Oxford Immunotec Ltd. v. Qiagen N.V. et al

Filing 271

Judge Nathaniel M. Gorton: ENDORSED ORDER entered. MEMORANDUM AND ORDER In accordance with the foregoing, plaintiffs motion for preliminary injunction (Docket No. 195) is DENIED. So ordered.(Caruso, Stephanie)

United States District Court
District of Massachusetts
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Oxford Immunotec Ltd.,
Plaintiff,
v.
Qiagen, Inc. et al.,
Defendants.

Civil Action No.
15-13124-NMG

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 tuberculosis in vitro (outside of the human body).
Five of the six patents-in-suit (collectively, “the ’646 patent

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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 TCells,” 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:

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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

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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.
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.
6 because it is secreted by M. tuberculosis.

Oxford uses ESATAfter 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.
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
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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
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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.

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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.

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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.

Amazon.com, Inc. v.

Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001).
Instead, the court “must weigh and measure each factor against
the other factors and against the form and magnitude of the
relief requested.” Printguard, Inc. v. Anti-Marking Sys., Inc.,
535 F. Supp. 2d 189, 196 (D. Mass. 2008) (quoting Hybritech,
Inc., v. Abbott Labs., 849 F.2d 1446, 1451 (Fed. Cir. 1988)).
1.

Likelihood of success on the merits

To establish likelihood of success on the merits, a
patentee must demonstrate that it will likely prove that its
patent was infringed and is valid.

See AstraZeneca LP v.

Apotex, Inc., 633 F.3d 1042, 1050 (Fed. Cir. 2010) (citing
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Amazon.com, 239 F.3d at 1350-51 (Fed. Cir. 2001)).

If an

accused infringer raises a “substantial question” regarding
enforcement, infringement or validity that the patentee has not
shown lacks “substantial merit”, a preliminary injunction should
not issue.

Holmes Products Corp. v. Catalina Lighting, Inc., 67

F. Supp.2d 10, 12 (D. Mass. 1999) (citing New England Braiding
Co. v. A.W. Chesterton Co., 970 F.2d 878, 882–83 (Fed. Cir.
1992)).
Defendants contend that plaintiffs have not demonstrated a
likelihood of success on the merits because: 1) the asserted
claims are unpatentable under Section 101, 2) the asserted
claims are invalid as anticipated and/or obvious under Sections
102 and 103, 3) Oxford cannot overcome Qiagen’s written
description defense, and 4) Qiagen’s product does not infringe.
The arguments will be considered seriatim.
a.

Claims are unpatentable under Section 101

Federal law determines what inventions are patentable. See
35 U.S.C. § 101.

Elemental concepts such as “laws of nature,

natural phenomena, and abstract ideas” are excluded from Section
101’s protection. Diamond v. Diehr, 450 U.S. 175, 185 (1981).
The court applies a two-step process for determining
whether the subject matter of an invention is patentable. See

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Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct.
1289, 1293 (2012).
First, the court determines whether the patent claims are
“directed” to one of the patent-ineligible concepts. 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 directed to an eligible concept, the inquiry is over:
the claims are patentable. Thales Visionix Inc. v. United
States, 850 F.3d 1343, 1349 (Fed. Cir. 2017).
In step two, the court asks, “[w]hat else is there in the
claims before us?” Alice Corp. Pty. v. CLS Bank Int’l, 134 S.
Ct. 2347, 2355 (2014) (quoting Mayo, 132 S. Ct. at 1297).

The

invention is patentable if the claims contain an element or
combination of elements that is
sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the [ineligible
concept] itself.
Id. at 2358 (additional citation omitted).
At the preliminary injunction stage, the trial court “does
not resolve the validity question,” but rather considers the
persuasiveness of the challenger’s argument, recognizing that
not all evidence is available. See Titan Tire Corp. v. Case New
Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009).

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Defendants assert that the ‘898 Patent, Claim 17 is
unpatentable because it reflects the same natural peptides that
had been previously encountered by the T cells. Defendants rely
on deposition testimony of the inventor, Dr. Lalvani:
Q. In your assay, in whatever peptide you are using, does
that mean that one of the T cells that is activated has
already encountered that peptide before?
A. Yes.
Q. That would be a peptide that it has already encountered
naturally in the body, correct?
A. Yes.
This exchange, defendants contend, establishes that the
plaintiff’s claims in its complaint are not true and that the
claims are drawn to ineligible subject matter.

