United States District Court, D. Delaware
WATERS CORPORATION AND WATERS TECHNOLOGIES CORPORATION, Plaintiffs,
AGILENT TECHNOLOGIES INC., Defendant.
L. Pascale, Robert M. Vrana, Young Conaway Stargatt &
Taylor LLP, Wilmington, DE; Matthew M. Wolf, David McMullen,
Jennifer A. Sklenar, Katie J.L. Scott, Arnold & Porter
Kaye Scholer LLP – attorneys for Plaintiffs.
M. Shandler, Travis S. Hunter, Richards, Layton & Finger,
P.A., Wilmington, DE; Anne Elise Herold Li, James K.
Stronski, Mark Jansen, Molly Jones, Chiemi Suzuki, Crowell
& Moring LLP – attorneys for Defendants September
20, 2019 Wilmington, Delaware
NOREIKA, U.S. DISTRICT JUDGE:
before the Court is the motion of Plaintiffs Waters
Corporation and Waters Technologies Corporation
(collectively, “Plaintiffs” or
“Waters”) for preliminary injunction seeking to
enjoin Defendant “Agilent [Technologies Inc.
(“Defendant” or “Agilent”)] and their
officers, partners, agents, servants, employees, parents,
subsidiaries, divisions, affiliate corporations, other
related business entities and all other persons acting in
concert, participation, or in privity with them” from
“any commercial manufacture, use, offer to sell, or
sale within the United States, or importation into the United
States, of the InstantPC glycan reagent, and any product that
is similar to or only colorably different from that
product.” (D.I. 7). Defendant opposes the motion. (D.I.
18). The Court has reviewed the briefing, declarations and
exhibits (e.g., D.I. 7, 8, 9, 10, 11, 12, 13, 18,
19, 20, 21, 23, 24, 27, 36, 37, 38, 41, 71, 72, 73, 77, 78,
81) and held oral argument on December 21, 2018. For the
reasons set forth below, the Court DENIES Plaintiffs’
motion. This opinion constitutes the Court’s findings
of fact and conclusions of law pursuant to Federal Rule of
Civil Procedure 52(a).
develop “analytical solutions . . . to support its
customers’ scientific discoveries, operations,
performance, and regulatory compliance.” (D.I. 12 at
¶ 8). In particular, Plaintiffs sell the
“GlycoWorks RapiFluor-MS N-Glycan Kit”
(“GlycoWorks Kit”) which they assert
“enables unprecedented fluorescent and mass
spectrometric performance for glycan detection while also
improving the speed and simplicity of N-glycan sample
preparation.” (D.I. 8 at 3 (citing D.I. 12 at
¶¶ 10-11)). The chemical structure of the labeling
reagent in the GlycoWorks Kit is (D.I. 13 at ¶ 16):
GlycoWorks kits make up approximately 75 to 80% of the market
for such products. (D.I. 11 at ¶ 8; D.I. 12 at ¶
14). Plaintiffs also sell mass spectrometry reagents and
instruments to be used in conjunction with the Glyco Works
Kit. (D.I. 12 at ¶ 11).
through its 2018 acquisition of a company called ProZyme,
manufactures products containing InstantPC glycan reagents,
which like the GlycoWorks Kit, are used to assist in the
detection and labeling of compounds, including for
identification of glycosylated proteins during the
development of biopharmaceuticals or biologies. (D.I. 18 at
4). The chemical structure of the labeling reagent in
InstantPC is (Id.; see also D.I. 19 at¶10):
announced its development of InstantPC in May of 2015,
began selling InstantPC in October of 2015. (D.I. 19 at
¶¶ 10, 14). As of December of 2018, ProZyme's
InstantPC reagent products had approximately 20 to 25% of the
market. (D.I. 11 at ¶ 8; D.I. 12 at ¶ 14).
Defendant sells mass spectrometry reagents and instruments,
which according to Plaintiffs will be marketed and used in
conjunction with InstantPC. (See D.I. 12 at
January 14, 2013, Plaintiffs obtained the exclusive license
(“Patent License Agreement”) to U.S. Patent No.
9, 658, 234 (“the ’234
Patent”) from Ajinomoto Co., Inc.
(“Ajinomoto”) of Tokyo, Japan. (Id. at
¶ 13). The ‘234 Patent, a continuation of patent
applications filed by Ajinomoto, issued on May 23, 2017.
(D.I. 8 at 4). On August 7, 2018, Ajinomoto assigned its
rights and interests in the ’234 Patent to Waters
Technologies Corporation. (D.I. 8 at 4). On September 18,
2018, Plaintiffs filed this patent infringement action,
alleging infringement of the ’234 patent by Agilent
“via the manufacture, use, sale, offer to sell,
exportation, and/or importation, in whole or in part, of
Agilent’s InstantPC reagent.” (D.I. 1 at ¶
injunctive relief is an “extraordinary” remedy
appropriate only in “limited circumstances.”
