Arnold B. Calmann (abc@saiber.com)
`Jeffrey Soos (js@saiber.com)
`Katherine A. Escanlar (kae@saiber.com)
`SAIBER LLC
`One Gateway Center, 10th Floor
`Newark, New Jersey 07102
`Telephone: (973) 662-3333
`Facsimile: (973) 286-2465
`
`Deepro R. Mukerjee (deepro.mukerjee@alston.com)
`Lance A. Soderstrom (lance.soderstrom@alston.com)
`ALSTON & BIRD LLP
`90 Park Avenue
`New York, NY 10016
`(212) 210-9400
`
`Attorneys for Defendants InnoPharma Licensing, Inc.,
`InnoPharma Licensing LLC, InnoPharma, Inc.,
`and InnoPharma, LLC
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`Plaintiffs,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and
`BAUSCH & LOMB PHARMA
`HOLDINGS CORP.,
`
`
`
`
`
`INNOPHARMA LICENSING INC.,
`INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., and
`INNOPHARMA LLC,
`
`
`
`
`
`Defendants.
`
`
`
`)
`)
`)
`)
`)
`
`)
` ) Civil Action No. 1:14-cv-6893-JBS-KMW
` )
` )
` )
` )
` )
` )
` )
` )
` )
`
`DEFENDANTS INNOPHARMA LICENSING INC., INNOPHARMA
`LICENSING LLC, INNOPHARMA INC., AND INNOPHARMA LLC’s
`INITIAL INVALIDITY CONTENTIONS PURSUANT TO L. PAT. R. 3.6(c)
`
`
`
`
`1
`
`Page 1 of 280
`
`SENJU EXHIBIT 2087
`LUPIN v. SENJU
`IPR2015-01099
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introductory Statement.........................................................................................................1
`
`General Information .............................................................................................................7
`
`A.
`
`B.
`
`C.
`
`Claim Construction ................................................................................................. 7
`
`Level of Ordinary Skill in the Art ........................................................................... 8
`
`Ongoing Discovery ................................................................................................. 8
`
`III.
`
`L. Pat. R. 3.3(a) - Identification of the Prior Art. ................................................................9
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
`
`U.S. Patent No. 4,910,225 to Ogawa et al. ........................................................... 10
`
`U.S. Patent No. 6,107,343 to Sallmann et al......................................................... 11
`
`U.S. Patent No. 6,274,609 to Yasueda et al. ......................................................... 12
`
`Hara, Yoshiyuki, Clinics & Drug Therapy 2000, 19:1014-1015 .......................... 14
`
`WO 02/13804 to Kapin et al. ................................................................................ 15
`
`U.S. Patent No. 5,414,011 to Fu et al. .................................................................. 16
`
`AU-B-22042/88 to Fu et al. .................................................................................. 17
`
`Regev and Zana, Journal of Colloid and Interface Science (210) 8–17
`(1999). ................................................................................................................... 19
`
`Yuan et al., J. Phys. Chem. B 2001, 105, 4611-4615 ........................................... 20
`
`U.S. Patent No. 2,454,541 to Bock et al. .............................................................. 21
`
`IV.
`
`L. Pat. R. 3.3(b) – Anticipation and Obviousness. ............................................................21
`
`A.
`
`U.S. Patent No. 8,129,431 (The ’431 patent)........................................................ 21
`
`1.
`
`Independent Claim 1 of the ’431 patent .................................................... 21
`
`a.
`
`b.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, alone or in combination with
`the ’609 patent................................................................................21
`
`Obvious under 35 U.S.C. § 103 over the ’343 patent in
`view of the ’225 patent, alone or in combination with Hara .........28
`
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`c.
`
`d.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev .............31
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, Yuan, and
`the ’541 patent................................................................................36
`
`2.
`
`Independent Claim 18 of the ’431 patent .................................................. 38
`
`a.
