Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 1 of 41 PageID #: 15732
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
` Defendants.
`
`
` Civil Action No. 2:15-cv-1455 WCB LEAD
` Civil Action No. 2:15-cv-1504 WCB
` Civil Action No. 2:16-cv-0401 WCB
`
`
` JURY TRIAL DEMANDED
`
`
`JOINT PRE-TRIAL ORDER
`
`This cause came before the Court at a pre-trial management conference held on August 1,
`
`2017, pursuant to the 13th Amended Docket Control Order (Dkt. No. 361) and Rule 16 of the
`
`Federal Rules of Civil Procedure.
`
`A.
`
`COUNSEL FOR THE PARTIES
`
`Plaintiff Allergan, Inc.:
`
`FISH & RICHARDSON P.C.
`Jonathan E. Singer
`(CA Bar No. 187908, MN Bar No. 283459)
`LEAD ATTORNEY
`singer@fr.com
`Juanita R. Brooks (CA Bar No. 75934)
`brooks@fr.com
`12390 El Camino Real
`San Diego, CA 92130
`Telephone: 858-678-5070
`Facsimile: 858-678-5099
`
`Michael J. Kane (MN Bar No. 0247625)
`kane@fr.com
`Deanna J. Reichel (MN Bar No. 0326513)
`reichel@fr.com
`Joseph A. Herriges (MN Bar No. 390350)
`herriges@fr.com
`60 South Sixth Street, #3200
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`Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 2 of 41 PageID #: 15733
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`Minneapolis, MN 55402
`Telephone: (612) 335-5070
`Facsimile: (612) 288-9696
`
`Douglas E. McCann (DE Bar No. 3852)
`dmccann@fr.com
`Susan E. Morrison (DE Bar No. 4690)
`morrison@fr.com
`Robert M. Oakes (DE Bar No. 5217)
`oakes@fr.com
`222 Delaware Avenue, 17th Floor
`Wilmington, DE 19801
`Telephone: (302) 652-5070
`Facsimile: (302) 652-0607
`
`J. Wesley Samples (OR Bar No. 121784)
`samples@fr.com
`901 15th Street, N.W., 7th Floor
`Washington, D.C. 20005
`Telephone: (202) 783-5070
`Facsimile: (202) 783-2331
`
`WARD, SMITH & HILL, PLLC
`T. John Ward, Jr.
`State Bar No. 00794818
`E-mail: jw@wsfirm.com
`Wesley Hill
`State Bar No. 24032294
`E-mail: wh@wsfirm.com
`Claire Abernathy Henry
`State Bar No. 24053063
`E-mail: claire@wsfirm.com
`Andrea L. Fair
`State Bar No. 24078488
`E-mail: andrea@wsfirm.com
`1507 Bill Owens Parkway
`Longview, Texas 75604
`Telephone: (903) 757-6400
`Facsimile: (903) 757-2323
`
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`Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 3 of 41 PageID #: 15734
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`Defendants Akorn, Inc., Famy Care Ltd., InnoPharma, Inc., Mylan Pharmaceuticals Inc.,
`Mylan Inc., and Teva Pharmaceuticals USA, Inc.:
`
`
`COUNSEL FOR DEFENDANT
`TEVA PHARMACEUTICALS USA, INC.
`
`STERNE, KESSLER, GOLDSTEIN & FOX
`P.L.L.C.
`J.C. Rozendaal
`jcrozendaal@skgf.com
`LEAD ATTORNEY
`Michael E. Joffre
`mjoffre@skgf.com
`Pauline M. Pelletier
`ppelletier@skgf.com
`R. Wilson Powers III
`tpowers@skgf.com
`1100 New York Ave. NW, Suite 600
`Washington, DC 20005
`Tel: 202-371-2600
`Fax: 202-371-2540
`
`NIX, PATTERSON & ROACH L.L.P.
`Louis B. (“Brady”) Paddock
`Texas Bar No. 00791394
`bpaddock@nixlawfirm.com
`2900 St. Michael Drive, Ste. 500
`Texarkana, TX 75503
`(903) 223-3999
`(903) 223-8520 (fax)
`
`COUNSEL FOR DEFENDANT
`AKORN, INC.
