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Oxford Immunotec Ltd. v. Qiagen, Inc.

United States District Court, D. Massachusetts

August 31, 2016

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

          Oxford Immunotec Ltd., Plaintiff, represented by Siegmund Y. Gutman, Proskauer Rose LLP, pro hac vice.

          Oxford Immunotec Ltd., Plaintiff, represented by Steven M. Bauer, Proskauer Rose LLP, Thomas C. Chen, Proskauer Rose LLP, pro hac vice, Brendan S. Cox, Proskauer Rose, LLP & Kimberly Ann Mottley, Proskauer Rose, LLP.

          Qiagen, Inc., Defendant, represented by Bhanu Sadasivan, McDermott Will & Emery LLP, pro hac vice, David Mlaver, McDermott Will & Emery, LLP, pro hac vice, Michael V. O'Shaughnessy, McDermott Will & Emery LLP, pro hac vice, Sarah Chapin Columbia, McDermott, Will & Emery LLP, William G. Gaede, III, McDermott, Will & Emery LLP, pro hac vice & Melissa Nott Davis, McDermott, Will & Emery LLP.

          Quest Diagnostics, Inc., Defendant, represented by Bhanu Sadasivan, McDermott Will & Emery LLP, pro hac vice, Emmett J. McMahon, Robins Kaplan LLP, pro hac vice, Manleen K. Singh, Robins, Kaplan, Miller & Ciresi LLP, Sarah Chapin Columbia, McDermott, Will & Emery LLP, William G. Gaede, III, McDermott, Will & Emery LLP, David Mlaver, McDermott Will & Emery, LLP, Melissa Nott Davis, McDermott, Will & Emery LLP & Michael V. O'Shaughnessy, McDermott Will & Emery LLP.

          Laboratory Corporation of America Holdings, Defendant, represented by Bhanu Sadasivan, McDermott Will & Emery LLP, pro hac vice, Sarah Chapin Columbia, McDermott, Will & Emery LLP, William G. Gaede, III, McDermott, Will & Emery LLP, Christopher Robert Howe, Campbell, Campbell, Edwards & Conroy, PC, David Mlaver, McDermott Will & Emery, LLP, James M. Campbell, Campbell, Campbell, Edwards & Conroy, PC, Melissa Nott Davis, McDermott, Will & Emery LLP & Michael V. O'Shaughnessy, McDermott Will & Emery LLP.

          REPORT AND RECOMMENDATION ON DEFENDANTS' JOINT MOTION TO DISMISS (Dkt. No. 36)

          DONALD L. CABELL, Magistrate Judge.

         This is an action for infringement of six patents related to a method for diagnosing tuberculosis. The plaintiff, Oxford Immunotec, Ltd., develops tests to diagnose and monitor patients with auto-immune diseases. Defendants Qiagen, N.V. and Qiagen, Inc. are alleged to have infringed the plaintiff's patents by developing their own tuberculosis test. The remaining defendants, Quest Diagnostics, Inc. and Laboratory Corporation of America Holdings, are alleged to have infringed the plaintiff's patents by using and selling the allegedly infringing product the Qiagen defendants developed. (Dkt. No. 1).

         Currently before the court is the defendants' joint motion to dismiss. The motion is premised on the argument that the defendants' affirmative defense of patent invalidity is certain to succeed because the plaintiff's patents are drawn to a law of nature. As discussed below, I recommend that the motion be allowed in part and denied in part.

         I. SCIENTIFIC BACKGROUND AND PATENTS[1]

         An antigen is a molecule produced by a pathogen ( e.g., bacteria), that produces an immune response in the host organism. In the human immune system, T-cells are white blood cells that can recognize pathogens by recognizing the antigens that the pathogens produce. A T-cell that has seen a particular pathogen is "antigen-experienced." When it encounters that pathogen again, it will activate to fight it. One part of that activation is the production of cytokines, which are small proteins that have a specific effect on the interactions and communications between cells. The cytokines produced by T-cells signal other types of cells in the immune system, which respond to the site of the infection to assist in attacking the responsible pathogen.

          Mycobacterium tuberculosis (" M. tuberculosis ") is the bacterium that causes tuberculosis (TB). M. tuberculosis produces a unique protein ( i.e., antigen) called ESAT-6. ESAT-6, like all proteins, is composed of a chain of peptides, which are naturally occurring chains of two or more amino acids.

         The patents-in-suit teach a method for in vitro diagnosis of TB. In vitro diagnosis occurs in a test tube outside the human body. In contrast, the prevailing method of diagnosing TB is an in vivo skin test where TB antigens are injected into the patient's arm.

         The plaintiff's test uses specified concentrations of eight peptides that are components of ESAT-6. The peptides are synthetic ( i.e., made in a lab), but their amino acid makeup is the same as the peptides that occur naturally in ESAT-6. The eight-peptide panel is "contact[ed]" with "a population of T cells from the host" and it is "determin[ed] in vitro whether T cells in the T cell population show a recognition response to the panel by detecting an IFN-y [interferon gamma] secretion from the T cells." In other words, the eight peptides are mixed with the test subject's blood in a test tube and the doctor observes whether the T cells produce cytokines, a response that occurs only if the T cell has seen M. tuberculosis before.

         Before the plaintiff developed its in vitro blood test, there was no such in vitro diagnostic test for TB in common use. Instead, there were two standard methods for diagnosing TB. The Mantoux tuberculosis skin test (TST), involves injecting a small amount of TB protein derivative into a patient's forearm and then observing the injection site 48 to 72 hours after the injection. A positive TST test indicates that a patient has been infected with TB bacteria. A sputum culture - collecting and culturing phlegm from the upper respiratory tract - is used to determine whether an infected patient actually has TB as distinguished from a latent infection. The patented in vitro test is superior to prior in vivo skin tests because it is faster, more convenient, less dependent on the administering physician's subjective judgment, and has a lower rate of false positives.

         The complaint asserts that the defendants have infringed six of the plaintiff's patents. United States Patent No. 7, 632, 646, entitled "Tuberculosis Diagnostic Test" ("the'646 patent"), was issued on December 15, 2009. United States Patent No. 7, 901, 898, entitled "Tuberculosis Diagnostic Test" ("the '898 patent"), was issued on March 8, 2011. United States Patent No. 8, 216, 795, entitled "Tuberculosis Diagnostic Test" ("the '795 patent"), was issued on July 10, 2012. United States Patent No. 8, 507, 211, entitled "Tuberculosis Diagnostic Test" ("the '211 patent"), was issued on August 13, 2013. United States Patent No. 8, 617, 821, entitled "Assay Method for Peptide Specific T-Cells" ("the '821 patent"), was on December 31, 2013. United States Patent No. 9, ...


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