Oxford Immunotec Ltd. v. Qiagen, Inc., Civil Action No. 15–13124–NMG

271 F.Supp.3d 358

OXFORD IMMUNOTEC LTD., Plaintiff,

v.QIAGEN, INC. et al., Defendants.

Civil Action No. 15–13124–NMG

United States District Court, D. Massachusetts.

Signed September 26, 2017

Siegmund Y. Gutman, Thomas C. Chen, Proskauer Rose LLP, Los Angeles, CA, Steven M. Bauer, Brendan S. Cox, Gourdin W. Sirles, James R. Anderson, Kimberly Ann Mottley, Proskauer Rose LLP, Boston, MA, for Plaintiff.

Bhanu Sadasivan, William G. Gaede, III, McDermott Will & Emery LLP, Menlo Park, CA, David Mlaver, Michael V. O'Shaughnessy, McDermott Will & Emery, LLP, Washington, DC, Sarah Chapin Columbia, Lauren Nelson Martin, Melissa Nott Davis, McDermott, Will & Emery LLP, Manleen K. Singh, Lisa A. Furnald, Robins, Kaplan, Miller & Ciresi LLP, Christopher Robert Howe, James M. Campbell, Campbell, Campbell, Edwards & Conroy, PC, Boston, MA, Emmett J. McMahon, Robins Kaplan LLP, Minneapolis, MN, Clifford Katz, Robert I. Steiner, Kelley Drye & Warren LLP, New York, NY, for Defendants.

MEMORANDUM & ORDER

GORTON, J.

Plaintiff Oxford Immunotec Ltd. ("plaintiff" or "Oxford") alleges defendants Qiagen, Inc., Quest Diagnostics, Inc. and Laboratory Corporation of America Holdings ("defendants" or "Qiagen") infringed its patents relating to a method and kit for diagnosing tuberculosis. Oxford seeks a preliminary injunction to enjoin Qiagen from selling the QFT–Plus one-tube option to new customers currently using a tuberculin skin test or TSPOT.TB.

I. Background

A. Overview of the Patented Technology

Oxford owns six patents describing a method and kit for diagnosing tuberculosisin vitro (outside of the human body). Five of the six patents-in-suit (collectively, "the '646 patent family") share a common specification. Those five patents, each entitled "Tuberculosis Diagnostic Test," are:

1) U.S. Patent No. 7,632,646 ("the '646 patent"), issued on December 15, 2009,

2) U.S. Patent No. 7,901,898, ("the '898 patent"), issued on March 8, 2011,

3) U.S. Patent No. 8,216,795, ("the '795 patent"), issued on July 10, 2012,

4) U.S. Patent No. 8,507,211, ("the '211 patent"), issued on August 13, 2013 and

5) U.S. Patent No. 9,005,902 ("the '922 patent"), issued on April 14, 2015.

The sixth patent-in-suit, U.S. Patent No. 8,617,821 ("the '821 patent"), entitled "Assay Method for Peptide Specific T–Cells," has a different specification. It was issued on December 31, 2013.

Oxford's amended complaint contains six counts alleging infringement of those six patents, in violation of 35 U.S.C. § 271(a) - (c).

Oxford's motion for preliminary injunction rests on two exemplary patent claims.

Claim 1 of the '211 patent is for:

A method of in vitro diagnosis of Mycobacterium tuberculosis infection in a host, comprising (a) keeping a population of T cells isolated from said host in contact with a peptide panel comprising one or more epitopes contained within peptide SEQ ID NO: 1, and (b) detecting a recognition response by the T cells to the peptide panel.

Claim 17 of the '898 patent is for:

A kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses ESAT–6, comprising a peptide represented by SEQ ID NO: 1.

Plaintiff rests its motion for preliminary injunction on those two claims.

B. The '646 Patent Family

Approximately one-third of the world population is infected by tuberculosis and between 5% and 10% of infected individuals will develop the active disease. Tuberculosis detection is currently performed in one of two ways: through a tuberculin skin test ("TST") or through an in vitro blood test known as an interferon gamma release assay ("IGRA").

Oxford's patents pertain to an IGRA for tuberculosis. When the body encounters a pathogen such as Mycobacterium tuberculosis ("M. tuberculosis"), proteins from that pathogen are broken down into pieces known as peptides comprised of strings of amino acids. T cells, cells that mediate immune responses in the body, become "antigen-experienced" after they encounter a harmful peptide. Then, in a process known as activation, T cells that encounter that peptide a second time can bind to it. Once activated, the T cells release so-called cytokines, such as IFN-?, which act as chemical messengers in order to elicit a full immune response.

The '646 patents -in-suit are drawn to a method for diagnosing tuberculosis whereby T cells are placed in contact with peptides from a protein known as ESAT–6. Oxford uses ESAT–6 because it is secreted by M. tuberculosis. After contact, one can measure the level of cytokines released (e.g., IFN-?) to determine whether there is a tuberculosis infection. Importantly, ESAT–6 is absent from the most common TB vaccine, which means that Oxford's method will trigger fewer false positives than conventional skin tests in people who are vaccinated but not infected with TB.

