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`ALsTON&BIRD LLP
`
`90 PDrk A venue
`New York, ~y 10016
`212-210-9400
`FHx:lll-21 0-9444
`www.nl~ton.s:om
`
`Dee pro R. Mukerjce
`
`Direct DI.al: Z12·Zlo-9501
`
`E·mall: deepro.mukerjeeOalslorLc:om
`
`October 30, 2014
`
`CONFIDENTIAL
`
`VIA FEDEX OVERNIGHT DELIVERY'
`
`President & CEO
`SENJU PHARMACEUTICAL Co., LTD.
`2-5-8, Hiranomichi, Chuo-Ku
`Osaka 541-0046 Osaka Japan
`
`President & CEO
`SENJU USA, INC.
`21700 Oxnard Street, Suite 1 070
`Woodland Hills, CA 91367
`
`President & CEO
`BAUSCH & LOMB
`1 Bausch & Lomb Place
`Rochester, NY 14604
`
`President & CEO
`SENJU PHARMACEUTICAL Co., LTD.
`5-8, Hiranomichi 2-Chome, Chuo-Ku
`Osaka-Shi, Osaka, Japan 541-0046
`
`President & CEO
`BAUSCH & LOMB (Global Headquarters)
`700 Route 202/206 North
`Bridgewater, NJ 08807
`
`Re: ANDA No. 206326 (Bromfcnac) Notification of Certification of Noninfringcmcnt
`and/or Invalidity for U.S. Patent No. 8,754,131 Pursuant to § 505(j)(2)(B)(ii) of
`the U.S. Federal Food, Drug and Cosmetic Act
`
`To whom it may concern:
`
`We represent Innopharma Licensing, Inc. ("lnnopharma") in connection with this
`letter and in connection with any litigation that ensues therefrom.
`Pursuant to
`Section 505(j)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.95,
`Innopharma hereby provides notice that today it has amended Abbreviated New Drug
`206326
`("ANDA'')
`certifying,
`described
`in
`21 C.F.R.
`Application No.
`as
`§ 319.94(a)(l2)(i)(A)(4) ("Paragraph IV"), that U.S. Patent No. 8,754,131 ("the '131 patent")
`
`I lnnopharma has obtained approval from the FDA to use Federal Express in lieu of the U.S. Postal Service for
`the purpose of providing notice to the NDA holder and any patent assignees associated with Paragraph IV
`certification(s) contained within ANDA 206326 (attached as Exhibit B). The assignee's name for the '131
`patent is taken from the face page of the '1 31 patent. The USPTO's web-based assignment records accessed on
`October 30, 2104 report that the assignment data for the '13 I patent is not currently available.
`
`Atlonta • O>rlol~ • O.llos • Los Angeles • New York • Rcsean:l1 Triangle • Slllcon Vol~y • Vuntura County • Washington. D.C.
`Munlch ( Ualson !lam)
`
`SENJU EXHIBIT 2007
`INNOPHARMA v. SENJU
`IPR2015-00903
`
`Page 1 of 72
`
`

