United States District Court, D. Delaware
NOVEL DRUG SOLUTIONS, LLC and EYE CARE NORTHWEST, PA, Plaintiffs,
IMPRIMIS PHARMACEUTICALS, INC., Defendant.
G. Kraman, Esquire: Young Conaway, Stargatt & Taylor,
LLP, Wilmington, DE; Charles X. Gormally, Esquire, Paul M.
Bishop, Esquire: Brach EiCHLER LLC, Roseland, N.J. -attorneys
for Plaintiffs Novel Drug Solutions, LLC and Eye Care
Michael P. Kelly, Esquire, Daniel M. Silver, Esquire, Dawn
Kurtz Crompton, Esquire: McCarter & English, LLP,
Wilmington, DE - attorneys for Defendant Imprimis
NOREIKA, U.S. DISTRICT JUDGE
April 11, 2018, Novel Drug Solutions, LLC and Eye Care
Northwest (jointly "Plaintiffs") commenced this
action alleging that, pursuant to the Asset Purchase
Agreement ("APA") entered by the parties, Imprimis
Pharmaceuticals, Inc. ("Defendant" or
"Imprimis") owes Plaintiffs royalty payments for,
and financial information pertaining to, an injectable
compounded pharmaceutical formulation called DropLess, as
well as topical formulation called LessDrops." (D.I. 1;
D.I. 23 at 1). On June 29, 2018, Imprimis, moved to dismiss
Counts One and Three of the Complaint. (D.I. 9). Count One
sought declaratory judgment that Imprimis owes royalties on
the sales of LessDrops under the APA and Count Three alleged
breach of the APA for failure to pay required royalties.
11, 2018, Plaintiffs filed their First Amended Complaint
(D.I. 12) (the "Amended Complaint") adding
"Factual Allegations" in support of the claims as
well as Count Six for fraudulent inducement. The parties
agreed that the filing of the Amended Complaint mooted the
original motion to dismiss. (D.I. 15).
the Court is Defendant's motion to dismiss Counts One and
Three of the Amended Complaint pursuant to Rule 12(b)(6) of
the Federal Rules of Civil Procedure. (D.I. 17).
entered the APA, dated August 8, 2013, with Plaintiffs. (D.I.
12 at ¶ 13; D.I. 18 at 3). Plaintiffs allege that
Imprimis drafted the APA. (D.I. 12 at ¶ 13). By its
terms, the APA is governed by Delaware law. (D.I. 18, Ex. A
at § 9.5).Pursuant to the APA, Imprimis acquired
certain assets, including technology and intellectual
property, pertaining to a poloxamer technology. (D.I. 12 at
¶ 13). The acquired assets ("Assets")
included, inter alia, the injectable DropLess
formulation, as well as "all formulae, data,
information, results of experimentation and testing, and
other know-how," as well as "all intellectual
property rights" relating thereto. (D.I. 18, Ex. A at
§ 1.2; D.I. 18 at 3). The APA also requires that
Imprimis pay a royalty on any "Product". (D.I. 12
at ¶ 14, 15; D.I. 18, Ex. A at § 5.1).
"Product" is defined as:
any product, in any form or formulation, of an injectable
ophthalmological pharmaceutical composition, the composition
comprising at least one therapeutically effective
quantity of an anti-bacterial agent, at least one
therapeutically effective quantity of an
anti-inflammatory agent, at least one
pharmaceutical, acceptable excipient and at least
one pharmaceutical, acceptable carrier appropriate for
intraocular or intravitreal injection, in each case for
use in the prevention or treatment of any ophthalmic disease
(D.I. 12 at ¶ 15; D.I. 18, Ex. A at § 1.16)
(emphasis added). No. definition or description of "an
injectable ophthalmological pharmaceutical composition"
is provided in the APA other than the language specifying
that such a composition must comprise at least the
above-referenced agents, excipient and carrier.
execution of the APA, Imprimis began commercializing the
DropLess formulation, which all parties agree is an
injectable compounded eye medication. (D.I. 18 at 4; D.I. 12
at ¶ 18). Imprimis also produced a product line called
"LessDrops," a "topical eye drop" (D.I.
12 at ¶ 19) which is "sold for non-injectable,
topical use." (D.I. 12 at ¶24). Plaintiffs allege
that "[b]oth DropLess and LessDrops are derived from
Plaintiffs' invention" (D.I. 12 at ¶23), and
that Plaintiffs have not received royalty payments for
LessDrops "despite the fact that the LessDrops products
are identical formulations to the DropLess products."
(D.I. 12 at ¶ 25).
also allege that LessDrops, while sold for topical use,
"has been injected by doctors into patients" and
"found to be curative and successful in improving medial
difficulty." (D.I. 12 at ¶ 24). Plaintiffs further
add that "[u]pon information and belief, numerous
surgeons have inadvertently injected LessDrops into eye
tissue without consequence and have been assured by Imprimis
that the formulations are identical to DropLess."
(Id.). Thus, according to Plaintiffs, LessDrops
is "appropriate for intraocular or intravitreal
injection" and falls within the definition of Product in