This Court

denied defendants’ motion to dismiss plaintiff’s “kit” claims,
reasoning that the kit peptides, as alleged, are “chemically
different than the naturally occurring amino acids in the ESAT-6
protein.”

Dr. Lalvani’s testimony, defendants contend,

vindicates the Magistrate Judge’s initial finding that the kit
peptides are found in nature and have not been changed beyond
the act of isolation from the larger ESAT-6.
Plaintiff counters that this exchange is presented out of
context, and that elsewhere Dr. Lalvani testified that the
relevant peptide is not naturally occurring.

Oxford explains

that the testimony quoted by defendants referred to whether, in
general, a synthesized peptide would react identically to a
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naturally occurring peptide of the same length and structure.
While plaintiff agrees that is true as a general proposition, it
contends the peptides used in Oxford’s patent do not occur
naturally.
This Court finds plaintiff’s explanation persuasive.
Dr. Lalvani identified an epitope that exists naturally in
the ESAT-6 protein.

He then synthesized a peptide that contains

that epitope and used the synthesized peptide in his
experiments.

Dr. Lalvani created something new with synthesized

peptides and simply because a particular peptide contains a
naturally occurring epitope that does not change this analysis.
See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133
S. Ct. 2107, 2119 (2013) (distinguishing unpatentable naturally
occurring DNA strands from patentable synthesized cDNA strands).
Discoveries that possess “markedly different
characteristics” from any entity found in nature may be
patented.

In re Roslin Inst. (Edinburgh), 750 F.3d 1333, 1336

(Fed. Cir. 2014) (quoting Diamond v. Chakrabarty, 447 U.S. 303,
310 (1980)).

It is likely that Oxford will be able to

demonstrate at trial that 1) Dr. Lalvani’s peptides are
synthesized and are “markedly different” from naturally
occurring peptides and 2) its discovery is the product of “human
ingenuity” and not merely “nature’s handiwork.” See Chakrabarty,
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750 F.3d at 309-310.

Whether or not Qiagen has raised a

“substantial question” as to the validity of Claim 17 of the
‘898 patent, Oxford’s response shows that this objection lacks
“substantial merit.” Holmes, 67 F. Supp.2d at 12 (additional
citation omitted).

Accordingly, plaintiff is likely to succeed

at trial on the merits of the Section 102 validity issue. See
Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1379
(Fed. Cir. 2009) (citing New England Braiding, 970 F.2d at 883).
Defendants further submit that claim 1 of the ‘211 patent,
also known as the “method” claim, is invalid because Oxford did
not create an inventive concept.

Defendant asserts that the

plaintiff’s allegations, upon which this Court relied in denying
the motion to dismiss, have proven to be false.

Those

allegations were 1) that plaintiff’s method improved on the
existing testing procedures for tuberculosis and 2) that there
was no in vitro diagnostic test for tuberculosis in common use
when plaintiff developed its test. Defendants dispute only the
latter claim.
This Court is not convinced by defendants’ common use
theory.

When Oxford applied for its patent the use of IGRAs was

not widespread. Less than one hundred IGRA test kits were sold
per year in the decade before plaintiff applied for its patent.

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Defendants have not raised a “substantial question” with respect
to the validity of the ‘211 patent under Section 101.
On the issue of validity under Section 101, plaintiff
appears likely to prevail on the merits.
b.

Claims are anticipated and/or obvious

Section 102(b) of the Patent Act provides that an invention
is not patentable if it is
described in a printed publication . . . more than one year
prior to the [application] date.
To prove invalidity by anticipation, the movant must show
that “every element and limitation of the claim” was described
in a single prior art reference, placing a person of ordinary
skill in possession of the invention. Sanofi–Synthelabo v.
Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008).
Differences between the prior art reference and claimed
invention, no matter how small, implicate obviousness, and not
anticipation. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d
1359, 1371 (Fed. Cir. 2008).
Pursuant to § 103 of the Patent Act, a patent is invalid
for obviousness if
the differences between the subject matter sought to be
patented and the prior art are such that the subject matter
as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the
art to which said subject matter pertains.

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35 U.S.C. § 103(a). See generally KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398 (2007).