`

`CONFIDENTIAL
`October 30,2014
`Page 2
`
`is invalid, unenforceable, and/or will not be infringed by the manufacture, use, sale, offer for
`sale, or importation of Innophanna's Bromfenac Product as defined by lnnopharma's ANDA
`No. 206326.
`
`Innophanna's ANDA is for a generic drug product having the established name
`PROLENSA ™. The active ingredient in the proposed drug product is bromfenac, which is
`present in the PROLENSA TM ophthalmic solution product in the form of bromfenac sodium
`sesquihydrate. PROLENSA ™ is supplied as a sterile, aqueous 0.07% solution with a pH of7.8.
`
`The United States Food and Drug Administration ("FDA") has accepted
`Innophanna's ANDA for filing and has assigned the application No. 206326. The ANDA
`contains
`the required bioavailability and/or bioequivalence data
`from studies on
`lnnophanna's Bromfenac Product that is the subject of the ANDA.
`
`Innophanna originally submitted its ANDA under 21 U.S.C. § 3550)(1) and (2)(A)
`with Paragraph IV certifications to U.S. Patent Nos. 8,129,431 (''the '431 patent") and the
`8,669,290 ("the '290 patent"). On September 19, 2014, Innopharma sent to Senju
`Pharmaceuticals and Bausch & Lomb written notification of its PIV certification and a
`detailed statement of its then-existing factual and legal bases of Innopharma's belief that
`each of the '431 and ' 290 patents is invalid, unenforceable, or will not be infringed by the
`manufacture, use, sale, offer for sale, or importation of the drug product described in
`lnnophanna's ANDA.
`Innopharma has amended
`its ANDA under 21 C.F.R. §
`314.94(a)( 12)(vi) to further include a Paragraph IV certification to the '131 patent, which
`lists as an issuance date on its face of July 17,2014. Each ofthe '131, '431 and '290 patents
`is listed in Approved Drug Products with Therapeutic Equivalence Evaluations ("the Orange
`Book") in connection with Bausch & Lomb, Inc.'s ("B&L") approved NDA No. 203168 for
`PROLENSA·rM ophthalmic solution.
`
`Innophruma seeks the FDA's approval to market its proposed Bromfenac Product
`Innopharma alleges, and originally
`prior to the expiration of the Orange Book Patents.
`certified to the FDA that, to the best of Innopharma's knowledge, the '431 and '290 patents
`are invalid, unenforceable, and/or will not be infringed by the manufacture, use, sale, offer
`for sale, or importation of the drug product described in lnnopharma's ANDA. lnnophanna
`additionally alleges and has certified to the FDA that, to the best of lnnopharma's
`knowledge, the '131 patent is invalid, unenforceable, and/or will not be infringed by the
`manufacture, use, sale, offer for sale, or importation of the drug product described in
`Innophanna's ANDA. With regard to the' 131 patent, according to the FDA's Orange Book:
`
`•
`
`the '13 1 patent wi 11 expire on January, 16 2024.
`
`Attached as Exhibit A is a detailed statement, made pursuant to 21 U.S.C.
`§ 355U)(2)(B)(iv)(II) and 21 C.F.R. § 314.95, of the present factual and legal bases for
`lnnopharma's Paragraph IV certification to the 'I 31 patent of the Orange Book Patents. The
`statements made therein are based on the information currently available to Innophanna.
`Innopharma reserves all rights to raise any additional defenses relating to invalidity,
`
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`Page 2 of 72
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`

