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Oxford Immunotec Ltd. v. Qiagen, Inc.

United States District Court, D. Massachusetts

September 30, 2016

Oxford Immunotec Ltd., Plaintiff,
v.
Qiagen, Inc. et al., Defendants.

          MEMORANDUM & ORDER

          NATHANIEL M. GORTON, UNITED STATES DISTRICT JUDGE

         Plaintiff Oxford Immunotec Ltd. alleges defendants Qiagen, Inc., Quest Diagnostics, Inc. and Laboratory Corporation of America Holdings infringed six of its patents relating to a method for diagnosing tuberculosis.

         Defendants filed a joint motion to dismiss, asserting plaintiff's patents are invalid. On August 31, 2016, Magistrate Judge Donald L. Cabell entered a Report and Recommendation (“R&R”), recommending dismissal of plaintiff's “kit” claims but denial of defendants' motion to dismiss plaintiff's “method” claims. Both parties timely objected to the R&R.

         I. Legal Standard for Patentable Subject Matter

         The parties agree that the two-step framework for patentable subject matter described in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012), controls. First, the Court must determine whether the patent claims are “directed” to one of the patent-ineligible concepts, including natural laws and phenomena. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed. Cir. 2016) (quoting Mayo, 132 S.Ct. at 1296-97). If the claims are not directed to an ineligible concept, the claims are patentable. Id. If the claims are directed to an ineligible concept, then the Court must look for an “inventive concept” by determining whether the elements of the invention, individually and combined, “transform” the claims into an application eligible for a patent. Id.

         II. Report and Recommendation on the Motion to Dismiss

         A. Kit Claims

         The Magistrate Judge recommended dismissing plaintiff's “kit” claims because the peptides used in plaintiff's diagnostic kit exist in nature and have not been changed beyond the act of isolation from the larger ESAT-6 protein (step one) and the peptide claims do not include any inventive concept (step two). Although the R&R is well-reasoned, this Court concludes that dismissal of the kit claims at this stage would be premature.

         Magistrate Judge Cabell agreed with the defendants argument which relies primarily on Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013). The Supreme Court in Myriad concluded the plaintiff's patent for isolating the BRCA1 and BRCA2 genes in DNA was not patentable subject matter because

Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.

Id. at 2116.

         The Magistrate Judge rejected plaintiff's contention that Myriad focuses on the “informational” element of DNA, which is different from plaintiff's “functional” peptides. The Supreme Court in Myriad noted, however, that the patent claims did not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” Id. at 2118. The Supreme Court concluded that,

[Myriad's] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical ...

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