`
`b.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, alone or in combination with
`the ’609 patent, or alternatively, over the ’343 patent in
`view of the ’225 patent, alone or in combination with Hara .........38
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev, or
`alternatively, the ’225 patent in view of the ’804
`Publication, the ’011 patent, Yuan, and the ’541 patent ................41
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Dependent Claims 2 and 19 of the ’431 patent ......................................... 42
`
`Dependent Claims 3 and 4 of the ’431 patent ........................................... 43
`
`Dependent Claims 6 and 20 of the ’431 patent ......................................... 48
`
`Dependent Claims 7 and 8 of the ’431 patent ........................................... 52
`
`Dependent Claims 9 and 10 of the ’431 patent ......................................... 54
`
`B.
`
`U.S. Patent No. 8,669,290 (The ’290 patent)........................................................ 55
`
`1.
`
`Independent Claims 1 and 14 of the ’290 patent ...................................... 56
`
`a.
`
`b.
`
`c.
`
`d.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, or alternatively, over the ’225
`patent in view of the ’343 patent and the ’609 patent ....................56
`
`Obvious under 35 U.S.C. § 103 over the ’343 patent in
`view of the ’225 patent, or alternatively, over the ’343
`patent in view of the ’225 patent and Hara ....................................62
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev .............65
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, Yuan, and
`the ’541 patent................................................................................68
`
`2.
`
`Independent Claim 8 of the ’290 patent .................................................... 71
`
`
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`a.
`
`b.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, or alternatively, over the ’225
`patent in view of the ’343 patent and the ’609 patent, or
`alternatively, over the ’343 patent in view of the ’225
`patent, or alternatively, over the ’343 patent in view of
`the ’225 patent and Hara ................................................................71
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev or,
`alternatively, in view of the ’804 Publication, the ’011
`patent, Yuan, and the ’541 patent ..................................................72
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Dependent Claims 10, 20 and 22 of the ’290 patent ................................. 74
`
`Dependent Claims 2, 9, 15 and 21 of the ’290 patent ............................... 75
`
`Dependent Claims 3 and 16 of the ’290 patent ......................................... 77
`
`Dependent Claims 4, 11, 17 and 23 of the ’290 patent ............................. 77
`
`Dependent Claims 6, 12, 18 and 24 of the ’290 patent ............................. 81
`
`Dependent Claims 7, 13, 19, and 25 of the ’290 patent ............................ 82
`
`Dependent Claims 26-30 of the ’290 patent ............................................. 87
`
`C.
`
`U.S. Patent No. 8,754,131 (The ’131 patent)........................................................ 89
`
`1.
`
`Independent Claims 1, 7, and 13 of the ’131 patent ................................. 89
`
`a.
`
`b.
`
`c.
`
`d.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, or alternatively, over the ’225
`patent in view of the ’343 patent and the ’609 patent ....................89
`
`Obvious under 35 U.S.C. § 103 over the ’343 patent in
`view of the ’225 patent, or alternatively, over the ’343
`patent in view of the ’225 patent and Hara ....................................97
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev ...........100
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, Yuan, and
`the ’541 patent..............................................................................104
`
`2.
`
`3.
`
`Dependent Claims 2, 8, and 14 of the ’131 patent .................................. 107
`
`Dependent Claims 3 and 15 of the ’131 patent ....................................... 108
`
`
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`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Dependent Claim 4 of the ’131 patent .................................................... 109
`
`Dependent Claims 5, 11, and 17 of the ’131 patent ................................ 111
`
`Dependent Claims 6, 12, 18, and 24 of the ’131 patent .......................... 113
`
`Dependent Claims 9, 19 and 21 of the ’131 patent ................................. 121
`
`Dependent Claims 10, 16, and 22 of the ’131 patent .............................. 123
`
`Dependent Claim 20 of the ’131 patent .................................................. 127
`
`10.
`
`Dependent Claim 23 of the ’131 patent .................................................. 128
`
`11.
`
`Dependent Claims 25-29 of the ’131 patent ........................................... 129
`
`12.
`
`Dependent Claim 30 of the ’131 patent .................................................. 132
`
`D.
`
`U.S. Patent No. 8,871,813 (The ’813 patent)...................................................... 133
`
`1.
`
`Independent Claims 1 and 13 of the ’813 patent .................................... 134
`
`a.