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`CONFIDENTIAL
`October 30, 2014
`Page 3
`
`unenforceability, and/or noninfringement should additional information become known to
`lnnopharma.
`
`Offer of Confidential Access to ANDA
`
`Pursuant to 21 U.S.C. § 355(j)(5)(C), this notice letter includes an Offer of Confidential
`Access to Innopharma's ANDA and any supplement(s) thereto. As required by Section
`35S(j)(5)(C)(i)(III), Innopharma offers to provide confidential access to certain information
`from its ANDA No. 206326 for the sole and exclusive purpose of determining whether an
`infringement action referred to in Section 355(j)(5)(B)(iii) can be brought.
`
`Section 355(j)(5)(C)(i)(III) allows lnnopharma to impose restrictions "as to persons
`entitled to access, and on the use and disposition of any information accessed, as would apply
`had a protective order been entered for the purpose of protecting trade secrets and other
`confidential business information." That provision also grants Innopharma the right to redact
`its ANDA to exclude non-relevant information in response to a request for Confidential Access
`under this Offer.
`
`(1)
`
`As permitted by statute, Innopharma imposes the following terms and restrictions on its
`Offer of Confidential Access:
`Innopharma will permit confidential access to certain information from its
`proprietary ANDA No. 206326 to attorneys from one outside law firm
`representing B&L; provided, however, that such attorneys do not engage,
`formally or informally, in any patent prosecution for B&L or any FDA
`counseling, litigation, or other work before or involving the FDA. Such
`information (hereinafter, "Confidential Innopharrna Information") shall be
`marked
`with
`the
`legend
`"CONFIDENTIAL
`INNOPHARiv1A
`INFORMATION."
`
`(2)
`
`(3)
`
`The attorneys from the outside law firm representing B&L shall not disclose
`any Confidential Innopharma Information to any other person or entity,
`including B&L employees, outside scientific consultants, and/or other outside
`counsel retained by B&L, without the prior written consent of lnnopharrna.
`
`As provided by Section 355(j)(5)(C)(i)(III), B&L's outside law firm shall make
`usc of the Confidential Innopharma Information for the sole and exclusive
`purpose of determining whether an action
`referred
`to
`in Section
`35S(j)(S)(B)(iii) can be brought and for no other purpose. By way of example
`only, the Confidential Innopharrna Information shall not be used to prepare or
`prosecute any future or pending patent application by B&L in connection with
`any filing to, or communication with, the FDA relating to Innopharrna's ANDA
`No. 206326. B&L's outside law firm agrees to take all measures necessary to
`prevent unauthorized disclosure or use of the Confidential
`lnnopharma
`Information, and that all Confidential lnnopharma Information shall be kept
`confidential and not disclosed in any manner inconsistent with this Offer of
`Confidential Access.
`
`Page 3 of 72
`
`

`

`CONFIDENTIAL
`October 30, 2014
`Page4
`
`(4)
`
`(5)
`
`(6)
`
`(7)
`
`(8)
`
`The Confidential lnnopharma Information disclosed is, and remains, the
`Innophanna
`property of lnnopharma. By providing said Confidential
`Information, Innophanna does not grant B&L and/or its outside law firm any
`interest in or license for and to the Confidential Innopharma Information.
`B&L's outside law finn shall, within thirty-five (35) days from the date that it
`first receives the Confidential Innopharrna Information, return to Innopharrna
`all Confidential Innopharma Information and any copies thereof. B&L' s
`outside law firm shall return all Confidential Innophanna Information to
`Innopharrna before any infringement suit is filed by B&L, if suit is commenced
`before this 35-day period expires. In the event that B&L opts to file suit, none
`of the information contained in or obtained from any Confidential Innopharma
`Information that Innophanna provides, including Exhibit A to this letter, shall
`be included in any publicly-available complaint or other pleading.
`Nothing in this Offer of Confidential Access shall be construed as an admission
`by Innopharma regarding the validity, enforceability, and/or infringement of
`any U.S. patent. Further, nothing herein shall be construed as an agreement or
`admission by Innopharma with respect to the competency, relevance, or
`materiality of any such Confidential lnnopharma Information, document, or
`thing. The fact that Innophanna provides Confidential Innopharma Information
`to B&L upon B&L's request shall not be construed as an admission by
`Innopharma that such Confidential Innopharma Infonnation is relevant to the
`disposition of any issue relating to any alleged infringement of the Orange
`Book Patents or to the validity or enforceability of any or all of these patents.
`The attorneys from B&L's outside law firm shall acknowledge in writing their
`receipt of a copy of these terms and restrictions prior to production of any
`Confidential Innopharma Information. Such written acknowledgement shall be
`provided to the undersigned.
`This Offer of Confidential Access shall be governed by the laws of the State of
`New Jersey, USA.
`
`Section 355(j)(5)(C)(i)(III) provides that any request for access that B&L makes
`under this Offer of Confidential Access "shall be considered acceptance of the offer of
`confidential access with restrictions as to persons entitled to access, and on the use and
`disposition of any information accessed, contained in [this] offer of confidential access" and
`that the "restrictions and other terms of [this] offer of confidential access shall be considered
`terms of an enforceable contract." Thus, to the extent that B&L requests access to
`Confidential Innophanna Information, it necessarily accepts the tenns and restrictions
`outlined above.
`
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`Page 4 of 72
`
`

