ALSTON&BIRD LLP
`
`90 Park Avenue
`New York, NY 10016
`
`212-210-9400
`Fax:212-21 0-9444
`www.alston.com
`
`.,
`
`•
`
`Deepro R. Mukerjee
`
`Direct Dial: 212-210-9501
`
`E-mail: deepro.mukerjee@alstoiLcom
`
`June 12,2015
`
`CONFIDENTIAL
`
`VIA FED EX OVERNIGHT DELIVERY1
`
`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 I 070
`Woodland Hills, CA 91367
`
`President & CEO .
`BAUSCH & LOMB
`I 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 PHARMA HOLDINGS CORP.
`700 Route 202/206 North
`Bridgewater, NJ 08807
`
`President & CEO
`BAUSCH & LOMB INCORPORATED
`1400 North Goodman Street
`Rochester, NY 14609
`
`Re: ANDA No. 206326 (Bromfenac) Notification of Certification of Noninfringement
`and/or Invalidity for U.S. Patent No. 8,871,813 Pursuant to § 505(j)(2)(B)(ii) of
`the U.S. Federal Food, Drug and Cosmetic Act
`
`To whom it may concern:
`
`We represent Innopharrna Licensing, Inc. ("Innopharrna") in connection with this
`Pursuant to
`letter and in connection with any litigation that ensues. therefrom.
`Section 505G)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act and 21 C.P.R.§ 314.95,
`Innophanna hereby provides notice that today it has amended Abbreviated New Drug
`Application No.
`206326
`("ANDA'')
`certifying,
`as
`described
`in
`21 C.F.R.
`§ 319.94(a)(12)(i)(A)(4) ("Paragraph IV"), that U.S. Patent No. 8,871,813 ("the '813 patent")
`
`1 Innopharrna 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 '813 patent is taken from the face of the
`'813 patent. The USPTO's web-based assignment records accessed on June 8, 2015 report
`that the assignment data for the '813 patent is not currently available.
`
`Atlanta • Charlotte • Dallas • Los Angeles • New York • Research Triangle • Silicon Valley • Ventura County • Washington, D.C.
`Munich (Liaison Bam)
`
`SENJU EXHIBIT 2018
`LUPIN v. SENJU
`IPR2015-01097
`
`Page 1 of 74
`
`

`
`CONFIDENTIAL
`June 12,2015
`Page2
`
`•
`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 Innophanna'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 ™ ophthalmic solution product in the fonn of bromfenac sodium
`sesquihydrate. PROLENSATM is supplied as a sterile, aqueous 0.07% solution with a pH of7.8.
`
`The United States Food and Drug Administration ("FDA") has accepted
`Innopharma's ANDA for filing and has assigned the application No. 206326. The ANDA
`contains
`the
`required bioavailability and/or bioequivalence data from studies on
`Innophanna' s Bromfenac Product that is the subject ofthe ANDA.
`
`Innopharma originally submitted its ANDA under 21 U.S.C. § 355(j)(l) 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 Paragraph IV 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
`Innopharma's ANDA. On October 30, 2014, Innopharma sent to Senju Pharmaceuticals and
`Bausch & Lomb written notification of its amendment to Innopharma's ANDA to further
`include a Paragraph IV certification to U.S. Patent No. 8,754,131 ("the '131 patent") and a
`detailed statement of its then-existing factual and legal bases oflnnopharma's belief that the
`'131 patent is invalid, unenforceable, or will not be infringed by the manufacture, use, sale,
`offer for sale, or importation of the drug product described in Innopharma's ANDA. On
`March 25, 2015, Innopharma sent to Senju Pharmaceuticals and Bausch & Lomb, written
`notification of its amendment to Innopharma's ANDA to further include a Paragraph IV
`certification to U.S. Patent No. 8,927,606 ("the '606 patent") and a detailed statement of its
`then-existing factual and legal bases of Innopharma's belief that the '606 patent is invalid,
`unenforceable, or will not be infringed by the manufacture, use, sale, offer for sale, or
`importation of the drug product described in Innopharma'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 '813 patent, which lists as an issuance date on its face of October 28,
`2014. Each of the '431, '290, '131, '606, and '813 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™ ophthalmic
`solution.
`
`Innopharma seeks the FDA's approval to market its proposed Bromfenac Product
`prior to the expiration of the Orange Book Patents.
`Innophanna alleges, and originally
`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 Innopharma's ANDA. Innopharma
`
`Page 2 of 74
`
`

