MAR-25-2613 18:27 FROM: CONNELLFOLEY
`.
`
`9735359217
`
`TO:1 856 757 5e76
`
`P.276
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. 1:09-cv-37-RBK-JS
`(Consolidated)
`
`Civil Action No. 1:10-cv-00135-RBK-JS
`
`SCIELE PHARMA, INC., ANDRX
`CORPORATION, ANDRX
`PHARMACEUTICALS,INC. (N/K/A WATSON
`LABORATORIES, INC.-FLORIDA), ANDRX
`PHARMACEUTICALS, L.L.C., ANDRX
`LABORATORIES(NJ), INC., ANDRX EU
`LTD., and ANDRX LABS, L.L.C.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LTD. and LUPIN
`PHARMACEUTICALS,INC.,
`
`Delendants.
`
`SHIONOGT PHARMA, INC., ANDRX
`CORPORATION, ANDRX
`PHARMACEUTICALS,INC. (N/K/A WATSON
`LABORATORIES, INC.-FLORIDA), ANDRX
`PHARMACEUTICALS,L.L.C., ANDRX
`LABORATORIES(NJ), INC., ANDRX EU
`LTD., and ANDRX LABS, 1..1.C.,
`
`Plaintiffs,
`
`Vv.
`
`MYLANINC., and MYLAN
`PHARMACEUTICALSINC.,
`
`
`
`Defendants.
`
`STIPULATION AND ORDER OF DISMISSAL
`
`Whereas this action for patent infringement (the “Patent Litigation”) has been brought by
`Shionogi Inc. (formerly Shionogi Pharma, Inc.), Andrx Corporation, Andrx Pharmaceuticals,
`Inc.
`(n/k/a Watson Laboratories,
`Inc.-Florida), Andrx Pharmaceuticals, L.L.C., Andrx
`Laboratories (NJ), Inc., Andrx EU Ltd., Andrx Labs, L.L.C. (collectively “Plaintiffs”) against
`Defendants Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively “Mylan”) (collectively,
`Plaintitts and Mylan may be referred to as “the Parties”) for alleged infringement of United
`States Patent Nos. 6,099,859 (“the °859 patent”) and 6,866,866 (“the ‘866 patent);
`
`AUROBINDO EX1009, 1
`
`AUROBINDO EX1009, 1
`
`

`

`MAR-2S-2@13 16:27 FROM: CONNELLFOLEY
`é
`
`9735359217
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`TO:1 856 757 5876
`
`P.3°6
`
`Whereas this Court has subject matter junsdiction over the above-captioned patent
`infringement action and has personal jurisdiction over the Parties:
`
`Whereas Mylan does not contest personal jurisdiction for the purposes of the Patent
`Litigation,
`
`Whereas venue is proper in this Court as to the Parties;
`
`Whercas Mylan does not contest venue for the purposes of the Patent Litigation,
`
`Whereasin this Patent Litigation, Plaintiffs have charged Mylan with infringementof the
`859 and ‘866 patents;
`
`Whereas the °*859 and ‘866 patents are owned by Andrx Corporation, Andrx
`Pharmaceuticals, Inc. (n/k/a Watson Laboratories, Inc.-Florida), Andrx Pharmaceuticals, L.L.C.,
`Andrx Laboratories (NJ), Inc., Andrx EU Ltd., Andrx Labs, L.L.C. (collectively “Andrx”), and
`Andrx has granted Shionogi Inc. an exclusive license to the °859 and ‘866 patents in the United.
`States with regard to extended release tablets contaming metformin HCI;
`
`Whercas Andrx holds New Drug Application (“NDA”) No. 21-574 for 500 mg and 1000
`mg metformin HC! extendcd release tablets and Shionogi Inc. markets these tablets in the United
`States under the trade name “Fortamet®,”
`
`Whereas the °859 and ‘866 patents are listed for Fortamet® in the Approved Drug
`Products with Therapeutic Equivalence Evaluations (“Orange Book”) published by the United
`States Food & Drug Administration (“FDA”);
`
`Whereas the commencement of the Patcnt Litigation by Plaintiffs was based on
`Plaintiffs’ receipt of notice from Mylan that Mylan had filed Abbreviated New Drug Apphcation
`20-0690 (the “Mylan ANDA”) with the FDA containing a certification putsuant to 21 U.S.C. §
`355(j)(2)(A)(vii)(TV) directed to the °859 and ‘866 patents as well as U.S. Patent Nos. 6,495,162
`(“the ‘162 patent”), 6,790,459 (“the ‘459 patent”) and 7,919,116 (“the ‘116 patent) secking
`approval for the commercial manufacture, use, and sale of 500 mg and 1000 mg metformin HC1
`extcnded release tables (“Mylan’s ANDA Products”);
`
`infringement, Mylan has
`Whereas in response to the charges by Plaintiffs of patent
`alleged certain defenses and counterclaims, including that the ’859, ‘866, ‘162, ‘459 and ‘116
`patents are invalid, unenforceable, and not infringed by Mylan’s generic products defined by the
`Mylan ANDA;
`
`Whereas Plaintiffs have not asserted any charges of infringement against Mylan with
`to the ‘162,
`‘459 and ‘116 patents, but Mylan has asserted certain defenses and
`respect
`counterclaims for these patents,
`
`Whereas, to date, this Court has not ruled on Plaintiffs’ charges of patent infringement
`against Mylan, nor Mylan’s defenses and counterclaims,
`
`Whereas, no Party concedesthat its claims, defenses, or counterclaims lack merit:
`
`2
`
`AUROBINDO EX1009, 2
`
`AUROBINDO EX1009, 2
`
`