A patent composed of several

elements is not obvious just because all of its elements were
known independently in the prior art. KSR Int’l Co., 550 U.S. at
418.
Defendants contend that plaintiff’s claims are invalid
because they are anticipated under Section 102 and obvious under
Section 103.

Specifically, they allege that two studies

(Melendez-Herrada 1997 and Pathan 1997) anticipate both asserted
claims.
Qiagen notes that several groups of researchers
investigated T-cell response to ESAT-6 peptides prior to
plaintiff’s priority date.

Although defendants have

demonstrated that some researchers were actively investigating
the development, they have not shown that the claimed invention
as a whole would have been obvious.

Even if those skilled in

the art were considering using ESAT-6, as defendants assert, it
does not follow that the development was obvious.
“Mere identification in the prior art of each element is
insufficient” to establish obviousness. Abbott Labs. v. Andrx
Pharms., Inc., 452 F.3d 1331, 1336 (Fed. Cir. 2006) (citing In
re Kahn, 441 F.3d 977, 986 (Fed. Cir. 2006)).

Instead, Qiagen

must articulate the reasons why one of ordinary skill in the art
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would have been motivated to select and combine the references.
See id.

It has failed to do so.

“Obvious to try” does not

constitute “obviousness” and this Court is reminded that when
determining obviousness it “must avoid hindsight bias and must
be cautious of arguments reliant upon ex post reasoning”. Arendi
S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1361 (Fed. Cir. 2016)
(citing KSR, 550 U.S. at 421) (internal quotation omitted).
Finally, this Court notes that Qiagen presented similar, if
not identical, arguments with respect to anticipation and
obviousness to the PTO during inter partes review.

The PTO did

not find those arguments meritorious.
Plaintiff is likely to prove that its patent claims were
not anticipated or obvious.
c.

Qiagen’s written description defense

To satisfy the written description requirement, the
patent’s description must “clearly allow persons of ordinary
skill in the art to recognize that [the inventor] invented what
is claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc) (quoting Vas–Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)) (internal
quotations omitted).

That is,

the test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed
subject matter as of the filing date.
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Id. (citing Vas–Cath, 935 F.2d at 1563).
Defendants maintain that Oxford’s claim, construed as
peptides “comprising SEQ ID. NO. 1” encompasses a genus of all
peptides comprising SEQ ID. NO. 1.

According to defendants, one

skilled in the art would not know whether a particular peptide
would be effective but that argument is unpersuasive.
First, the SEQ ID. NO. 1 designation constitutes a “common
structural feature” that satisfies the written description
requirement.

Second, the Court notes that the PTO reviewed

Oxford’s patents for adequate written description as part of the
application process and found the description satisfactorily
clear.
Plaintiff is likely to be successful in proving that its
patents are not invalid for a lack of written description.
d.

Qiagen’s product does not infringe

Defendants contend that the QFT-Plus does not infringe
Oxford’s patents.

First, they assert that the QFT-Plus does not

“diagnose” tuberculosis infection.

Second, they suggest that

the Markman order limits the phrase “peptide SEQ ID NO: 1” to a
specific 15 amino acid sequence, which the QFT-Plus does not
employ.

Finally, defendants request that this Court re-construe

the ‘898 patent.

Their arguments fall short.

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On the first issue, Qiagen’s claim that the QFT-Plus does
not actually “diagnose” is belied by the first page of its QFTPlus package insert which states that the product is “[f]or in
vitro diagnostic use.”

Second, the Markman order does not limit

Oxford’s patent to a single 15 amino acid sequence.
relevant construction includes analogues.

The

Finally, Qiagen

proffers no new evidence to justify altering the ‘898
construction.
Qiagen is not likely to be successful in avoiding Oxford’s
claims of infringement.
2. Irreparable Harm
Plaintiffs seeking injunctive relief must make a “clear
showing” that substantial and immediate irreparable harm is
“likely” in the absence of an injunction. Winter v. Nat. Res.
Def. Council, Inc., 555 U.S. 7, 22 (2008).

A mere showing that

the moving party “might lose some insubstantial market share as
a result of [the] infringement is not enough.” Apple, Inc. v.
Samsung Elecs. Co., 678 F.3d 1314, 1325 (Fed. Cir. 2012) (“Apple
I”).

