Free Consent Judgment - District Court of Delaware - Delaware

‘ Case 1 :07-cv-00204-SLR Document 40 Filed 04/21 /2008 Page 1 of 4
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
)
MEDA PHARMACEUTICALS INC., )
Plaintiff, l Civil Action No. 07-204-SLR
)
v. )
)
APOTEX INC. and APOTEX CORP., )
Defendants. g
__ ?- i )
FINDINGS OF FACT AND CONSENT JUDGMENT AND ORDER
The Court, upon the consent and request of Plaintiff Meda Pharmaceuticals Inc.,
formerly known as MedPointe Healthcare Inc. ("Meda"), and Defendants Apotex Inc. and
Apotex Corp. (collectively, "Apotex"), hereby makes the following Findings of Fact and issues
the following Consent Judgment and Order:
FINDINGS OF FACT
l. This Court has subject matter jurisdiction over this patent infringement
action (the "Action") and personal jurisdiction over all ofthe parties to the Action. Venue is
proper in this Court as to all parties to the Action.
2. In this Action, Meda has charged Apotex with infringement of United
States Patent No. 5,164,194 ("the 'l 94 Patent") in connection with Apotex‘s submission of
Abbreviated New Drug Application ("ANDA") 78-62] directed to a generic azelastine
hydrochloride ophthalmic solution to the U.S. Food and Drug Administration ("FDA").

’ Case 1:07-cv-00204-SLR Document 40 Filed 04/21/2008 Page 2 of 4
3. In response to Meda's charge of patent infringement, Apotex has alleged
certain defenses and counterclaims, including that the 'l 94 Patent is invalid, unenforceable and
not infringed by the generic azelastine hydrochloride ophthalmic solution defined by ANDA 78-
621.
4. The claims, defenses and counterclaims in this action were scheduled for
trial beginning on February 23, 2009.
5. Apotex has not rebutted the statutory presumption that the '194 Patent is
valid and enforceable in this Action. This admission, however, is without prejudice to Ap0tex's
allegations that the asserted claims of the 'l 94 patent are invalid and unenforceable.
6. Apotex admits that the submission of ANDA 78-621 to the FDA for the
purpose of obtaining regulatory approval to engage in the commercial manufacture, use and/or
sale of a generic azelastine hydrochloride ophthalmic solution, the use of which is claimed in the
'I94 Patent, within the United States before the expiration of the 'l 94 Patent is an act of patent
infringement. This admission, however, is without prejudice to Apotex‘s allegations that the
asserted claims of the 'l 94 patent are invalid and unenforceable.
7. Apotex has agreed that each of the defenses and counterclaims set forth in
Defendants Apotex lnc.'s And Apotex Corp.‘s Answer, Defenses and Counterclaims in this
Action, including the allegations and averrnents contained therein, should be dismissed, without
prejudice.
CONSENT JUDGMENT AND ORDER
Accordingly, pursuant to the above Findings of Fact, and upon the consent and
request of Meda and Apotex, IT IS HEREBY ORDERED, ADJUDGED AND DECREED
THAT:
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‘ Case 1:07-cv-00204-SLR Document 40 Filed 04/21/2008 Page 3 of 4
1. The filing of ANDA 78-621 was a technical act of infringement of the
'194 Patent under 35 U.S.C. § 27l(e)(2)(A).
2. Apotex's defenses and counterclaims with respect to the 'l 94 Patent are
hereby dismissed, without prejudice.
3. Apotex, its officers, agents, servants, employees and attorneys, and those
persons in active concert or participation with them who receive actual notice of this Order by
personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell or
selling within the United States, or importing into the United States, the generic azelastine
ophthalmic solution defined by ANDA 78-621 during the life of the 'l94 Patent, including any
extensions and pediatric exclusivity, absent authorization by Meda, unless all of the claims of the
'194 Patent are found invalid or unenforceable by a court decision from which no appeal has
been or can be taken.
4. Meda and Apotex each expressly waives any right to appeal or otherwise
move for relief from these Findings of Fact and Consent Judgment and Order.
5. This Court retains jurisdiction over Meda and Apotex for purposes of
enforcing these Findings of Fact and Consent Judgment and Order.
6. These Findings of Fact and Consent Judgment and Order shall finally
resolve this Action between Meda and Apotex. Each party shall bear its own fees and costs in
connection with this action, including attorney fees.
7. The Clerk of the Court is directed to enter this Hnal judgment forthwith.
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’ Case 1:07-cv-00204-SLR Document 40 Filed 04/21/2008 Page 4 of 4
SO ORDERED:
This d 9+ day of 4 , 2008
HONORABLE Séé L. ROBINSON
UNITED STATES DISTRICT JUDGE
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