IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

HELSINN HEALTHCARE S.A. and

ROCHE PALO ALTO LLC,
Plaintiffs,
V.

CIPLA LTD., CIPLA USA, INC.,

EUROHEALTH INTERNATIONAL SARL,
WEST-WARD PHARMACEUTICAL CORP.,
and MYLAN INSTITUTIONAL LLC,
Defendants.

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Civil Action No. 13-688-GMS

CONSOLIDATED

ORDER

WHEREAS, on April 6, 2013, plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto
LLC (collectively, "the Plaintiffs") initiated the instant patent infringement lawsuit. (D.I. 1.)
The Plaintiffs own numerous patents related to the brand-name drug Aloxi. On July 11, 2014,
the Plaintiffs amended their complaint to include defendants Cipla Ltd. and Cipla USA
(collectively, "Cipla"), after Cipla submitted an Abbreviated New Drug Application ("ANDA")
with the FDA, seeking permission to market a generic version of Aloxi (D.I. 68);
WHEREAS, among the patents associated with Aloxi are U.S. Patent Nos. 7,947,724
("the '724 Patent") and 7,947,725 ("the '725 Patent"). The Plaintiffs did not assert the '724 and
'725 Patents against Cipla in this litigation. On June 4, 2014, the Plaintiffs granted Cipla a
covenant not to sue for infringement of the '724 and '725 Patents (D.I. 81, Amended
Counterclaims,~

69);

WHEREAS, on August 18, 2014, Cipla filed an amended answer and asserted, inter alia,
two counterclaims seeking declaratory judgment of noninfringement of the '724 and '725 Patents
("First and Second Counterclaims") (D.I. 81);
WHEREAS, on October 17, 2014, the Plaintiffs filed the instant Motion to Dismiss
Cipla's First and Second Counterclaims for Lack of Subject Matter Jurisdiction. (D.I. 100.) The
Plaintiffs contend that there is no subject matter jurisdiction over the counterclaims because there
is no "case or controversy" requiring adjudication. Specifically, the Plaintiffs explain that Cipla
provided a Paragraph III certification relating to U.S. Patent No. 5,202,333 ("the '333 Patent"),
thus preventing Cipla from entering the market until October 13, 2015, at the earliest (when the
'333 Patent expires). Therefore, because the '724 and '725 Patents were not asserted against
Cipla and Cipla is not in a position to go to market currently, the Plaintiffs maintain that there is
not subject matter jurisdiction over the First and Second Counterclaims;
WHEREAS, Cipla responded on November 17, 2014, arguing that standing is created by
virtue of earlier ANDA filers. (D.I. 112.) There is parallel Aloxi litigation presently ongoing in
the District of New Jersey involving these earlier ANDA filers, who would be entitled to a
180-day period of exclusivity to market a generic version of Aloxi.

See 21 U.S.C.

355G)(5)(B)(iv). Should the early ANDA filers fail in that litigation, they would be prevented
from marketed generic Aloxi until 2024, when the '724 and '725 Patents expire. The 180-day
exclusivity would remain, however, and Cipla would also have to wait until 2024. Thus, Cipla
argues the specific factual circumstances of this case suffice to create an injury for the purpose of
satisfying subject matter jurisdiction;
WHEREAS, having considered the party's positions as set forth in their papers, the
pleadings, as well as the applicable law;

IT IS HEREBY ORDERED THAT:

The Plaintiffs' Motion to Dismiss Cipla's First and Second Counterclaims for
Lack of Subject Matter Jurisdiction (D.I. 100) is GRANTED without prejudice. 1

Dated: January

k, 201.S

Article III of the Constitution requires that the federal courts only exercise jurisdiction where an actual
case or controversy exists. U.S. Const. art. III. This is true for all causes of actions, including those for declaratory
judgment. See Frasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1335 (Fed. Cir. 2008). "[T]he dispute must
be definite and concrete, touching the legal relations of parties having adverse legal interests .... " Id. at 1335-36
(internal quotation marks omitted). In the ANDA-litigation context, there is cognizable injury to a generic drug
manufacturer when it is "restrain[ed from] the free exploitation of non-infringing goods." Caraco Pharm. Labs., Ltd.
v. Forest Labs., Inc., 527 F.3d 1278, 1292 (Fed. Cir. 2008) (alteration in original). The inclusion of "noninfringing" in this statement is key, however. Where the generic company accepts the "validity, infringement, and
enforceability" of a drug patent, there is no injury giving rise to a case or controversy. See Janssen Pharm., NV v.
Apotex, Inc., 540 F.3d 1353, 1361 (Fed. Cir. 2008) (finding that the generic defendant's "harm ... ceased to exist
once Apotex stipulated to the validity, infringement, and enforceability'' of the patent).
Here, Cipla's Paragraph III certification concerning the '333 Patent functions the same as a stipulation
because it effectively provides consent to a delay until "the date on which [the] patent will expire." 21 U.S.C.
355(b)(2)(A)(iii); see also Apotex Inc. v. Eisai Inc., No. 1:09CV477, 2010 WL 3420470, at 10-11 & n.4 (M.D.N.C.
Aug. 27, 2010) ("[F]iling a Paragraph III certification to a patent is done for the purposes of declaring, and serves as
recognition of the fact, that the patent is valid and enforceable." (citing Jannsen, 540 F.3d at 1358)). Because the
Plaintiffs never asserted the '724 and '725 Patents against Cipla, these patents cannot yet be considered responsible
for restraining Cipla's "exploitation of non-infringing goods," at least until after the expiration of the '333 Patent.
See Caraco, 527 F.3d at 1292.
The court is cognizant of Cipla' s concern that the Plaintiff's litigation tactics may prevent Cipla from going
to market until sometime in 2024, after the early ANDA filers' market exclusivity period. But this does not generate
standing for Cipla to challenge the '724 and '725 Patents at this time, when Cipla is concededly not in a position to
go to market until after the expiration of the '333 Patent. Subject matter jurisdiction must exist at all stages of
litigation. See Benitec Aust/., Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344 (Fed. Cir. 2007); Int'/ Med. Prosthetics
Research Assocs., Inc. v. Gore Enter. Holdings, Inc., 787 F.2d 572, 575 (Fed. Cir. 1986). Thus, Cipla's judicial
economy arguments also fail. The court will permit Cipla to refile its counterclaims after expiration of the '333
Patent.