`
`SUGHRUE MION PLLC
`Michael R. Dzwonczyk
`mdzwonczyk@sughrue.com
`LEAD ATTORNEY
`Azadeh Kokabi
`akokabi@sughrue.com
`Mark Boland
`mboland@sughrue.com
`Benjamin Cappel
`bcappel@sughrue.com
`2100 Pennsylvania Ave NW, Suite 800
`Washington, DC 20037
`
`
`COUNSEL FOR DEFENDANTS MYLAN
`PHARMACEUTICALS INC. AND
`MYLAN INC.
`
`WILSON SONSINI GOODRICH & ROSATI
`Douglas H. Carsten
`dcarsten@wsgr.com
`LEAD ATTORNEY
`Wendy Devine
`wdevine@wsgr.com
`Christina E. Dashe
`cdashe@wsgr.com
`Alina L. Litoshyk
`alitoshyk@wsgr.com
`Nellie J. Amjadi
`namjadi@wsgr.com
`12235 El Camino Real, Suite 200
`San Diego, CA 92130-3002
`Tel: 858-350-2300
`Fax: 858-350-2399
`
`Anna G. Phillips
`Texas Bar No. 24090329
`anphillips@wsgr.com
`900 South Capital of Texas Highway
`Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`Tel: 512-338-5400
`Fax: 512-338-5499
`
`GILLAM & SMITH LLP
`Melissa Smith
`melissa@gillamsmithlaw.com
`Allen Franklin Gardner
`allen@gillamsmithlaw.com
`303 S. Washington Ave.
`Marshall, Texas 75670
`Tel: 903-934-8450
`Fax: 903-934-9257
`
`
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`Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 4 of 41 PageID #: 15735
`
`Tel: 202-293-7060
`Fax: 202-293-7860
`
`POTTER MINTON
`Earl Glenn Thames, Jr.
`glennthames@potterminton.com
`110 N College Avenue, Suite 500
`Tyler, TX 75702
`Tel: 903-597-8311
`Fax: 903-593-0846
`
`COUNSEL FOR DEFENDANT
`FAMY CARE LIMITED
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`William A. Rakoczy
`wrakozcy@rmmslegal.com
`LEAD ATTORNEY
`Deanne M. Mazzochi
`dmazzochi@rmmslegal.com
`Peter Curtin
`pcurtin@rmmslegal.com
`Kevin P. Burke
`kburke@rmmslegal.com
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: (312) 222-6301
`Fax: (312) 222-6321
`
`FINDLAY CRAFT, P.C.
`Eric H. Findlay
`Texas Bar No. 00789886
`Walter Wayne Lackey, Jr.
`Texas Bar No. 24050901
`102 North College Avenue, Suite900
`Tyler, TX 75702
`Tel: (903) 534-1100
`Fax: (903) 534-1137
`
`
`
`
`
`
`
`COUNSEL FOR DEFENDANT
`INNOPHARMA, INC.
`
`WINSTON & STRAWN LLP
`Stephen R. Smerek
`ssmerek@winston.com
`Lead Attorney
`Jason C. Hamilton
`jhamilton@winston.com
`Shilpa Coorg
`scoorg@winston.com
`333 South Grand Avenue, 38th Floor
`Los Angeles, CA 90071-1543
`Tel: 213-615-1933
`Fax: 213-615-1750
`
`Charles B. Klein
`cklein@winston.com
`1700 K Street, NW
`Washington, DC 20006
`Tel: 202-282-5977
`Fax: 202-282-5100
`
`THE DACUS FIRM, PC
`Deron R. Dacus
`ddacus@dacusfirm.com
`Peter Aaron Kerr
`pkerr@dacusfirm.com
`821 ESE Loop 323, Suite 430
`Tyler, TX 75701
`Tel: 903-705-1117
`Fax: 903-581-2543
`
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`Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 5 of 41 PageID #: 15736
`
`B.
`
`STATEMENT OF JURISDICTION
`
`This civil case is brought before the United States District Court for the Eastern District
`
`of Texas. This action arises under the Patent Laws of the United States, 35 U.S.C. §§ 1, et seq.