`

`CONFIDENTIAL
`October 30, 2014
`Page 5
`
`Written notice requesting access under this Offer of Cunfidt:ntial Access should be
`made to:
`
`Deepro R. Mukerjee
`Alston & Bird LLP
`90 Park A venue
`New York, New York 10016
`Tel: (212) 210-9400
`Fax: (212) 210-9444
`dccpro .m ukcrj cc@alston.com
`
`By providing this Offer of Confidential Access, Innophanna maintains the right and
`ability to bring and maintain n Declaratory Judgment action under 28 U.S.C. § 2201 et seq.,
`pursuant to 2 J U .S.C. § 355(j)(5)(C).
`
`Copies of this letter and the attached exhibits are also being provided by U.S.
`Registered mail, return receipt requested.
`
`Sincerely,
`
`.J- A' --v (-·
`
`Deepro R. Mukerjee
`
`Enclosures: Exhibits A & B
`
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`Page 5 of 72
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`

`

`CONFIDENTIAL
`October 30, 2014
`Page 3
`
`unenforceability, and/or noninfringement should additional information become known to
`Innopharma.
`
`Offer of Confidential Access to ANDA
`Pursuant to 21 U.S.C. § 355(j)(5)(C), this notice letter includes an Offer of Confidential
`Access to Innopharma's ANDA and any supplement(s) thereto. As required by Section
`355U)(5)(C)(i)(III), Innopharma offers to provide confidential access to certain information
`from its ANDA No. 206326 for the sole and exclusive purpose of determining whether an
`infringement action referred to in Section 355(j)(5)(B)(iii) can be brought.
`
`Section 355(j)(5)(C)(i)(III) allows Jnnopharma to impose restrictions "as to persons
`entitled to access, and on the use and disposition of any information accessed, as would apply
`had a protective order been entered for the purpose of protecting trade secrets and other
`confidential business information." That provision also grants Innopharma the right to redact
`its ANDA to exclude non-relevant information in response to a request for Confidential Access
`under this Offer.
`
`As permitted by statute, Innopharma imposes the following terms and restrictions on its
`Offer of Confidential Access:
`(1)
`Innopharma will permit confidential access to certain information from its
`proprietary ANDA No. 206326 to attorneys from one outside law firm
`· representing B&L; provided, however, that such attorneys do not engage,
`formally or informally, in any patent prosecution for B&L or any FDA
`counseling, litigation, or other work before or involving the FDA. Such
`information (hereinafter, "Confidential Innopharrna Information") shall be
`marked
`with
`the
`legend
`"CONFIDENTIAL
`INNOPHARMA
`INFORMATION."
`
`(2)
`
`(3)
`
`The attorneys from the outside law firm representing B&L shall not disclose
`any Confidential Jnnopharma Information to any other person or entity,
`including B&L employees, outside scientific consultants, and/or other outside
`counsel retained by B&L, without the prior written consent of lnnopharma.
`As provided by Section 355G)(5)(C)(i)(Hl), B&L's outside law firm shall make
`usc of the Confidential Innopharma Information for the sole and exclusive
`purpose of determining whether an action
`referred
`to
`in Section
`355(j)(5)(B)(iii) can be brought and for no other purpose. By way of example
`only, the Confidential Innopharma Information shall not be used to prepare or
`prosecute any future or pending patent application by B&L in connection with
`any filing to, or communication with, the FDA relating to lnnopharma's ANDA
`No. 206326. B&L's outside law firm agrees to take all measures necessary to
`prevent unauthorized disclosure or use of the Confidential Innopharma
`Information, and that all Confidential lnnopharma Information shall be kept
`confidential and not disclosed in any manner inconsistent with this Offer of
`Confidential Access.
`
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`Page 6 of 72
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`

`

`EXHIBIT A
`
`EXHIBIT A
`
`r
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`""""
`v
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`Page 7 of 72
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`

