Judge Burke recommends dismissing complaint under Section 101

In Genetic Technologies Limited v. Laboratory Corporation of America Holdings, et al., C.A. No. 12-1736-LPS-CJB (D. Del. Sept. 3, 2014), Magistrate Judge Christopher J. Burke recommended the grant of defendants’ motion to dismiss for failure to state a claim. The Court determined that the single asserted claim of U.S. Patent No. 7,615,342, entitled “ACTN3 Genotype Screen for Athletic Performance,” was directed to non-patent-eligible subject matter under Section 101.

“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. at 3. The asserted claim included steps for “analyzing” a sample obtained, “detecting” the presence of certain alleles at a certain location, and then “predicting the potential sprinting, strength, or power performance of the human” where the presence of the two alleles would be positively associated with these attributes.

The Court first concluded that defendants’ motion to dismiss was not premature because (i) “[p]laintiff has failed to articulate why there are any disputed areas of fact relevant to resolution of the Motion,” id. at 10, and (ii) the Court concluded that claim construction was not necessary to resolve the Section 101 question, see id. at 11-13. The Court also prefaced its analysis with an examination of the holdings of decisions it found “especially instructive:” Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012) (“Prometheus”), PerkinElmer, Inc. v. Intema Ltd., 496 F. App’x 65 (Fed. Cir. 2012), and Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 698 F.3d 1303 (Fed. Cir. 2012). See id at 14-20.

Applying the Supreme Court’s two-part test for patent eligibility of patent-ineligible concepts (such as laws of nature), see id. at 9-10, the Court first identified the patent’s “link between a particular genetic variation and the potential for elite athletic performance” to be a natural law. Id. at 20-21. Next the Court assessed whether the elements of the claim transformed it into a patent-eligible application of the natural law because they contained an inventive concept. The Court concluded that this was not the case; rather, the elements of the claim that applied the law of nature – the “analyzing,” “detecting,” and “predicting” steps – utilized methods that were already well-known and/or were merely instructions on how to apply the natural law. See id. at 22-28. The Court came to the same conclusion when looking at these elements “as a whole” and found that “the steps in combination do not make the natural law and insignificant post-solution activity into patent-eligible subject matter.” Id. at 28. The Court concluded that the claims were similar to those rejected in Prometheus where the claimed steps “amount[ed] to nothing significantly more than an instruction to [testers] to apply the applicable laws.” Id. at 29 (internal citations omitted). The Court also rejected plaintiff’s argument that the claim was patentable because it may meet the machine-or-transformation test because “the Supreme Court has held that the machine-or-transformation test is non-dispositive in these types of cases – a claim can still pass the test, but fail the Section 101 law of nature inquiry.” Id. at 29 n.14 (citing Prometheus).

Finally, the Court observed that “[t]he presence here of the basic underlying concern that [claim 1 of the ‘342 Patent] tie[s] up too much future use of laws of nature simply reinforces [the Court’s] conclusion that the process[] described in [claim 1] [is] not patent eligible.” Id. at 30 (alternations in original) (citing Prometheus).

As a result, the Court recommended that plaintiff’s complaint be dismissed as to claim 1 and that, should the District Court adopt this recommendation, the District Court direct the plaintiff to provide “notice as to whether any other claims of the patent-in-suit will be asserted here, or whether the case should be closed.” Id. at 30.


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