Here, plaintiff has not made the required “clear showing”

of irreparable harm.
Plaintiff’s quintessential contention, both in briefing and
at oral argument, is that Oxford will suffer an irreparable
injury of lost customers if an injunction is not entered.
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Customers in the medical sector, Oxford explains, are “sticky”.
Oxford maintains that Qiagen will make a herculean effort to
entice customers to use its new product in the short time
remaining before trial.

Because the IFRA market has only two

suppliers, Oxford contends, every customer that Qiagen gains
will be at Oxford’s expense and that relationship is likely to
persist for years.

The alleged harm is not quantifiable and

therefore cannot be remedied by money damages.
Two major considerations stand is plaintiff’s way.
First, plaintiff’s motion has come at a conspicuously late
date in this litigation.

Oxford knew in January, 2017, that

Qiagen was about to apply for FDA approval of the QFT-Plus and
planned to launch the product in the second half of 2017.

It

waited until August 30, 2017, to file its motion for a
preliminary injunction and its explanation for the delay is
underwhelming.
Plaintiff contends that it waited this long because
defendant asked it to.

Such a contention is dubious.

In

response to plaintiff’s discovery inquiry, counsel for defendant
stated that
Qiagen does not know when or whether the QFT-Plus product
will be approved for sale in the United States. But it is
fair to say that the approval is not imminent.

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Plaintiff characterizes that statement as Qiagen “urg[ing]
Oxford to wait until FDA approval” before filing its motion for
preliminary injunction.

Such a reading is a stretch.

Oxford had reason to know in January, 2017, that the QFTPlus would be “rolled-out” in the second half of this year.

Its

delay until late August, 2017, counsels against its claim of
urgency.
Second and perhaps more important to the question of
irreparable harm, plaintiff has not established that money
damages would be insufficient.

“Evidence of potential lost

sales alone does not demonstrate irreparable harm.” Metalcraft
of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1368 (Fed.
Cir. 2017)(citing Abbott Labs., 452 F.3d at 1348 (Fed. Cir.
2006)).

Plaintiff must do more than demonstrate that it might

lose market share as a result of defendant’s infringement. Apple
I, 678 F.3d at 1325.

It must make a “clear showing that it is

at risk of irreparable harm.”

Apple Inc. v. Samsung Elecs. Co.,

695 F.3d 1370, 1374 (Fed. Cir. 2012) (“Apple II”) (quoting Apple
I, 678 F.3d at 1325) (emphasis added) (additional citations
omitted).

As the Supreme Court has explained,

Issuing a preliminary injunction based only on a
possibility of irreparable harm is inconsistent with our
characterization of injunctive relief as an extraordinary
remedy that may only be awarded upon a clear showing that
the plaintiff is entitled to such relief.
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Winter, 555 U.S. at 22 (citing Mazurek v. Armstrong, 520 U.S.
968, 972 (1997) (per curiam)).
If plaintiff prevails at trial, it is likely that the
infringing aspects of the QFT-Plus will be permanently enjoined.
Oxford does not proffer evidence of how, between now and the
trial, irreparable harm may occur.

In fact, its own financial

projections, such as its 2016 U.S. Commercial Strategy Revenue
Projection, forecast the anticipated monetary harm that an
infringing QFT-Plus product would cause.

To Oxford, it was

quantifiable.
Oxford may well lose some customers to Qiagen due to the
QFT-Plus and defendant’s assurances to the contrary are cold
comfort.

Qiagen’s “service/kit” contrast is a distinction

without a difference because both target the same TST customers
and Qiagen’s forecast that no customers would be gained for six
to twelve months fails to account for the inroads made before
then.

Nevertheless, Oxford has the burden of proving

irreparable harm with respect to its motion and it has failed to
make the “clear showing” that it is entitled to injunctive
relief.

See Apple II, 695 F.3d at 1374.

As a final matter, this Court rejects Qiagen’s causal nexus
arguments.

Defendants aver that the single-tube option is not

provided for in Oxford’s claims and therefore no “causal nexus”
between alleged infringement and harm exists.
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See Apple Inc. v.

Samsung Elecs. Co., 735 F.3d 1352, 1360 (Fed. Cir. 2013) (“Apple
III”) (citation omitted) (holding that to show irreparable harm
the patentee must demonstrate a “causal nexus between [the
defendant’s] infringement and the alleged harm” to the
patentee).

The Court finds that it is likely that Oxford will

be able to establish such a nexus.
A patentee need not demonstrate that a “patented feature is
the one and only reason for consumer demand.” Id. at 1364.
Rather, the patentee must show that an infringing feature
“drives consumer demand.” Apple II, 695 F.3d at 1375.