`

`Table of Contents
`
`I.
`II.
`Ill.
`
`5.
`
`6.
`
`2.
`3.
`4..
`
`B.
`
`1..
`2.
`3..
`4.
`
`Introduction ......................................................................................................................... 1
`Summary ............................................................................................................................. 2
`Analysis ............................................................................................................................... 2
`A.
`General Legal Principles ......................................................................................... 2
`Burdens and Presumptions .................. u···············--·· .. ············ .. ·~············· ................ 2
`Claim Construction ..................................................................................... 3
`Invalidity Analysis ...................... "' ................................................................................... 4
`Obviousness Under 35 U.S.C. § 103 .......................................................... 4
`Level of Ordinary Skill in the Art ................................................... 6
`a)
`Scope and Content of the Prior Art ................................................. 6
`Differences between the Prior Art and
`the Claimed
`Invention ......................................................................................... 6
`Obviousness of Structurally Similar Compounds ....................................... 7
`Lead Compound .............................................................................. 7
`Structural Modifications ................................................................. 8
`b)
`Reasonable Expectation of Success ................................................ 9
`c)
`Objective Indicia of Non..Qbviousness ......................................... 10
`d)
`Infringement Analysis ............................................................................... 10
`Direct Infringement ....................................................................... 10
`a)
`U.S. Patent No. 8,754,131. .................................................................................... 1 1
`I.
`Priority lnfonnation and Related Applications ......................................... 1 1
`Claims of the ' 131 Patent .......................................................................... 11
`Specification ofthe '131 Patent ................................................................ 15
`P.f'OS.eC'ution Histories· ~· · ···· ........................................................................................ 16
`a)
`Prose1:ution History of The ' 131 Patent. ....................................... 16
`Preliminary Amendment ................................................... 16
`i)
`Office Action dated March 13,2014 ................................ 16
`ii)
`iii)
`Response dated March 20, 2014 ....................................... 17
`Notjce of Allowance ......................................................... 17
`iv)
`Prosecution History ofThe '431 Patent.. ...................................... 17
`Preliminary Amendments ................................................. 17
`
`b)
`
`c)
`
`a}
`
`b)
`
`i)
`
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`Page 8 of 72
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`

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`ii)
`
`iii)
`
`iv)
`
`v)
`
`vi)
`
`Office Action dated September 27, 2007 .......................... 17
`
`Response dated March 26, 2008 ....................................... 19
`
`Office Action dated July 18, 2008 .................................... 21
`
`Response dated January 15, 2009 ..................................... 22
`
`Office Action dated June 3, 2009 ..................................... 23
`
`vii)
`
`RCE and Rejection ............................................................ 23
`
`viii) Response dated March 24, 2010 ....................................... 23
`
`ix)
`
`x)
`
`xi)
`
`Office Action dated June 24, 2010 ................................... 24
`
`Response dated October 25, 2010 ..................................... 24
`
`Office Action of May 6, 2011 and Interview of
`September 1, 2011 ............................................................ 25
`
`xii)
`
`Response dated September 6, 2011 .................................. 25
`
`xiii) Notice of Allowance ......................................................... 26
`
`xiv)
`
`Inter Partes Review ........................................................... 26
`
`c)
`
`Prosecution History of U.S. Patent No. 8,497,304 ....................... 27
`
`i)
`
`ii)
`
`iii)
`
`Preliminary Amendments, Restriction and Election ......... 27
`
`Office Action of August 30, 2012 ..................................... 27
`
`Response dated January 30, 2013 and Final
`rejection ....................................... ...................................... 27
`
`iv)
`
`Response after Final and Notice of Allowance ................. 28
`
`d)
`
`Prosecution history of U.S. Patent 8,669,290 ............................... 28
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`v)
`
`Preliminary Amendment ................................................... 28
`
`Office Action dated August 1, 2013 ................................. 29
`
`Response dated October 22, 2013 ..................................... 30
`
`Notice of Allowance ......................................................... 31
`
`Inter Partes Review ........................................................... 31
`
`c.
`
`INVALIDITY OF THE ' 131 PATENT ................................................................ 31
`
`1.
`
`Invalidity Analysis of the '131 Patent ...................................................... 31
`
`a)
`
`The Scope and Content of the Prior Art ........................................ 32
`
`i)
`
`ii)
`
`iii)
`
`U.S. Patent No. 4,910,225 to Ogawa et al. ....................... 32
`
`WO 02/13804 to Kapin et al. ............................................ 33
`
`U.S. Patent No. 5,414,011 toFu et al. .............................. 34
`
`II
`
`Page 9 of 72
`
`