`
`and the Declaratory Judgment Act, 28 U.S.C. §§ 2201, 2202, and Plaintiff-Counterclaim
`
`Defendant Allergan, Inc. (“Allergan”) asserts that subject matter jurisdiction of this Court exists
`
`under at least 28 U.S.C. §§ 1331, 1338(a) and 2201-02.
`
`The Defendant-Counterclaim Plaintiffs Akorn Inc. (“Akorn”), Famy Care Ltd. (“Famy
`
`Care”), InnoPharma, Inc. (“InnoPharma”), Mylan Pharmaceuticals, Inc., Mylan, Inc.
`
`(collectively, “Mylan”), and Teva Pharmaceuticals USA, Inc. (“Teva”), (collectively,
`
`“Defendants”) deny that the court has subject matter jurisdiction for the reasons set forth in
`
`Defendants’ Motion to Dismiss for Lack of Standing, or in the Alternative for Summary
`
`Judgment of Invalidity under 35 U.S.C. § 102(f) and the associated briefs and exhibits.
`
`Further, Mylan previously filed a motion to dismiss the complaint for lack of personal
`
`jurisdiction and improper venue (Doc. No. 32). The Court denied the motion (Doc. No. 130).
`
`Nevertheless, Mylan maintains its challenges to personal jurisdiction and venue in this Court (see
`
`Doc. No. 102). Mylan contends that it is not subject to personal jurisdiction in the Eastern
`
`District of Texas. Daimler AG v. Bauman, 134 S. Ct. 746, 754 (2014). In addition, Mylan
`
`contends that venue is not proper in this judicial district under 28 U.S.C. § 1400(b) and denies
`
`any allegation that it has waived any objection to venue.
`
`Allergan alleges that personal jurisdiction and venue are proper, and that Mylan waived
`
`any defense of lack of personal jurisdiction or improper venue by continuing to litigate this case.
`
`Other than Mylan, Defendants do not contest personal jurisdiction or venue in this Court solely
`
`for the purpose of this action.
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`Case 2:15-cv-01455-WCB Document 379 Filed 07/25/17 Page 6 of 41 PageID #: 15737
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`C.
`
`NATURE OF THE ACTION
`
`This action for alleged patent infringement, arising under the Patent Laws of the United
`
`States, Title 35, consolidates the litigations between the parties relating to Akorn’s, Famy Care’s,
`
`InnoPharma’s, Mylan’s, and Teva’s respective filings of Abbreviated New Drug Application
`
`(“ANDA”) Nos. 204561, 208469, 206835, 205894, and 203880 with the FDA seeking to market
`
`generic versions of Allergan’s Restasis® product, which Allergan alleges is covered by the
`
`Patents-in-Suit.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 21-023 for
`
`Restasis® brand 0.05% cyclosporin A (“CsA”) ophthalmic emulsion. Allergan’s position is that
`
`it is the owner by assignment of the “Patents-in-Suit”: U.S. Patent Nos. 8,629,111 (the “’111
`
`patent”); 8,648,048 (the “’048 patent”); 8,685,930 (the “’930 patent”); and 9,248,191 (the “’191
`
`patent”), which are listed in the FDA Orange Book for Restasis®.1 Allergan’s position is that it
`
`obtained assignments from each of the four named inventors of the Patents-in-Suit, and the
`
`Patents-in-Suit are assigned on their face to Allergan. Allergan’s further position is that Dr.
`
`Ding is not an inventor on the Patents-in-Suit and that, even if she is, Dr. Ding assigned any
`
`rights in the invention to Allergan. Defendants’ position is that Dr. Ding alone invented the
`
`subject matter claimed in the patents-in-suit and that she has never assigned the patents to
`
`
`1 Two additional patents, U.S. Patent Nos. 8,633,162 and 8,642,556 (the “’162 patent” and the
`“’556 patent,” respectively) are listed in the Orange Book, but are no longer asserted by Allergan
`in an attempt to streamline this matter. Allergan has limited the number of asserted claims in this
`case pursuant to this Court’s order and Defendants’ motion. (Dkt. Nos. 238, 239, 247, 265.) It is
`Allergan’s position that the Court lacks jurisdiction over the non-asserted claims. However,
`declaratory judgment counterclaims regarding these patents, filed by the Defendants, remain
`pending. To date, Allergan has not stipulated to dismiss all claims on these patents (and any
`other unasserted claims) with prejudice, provided a covenant not to sue or otherwise attempted to
`fully remove these patents from the litigation.