Kos Pharm., Inc. v. Andrx Corp., 369 F.3d 700, 708
(3d Cir. 2004); see also Intel Corp. v. ULSI Sys. Tech.,
Inc., 995 F.2d 1566, 1568 (Fed. Cir. 1993) (“[A]
preliminary injunction is a drastic and extraordinary remedy
that is not to be routinely granted.”). A preliminary
injunction may be granted only if the moving party shows (1)
a likelihood of success on the merits, (2) irreparable harm
is likely if an injunction is not granted, (3) the balance of
equities tips in favor of the moving party, and (4) an
injunction is in the public interest. See Winter v. Nat.
Res. Def. Council, Inc., 555 U.S. 7, 20 (2008); see
also Osorio-Martinez v. Attorney Gen. United States of
Am., 893 F.3d 153, 178 (3d Cir. 2018); Altana Pharma
AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1005 (Fed.
Cir. 2009). “These factors, taken individually, are not
dispositive; rather, the district court must weigh and
measure each factor against the other factors and against the
form and magnitude of the relief requested.”
Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1451
(Fed. Cir. 1988). The Court, however, cannot grant a
preliminary injunction unless the moving party establishes
both a likelihood of success on the
merits and the existence of irreparable harm without the
injunctive relief. Amazon.com, Inc. v.
Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir.
2001). “[A]ll findings of fact and conclusions of law
at the preliminary injunction stage are subject to change
upon the ultimate trial on the merits.” Purdue
Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359,
1363 (Fed. Cir. 2001).
assert that “Agilent is infringing several claims of
the ’234 Patent, ” but for purposes of its
motion, it has focused on “independent claims 1 and
6.” (D.I. 8 at 7). The Court begins its analysis by
addressing the first preliminary injunction factor –
i.e., likelihood of success on the merits – in
the context of the asserted claims and defenses.
Likelihood of Success
regard to the first factor – establishing a likelihood
of success on the merits – the patentee seeking a
preliminary injunction in a patent infringement suit must
show that it will likely prove infringement, and that it will
likely withstand challenges, if any, to the validity of the
patent.” Titan Tire Corp. v. Case New Holland,
Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009); see also
Amazon.com, 239 F.3d at 1350. In evaluating whether
Plaintiffs are likely to succeed in proving infringement of
the asserted claims, the Court employs the same two-step
process used to determine infringement on summary judgment or
at trial. See Oakley, Inc. v. Sunglass Hut
Int’l, 316 F.3d 1331, 1339 (Fed. Cir. 2003).
First, the Court must determine the meaning and scope of the
asserted claims. Markman v. Westview Instruments,
Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), affd,
517 U.S. 370 (1996). Second, the Court must compare the
accused product (InstantPC glycan reagent) to the claims as
properly construed. Id. Similarly, in assessing
whether Plaintiffs are likely to withstand validity
challenges involving prior art, the Court compares the
asserted claims as construed to the asserted prior art.
See Oakley, 316 F.3d at 1339. The Court should not
grant a preliminary injunction if Defendant “raises a
substantial question concerning either infringement or
validity.” Amazon.com, 239 F.3d at 1350;
see also Tate Access Floors, Inc. v. Interface
Architectural Res., Inc., 279 F.3d 1357, 1365 (Fed. Cir.
2002) (“substantial question” means assertion of
a defense that patentee cannot prove “lacks substantial
’234 Patent, titled “Method For Analysis Of
Compounds With Amino Group And Analytical Reagent Therefor,
” is generally directed to carbamate compounds and
methods of labeling and analysis with those compounds, which
can be used for N-glycan detection. See ’234
Patent at 1:22-30. According to Plaintiffs’ expert:
carbamate compounds have a strong fluorescent signal due to
an aromatic carbocyclic or heterocyclic group, a strong mass
spectrometry signal due to an electronically isolated amino
group, and readily react with nitrogen-containing compounds,
such as amino acids and proteins. Thus, the claimed carbamate
compounds can be used for improved N-glycan labeling,
detection, and analysis, including with mass spectrometry.
(D.I. 13 at ¶ 21).
claims 1 and 6 of the ’234 Patent recite, in pertinent
part (D.I. 1, Ex. A):
A carbamate compound represented by formula (1):
Ar is an aromatic carbocyclic group or an aromatic
heterocyclic group residue, wherein said aromatic carbocyclic
group or said aromatic heterocyclic group residue has a
in the bond between Ar and the nitrogen atom of the carbamate
group, a carbon atom within the ring of Ar is bound to the
nitrogen atom of the carbamate group, a carbon atom within
the ring of Ar is bound to the nitrogen atom of the carbamate
group, whereby said carbamate compound may be in a form of a
said substituent contains a sulfonic acid group, a phosphoric
acid group, a guanidyl group, a dialkylamino ...