`

`iv)
`
`v)
`
`Regev and Zana, Journal of Colloid and Interface
`Science (21 0) 8-1 7 ( 1999) ................................................ 36
`
`Yuan et al., J. Phys. Chern. B, 2001, 105, 46 11-
`4615 ................................................................................... 37
`
`vi)
`
`U.S. Patent Number 2,454,54 1 to Bock et al. ................... 37
`
`b)
`
`Claim Interpretation ...................................................................... 38
`
`i)
`
`Interpretation of Independent Claims 1 and 13 ................. 38
`
`d )
`
`Obviousness of Claims I and 13 In Light of the ' 804
`Publication, the ' 0 II Patent and Regev ........................................ 39
`
`i)
`
`ii)
`
`iii)
`
`Scope and Content of the Prior Art ................................... 39
`
`Level of Ordinary Skill in the Art ..................................... 39
`
`Differences Between the Art and the Claims .................... 40
`
`e)
`
`iv)
`Motivation to Combine the References ............................ 42
`Obviousness of Claims I and 13 In Light of the '804
`Publication, the 'Oil Patent, Yuan, and the '541 Patent .............. 44
`
`i)
`
`ii)
`
`Scope and Content of the Prior Art ................................... 44
`
`Level of Ordinary Skill in the Art ..................................... 44
`
`iii)
`
`Differences Between the Art and the Claims .................... 44
`
`iv) Motivation to Combine the References ............................ 44
`
`Obviousness of Independent Claim 7 ........................................... 45
`
`Secondary Considerations ............................................................. 48
`
`Obviousness of Claims 2, 8 and 14: Quaternary
`Ammonium Salt ............................................................................ 48
`
`Obviousness of Claims 3 and 15: Bromfenac Sodium Salt.. ........ 49
`
`Obviousness of Claim 4: Amount ofTyloxapol ........................... 49
`
`Obviousness of Claims 5, 11 and 17: pH From About 7.5
`To About 8.5 ................................................................................. 50
`
`Obviousness of Clams 6, 12, 18 and 24: Specific
`Forrnualtions ................................................................................. 51
`
`Obviousness of Claims 9, 19 and 21: Storage Stability ................ 53
`
`Obviousness of Claims 10, 16 and 22: Amounts of
`Bromfenac and Tyloxapol... .......................................................... 54
`Obviousness of Claim 20: Quaternary Salt ................................... 55
`Obviousness of Claim 23: pH of About 7.5 to About 8.5 ............. 56
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`Obviousness of Claims 25, 26, 27, 28 and 29: Preservative
`Efficacy Standard .......................................................................... 56
`Obviousness of Claim 20: Additive .............................................. 58
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`NON-INFRING EMENT OF THE '13 1 PATENT ............................................... 58
`
`D.
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`IV
`
`Page 11 of 72
`
`