`
`b.
`
`c.
`
`d.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, or alternatively, over the ’225
`patent in view of the ’343 patent and the ’609 patent ..................134
`
`Obvious under 35 U.S.C. § 103 over the ’343 patent in
`view of the ’225 patent, or alternatively, over the ’343
`patent in view of the ’225 patent and Hara ..................................141
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev ...........144
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, Yuan, and
`the ’541 patent..............................................................................147
`
`2.
`
`Independent Claim 7 of the ’813 patent .................................................. 150
`
`a.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’343 patent, or alternatively, over the ’225
`patent in view of the ’343 patent and the ’609 patent, or
`alternatively, over the ’343 patent in view of the ’225
`patent, or alternatively, over the ’343 patent in view of
`the ’225 patent and Hara ..............................................................150
`
`b.
`
`Obvious under 35 U.S.C. § 103 over the ’225 patent in
`view of the ’804 Publication, the ’011 patent, and Regev or,
`
`
`
`
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`alternatively, in view of the ’804 Publication, the ’011
`patent, Yuan, and the ’541 patent ................................................153
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Dependent Claims 2, 8, and 14 of the ’813 patent .................................. 155
`
`Dependent Claims 3 and 15 of the ’813 patent ....................................... 156
`
`Dependent Claim 4 of the ’813 patent .................................................... 157
`
`Dependent Claims 5, 11, and 17 of the ’813 patent ................................ 159
`
`Dependent Claims 6, 12, 18, and 23 of the ’813 patent .......................... 160
`
`Dependent Claims 9, 19 and 20 of the ’813 patent ................................. 169
`
`Dependent Claims 10, 16, and 21 of the ’813 patent .............................. 171
`
`10.
`
`Dependent Claim 22 of the ’813 patent .................................................. 174
`
`11.
`
`Dependent Claim 27 of the ’813 patent .................................................. 176
`
`E.
`
`Secondary Considerations Are Insufficient to Rebut the Prima Facie
`Obviousness of the Asserted Claims................................................................... 178
`
`V.
`
`L. Pat. R. 3-3(c) – Claim charts. ......................................................................................183
`
`VI.
`
`L. Pat. R. 3-3(d) - Contentions based on 35 U.S.C. § 112. ..............................................183
`
`A.
`
`Claims 3, 4, 6, 9, 10, and 20 of the ’431 patent, Claims 4, 6-13, 17-25, 27,
`29, and 30 of the ’290 patent, Claims 1-30 of the ’131 patent, and Claims
`1-23 and 27 of the ’813 patent are Invalid for Indefiniteness under 35
`U.S.C. § 112(b) ................................................................................................... 184
`
`B.
`
`Claim 27 of the ’813 patent is Invalid for Indefiniteness under 35 U.S.C.
`§§ 112(b) and (d) ................................................................................................ 186
`
`C.
`
`Lack of Written Description and/or Enablement under 35 U.S.C. § 112(a) ....... 186
`
`VII. Conclusion .......................................................................................................................187
`
`
`
`v
`
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`In compliance with L. Pat. R. 3.6(c) and the Court’s Amended Scheduling Order of
`
`February 27, 2015, Defendants InnoPharma Licensing Inc., InnoPharma Licensing LLC,
`
`InnoPharma Inc. and InnoPharma LLC (“InnoPharma”) hereby submits InnoPharma’s Initial
`
`Invalidity Contentions1 with respect to the claims of U.S. Patent Nos. 8,129,431 (“the ’431
`
`patent”), 8,669,290 (“the ’290 patent”), 8,754,131 (“the ’131 patent”), and 8,871,813 (“the ’813
`
`patent”) (collectively, “the Asserted Patents”) identified by Plaintiffs Senju Pharmaceutical Co.,
`
`Ltd. (“Senju”), Bausch & Lomb, Incorporated (“B+L”), and Bausch & Lomb Pharma Holdings
`
`Corp. (“B+L Pharma Holdings”), (collectively, “Plaintiffs”) in their Disclosure of Asserted
`
`Claims dated April 30, 2015.2 Specifically, Plaintiffs have asserted claims 1-4, 6-10, and 18-20
`
`of the ’431 patent, claims 1-4 and 6-30 of the ’290 patent, claims 1-30 of the ’131 patent, and
`
`claims 1-23 and 27 of the ’813 patent (collectively, “the Asserted Claims”) against InnoPharma
`
`in this litigation. The Asserted Claims purport to claim Bausch & Lomb’s PROLENSA
`
`TM product
`
`either generically or specifically. As discussed in more detail below, all of these claims are
`
`invalid. Accordingly, because the Asserted Claims are invalid, InnoPharma cannot infringe any
`
`of these claims.
