Case 1:09-cv-00037-RBK-JS Document 692 Filed 06/13/13 Page 1 of 5 PageID #: 11320
`Case 1:09-cv-00037-RBK-JS Document 692 Filed 06/13/13 Page 1 of 5 PagelD #: 11320
`¥
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. 09-037-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.,
`
`Defendants.
`
`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., and ANDRX LABS,L.L.C.,
`
`Plaintiffs,
`
`Vv.
`
`LUPIN INC., and LUPIN
`PHARMACEUTICALSINC.,
`
`Defendants.
`
`
`
`eeeeee’
`
`STIPULATION AND ORDER OF DISMISSAL
`
`Whereasthis action for patent infringement(the “Patent Litigation”) has been brought by
`Shionogi Inc. (formerly Shionogi Pharma, Inc. and Sciele Pharma, Inc.), Andrx Corporation,
`Andrx Pharmaceuticals, Inc. (n/k/a Watson Laboratories, Inc.-Florida), Andrx Pharmaceuticals,
`(collectively
`L.L.C., Andrx Laboratories (NJ), Inc., Andrx EU Ltd., Andrx Labs, L.L.C.
`“Plaintiffs”) against Defendants Lupin Pharmaceuticals,
`Inc. and Lupin Inc.
`(collectively
`
`AUROBINDO EX1008, 1
`
`AUROBINDO EX1008, 1
`
`

`

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`“Lupin”) (collectively, Plaintiffs and Lupin 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);
`Whereas this Court has subject matter jurisdiction over the above-captioned patent
`infringementaction;
`Whereas Lupin does not contest personal jurisdiction for the purposes of the Patent
`Litigation;
`Whereas Lupin does not contest venue for the purposes ofthe Patent Litigation;
`Whereasin this Patent Litigation, Plaintiffs have charged Lupin with infringement of 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 containing metformin HCl;
`Whereas Andrx holds New Drug Application (“NDA”) No.21-574 for 500 mg and 1000
`mg metformin HCl extended 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 Patent Litigation by Plaintiffs was based on Plaintiffs’ receipt of notices
`from Lupin that Lupin had filed Abbreviated New Drug Application 90-692 (the “Lupin
`ANDA”) with the FDA containing a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`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) seeking approval for the
`commercial manufacture, use, and sale of 500 mg and 1000 mg metformin HCl extended release
`tablets (“Lupin’s ANDA Products”);
`Whereas in response to the charges by Plaintiffs of patent infringement, Lupin has
`alleged certain defenses and counterclaims, including that the 859, ‘866, ‘162, °459 and ‘116
`patents are invalid, unenforceable, and not infringed by Lupin’s generic products defined by the
`Lupin ANDA;
`Whereas Plaintiffs have not asserted any charges of infringement against Lupin with
`to the ‘162,
`‘459 and ‘116 patents, but Lupin 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 Lupin, nor Lupin’s defenses and counterclaims;
`
`AUROBINDO EX1008, 2
`
`AUROBINDO EX1008, 2
`
`

`

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`4
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`Whereas, Plaintiffs claim damages asaresult of the actions of Lupin and Lupin claims
`damagesasa result ofthe actions of ShionogiInc.;
`Whereas, no Party concedesthatits claims, defenses, or counterclaims lack merit;
`Whereas the Patent Litigation has been hard fought and expensive to Plaintiffs and to
`
`Lupin;
`
`Whereas the Parties have entered into a good-faith final Settlement and License
`Agreement regarding this Patent Litigation, on the expectation 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 interest by saving judicial resources and avoiding the risks to each of the Parties
`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 ofthis Patent Litigation, to the benefit of the Parties and consumers
`alike, such as by investing more resources into pharmaceutical research and development;
`Whereas under the Settlement and License Agreement entered into by the Parties, Lupin
`was granted the right to market generic versions of products covered by the °859, “866, ‘162,
`‘459 and ‘116 patents as of September1, 2011, allowing entry of generic versions of Fortamet®
`over nine years in advance ofthe March17, 2021 expiration ofthe ‘866 patent;
`Whereas the Parties acknowledgethereis 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 settlement as reflected herein;
`Whereasthis settlement resolves the Patent Litigation among the Parties;
`
`AUROBINDO EX1008, 3
`
`AUROBINDO EX1008, 3
`
`

