United States District Court, D. Massachusetts
MEMORANDUM & ORDER
Nathaniel M. Gorton, United States District Judge.
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.
Overview of the Patented Technology
owns six patents describing a method and kit for diagnosing
tuberculosis in 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.
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.
amended complaint contains six counts alleging infringement
of those six patents, in violation of 35 U.S.C. §
motion for preliminary injunction rests on two exemplary
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.
rests its motion for preliminary injunction on those two
The ‘646 Patent Family
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”).
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-γ, which act as chemical messengers in
order to elicit a full immune response.
'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-γ) 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.
invention also provides a kit for carrying out the claimed
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.
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
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.
The launch of the QFT-PLUS
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.
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.
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.
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
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.
court thus concluded that the peptides allegedly arise from
“human ingenuity” and have a distinctive
character and use, thus being drawn to eligible subject
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
February 2017, the Patent and Trademark Office
(“PTO”) rejected all five of Qiagen's
petitions for inter partes review. Those petitions ...