`
`I.
`
`
`
`Introductory Statement
`
`InnoPharma’s contentions are being provided under L. Pat. R. 2.2 on an “OUTSIDE
`
`ATTORNEY’S EYES ONLY” basis exclusively for the purposes of the above-captioned
`
`
`1 InnoPharma expressly incorporates by reference herein each basis of invalidity set forth in its
`respective Detailed Factual and Legal Bases in Support of Its Paragraph IV Certifications
`(“Notice Letters”) provided to Plaintiffs. InnoPharma also expressly incorporates by reference
`herein each basis of invalidity set forth in its respective Petitions for Inter Partes Review of the
`’290 and ’431 patents previously submitted to the USPTO and provided to Plaintiffs. See
`IPR2015-00902 & 903, filed March 19, 2015.
`
`2 Nothing in this statement of contentions should be construed as limiting InnoPharma’s statutory
`rights pursuant to 35 U.S.C. § 282, which requires a party asserting non-infringement or
`invalidity defenses to provide notice of relevant prior art thirty days before trial.
`
`
`
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`litigation only, and neither these contentions nor any information contained herein may be
`
`disclosed to Plaintiffs or any other persons pending the entry of an appropriate discovery
`
`confidentiality order. InnoPharma provides its contentions regarding the Asserted Patents
`
`subject to the following objections and reservation of rights, subject further to the Federal Rules
`
`of Civil Procedure and the New Jersey Local Rules of Civil Procedure and Local Patent Rules:
`
`A. Objections to the New Jersey Local Patent Rules
`
`
`
`InnoPharma respectfully objects to the New Jersey Local Patent Rules to the extent that
`
`such rules require an early and exhaustive disclosure of InnoPharma’s factual and legal bases for
`
`its defenses to the Plaintiffs’ claims of infringement and to support its counterclaims for
`
`declaratory judgment. The District of New Jersey's disclosure requirements, and the limitations
`
`on InnoPharma’s ability to amend the same, effectively conflict with Rules 8, 9, and 15 (perhaps
`
`among others) of the Federal Rules of Civil Procedure. These rules respectively (1) provide for
`
`liberal pleading requirements, (2) specifically limit the circumstances in which specificity in
`
`pleading is required, and (3) require the courts to “freely give leave” to amend pleadings, even
`
`during the midst of trial when the amendment “will aid in presenting the merits” without
`
`prejudicing an objecting party. See generally Fed. R. Civ. P. 8, 9, 15; see also Fed. R. Civ. P. 83
`
`(“A local rule must be consistent with ... federal statutes and rules adopted under 28 U.S.C. §§
`
`2072 and 2075 ... “); see also, e.g., Bjorgung v. Whitetail Resort, LP, 550 F.3d 263, 266 (3d Cir.
`
`2008) (“[T]he liberal pleading philosophy of the federal rules does limit a district court’s
`
`discretion to deny leave to amend,” and “[t]he district court has discretion to deny [a] request [to
`
`amend a pleading] only if the ... delay in seeking to amend is undue, motivated by bad faith, or
`
`prejudicial to the opposing party.”).
`
`
`
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`Furthermore, InnoPharma objects to any application of the New Jersey Local Patent
`
`Rules that would relieve Plaintiffs of the burden of proving infringement. See, e.g., LNP Eng’g
`
`Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347, 1356 (Fed. Cir. 2001) (“To prove RTP
`
`literally infringed claim 1 of the 450 patent, LNP bore the burden of proving preponderant
`
`evidence that RTP’s accused products satisfy every limitation of claim 1.”).