Oxford's invention also provides a kit for carrying out the claimed method.

C. Tuberculosis diagnosis

IGRAs provide more convenience and accuracy than skin tests. There are currently two IGRAs available in the United States market: Oxford's T–SPOT.TB and Qiagen's QuantiFERON–Gold In–Tube ("QFT–Gold") product. Accordingly, both companies seek to convert skin test users, who currently comprise about 80% of the tuberculosis diagnosis market, to IGRA users.

Oxford maintains that the T–SPOT.TB is a superior product to the QFT–Gold because the former uses a single, standardized tube while the latter requires multiple specialized tubes. The QFT–Plus, Qiagen's next generation product, mimics the QFT–Gold but also contains an additional single test tube option. Qiagen's single tube option has been offered outside the United States. Oxford maintains that the single tube option in the QFT–Plus is meant to emulate their T–SPOT.TB test.

Plaintiff requests that this Court enjoin the sale of the QFT–Plus one-tube option to new customers currently using the skin tests or TSPOT.TB until after trial to prevent defendants' allegedly infringing product from gaining market share at plaintiff's expense.

D. The launch of the QFT–PLUS

On June 8, 2017, Qiagen announced that it had received FDA approval for its next generation "QFT–Plus" product. According to its corporate representative, Qiagen intends to launch the product in the U.S. market in October, 2017. Qiagen maintains that Oxford knew in January, 2017, that Qiagen had applied for FDA approval. In fact, Oxford has been aware of the launch of the QFT–Plus since at least September 2015 and, shortly thereafter, informed Qiagen that it would move for a preliminary injunction when the product launched.

E. Procedural history

Plaintiff filed its complaint in August, 2015. Defendants jointly moved to dismiss that suit in October, 2015, asserting that Fed. R. Civ. P. 12(b)(6) and 35 U.S.C. § 101 mandated dismissal. The motion was referred to Magistrate Judge Cabell, who issued his report and recommendation ("R & R") regarding the motion on August 31, 2016. He recommended dismissing plaintiff's "kit" claims but denying the defendant's motion to dismiss the plaintiff's "method" claims. Both parties timely objected to the R & R.

On September 30, 2016, this Court adopted, in part, and rejected, in part, the Magistrate Judge's R & R, allowing both the "kit" and the "method" claims to proceed.

Magistrate Judge Cabell found that the "kit" claim was directed towards ineligible subject matter because the peptides used in plaintiff's diagnostic kit exist in nature and have not been changed beyond the act of isolation from the ESAT–6 protein. Accordingly, Magistrate Judge Cabell reasoned, the peptide claims lacked an inventive concept. This Court rejected that finding because, taking the plaintiff's allegations as true, the claimed peptides were

chemically different than the naturally occurring amino acids in the ESAT–6 protein and that purportedly results in the peptides behaving differently in plaintiff's in vitro tests than would the amino acids in the ESAT–6 protein.

This court thus concluded that the peptides allegedly arise from "human ingenuity" and have a distinctive character and use, thus being drawn to eligible subject matter.

This Court accepted the Magistrate Judge's recommendation that the "method" claims proceed. Defendants claimed that plaintiff's method claims involved "routine and conventional" steps lacking an inventive concept. This Court found, however, that the method claims, when considered in combination, improved on current tuberculosis testing methods and that, accepting the plaintiff's allegations as true, there was no in vitro diagnostic test for tuberculosis in common use before plaintiff developed its test.

In February 2017, the Patent and Trademark Office ("PTO") rejected all five of Qiagen's petitions for inter partes review. Those petitions challenged the patents under 35 U.S.C. § 103.

This Court conducted a Markman hearing on June 8, 2017 and entered an order the following week construing every disputed claim term in plaintiff's favor.

On August 4, 2017, plaintiff filed this motion for a preliminary injunction, seeking to enjoin the U.S. commercialization of the QFT–Plus until after the trial, which is scheduled to begin on January 16, 2018. The scope of the injunction sought has now been narrowed to prohibiting the use of the one-tube option by new customers.

II. Analysis

A. Motion for Preliminary Injunction

The purpose of a preliminary injunction is to preserve the relative positions of the parties until a trial on the merits is held. New Hampshire Right to Life Political Action Comm. v. Gardner, 99 F.3d 8, 16 (1st Cir. 1996). To obtain injunctive relief, the plaintiff bears the burden of demonstrating:

1) a substantial likelihood of success on the merits, 2) a significant risk of irreparable harm if the injunction is withheld, 3) a favorable balance of hardships and 4) a fit (or lack of friction) between the injunction and the public interest.

Nieves–Márquez v. Puerto Rico, 353 F.3d 108, 120 (1st Cir. 2003) (citation omitted).

No individual factor is dispositive....