THE MEDICINES COMPANY v. EAGLE PHARMACEUTICALS, INC. et al

Filing 109

OPINION & ORDER denying 47 Motion to Dismiss the Amended Complaint, etc. Signed by Judge Stanley R. Chesler on 8/17/2016. (JB, )

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
:
THE MEDICINES COMPANY,
:
:
Plaintiff,
:
:
v.
:
:
EAGLE PHARMACEUTICALS, INC. et al.:
:
Defendants.
:
:

Civil Action No. 16-569 (SRC)

OPINION & ORDER

CHESLER, U.S.D.J.
This matter comes before this Court on the motion to dismiss the Amended Complaint for
failure to state a valid claim for relief, pursuant to Federal Rule of Civil Procedure 12(b)(6), by
Defendants Eagle Pharmaceuticals, Inc. (“Eagle”), Scidose LLC, and Therdose Pharma PVT.
LTD. (collectively, “Defendants”). For the reasons stated below, the motion will be denied.
This case arises from a dispute between pharmaceutical companies related to a
medication, bivalirudin. In brief, the Amended Complaint alleges that the parties entered into
the “Development Agreement” with the goal of developing a ready-to-use (“RTU”) formulation
of Plaintiff’s bivalirudin product, Angiomax®. Two patents issued from the development
program, U.S. Patent Nos. 7,713,928 and 7,803,762 (the “Patents at issue.”) The Amended
Complaint alleges that Defendants terminated the Development Agreement and misappropriated
the program’s intellectual property; Eagle filed a patent application for a RTU bivalirudin
product. The Amended Complaint asserts seventeen claims: 1 and 2) patent infringement; 3)
declaratory judgment of patent ownership; 4) breach of contract; 5) conversion; 6)
misappropriation of intellectual property; 7) unjust enrichment; 8) constructive trust; 9) federal

trademark infringement; 10) false designation of origin and unfair competition under the Lanham
Act; 11) common law unfair competition; 12) unfair competition under New Jersey law; 13)
common law trademark infringement; 14) common law unfair and deceptive acts; 15) federal
dilution; 16) New Jersey state law dilution and injury to business reputation; and 17) tortious
interference with contract and prospective economic advantage.
Defendants moved to dismiss every claim in the Amended Complaint. Subsequently, the
parties stipulated to the dismissal of Counts 9, 10, and 12 through 16, as well as the withdrawal
of one allegation from Count 11. (Docket Entry No. 80.) Therefore, as to Counts 9, 10, and 12
through 16, the motion to dismiss will be denied as moot.
Defendants’ motion to dismiss must be denied in largest part because it relies on factual
matters extrinsic to the Amended Complaint. As a matter of black-letter law in the Third Circuit,
“a district court ruling on a motion to dismiss may not consider matters extraneous to the
pleadings.” In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997). On a
motion to dismiss, the Court “must accept all factual allegations in the complaint as true,
construe the complaint in the light favorable to the plaintiff, and ultimately determine whether
plaintiff may be entitled to relief under any reasonable reading of the complaint.” Mayer v.
Belichick, 605 F.3d 223, 229 (3d Cir. 2010). A movant cannot prevail on a motion to dismiss by
asserting that the true facts are not as alleged in the Complaint.
Defendants move to dismiss the claims for infringement of the two Patents at issue,
Counts 1 and 2, on two grounds: 1) 35 U.S.C. § 271(e)(2) applies only to patents listed in the
Orange Book, and these are not; and 2) a joint owner of a patent cannot infringe it.
As to the Orange Book argument, the Amended Complaint alleges that Eagle has
submitted an NDA under section 505(b)(2) of the FDCA, seeking approval for a bivalirudin
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product. The relevant statute, 35 U.S.C. § 271(e)(2), states:
It shall be an act of infringement to submit-(A) an application under section 505(j) of the Federal Food, Drug, and
Cosmetic Act [21 USCS § 355(j)] or described in section 505(b)(2) of such Act
[21 USCS § 355(b)(2)] for a drug claimed in a patent or the use of which is
claimed in a patent . . .
Defendants argue that the Amended Complaint does not allege sufficient facts to give this Court
subject matter jurisdiction under 35 U.S.C. § 271(e)(2). This does not appear to be correct. The
Amended Complaint alleges that Plaintiff co-owns two patents and that Eagle submitted an NDA
under section 505(b)(2) for a drug claimed in those patents. Section 271(e)(2)(A) does not
require more. This is sufficient to give this Court subject matter jurisdiction for the claims of
patent infringement.
Defendants quote out of context the only Federal Circuit decision cited, AstraZeneca
Pharms. LP v. Apotex Corp., 669 F.3d 1370, 1377 (Fed. Cir. 2012), which, contrary to
Defendants’ assertions, holds: “the requirements for jurisdiction in the district courts are met
once a patent owner alleges that another’s filing of an ANDA infringes its patent under §
271(e)(2), and this threshold jurisdictional determination does not depend on the ultimate merits
of the claims.” The Amended Complaint meets the jurisdictional requirements of AstraZeneca.1
Defendants next argue that the patent infringement claims are invalid because a joint
owner of a patent cannot infringe it. In opposition, Plaintiff argues that it is an exclusive
licensee of the jointly owned patents under the Development Agreement, and that an exclusive