`
`
`
`InnoPharma further objects to the application of the New Jersey Patent Rules in general,
`
`and specifically as they apply to Hatch-Waxman cases, inasmuch as they improperly place
`
`burdens upon InnoPharma that are prejudicial and unfairly one-sided, and to the extent they seek
`
`to limit InnoPharma’s right to obtain discovery under the Federal Rules of Civil Procedure, and
`
`to the extent they are construed as limiting InnoPharma’s statutory rights, including, without
`
`limitation, those arising under 35 U.S.C. § 282 (requiring a party asserting non-infringement or
`
`invalidity defenses to provide notice of relevant prior art thirty days before trial). InnoPharma
`
`further reserves the right to maintain that the New Jersey Local Patent Rules (1) impose burdens
`
`upon InnoPharma that adversely impact the duration of this case, and. therefore, delay
`
`introduction of generic products into the market and impede the Congressionally-mandated goal
`
`of the Hatch-Waxman Amendments, which is to “get generic drugs into the hands of patients at
`
`reasonable prices- fast,” In re Barr Labs, Inc., 930 F.2d 72, 76 (D.C. Cir. 1991); and/or (2)
`
`otherwise prejudice InnoPharma’s due process rights.
`
`
`
`InnoPharma respectfully objects specifically to the application of New Jersey Local
`
`Patent Rule 3.6 on the grounds that the rule is unfair, inequitable, contrary to standard practice in
`
`similar cases in federal courts throughout the United States, and inconsistent with New Jersey
`
`Local Patent Rule 3.5 relating to cases for declaratory judgment of invalidity. InnoPharma
`
`further objects to New Jersey Local Patent Rule 3.6 on the grounds that it violates InnoPharma’s
`
`
`
`
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`due process rights resulting in fundamental unfairness to InnoPharma. By inverting the
`
`obligations of the parties, Rule 3.6 places InnoPharma in the highly unfair position of having to
`
`identity its invalidity and non-infringement contentions and produce the documents upon which
`
`InnoPharma intend to rely in support of the same before Plaintiffs are required to identify its
`
`patent claim constructions and infringement contentions and well before discovery is complete.
`
`This prejudice is not remedied by the Plaintiffs’ disclosure of asserted claims in accordance with
`
`New Jersey Local Patent Rule 3 .6(b).
`
`
`
`Accordingly, and without waiver of any rights, InnoPharma reserves the right to
`
`challenge the application of the New Jersey Patent Rules generally and New Jersey Patent Rule
`
`3.6 specifically, in whole or in part.
`
`
`
`
`
`B.
`
`Preliminary Nature of Contentions
`
`These contentions are based on information reasonably available to InnoPharma at this
`
`time. These contentions are necessarily preliminary and may require subsequent amendment,
`
`alteration or supplementation. By submitting these contentions, InnoPharma does not waive its
`
`claims or defenses in this case.
`
`
`
`These contentions do not indicate InnoPharma’s position with regard to the proper claim
`
`construction of any term of the patents-in-suit. InnoPharma has made reasonable assumptions, to
`
`the extent necessary and appropriate, with respect to the meaning of patent claim terms for the
`
`purpose of preparing these contentions. InnoPharma reserves the right to rely upon different
`
`meanings in the conduct of this litigation and to assert different meanings as appropriate in
`
`connection with Markman procedures and proceedings. InnoPharma further reserves the right to
`
`update these contentions following a Markman opinion adopting meanings that differ from those
`
`
`
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`assumed by InnoPharma or any other judicial clarification or alteration of the meaning of claim
`
`terms, and/or as otherwise authorized or permitted by the New Jersey Local Patent Rules, the
`
`Local Rules of the U.S. District of New Jersey and the Federal Rules of Civil Procedure.