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`Allergan. Thus, Allergan does not own the Patents-in-Suit, and has not proven that it has
`
`standing to bring this suit.
`
`Allergan’s Statement Regarding the Description of the Case
`
`This is a patent infringement case wherein Allergan alleges that Defendants have
`
`infringed claims 26 and 27 of the ’111 patent, claims 1, 11, 13, 14, and 23 of the ’048 patent,
`
`claim 35 of the ’930 patent, and claims 13, 16, 22, 26, and 27 of the ’191 patent (“the Asserted
`
`Claims”) pursuant to 35 U.S.C. § 271. It is Allergan’s position that the Court lacks subject
`
`matter jurisdiction over Defendants’ counterclaims on any of the non-asserted claims of the ’111,
`
`’162, ’556, ’048, ’930, and ’ 191 patents. Allergan asserts that the filing of Defendants’ ANDAs
`
`infringed the asserted claims under 35 U.S.C. § 271(e)(2). Allergan requests that this Court enter
`
`an order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective date of approval of Defendants’
`
`ANDA products be a date not earlier than the latest expiration date of the Patents-in-Suit.
`
`Allergan further requests that Defendants be enjoined pursuant to 35 U.S.C. § 271(e)(4)(B) and
`
`any other applicable statutory or other provision from engaging in the commercial manufacture,
`
`use, offer to sell, or sale within the United States, or importation into the United States, of any
`
`drug product covered by the Patents-in-Suit. Allergan further requests that, should any of the
`
`Defendants attempt to engage in the commercial manufacture of the products described in their
`
`respective ANDAs prior to the expiration of the Patents-in-Suit, that Allergan be awarded
`
`damages resulting from such infringement under 35 U.S.C. § 271(e)(4)(C), increased to treble
`
`the amount found or assessed together with interest pursuant to 35 U.S.C. § 284. Allergan also
`
`requests that the Court declare this case exceptional and award Allergan reasonable attorneys’
`
`fees and costs pursuant to 35 U.S.C. § 285. Allergan also seeks a declaratory judgment of
`
`infringement under 35 U.S.C. §§ 271 (a), (b), and (c) of the ’111 and ’930 patents, and under 35
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`U.S.C. § 271(b) and (c) of the ’048 and ’191 patents. Allergan requests that that Court issue a
`
`declaration under 28 U.S.C. § 2291 that if Defendants, their officers, agents, servants,
`
`employees, licensees, representatives, attorneys, or any persons acting or attempting to act in
`
`concert of participation with them or acting on their behalf, engage in the commercial
`
`manufacture, use, offer for sale, sale and/or importation of Defendants’ proposed products, such
`
`conduct will constitute an act of infringement of the Patents-in-Suit under 35 U.S.C. § 271(a),
`
`(b), and (c) for the ’111 and ’930 patents, and under § 271(b) and (c) for the ’048 and ’191
`
`patents. Allergan does not necessarily agree with Defendants’ position concerning the claims at
`
`issue in this case, and will elaborate on that in its brief to be filed on July 28, 2017.
`
`Defendants’ Statement Regarding the Description of the Case
`
`Allergan initially alleged that each Defendant infringed claims 1-27 of the ’111 patent,
`
`claims 1-23 of the ’048 patent, claims 1-24 of the ’162 patent, claims 1-20 of the ’556 patent,
`
`claims 1-36 of the ’930 patent, and claims 1-27 of the ’191 patent pursuant to 35 U.S.C. § 271.
`
`Defendants2 counterclaim for non-infringement and invalidity of all claims of the Patents-in-Suit.