`

`EXHIBIT A
`DETAILED STATEMENT OF THE FACTUAL AND LEGAL BASIS FOR
`INNOPHARMA LICENSING INC.'S CERTIFICATION THAT U.S. PATENT NO.
`8,754,131 IS INVALID, UNENFORCEABLE, AND/OR WILL NOT BE INFRINGED BY
`THE MANUFACTURE, USE, SALE, OFFER FOR SALE, OR IMPORTATION OF
`INNOPHARMA'S BROMFENAC PRODUCT AS DEFINED BY ANDA NO. 206-326
`
`For at least the reasons set forth below, U.S. Patent No. 8,754,1 31 ("the ' 131 patent")
`does not prohibit lnnopharma Licensing Inc. ("Innopharma'·) from manufacturing, using, selling,
`offering for sale, or importing lnnopharma's Bromfenac Product as covered by ANDA No. 206-
`326 after the FDA approves its ANDA. 1
`
`I.
`
`Introduction
`
`Bausch & Lomb ("B&L") markets an ophthalmic solution having an active agent known
`as bromfenac under the name PROLENSATM. Bromfenac is a nonsteroidal anti-inflammatory drug
`(NSAID) for ophthalmic use. The FDA has approved PROLENSA TM for the treatment of
`postoperative inflammation and reduction of ocular pain in patients who have undergone cataract
`surgery. Exhibit 1, PROLENSA™ Label.
`
`PROLENSA TM is formu lated as bromfenac sodium sesquihydrate. The USAN name for
`bromfenac sodium sesquihydrate is bromfenac sodium. The standard chemical name for
`bromfenac sodium is sodium [2-amino-3-( 4-bromobenzoyl)phenyl] acetate sesquihydrate. It has
`an empirical formula of C 1sH 11BrNNa03•1 YI H20. The structural formula for bromfenac sodium
`is:
`
`The Orange Book lists the following patents for PROLENSATM: the '131 patent; U.S.
`Patent No. 8, 128,43 1 ("the '431 patent"); and U.S. Patent No. 8,669,290 ("the '290 patent")
`(collectively, "the Orange Book Patents"). The Orange Book also indicates that PROLENSA ™ is
`associated with New Drug Application No. 203-168, which is held by B&L. The FDA has
`approved NDA No. 203-168 for PROLENSA TM 0.07% ophthalmic solution.
`
`1 Innopharma reserves its rights to raise any additional defenses relating to invalidity,
`for alleged patent
`in any and all proceedings
`unenforceability, and non·infringement
`infringement.
`
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`Page 12 of 72
`
`

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`lnnophanna hereby incorporates by reference the Notification letter dated September 19,
`2014 and related exhibits, the combined contents of which provided notice to the NDA holder
`and assignee of the '431 and ' 290 patents and set forth the factual and legal bases for
`lnnopharma's certification that the '431 and '290 patents are invalid, unenforceable, and/or will
`not be infringed by the manufacture, use, sale, offer for sale, or importation of lnnopharma's
`Bromfenac Product as defined by ANDA No. 206-326.
`
`II.
`
`Summary
`
`lnnopharma' s manufacture, use, sale, offer for sale, or importation of its Bromfenac
`Product will not infringe any of the claims of the '131 patent for at least the following reasons: 2
`
`The '131 Patent
`
`As set forth in detail below, Innopharma cannot infringe claims 1-30 of the '431 patent
`because each of these claims is invalid under 35 U.S.C. § 103 as follows:
`
`• Each of claims 1-30 of U.S. Patent Number 8,754,131 is invalid as obvious in
`light of U.S. Patent No. 4,910,225 ("the '225 patent") in view of WO 02/13804
`("the '804 publication"); U.S. Patent Number 5,414,011 ("the '011 patent"); and
`Regev, Journal of Colloid and Interface Science 210, 8-17 (1999) ("'Regev").
`
`• Each of claims 1-3, 5, 7-9, 11, 13-15, 17, and 19-22 is invalid as obvious in light
`of the'225 patent in view of the '804 publication; the '0 II patent; Yuan et al., J.
`Phys. Chem. B 2001, I 05, 4611-4615 ("Yuan") and U.S. Patent No. 2,454,541
`(the '541 patent).
`
`III. Analysis
`
`A.
`
`General Legal Principles
`
`1.
`
`Burdens and Presumptions
`
`Each claim of a patent issued by the United States Patent and Trademark Office ("PTO")
`is presumed to be valid; this presumption is independent of the validity of other claims. 35
`U.S.C. § 282. A party may overcome this presumption by presenting clear and convincing
`evidence of a patent's invalidity. See, e.g., Beckson Marine, Inc. v. NFM, Inc., 292 F.3d 718,725
`(Fed. Cir. 2002). The presumption ofvalidity includes a "presumption ofnonobviousness which
`the patent challenger must overcome by proving facts with clear and convincing evidence." See
`e.g., Apotex USA, Inc. v. Merck& Co., 254 F.3d 1031, 1036 (Fed. Cir. 2001).
`
`2 In addition to the reasons of invalidity set forth in this Exhibit A, lnnopharma incorporates by
`reference, and reserves the right to assert, any invalidity positions set forth in any inter partes
`review related to any patent at issue.
`
`2
`
`Page 13 of 72
`
`