`
`
`
`In addition, InnoPharma reserves its right to identify other art or to amend, alter, or
`
`supplement these contentions at any time and/or as otherwise authorized or permitted by the
`
`aforesaid Rules, based on the following:
`
`
`
`1. Any further investigation;
`2. Any fact or expert discovery materials, including, but not limited to, documents,
`laboratory notebooks, reports, communications and deposition testimony, that
`have not yet been obtained, produced or provided to InnoPharma;
`
`3. Any further evaluation of the scope and content of the prior art or as prior art is
`
`discovered;
`4. Clarification of Plaintiffs’ infringement positions;
`5. The Markman decision and/or any claim construction by a Court relating to the
`
`patents-in-suit;
`6. Any claim contentions that Plaintiffs may assert that are different from any
`
`assumptions InnoPharma has made in preparing these contentions;
`7. Any constructions or additional or different infringement allegations that
`Plaintiffs may assert at a later date; or
`8. Any other grounds otherwise provided under the Local Patent Rules or any other
`
`applicable Rules or upon leave of the Court and/or any other reason requiring
`
`same.
`
`These contentions may be asserted in the alternative and do not constitute any concession
`
`
`
`
`
`
`
`
`
`by InnoPharma for purposes of claim construction or infringement. See Fed. R. Civ. P. 8(d).
`
`
`
`InnoPharma incorporates, in full, all prior art references cited in the patents-in-suit as
`
`well as any related patents and/or applications, and their respective prosecution histories,
`
`whether the related patents and/or applications were filed in the United States or in a foreign
`
`country.
`
`
`
`Furthermore, these contentions are provided without prejudice to the rights of
`
`InnoPharma to introduce at trial any subsequently-discovered evidence or expert opinions
`
`relating to currently-known facts and to produce and introduce at trial all evidence, whenever
`
`
`
`
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`discovered, relating to the proof of subsequently-discovered facts. Moreover, facts, documents
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`and things now known may be imperfectly understood and, accordingly, such facts, documents
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`and things may not have been included in this statement. InnoPharma reserves its right to refer
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`to, conduct discovery with reference to, or offer into evidence at the time of trial, any and all
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`facts, expert opinion testimony, documents and things notwithstanding the written statements
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`herein and subject to the Rules of this Court. InnoPharma further reserves its right to refer to,
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`conduct discovery with reference to, or offer into evidence at the time of trial, any and all facts,
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`documents and things that are not currently recalled but might be recalled at some time in the
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`future.
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`InnoPharma objects to the disclosure of information that is protected by the attorney-
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`client privilege, attorney work-product immunity, the common interest privilege, or any other
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`applicable privilege or immunity. To the extent that InnoPharma inadvertently disclose
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`information that may be protected from discovery under the attorney-client privilege, the
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`attorney work-product immunity, the common interest privilege or any other applicable privilege
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`or immunity, such inadvertent disclosure does not constitute a waiver of any such privilege or
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`immunity.
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`The information set forth below is provided without waiver of (1) the right to object to
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`the use of any statement for any purpose, in this action or in any other action, on the grounds of
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`privilege, relevance, materiality or any other appropriate grounds; (2) the right to object to any
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`request involving or relating to the subject matter of the statements herein; or (3) the right to
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`revise, correct, supplement or clarify any of the statements provided below at any time.
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`InnoPharma reserves the right to amend and/or supplement these contentions in accordance with
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`the Federal Rules of Civil Procedure and the Rules of this Court.
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`InnoPharma incorporates by reference any and all non-infringement and invalidity
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`contentions served by others in connection with litigation concerning the patents-in-suit and
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`reserves the right to rely upon such contentions if, and to the extent, InnoPharma deems
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`appropriate.
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`InnoPharma reserves the right to allege the invalidity of the patents-in-suit on bases other
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`than those disclosed herein.
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`InnoPharma reserves all rights to supplement and/or amend these contentions, including
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`the prior art disclosed and the stated grounds of invalidity as well as the right to articulate the
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`definition of a person of ordinary skill in the art (“POSA”) at the appropriate time during
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`discovery. In addition, InnoPharma reserves the right to prove the invalidity of the Asserted
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`Claims on bases other than those asserted here and/or amend these contentions at a later date.
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`Subject to the foregoing, InnoPharma hereby submits the following invalidity
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`contentions.
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`II.
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`General Information
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`A.