`
`Through Allergan’s Identification of Asserted Claims Pursuant to Local Patent Rule 3-8(b),
`
`served on December 15, 2015 (Dkt. No. 69) and Disclosure of Asserted Claims and Infringement
`
`Contentions Pursuant to Local Patent Rule 3-8(e), served on March 25, 2016 (Dkt. No. 113)
`
`Allergan has reduced the number of asserted claims. As indicated in Allergan’s Identification of
`
`Asserted Claims, as modified by correspondence from counsel for Allergan on November 30,
`
`2016, Allergan asserted the following claims: claims 3, 4, 6-9, 11-13, 15-17, and 19-27 of the
`
`’111 patent; claims 1, 3, 4, 6-9, 11-16, 18, and 20-24 of the ’162 patent; claims 1, 3, 4, 6-9, 11-
`
`15, and 17-20 of the ’556 patent; claims 1, 3, 4, 6-9, 11-16, 18, and 20-23 of the ’048 patent;
`
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`2 Mylan does not assert counterclaims in this action.
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`claims 1, 3, 4, 6-9, 11-16, 18-21, 23-25, 27, 28, 30-33, 35, and 36 of the ’930 patent; and claims
`
`1, 3, 4, 6-9, and 11-27 of the ’191 patent. While Allergan has now limited the Asserted Claims
`
`pursuant to Court order (as described in its description of the case), Allergan has neither
`
`dismissed the prior-asserted claims with prejudice (including the entirety of the claims of the
`
`’162 and ’556 patents) nor otherwise offered Defendants a covenant not to sue.
`
`The parties agree that it should not be necessary to try more than 13 claims at trial.
`
`Because Allergan initially asserted all claims from all six patents, but has subsequently
`
`voluntarily narrowed the case to these thirteen claims, Defendants do not believe it is necessary
`
`to burden the Court by presenting evidence on the invalidity of the currently un-asserted patents
`
`and claims Allergan previously asserted, Allergan, however, apparently takes the position that it
`
`retains the right to enforce in future litigation the claims and patents that it has dropped from the
`
`present case. Defendants cannot drop their counterclaims without assurances that such patents
`
`and claims cannot be re-asserted and put Defendants and their ANDA products in further
`
`jeopardy. It is therefore, in Defendants’ view, incumbent upon Allergan to provide adequate
`
`assurances (in the form of a covenant not to sue and stipulation of dismissal with prejudice) to
`
`remove these un-asserted patents and claims from the case, thereby conserving the resources of
`
`the Court and parties. Allergan’s repeated refusal to provide any such appropriate assurances
`
`that it will not attempt to re-litigate the dropped claims has kept the case or controversy as to
`
`those claims alive.
`
`The final judgment on the claims that Allergan has selected for trial should provide
`
`Defendants with certainty regarding whether they can bring their proposed ANDA products to
`
`market without fear of liability for infringing any of the patents Plaintiff identified in its
`
`complaints. Therefore, Defendants assert that the claims of the ’111, ’048, ’162, ’556, ’930, and
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`’191 patents are invalid under 35 U.S.C. §§ 101, 102, 103, and/or 112. Defendants further assert
`
`that each of them does not infringe any valid claims of the ’111, ’048, ’162, ’556, ’930, and ’191
`
`patent. Defendants seek:
`
`(1)
`
`A dismissal of each of Allergan’s complaints with prejudice and denial of each
`
`request for relief made by Allergan;
`
`(2)
`
`Judgment be entered in favor of Defendants, and against Allergan, finding that the
`
`Patents-in-Suit are invalid and/or not infringed;
`
`(3)
`
`A declaration that the filing of each of Defendants’ ANDAs has not infringed,
`
`does not infringe, and would not infringe any valid and enforceable claims of the
`
`Patents-in-Suit;
`
`(4)
`
`A declaration that the manufacture, use, sale, offer for sale, and/or importation
`
`into the United States of each of Defendants’ ANDA products do not and will not
`
`infringe any valid and enforceable claim of the Patents-in-Suit;
`
`(5)
`
`A declaration that the asserted claims of the Patents-in-Suit are invalid;
`
`(6)
`
`Costs and expenses, including its attorneys’ fees under 35 U.S.C. § 285; and
`
`(7)
`
`Any further and additional relief as this Court deems just and proper.
