with elite sprinting, strength, or power performance. (Id., col. 29:49-32:10) There are fourteen claims in the '342 Patent. (Id.) Claim 1, the only currently asserted claim in this matter, reads as follows:

1. A method to predict potential sprinting, strength, or power performance in a human comprising:
a) analyzing a sample obtained from the human for the presence of one or more genetic variations in a-actinin-3 (ACTN3) gene;
b) detecting the presence of two 577R alleles at the loci encoding amino acid number 577 of the a-actinin-3 (ACTN3) protein; and
c) predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.

(Id., col. 29:50-61)

According to Plaintiffs Complaint, Defendants work together to provide genetic testing to the public, including ACTN3 gene testing. (D.I. 1 at ¶ 17) Lab Corp, a clinical laboratory company, operates a national network of 54 primary laboratories, over 1, 700 patient service centers, and nine specialized Centers of Excellence, including the National Genetics Institute. (Id. at ¶¶ 15, 18) Though this network, Lab Corp provides a variety of testing, including advanced genomic testing such as ACTN3 gene testing. (Id. at ¶ 15)

Defendant 23andMe is said to market, inter alia, ACTN3 genomic testing and analysis services to the public, and to contract with LabCorp, which performs the actual testing of a customer's DNA. (Id. at ¶ 16) Upon completion of the testing, it is alleged that Defendants, "acting in concert, analyze the results; predict the sprinting, strength, or power performance of that purchaser; and report that prediction to the purchaser." (Id.)

B. Procedural Background

On December 20, 2012, Plaintiff commenced this action, asserting that Defendants directly and indirectly infringe one or more claims of the '342 Patent through their genotyping services. (D.I. 1 at ¶¶ 21-26) Plaintiffhas subsequently confirmed that claim 1 of the '342 Patent is the only claim that is presently being asserted in this action. (D.I. 24 at 39, 41) In lieu of filing an Answer, on February 25, 2013, Defendants filed the instant Motion. (D.I. 9) The Motion was fully briefed as of March 25, 2013. (D.I. 14)

On July 15, 2013, this matter was referred to the Court by Chief Judge Leonard P. Stark to hear and resolve all pretrial matters, up to and including the resolution of case-dispositive motions. (D.I. 21) On July 30, 2013, the Court heard oral argument regarding the Motion. (D.I. 24 (hereinafter, Tr.")) Thereafter, the parties submitted several supplemental letters to apprise the Court of recent opinions-including a number of important decisions by the Supreme Court of the United States-that might impact review of the Section 101-related issues that are at play in this matter. (D.I. 16, 18, 20, 23, 25, 26, 27, 28, 29, 30) Now having the benefit of these recent decisions, the Court finds the Motion ripe for decision.


Pursuant to Federal Rule of Civil Procedure 12(b)(6), a party may move to dismiss the plaintiffs complaint based on the failure to state a claim upon which relief may be granted. Fed.R.Civ.P. 12(b)(6). The sufficiency of pleadings for non-fraud cases is governed by Federal Rule of Civil Procedure 8, which requires "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). In order to survive a motion to dismiss pursuant to Rule 12(b)(6), "a complaint n1ust contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal quotation marks and citation omitted). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." I d. (citation omitted). In assessing the plausibility of a claim, the court must "construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading of the complaint, the plaintiff may be entitled to relief." Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (citing Phillips v. Cnty. of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).[3]

Patentability under Section 101 is a "threshold inquiry" and a question of law, In re Bilski, 545 F.3d 943, 950 (Fed. Cir. 2008), aff'd, Bilski v. Kappos, 561 U.S. 593 (2010), one that "may be informed by subsidiary factual issues[, ]" CyberFone Sys., LLC v. Cellco P'ship, 885 F.Supp.2d 710, 715 ...

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