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`Claim Construction
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`These contentions should not be taken as an indication of InnoPharma’s position with
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`regard to the proper construction of any claim term. Rather, InnoPharma has made reasonable
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`assumptions, to the extent necessary and appropriate, as to the meaning of claim terms for the
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`purpose of these contentions only and have used those meanings to prepare these contentions.
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`To the extent that InnoPharma determines that a different meaning is appropriate for any claim
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`term, it will assert that meaning in connection with the claim construction proceedings at the
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`appropriate time. Moreover, InnoPharma reserves the right to amend these contentions as a
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`result of the Markman hearing, or any other subsequent clarification or alteration of the meaning
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`of claim terms.
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`B.
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`Level of Ordinary Skill in the Art
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`At this stage of the litigation and for purposes of the Graham factors, InnoPharma states
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`that from the subject matter of the claims of the Asserted Patents, a POSA would have had
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`education and/or experience in the field of ophthalmic formulations and drug delivery, and
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`knowledge of the scientific literature concerning the same, specifically pharmaceutical
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`formulations for ophthalmic administration, including those comprising anti-inflammatory
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`compounds (such as non-sterioidal anti-inflammatory drugs (“NSAIDs”)) as of 2003. The
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`education and experience levels may vary between persons of ordinary skill, with some persons
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`holding a basic Bachelor’s degree, but with 5-10 years of relevant work experience, or others
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`holding more advanced degrees—e.g., Pharm.D., Ph.D., or M.D.—but having fewer years of
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`experience. A person of ordinary skill may work as part of a multi-disciplinary team and draw
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`upon not only his or her own skills, but also take advantage of certain specialized skills of others
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`in the team, to solve a given problem. The hypothetical POSA is assumed to be aware of all
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`pertinent prior art. See, e.g., Standard Oil Co., 774 F.2d at 454. InnoPharma reserves all rights
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`to supplement and/or modify and/or articulate this definition of a POSA at the appropriate time
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`during discovery.
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`C.
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`Ongoing Discovery
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`These Invalidity Contentions are based on information that is currently available to
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`InnoPharma. InnoPharma reserves the right to supplement and/or amend these contentions in
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`accordance with any Scheduling Order entered by the Court. InnoPharma further reserves the
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`right to supplement and/or amend these contentions in response to any contentions by Plaintiffs.
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`InnoPharma further reserves the right to supplement and/or amend these contentions as discovery
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`proceeds, including based on expert discovery disclosures and on any other discovery materials
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`that have not yet been produced or provided to InnoPharma, or upon further investigation.
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`InnoPharma also reserves the right to supplement and/or amend these contentions to the extent
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`any claim construction ruling by the Court modifies InnoPharma’s positions herein and/or
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`provides the basis for additional invalidity contentions. InnoPharma otherwise reserves the right
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`to supplement and/or amend these contentions as necessary and appropriate and as provided
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`under the Local Patent Rules or any other applicable Rules or Order of the Court.
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`These contentions are made pursuant to Federal Rule of Evidence 502. To the extent
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`these contentions contain any information that may be protected from discovery under the
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`attorney-client privilege, the attorney work-product immunity, the common interest privilege, or
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`any other applicable privilege or immunity, such disclosure is inadvertent and does not constitute
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`a waiver of any such privilege or immunity. The information set forth in these contentions is
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`provided without waiving: (1) the right to object to the use of any statement for any purpose, in
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`this action or any other, on the grounds of privilege, relevance, materiality, or any other
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`appropriate grounds; (2) the right to object to any request involving or relating to the subject
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`matter of the statements herein; or (3) the right to revise, correct, supplement, or clarify any of
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`the statements provided below at any time.
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`III. L. Pat. R. 3.3(a) - Identification of the Prior Art.
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`InnoPharma identifies the publications produced as PROLENSA00006074 through
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`PROLENSA00006178 as prior art that anticipate and/or render obvious the Asserted Claims
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`under 35 U.S.C. §§ 102 and 103, either alone or in combination. Because investigation and
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`discovery are ongoing and because the Court has not yet construed the Asserted Claims