`

`MAR-25-2613 18:27 FROM: CONNELLFOLEY
`
`9735359217
`
`TO:1 856 757 5@76
`
`P.4°6
`
`Whereas the Patent Litigation has been hard fought and expensive to Plaintiffs and to
`
`Mylan,
`
`Whereas the Parties have entered into a good-faith final Settlement and License
`Agreement regarding this Patent Litigation, on the cxpcctation and belief that this settlement
`would eliminate the substantial litigation costs, risks, and uncertainty that would otherwise be
`incurred and experienced by the parties during the Patent Litigation, while also serving the
`public intcrest by saving judicial resources and avoiding the risks to each of the Partics
`associated with continuedlitigation;
`
`Whereas the reasonable final settlement will afford the Parties the pro-competitive
`opportunity to more productively use resources that would have been spent in the continued
`prosecution and defense of this Patent Litigation, to the benefit of the Parties and consumers
`alike, such as by investing more resources into pharmaceutical research and development;
`
`Whercas under the Settlement and Licensc Agreement entered into by the Parties, Mylan
`was granted the right to markct generic versions of products covered by the °859, ‘866, ‘162,
`‘459 and ‘116 patents no later than August 1, 2013, allowing entry of generic versions of
`Forlamet® over scven years in advance of the March 17, 2021 expiration ofthe ‘866 patent:
`
`Whercas the Parties acknowledge there is significant risk and uncertainty to each of them
`associated with continued prosecution and defense of this Patent Litigation, and each has
`consented to entry ofthis Order of Dismissal through a final scttlement as reflected herein;
`
`Whereas this sctilement resolvesall litigation involving the Mylan ANDA among the
`
`Partics;
`
`In consideration of the above factual representations, the request and consent of the
`Parties and upon due consideration of the Settlement and License Agreement, IT IS HEREBY
`ORDERED, ADJUDGED, AND DECREED THAT:
`
`1.
`
`2.
`
`3.
`
`4,
`
`5.
`
`All claims, counterclaims, and affirmative defenses presented by the Parties in
`this Patent Litigation are hereby dismissed with prejudice;
`
`The Parties agree to be bound by the terms of the Settlement and License
`Agreement;
`
`Shionogi Inc., Andrx, and Mylan, each expressly waives any right to appeal or
`otherwise move for rclicf from this Order of Dismissal;
`
`This Courtretains jurisdiction over the Parties for purposes of enforcing and
`interpreting this Order of Dismissal;
`
`The Clerk of the Court is directed to enter this Order of Dismissal forthwith.
`
`Dated: March 13, 2013
`
`AUROBINDO EX1009, 3
`
`AUROBINDO EX1009, 3
`
`

`

`MAR-25-2613 14:27 FROM: CONNELLFOLEY
`
`9735359217
`
`TO:1 856 7S7 Sa76
`
`P.376
`
`Morris NICHOLS ARSHT & TUNNELL LLP
`
`Morris JAMES LLP
`
`/s/ Mary B. Matterer
`Mary B. Mattcrer (1.1, #2696)
`Richard K. Herrmann (LD.#405) _
`500 Delaware Avenue, Suite 1500
`Wilmington, Delaware 19801-1494
`(302) 888-6800
`mmattcrer@morrisjames.com
`rhermann@marrisjames.com
`OfCounsel:
`Timothy H. Kratz
`Robert L. Florence
`George J. Barry LI
`Anil H.Patel
`Micheal L. Binns
`Karen L. Carroll
`McGuiReWoops LLP
`1230 Peachiree Street, Suite 2100
`Atlanta, Georgia 30309
`(404) 443-5500
`
`Attorneysfor Mylan inc. and Mylan
`PharmaceuticalsInc.
`
`/[s/ Karen Jacobs Louden
`Jack B. Blumenfeld (1.D, #1014)
`Karen Jacobs Louden (LD. #2881)
`1201 North Market Street
`Wilmington, Delaware 19801-1494
`(302) 658-9200
`jblumenfeld@mnat.com
`klouden@muat.com
`OfCounsel:
`David B. Bassett
`David A. Manspeizer
`Christopher R. Noyes
`WILMERHALE LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`
`Attorneysfor Shionogi Pharma,Inc.
`
`RICHARDS, LAYTON & FINGER PA
`
`Steven J. Fineman
`S/
`Frederick L. Cottrell , IT (1.D. #2555)
`Steven J. Fineman (1.D. #4025)
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlficom
`fineman@rlf.com
`OfCounsel:
`
`Gary E. Hood
`POLSINELLI SHUGHART PC
`161 N. Clark Street, Suite 4200
`Chicago, TL 60606
`(312) 819-1900
`
`AttorneysforAndrx Corporation, Andrx Pharms., Inc.
`Andrx Pharmaceuticals, L.L.C., Andrx Labs. (NJ), Inc
`Andrx EU, Ltd. and Andrx Labs, LLC.
`
`AUROBINDO EX1009, 4
`
`AUROBINDO EX1009, 4
`
`

`

`MAR-25-2613 18:28 FROM: CONNELLFOLEY
`
`9735359217
`
`TO:1 856 7S? 5a76
`
`P.6°6
`
`a
`
`IT IS HEREBY SO ORDERED.
`
`Dated:4%?
`a
`
`7050489
`
`Thun, a __
`THE HONORABLE ROBERTB. KUGLER
`United States District Judge
`District OfNew Jersey
`
`AUROBINDO EX1009, 5
`
`AUROBINDO EX1009, 5
`
`