`

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`4
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`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.
`All claims, counterclaims, and affirmative defenses presented by the Parties in
`this Patent Litigation are hereby dismissed with prejudice;
`
`2.
`
`3.
`
`4.
`
`5.
`
`The Parties agree to be bound by the terms of the Settlement and License
`Agreement;
`Shionogi Inc., Andrx, and Lupin, each expressly waives any right to appeal or
`otherwise moveforrelief from this Order of Dismissal;
`
`This Court retains jurisdiction over the Parties for purposes of enforcing and
`interpreting this Order of Dismissal;
`
`The Clerk of the Court is directed to enter this Orderof Dismissal forthwith.
`
`May 21, 2013
`
`/s/ Karen Jacobs Louden
`Jack B. Blumenfeld (1-D. #1014)
`Karen Jacobs Louden (1.D. #2881)
`Morris NICHOLS ARSHT AND TUNNELL
`LLP
`1201 North Market Street
`Wilmington, Delaware 19801-1494
`(302) 658-9200
`jblumenfeld@mnat.com
`klouden@mnat.com
`
`OfCounsel:
`David A. Manspeizer
`David B. Bassett
`Christopher R. Noyes
`WILMER CUTLER PICKERING HALE
`& DORR LLP
`7 World Trade Center
`250 GreenwichStreet
`New York, NY 10007
`
`Attorneysfor Shionogi Pharma,Inc.
`
`/s/ Richard D. Kirk
`Richard D. Kirk (#922)
`Stephen B. Brauerman (#4592)
`BAYARD,P.A.
`222, Delaware Avenue, Suite 900
`Wilmington, Delaware 19801
`(302) 655-5000
`rkirk@bayardlaw.com
`sbrauerman@bayardlaw.com
`
`OfCounsel:
`Douglass C. Hochstetler
`KELLEY DRYE & WARREN LLP
`333 West Wacker Drive, 26th Floor
`Chicago, IL 60606
`
`Beth D. Jacob
`Clifford Katz
`KELLEY DRYE & WARREN LLP
`101 Park Avenue
`New York, NY 10178
`
`Attorneysfor Lupin Ltd. and Lupin
`Pharmaceuticals, Inc.
`
`AUROBINDO EX1008, 4
`
`AUROBINDO EX1008, 4
`
`

`

`Case 1:09-cv-00037-RBK-JS Document 692 Filed 06/13/13 Page 5 of 5 PageID #: 11324
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`eb
`
`/s/ Steven J. Fineman
`Frederick L. Cottrell , III (ID. #2555)
`Steven J. Fineman (1.D. #4025)
`RICHARDS, LAYTON & FINGER PA LLP
`920 N.King Street
`Wilmington, DE 19801
`(302) 658-6541
`cottrell@rlf.com
`fineman@rlf.com
`
`OfCounsel:
`Gary E. Hood
`POLSINELLI PC
`161 N. Clark Street, Suite 4200
`Chicago, IL 60606
`(312) 819-1900
`
`Attorneysfor Andrx Corporation,
`Andrx Pharmaceuticals, Inc.,
`Andrx Pharmaceuticals, L.L.C.,
`Andrx Laboratories (NJ), Inc.,
`Andrx EU, Ltd. and Andrx Labs, L.L.C.
`
`IT IS HEREBY ORDERED.
`
`
`
`| ThaOOKe
`
`Dated:
`
`12, Ws
`
`THE HONORABLE ROBERTB. KUGLER
`United States District Judge
`District Of New Jersey
`
`AUROBINDO EX1008, 5
`
`AUROBINDO EX1008, 5
`
`