Oxford’s

use of specific peptides, present in Oxford’s claims, satisfies
the causal nexus.
Plaintiff’s shortcomings with respect to proof of
irreparable harm do not include its failure to demonstrate a
causal nexus.
Nevertheless, Oxford has not made a “clear showing” that
the launch of Qiagen’s QFT-Plus product with the single tube
option will cause immediate and long-term harm that cannot be
quantified and remedied by monetary damages.

Its delay in

bringing this motion impugns its claim of exigency.

More

importantly, its own internal analysis indicates that the harm
can be quantified and remedied by money damages.
This factor weighs in favor of defendant.
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3. Balance of Hardships
To assess the balance of hardships, the court weighs the
magnitude of the threatened injury to the patent holder,
considered in light of the strength of the success on the merits
showing, against the harm that a preliminary injunction may
inflict on the accused infringer. Holmes, 67 F. Supp. 2d at 14
(D. Mass. 1999) (citing H.H. Robertson, Co. v. United Steel
Deck, Inc., 820 F.2d 384, 390 (Fed. Cir. 1987)) (internal
quotations omitted).
Plaintiff alleges that the potential harm to it as a
relatively small, single product company is grave. The harm to
the defendant, plaintiff avers, is a non-critical monetary loss.
Defendant counters that it has invested substantial resources in
the QFT-Plus. In addition, it claims, little harm can befall
Oxford during the four months in question.
Oxford Immunotec is essentially a one-product company, with
that one product being the T-SPOT.TB test.

That product

accounted for more than 90% of Oxford’s total revenue of $86
million in 2016.
products.

Qiagen, in contrast, sells over 500 core

Approximately 10% of Qiagen’s one billion plus

revenue for 2016 resulted from sales of QuintiFERON products.
Defendants note that they are prioritizing the transition
of existing companies from their QFT-Gold product to their QFT-23-

Plus. This process will take six to twelve months, they explain,
during which time Oxford need not worry about Qiagen pursuing
the skin test market.

Although that may be Qiagen’s priority,

it does not follow that Qiagen will sit idly by as Oxford
pursues the skin test market.
If an injunction is imposed, Qiagen risks a four-month
delay in transitioning existing customers whereas, in the
absence of injunctive relief, Oxford risks the loss of a
substantial portion of the market for its single core
product.

Although the balance of harms, in this case, seems to

favor Oxford slightly, the scales are not so unbalanced as to
overcome the ultimate transitory nature of the potential harm to
Oxford.
4. Public Interest
Finally, the Court considers the impact of granting or
denying an injunction on the public interest.

In considering

this impact, the court “should focus on whether a critical
public interest would be injured by the grant of injunctive
relief.” Metalcraft, 848 F.3d at 1369.
Defendants stress that an injunction would remove a useful
tool from healthcare providers, harming the public
health.

Plaintiff relies on the public interest in patent

rights.

There are surely off-setting public interests at play
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in this case and thus it is not a controlling factor. See Hearst
Stations Inc. v. Aereo, Inc., 977 F. Supp. 2d 32, 41 (D. Mass.
2013) (explaining that “[w]here the public interest factors cut
both ways” this factor does not weigh heavily in the Court’s
analysis).
III. Conclusion
The several factors to be considered with respect to
granting a preliminary injunction do not weigh heavily in either
party’s favor in this case.

Therefore, because preliminary

injunctive relief is a “drastic and extraordinary remedy that is
not to be routinely granted,” Inverness Med. Switzerland GmbH v.
Acon Labs., Inc., 323 F. Supp. 2d 227, 234 (D. Mass. 2004)
(quoting Intel Corp. v. ULSI Sys. Tech., Inc., 995 F.2d 1566,
1568 (Fed. Cir. 1993)) (internal quotation omitted), it will not
be awarded here.

Plaintiff has not made the “clear showing”

necessary to entitle it to this extraordinary remedy. See
Winter, 555 U.S. at 22.

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ORDER
In accordance with the foregoing, plaintiff’s motion for
preliminary injunction (Docket No. 195) is DENIED.

So ordered.
/s/ Nathaniel M. Gorton_____d
Nathaniel M. Gorton
United States District Judge
Dated September 26, 2017

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