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Defendants also cite two district court cases, Eisai Co. v. Mut. Pharm. Co., No. CIV.A.
06-3613(HAA), 2007 WL 4556958, at *12 (D.N.J. Dec. 20, 2007) and Novo Nordisk Inc. v.
Mylan Pharm. Inc., No. CIV A 09-2445 FLW, 2010 WL 1372437, at *10 (D.N.J. Mar. 31,
2010). These decisions were issued prior to AstraZeneca, and appear to run contrary to its
guidance. Defendants have not shown that the Federal Circuit has agreed to “read a Paragraph
IV requirement into § 271(e)(2).” Eisai, 2007 WL 4556958 at *12.
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licensee may sue a patentee/infringer, citing Textile Prods. v. Mead Corp., 134 F.3d 1481, 1484
(Fed. Cir. 1998). In reply, Defendants appear to concede this point, but argue that the exclusive
license did not survive the termination of the Development Agreement. This is both extraneous
to the Amended Complaint and a legal conclusion. The Amended Complaint alleges that Eagle
terminated the Development Agreement and that Plaintiff remains the exclusive licensee of the
patents. At this juncture, this Court accepts these assertions as true and leaves their proof to
summary judgment or trial. As to Counts 1 and 2, the motion to dismiss will be denied.
Defendants contend that the claims based on contractual rights, Counts 3 through 8, fail
to state any valid claim for relief on two grounds: 1) the Amended Complaint fails to plead due
performance; and 2) collateral estoppel, due to an arbitration award. Having asserted the first
point, Defendants then admit that the Amended Complaint does, in fact, plead due performance,
but contends that the allegation is false. As already explained, on a motion to dismiss, the wellpleaded factual allegations are taken as true. Arguments contesting the facts of performance and
breach may succeed on summary judgment, but not now. Similarly, the alleged arbitration
award is entirely extraneous to the Amended Complaint and will not be considered on this
motion.
Defendants also argue that Counts 5 through 8, for conversion, misappropriation, unjust
enrichment and constructive trust, are duplicative of the claim for breach of contract. In
opposition, Plaintiff points out correctly that Federal Rule of Civil Procedure 8(d)(2) allows
pleading in the alternative. These claims are alternative to the contract claims; they do not
duplicate them.
As to Counts 3 through 8, the motion to dismiss will be denied.
Defendants originally moved to dismiss several claims, including the unfair competition
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claims, Counts 10 and 11, with an argument targeting the trademark infringement elements of
these claims. The parties subsequently stipulated to the dismissal of Counts 9, 10, and 12
through 16, as well as the withdrawal of one allegation of trademark infringement from Count
11. Having carved out and dismissed the trademark infringement issues, Defendants’ argument
for dismissal of Count 11 no longer applies, and the motion to dismiss Count 11 will be denied.
Lastly, Defendants move to dismiss Count 17, the tortious interference claim, with the
argument that the allegation about the terms of the supply agreement, paragraph 100 of the
Amended Complaint, is false. As discussed, at this juncture, the well-pleaded allegations in the
Amended Complaint are taken as true, and the motion to dismiss on this point will be denied.
For these reasons,
IT IS on this 17th day of August, 2016
ORDERED that Defendants’ motion to dismiss the Amended Complaint (Docket Entry
No. 47) is DENIED.

s/ Stanley R. Chesler
STANLEY R. CHESLER, U.S.D.J.

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