United States District Court, D. Massachusetts
MEMORANDUM & ORDER
NATHANIEL M. GORTON, UNITED STATES DISTRICT JUDGE
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.
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
Legal Standard for Patentable Subject Matter
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.
Report and Recommendation on the Motion to Dismiss
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.
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
Id. at 2116.
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
[Myriad's] claim is concerned primarily with the
information contained in the genetic sequence, not with the
specific chemical ...