`
`D.
`
`CONTENTIONS OF THE PARTIES
`
`Allergan’s Contentions
`
`By providing these Contentions, Allergan does not concede that all of these issues are
`
`appropriate for trial.
`
`• Allergan contends that Defendants Akorn, Famy Care, InnoPharma, Mylan, and
`
`Teva are each infringing each of the asserted claims of the Patents-in-Suit under
`
`35 U.S.C. § 271(e) by Defendants Akorn’s, Famy Care’s, InnoPharma’s, Mylan’s,
`
`and Teva’s filing of ANDA Nos. 204561, 208469, 206835, 205894, and 203880,
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`respectively, seeking to market generic copies of Allergan’s Restasis® product
`
`that practice the inventions of the asserted claims of the Patents-in-Suit.
`
`• Allergan contends Defendants will infringe the ’111 and ’930 patents under 35
`
`U.S.C. § 271(a), (b), and (c) if the Defendants or their officers, agents, servants,
`
`employees, licensees, representatives, attorneys, or any other person acting or
`
`attempting to act in active concert or participation with Defendants, engage in the
`
`commercial manufacture, use, offer for sale, sale and/or importation of
`
`Defendants’ proposed products.
`
`• Allergan contends Defendants will infringe the ’048 and ’191 patents under 35
`
`U.S.C. § 271(b), and (c) if the Defendants or their officers, agents, servants,
`
`employees, licensees, representatives, attorneys, or any other person acting or
`
`attempting to act in active concert or participation with Defendants, engage in the
`
`commercial manufacture, use, offer for sale, sale and/or importation of
`
`Defendants’ proposed products.
`
`• Allergan contends that the inventions of the Patents-in-Suit were conceived at
`
`least as early as February 24, 1999, and that diligence was used from that point
`
`forward to reduce the inventions to practice.
`
`• Allergan denies Defendants’ allegations that the Patents-in-Suit are invalid.
`
`Specifically, Allergan denies that any of the references, alone or in combination,
`
`that Defendants’ experts have set forth in their expert reports render any of the
`
`asserted claims of the Patents-in-Suit anticipated or obvious, or that any of the
`
`asserted claims of the Patents-in-Suit are invalid for lack of written description,
`
`enablement, or definiteness.
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`• Allergan contends that secondary considerations of non-obviousness, including
`
`but not limited to unexpected results, failure of others, long felt need, commercial
`
`success, and copying support its contention that none of the asserted claims of the
`
`Patents-in-Suit are invalid as obvious.
`
`• Allergan contends that the asserted claims of the Patents-in-Suit are not invalid
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`for obviousness-type double patenting over U.S. Patent No. 5,474,979 to Ding.
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`• Allergan contends that the Patents-in-Suit are not invalid for failure to name the
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`proper inventors and, if found to be invalid for failure to name the proper
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`inventors, Allergan can and will correct inventorship under 35 U.S.C. § 256.
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`• Allergan contends that it is entitled to an order pursuant to 35 U.S.C. §
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`271(e)(4)(A) that the effective date of any approval of any of the Defendants’
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`ANDAs shall not be earlier than the expiration date of any one of the Patents-in-
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`Suit.
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`• Allergan contends that it will be irreparably harmed if Defendants are permitted to
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`launch the products described in their respective ANDAs, and requests that the
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`Court enter an order awarding permanent injunctive relief pursuant to 35 U.S.C. §
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`271(e)(4)(B) and any other applicable statutory or other provision.
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`• Allergan contends that should any of the Defendants attempt to engage in the
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`commercial manufacture of the products described in their respective ANDAs
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`prior to the expiration of the Patents-in-Suit, Allergan is entitled to damages
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`resulting from such infringement under 35 U.S.C. § 271(e)(4)(C), increased to
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`treble the amount found or assessed together with interest pursuant to 35 U.S.C. §
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`284.
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`• Allergan contends that this case is exceptional under 35 U.S.C. § 285.
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`• Allergan contends that it is entitled to recover its reasonable attorneys’ fees
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`incurred as a result of having to litigate this action.
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`• Allergan contends that it is entitled to recover its costs incurred as a result of
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`having to litigate this action.
