United States District Court, D. Delaware
BAYER INTELLECTUAL PROPERTY GMBH, BAYER ANIMAL HEALTH GMBH, and BAYER HEALTHCARE, LLC, Plaintiffs,
CAP IM SUPPLY, INC., Defendant.
Blumenfeld, MORRIS, NICHOLS, ARSHT & TUNNELL LLP,
Wilmington, DE; Gary H. Levin (argued), Stephanie M.
Papastephanou, Timothy J. Doyle, and Samuel A. McMahon, BAKER
HOSTETLER LLP, Philadelphia, PA; Irene E. Hudson, BAKER
HOSTETLER LLP, New York, NY. Attorneys for Plaintiffs
W. Shaw, Karen E. Keller (argued), and David M. Fry, SHAW
KELLER LLP, Wilmington, DE. Attorneys for Defendant.
ANDREWS, U.S. DISTRICT COURT JUDGE:
before the Court are Plaintiffs' motion for preliminary
injunction (D.I. 6), and Defendant's cross-motion for
summary judgment of non-infringement (D.I. 58), and
Defendant's motion to strike (D.I. 96) both the
declaration of Dr. Alan White (D.I. 81) and Plaintiffs'
reply brief in support of their motion for preliminary
injunction (D.I. 78). The issues have been fully briefed.
(D.I. 7, 59, 78). The Court held oral argument on February
23, 2018. (D.I. 115). For the reasons stated herein,
Plaintiffs' motion for preliminary injunction and
Defendant's cross-motion for summary judgment are
Plaintiffs assert U.S. Patent No. 7, 728, 011 ("the
'Oil patent), which issued on June 1, 2010, and covers
spot-on solutions for controlling fleas, ticks, and
mosquitoes on animals. (D.I. 7, p. 1). Claim 1 of the
'011 patent reads as follows:
1. A composition for controlling parasites on an animal
a. from about 35% to about 60% by weight of permethrin;
b. from about 2.5% to about 12.5% by weight of imidacloprid
or an analog;
c. from about 27.5% to about 62.5% by weight of
d. from 0% to about 5% by weight of water;
e. from 0% to about 0.5% by weight of phenolic antioxidants;
f. from 0% to about 0.5% by weight of at least one organic
('011 patent, claim 1). Plaintiffs' K9
Advantix®II product embodies the '011 patent. (D.I.
7, p. 1). Its active ingredients are imidacloprid,
permethrin, and pyriproxyfen, all of which are dissolved in
the solvent N-methylpyrrolidone ("NMP").
(Id.). Plaintiffs distribute K9 Advantix®II in
veterinary clinics and the pet specialty channel, which
includes large pet-specialty retailers. (Id.).
2014, Defendant began developing the accused products, which
contain the same active ingredients as K9 Advantix®II.
(D.I. 59, p. 2). The accused products' active ingredients
are dissolved in a mixture of NMP and another solvent,
dimethyl sulfoxide ("DMSO"). (Id.).
Specifically, Defendant's Advecta™3 product
contains 45.02% by weight permethrin; 8.80% by weight
imidacloprid; 36.35% of an NMP/DMSO mixture, namely: 18.88%
by weight NMP and 17.47% by weight DMSO; 0.39% by weight
water, 0.11% by weight BHT (a phenolic antioxidant); and
0.03% by weight citric acid (an organic acid). (D.I. 7, p.
April 2015, Defendant provided Plaintiffs with descriptions
of the formulations of two of the accused products. (D.I. 60
at 13-14). Plaintiffs' August 19, 2015, response
indicated that Plaintiffs could not assess infringement at
that time, and could not do so until Defendant's
formulations received marketing approval. (Id. at
14). In October 2015, Defendant sent a response letter taking
the position that market approval is not necessary to assess
infringement. (Id.). Though Defendant sent follow-up
letters in December 2015 and June 2016, Defendant received no
substantive response from Plaintiffs until September 15,
2016, when Plaintiffs sent Defendant a notice letter
asserting that Defendant's products may infringe the
'011 patent. (Id; D.I. 63-4 at 50). Defendant
replied by letter on September 28, 2016, denying infringement
and offering to discuss the matter further. (Id. at
51-52). On October 28, 2016, Plaintiffs replied, seeking
compensation for Defendant's use of Plaintiffs' data
to obtain EPA registration for its products, but making no
mention of infringement. (Id. at 53-54). Defendant
launched the accused products in January 2017. (D.I. 59, p.
3). Plaintiffs purchased two boxes of Defendant's
Advecta™3 product on January 30, 2017, for testing by a
third party. (D.I. 9, ¶¶ 3-5). The preliminary
results were provided to Plaintiffs on March 7, 2017 (D.I.
10, ¶ 20), and the final results were completed on April
20, 2017 (D.I. 78, p. 19). Plaintiffs filed their complaint
on May 22, 2017 (D.I. 1), and filed this motion approximately
two weeks later on June 5, 2017 (D.I. 6).
spot-on product market comprises multiple generic and branded
competitors and products, such as Bayer's K9
Advantix®II product, Frontline's fipronil product,
and Sergeant's fipronil generics. (D.I. 115 at
21:15-22:23; D.I. 63-9 at 63-64, 78). As of June 2017, the
entire spot-on product market was declining, due in part to
customer migration to flea and tick products with other modes
of administration, such as orally-administered products.
(D.I. 115 at 20:23-21:1, 51:2-5; D.I. 63-9 at 76).
court shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law."
Fed.R.Civ.P. 56(a). The moving party has the initial burden
of proving the absence of a genuinely disputed material fact
relative to the claims in question. Celotex Corp. v.
Catrett, 477 U.S. 317, 330 (1986). Material facts are
those "that could affect the outcome" of the
proceeding, and "a dispute about a material fact is
'genuine' if the evidence is sufficient to permit a
reasonable jury to return a verdict for the nonmoving
party." Lamont v. New Jersey, 637 F.3d 177, 181
(3d Cir. 2011) (quoting Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986)).
to 35 U.S.C. § 283, a court in a patent case "may
grant injunctions in accordance with the principles of equity
to prevent the violation of any right secured by patent, on
such terms as the court deems reasonable." 35 U.S.C.
§ 283. "The grant or denial of a preliminary
injunction under 35 U.S.C. § 283 is within the sound
discretion of the district court." Abbott Labs. v.
Andrx Pharm., Inc.,452 F.3d 1331, 1334 (Fed. Cir.
2006). The Federal Circuit has "cautioned, however, that
a preliminary injunction is a drastic and extraordinary