UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ILLINOIS

In re Nebivolol ('040) Patent Litigation C.A. No. 12-5026 (EEB) (JC)

STIPULATION AND ORDER

Case: 1:12-cv-05026 Document #: 121 Filed: 01/25/13 Page 1 of 5 PageID #:7117
The Court, upon the consent and request of Plaintiffs Forest Laboratories, Inc.

and Forest Laboratories Holdings, Ltd. (collectively, "Plaintiffs") and Defendants Torrent

Pharmaceuticals Ltd. and Torrent Pharma Inc. (collectively "Torrent"), hereby acknowledges the

following Stipulation and issues the following Order.

STIPULATION

1. This Court has subject matter jurisdiction over this patent infringement

action (the "Action") and personal jurisdiction over Plaintiffs and Torrent. Venue is proper in

this Court as to Plaintiffs and Torrent.

2. In this Action, Plaintiffs have charged Torrent with infringement of

United States Patent No. 6,545,040 ("the '040 Patent") in connection with Torrent's submission

of Abbreviated New Drug Application ("ANDA") No. 203966 directed to generic tablets

containing 2.5 milligrams, 5 milligrams, 10 milligrams, or 20 milligrams of nebivolol

hydrochloride per tablet to the U.S. Food and Drug Administration ("FDA").

3. In response to Plaintiffs' charges of patent infringement, Torrent has

alleged certain defenses and counterclaims, including that the '040 Patent is invalid,

unenforceable and/or not infringed by the generic tablet products containing 2.5 milligrams, 5

milligrams, 10 milligrams, or 20 milligrams of nebivolol hydrochloride that are the subject of

ANDA No. 203966. No decision has been obtained by either party from this Court regarding

these charges of infringement or these defenses and counterclaims.

4. Torrent has not rebutted the statutory presumption that the '040 Patent is

valid and enforceable in this Action. Given the discovery exchanged to date in the Action,

including contention discovery, Torrent acquiesces in, and stipulates to, the validity and

enforceability of the '040 Patent.

5. Torrent admits that the submission of ANDA No. 203966 to the FDA for

Case: 1:12-cv-05026 Document #: 121 Filed: 01/25/13 Page 2 of 5 PageID #:7118
the purpose of obtaining regulatory approval to engage in the commercial manufacture, use

and/or sale of generic tablets containing 2.5 milligrams, 5 milligrams, 10 milligrams, or 20

milligrams of nebivolol hydrochloride per tablet within the United States before the expiration of

the '040 Patent was a technical act of infringement of that patent under 35 U.S.C. § 271(e)(2)(A). 

Torrent further admits that the commercialization of each of the generic nebivolol hydrochloride

products defined by ANDA No. 203966 falls within the scope of Claims 2, 3, and 4 of the '040

Patent as properly construed. Torrent further admits that the use of each of the generic nebivolol

hydrochloride products defined by ANDA No. 203966 in accordance with its proposed labeling

falls within the scope of Claims 5 and 6 of the '040 Patent as properly construed.

6. Torrent submitted ANDA No. 203966 to the FDA for the purpose of

obtaining regulatory approval to engage in the commercial manufacture, use and/or sale of

nebivolol hydrochloride products claimed in the '040 Patent within the United States before the

expiration of that patent.

7. Torrent has agreed that each of the defenses and counterclaims set forth in

its Answer And Counterclaims, including the allegations and averments contained therein,

should be dismissed, with prejudice.

ORDER

Accordingly, pursuant to the above Stipulation, and upon the consent and request

of Plaintiffs and Torrent, IT IS HEREBY ORDERED, ADJUDGED AND DECREED

THAT:

1. The '040 Patent is neither invalid nor unenforceable.

2. Torrent's submission of ANDA No. 203966 to the FDA infringed the the

'040 Patent under 35 U.S.C. § 271(e)(2)(A).

Case: 1:12-cv-05026 Document #: 121 Filed: 01/25/13 Page 3 of 5 PageID #:7119
3. Each of the generic nebivolol hydrochloride products defined by ANDA

No. 203966 would infringe Claims 2, 3, and 4 of the '040 Patent if made, used, sold, or offered

for sale in the United States or imported into the United States. Use of each of the generic

nebivolol hydrochloride products defined by ANDA No. 203966 in accordance with its proposed

labeling would infringe Claims 5 and 6 of the '040 Patent.

4. Torrent's defenses and counterclaims with respect to the '040 Patent are

hereby dismissed, with prejudice.

5. Torrent, 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 tablet products

containing 2.5 milligrams, 5 milligrams, 10 milligrams, or 20 milligrams of nebivlol

hydrochloride per tablet that are the subject of ANDA No. 203966 during the life of the '040

Patent, including any extensions and pediatric exclusivities, absent a license agreement or other

authorization by Plaintiffs, unless all of the asserted claims of the '040 Patent are found invalid

and/or unenforceable by a court decision from which no appeal has been or can be taken, other

than petition for a writ of certiorari to the U.S. Supreme Court.

6. Each of Plaintiffs and Torrent expressly waives any right to appeal or

otherwise move for relief from this Stipulation And Order.

7. This Court retains jurisdiction over Plaintiffs and Torrent for purposes of

enforcing this Stipulation And Order.

8. This Stipulation And Order shall finally resolve this Action between

Case: 1:12-cv-05026 Document #: 121 Filed: 01/25/13 Page 4 of 5 PageID #:7120
Plaintiffs and Torrent. 

9. The Clerk of the Court is directed to enter this Stipulation And Order

forthwith.

SO ORDERED:

This 25th day of January, 2013

HONORABLE ELAINE E. BUCKLO

UNITED STATES DISTRICT JUDGE

Case: 1:12-cv-05026 Document #: 121 Filed: 01/25/13 Page 5 of 5 PageID #:7121