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`Defendants’ Contentions
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`By providing these Contentions, Defendants do not concede that all of these issues are
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`appropriate for trial:
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`• Defendants do not have the burden of proof on infringement. Defendants deny
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`that they infringe the claims of the Patents-in-Suit by the filing of their respective
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`ANDAs. Defendants will, to the extent necessary, introduce evidence to rebut
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`Allergan’s contentions.
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`• Defendants do not have the burden of proof on infringement. Defendants deny
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`that they will infringe, either directly and/or indirectly (by induced or contributory
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`infringement), the claims of the Patents-in-Suit if the Defendants or their officers,
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`agents, servants, employees, licensees, representatives, attorneys, or any other
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`person acting or attempting to act in active concert or participation with
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`Defendants, engage in the commercial manufacture, use, offer for sale, sale and/or
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`importation of Defendants’ proposed ANDA products. Defendants will, to the
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`extent necessary, introduce evidence to rebut Allergan’s contentions.
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`• A person of ordinary skill in the art (“POSA”) to whom the asserted patents are
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`directed would have some combination of: (a) experience formulating and/or
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`treating patients with pharmaceutical products; (b) experience designing,
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`preparing and/or selecting for treatment drug emulsions intended for topical
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`ocular administration; and (c) the ability to understand results and findings
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`presented or published by others in the field.
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`• A POSA would typically have an advanced degree, such as a medical degree, or a
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`Ph.D. in organic chemistry, pharmaceutical chemistry, medicinal chemistry,
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`pharmaceutics, physical pharmacy, biochemistry, immunology, or a related field.
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`Alternatively, a person of ordinary skill in the art with respect to the asserted
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`patents could have less education, but considerable professional experience in one
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`or more of these fields.
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`• Defendants contend that the claims of the Patents-in-Suit are not entitled to the
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`asserted September 15, 2003 priority date.
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`• Defendants contend that the claims of the Patents-in-Suit are invalid for
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`anticipation pursuant to 35 U.S.C. §§ 102(a) or (b) by U.S. Patent No. 5,474,979
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`(“Ding I”) and by Sall, et al., Two Multicenter, Randomized Studies of the
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`Efficacy and Safety of Cyclosporin Ophthalmic Emulsion in Moderate to Severe
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`Dry Eye Disease, 107 Ophthal. 631 (2000) (“Sall”).
`
`• Defendants contend that the claims of the Patents-in-Suit are invalid because, as
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`of the listed September 15, 2003 priority date, they would have been obvious
`
`under 35 U.S.C. § 103 to a POSA, in light of the scope and content of the prior
`
`art, the differences between each claim at issue and the prior art, the level of
`
`ordinary skill at that time, and objective indicia of non-obviousness. Defendants
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`contend that the claims of the Patents-in-Suit are invalid as obvious in light of one
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`or more of the following prior art combinations:
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`o Ding I.
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`o Ding I in view of Sall.
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`o Ding I in view of Sall and U.S. Patent No. 5,981,607 (“Ding II”).
`
`o Ding I in view of Sall and Acheampong, et al., Cyclosporin Distribution
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`into the Conjunctiva, Cornea, Lacrimal Gland, and Systemic Blood
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`Following Topical Dosing of Cyclosporin to Rabbit, Dog, and Human
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`Eyes, in Lacrimal Gland, Tear Film, and Dry Eye Syndromes 2 1001
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`(David A. Sullivan et al., eds., Plenum Press 1998) (“Acheampong”).
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`o Ding I in view of Sall and U.S. Patent No. 5,578,586 (“Glonek”).
`
`• Defendants do not have the burden of production on objective indicia of
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`nonobviousness. Defendants deny that objective indicia of nonobviousness,
`
`including unexpected results, failure of others, long felt need, commercial
`
`success, or copying demonstrate that the alleged inventions of the claims of the
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`Patents-in-Suit would not have been obvious. Defendants will, to the extent
`
`necessary, introduce evidence to rebut Allergan’s contentions.
`
`• Defendants contend that, to the extent Allergan presents any alleged evidence of
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`objective indicia of nonobviousness, no nexus exists between such evidence and
`
`any subject matter in the asserted claims not already found in the prior art.