`

`The ·'clear and convincing evidence" standard of proof applies even if the prior art under
`consideration was not previously considered by the PTO during prosecution. Microsoft Corp. v.
`i4i Ltd. Partnership, 131 S.Ct. 2238, 2250 (2011). A patent may also be found invalid based
`upon prior art already considered by the examiner if it can be shown through clear and
`convincing evidence that the examiner erred in interpreting or applying the prior art. Thus, after
`due consideration of the presumption of validity, a trial court is free to come to a different
`conclusion of patentability from the PTO on the basis of evidence before the court. See, e.g.,
`Purdue Phanna LP. v. Faulding, Inc., 230 F.3d 1320, 1329 (Fed. Cir. 2000); AK Steel Cmp. v.
`So/lac & Uginc, 344 F.3d 1234, 1245 (Fed. Cir. 2003).
`
`2.
`
`Claim Construction
`
`The first step in an invalidity or non-infringement analysis is to construe the claims of the
`patent. See, e.g., Rapoport v. Dement, 254 F.3d 1053, 1058 (Fed. Cir. 2001). The general rule is
`that claim language is given its ordinary and accustomed meaning as understood by one of
`ordinary skill in the art, unless the patentee ascribed a different meaning to a claim in either the
`specification or the prosecution history. Phillips v. AWH Corp., 415 F.3d 1303, 1312, 1321 (Fed.
`Cir. 2005). Claim interpretation involves consideration of the language of the patent claim itself,
`the other claims, the specification, the prosecution history, and extrinsic evidence if necessary.
`See, e.g., Phillips, 415 F.3d at 1312; Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
`(Fed. Cir. 1996); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979·80 (Fed. Cir. 1995)
`(en bane) ("Markman /''). When construing a claim, a court principally consults the evidence
`intrinsic to the patent: the claims themselves, the specification, and the prosecution history.
`Phillips, 415 F.3d at 1317; Vitro11ics, 90 F.3d at 1582-83. Usually, analysis of the intrinsic
`evidence suffices to enable one to determine the meaning of claim terms. Vitronics, 90 F.3d at
`1582. If the intrinsic evidence resolves ambiguity in a disputed claim, extrinsic evidence cannot
`be used to contradict the established meaning of the claim language. See, e.g., Mantec/1 Envtl.
`Cmp. v. Hudson Envtl. Servs., 152 F.3d 1368, 1373 (Fed. Cir. 1998); Bell & Howell Document
`Mgmt. Prods. Co. v. Altek Sys., 132 F.3d 701, 706 (Fed. Cir. 1999). Extrinsic evidence may
`include, for example, treatises and expert testimony.
`
`Patentees may limit claim scope by providing explicit definitions or by providing
`unequivocal guidance that dictates the manner in which the claims are to be construed. See, e.g.,
`SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed. Cir.
`2001 ). Thus, the specification may be used to determine if a patentee has limited the scope of the
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