`
`• Defendants contend that the claims of the Patents-in-Suit are invalid for improper
`
`inventorship pursuant to 35 U.S.C. § 102(f) because the patentees failed to
`
`identify the correct inventors of the purported invention, and therefore did not
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`themselves invent the subject matter sought to be patented.
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`• Allergan has the burden of proving standing to bring this suit. Defendants contend
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`that Dr. Shulin Ding should have been named as an inventor on the patents-in-
`
`suit. Defendants contend that Allergan lacks standing for failure to establish
`
`appropriate ownership of the patents-in-suit. Defendants contend that this suit
`
`should be dismissed for lack of standing.
`
`• Defendants contend that the claims of the Patents-in-Suit are invalid for
`
`obviousness-type double patenting over Ding I.
`
`• Defendants contend that the claims of the Patents-in-Suit are invalid for statutory
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`double patenting pursuant to 35 U.S.C. § 101 over Ding I.
`
`• Defendants contend that the claims of the Patents-in-Suit are invalid for lack of
`
`written description and/or enablement pursuant to 35 U.S.C. § 112.
`
`•
`
`If Allergan is the prevailing party, Allergan has the burden of proof to establish
`
`this is an exceptional case warranting the award of attorneys’ fees and costs under
`
`the totality of the circumstances. Defendants will, to the extent necessary,
`
`introduce evidence to rebut plaintiff’s contentions.
`
`• Defendants contend that this case is exceptional under 35 U.S.C. § 285.
`
`• Defendants contend that they are entitled to recover their reasonable attorneys’
`
`fees incurred as a result of having to litigate this action.
`
`• Defendants contend that they are entitled to recover their costs incurred as a result
`
`of having to litigate this action.
`
`•
`
`In any action for patent infringement brought under 35 U.S.C. § 271(e), no
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`injunctive or other relief may be granted which would prohibit the making, using,
`
`offering to sell, or selling within the United States or importing into the United
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`States of a patented invention under 35 U.S.C. § 271(e)(1). Defendants contend
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`that, to the extent it is entitled to any relief, Allergan is not entitled to any relief
`
`enjoining activities under 35 U.S.C. § 271(e)(1).
`
`• Allergan bears the burden to show that they are entitled to the injunctive relief it
`
`seeks. Defendants contend that Allergan has failed to show a nexus between any
`
`alleged harms by any entity and Defendants’ product labeling.
`
`• Defendants contend Allergan has not shown, and cannot show, that it has suffered
`
`or will suffer the irreparable harm, not compensable by remedies available at law,
`
`required to secure a permanent injunction against any Defendant.
`
`• Defendants contend Allergan has not shown, and cannot show, that the balance of
`
`hardships between Allergan and Defendants warrants a remedy in equity.
`
`• Defendants contend Allergan has not shown, and cannot show, that the public
`
`interest would not be disserved by a permanent injunction.
`
`• Defendants contend that Allergan is entitled to no relief whatsoever.
`
`•
`
` Defendants contend that Allergan lacked standing to sue, and lacks standing to
`
`maintain its claims, and that this court therefore lacks subject matter jurisdiction.
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`E.
`
`STIPULATION OF UNCONTESTED FACTS
`
`The parties agree to the following stipulations and uncontested facts:
`
`• Allergan Inc. is a corporation organized and existing under the laws of the State
`
`of Delaware with a place of business located at 2525 Dupont Drive, Irvine,
`
`California 92612.
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`• Akorn, Inc. is a corporation organized and existing under the laws of the State of
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`Louisiana with its principal place of business located at 1925 West Field Court,
`
`Suite 300, Lake Forest, Illinois 60045.
`
`• Famy Care Ltd. is an Indian corporation, organized and existing under the laws of
`
`India, with its places of business solely in India, including at 3rd Floor, Brady
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`House, 12/14, Veer Nariman Road, Fort, Mumbai – 400 001, Maharashtra, India.
`
`•
`
`InnoPharma, Inc. is a corporation organized and existing under the laws of
`
`Delaware with its principal place of busi