`
`CONFIDENTIAL
`June 12,2015
`Page 3
`
`•
`additionally alleges and has certified to the FDA that, to the best of Innophanna's
`knowledge, the '131 and '606 patynts 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
`Innopharma's ANDA. Further, Innophanna additionally alleges and has certified to the FDA
`that, to the best ofinnopharma's knowledge, the '813 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 '813 patent, according to the
`FDA's Orange Book:
`
`•
`
`the '813 patent will expire on January 16,2024.
`
`Attached as Exhibit A is a detailed statement, made pursuant to 21 U.S.C.
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95, of the present factual and legal bases for
`Innopharma' s Paragraph IV certification to the '813 patent of the Orange Book Patents. The
`statements made therein are based on the information currently available to Innopharma.
`Innopharma reserves all rights to raise any additional defenses relating to invalidity,
`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
`355(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 Innopharma 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)
`
`Innophanna 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 infonnally, in any patent prosecution for B&L or any FDA
`counseling, litigation, or other work before or involving the FDA. Such
`information (hereinafter, "Confidential Innopharma Information") shall be
`marked
`with
`the
`legend
`"CONFIDENTIAL
`INNOPHARMA
`INFORMATION."
`
`Page 3 of 74
`
`

`
`CONFIDENTIAL
`June 12, 2015
`Page4
`
`.....
`
`(2)
`
`(3)
`
`(4)
`
`(5)
`
`(6)
`
`•
`The attorneys from the outside law firm representing B&L shall not disclose
`any Confidential Innophanna 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 Innophanna.
`
`As provided by Section 355(j)(5)(C)(i)(III), B&L's outside law finn shall make
`use of the Confidential Innopharma Information for the sole and exclusive
`referred
`to
`in Section
`purpose of determining whether an action
`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 Innophanna'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 Innopharma Information shall be kept
`confidential and not disclosed in any manner inconsistent with this Offer of
`Confidential Access.
`
`The Confidential Innopharma Information disclosed is, and remains, the
`Innophanna
`property of Innopharma. By providing said Confidential
`Information, Innopharma does not grant B&L and/or its outside law firm any
`interest in or license for and to the Confidential Innophanna Information.
`
`B&L's outside law firm shall, within thirty-five (35) days from the date that it
`first receives the Confidential Innopharma Information, return to Innopharma
`all Confidential lnnopharma Information and any copies thereof. B&L's
`outside law firm shall return all Confidential Innopharma Information to
`Innopharma 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 Innophanna
`Information that Innopharma 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 Innophanna regarding the validity, enforceability, and/or infringement of
`any U.S. patent. Further, nothing herein shall be construed as an agreement or
`admission by Innophanna with respect to the competency, relevance, or
`materiality of any such Confidential Innopharma Information, document, or
`thing. The fact that Innopharma provides Confidential Innophanna Information
`to B&L upon B&L's request shall not be construed as an admission by
`Innopharma that such Confidential Innopharma Information 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.
`
`(7)
`
`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
`
`Page 4 of 74
`
`

`
`CONFIDENTIAL
`June 12, 2015
`Page 5
`
`•
`Confidential Innophanna Infonnation. Such written acknowledgement shall be
`provided to the undersigned.
`
`(8)
`
`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 Innopharma Information, it necessarily accepts the tenns and restrictions
`outlined above.
`
`Written notice requesting access under this Offer of Confidential 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
`deepro.mukerjee@alston.com
`
`By providing this Offer of Confidential Access, Innophanna maintains the right and
`ability to bring and maintain a Declaratory Judgment action under 28 U.S. C. § 2201 et seq.,
`pursuant to 21 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,
`
`Deepro R. Mukerjee
`
`Enclosures: Exhibits A & B
`
`Page 5 of 74
`
`

`
`EXHIBIT A
`EXHIBIT A
`
`•
`
`I
`
`Page 6 of 74
`
`Page 6 of 74
`
`

`
`Table of Contents
`
`I.
`
`II.
`
`III.
`
`lntroduction ................................................................................................................... L ... I
`
`Summary ............................................................................................................................. 2
`
`Analysis ............................................................................................................................... 3
`
`A.
`
`General Legal Principles ......................................................................................... 3
`
`I.
`
`2.
`
`3.
`
`4.
`
`Burdens and Presumptions .......................................................................... 3
`
`Claim Construction ..................................................................................... 3
`
`Invalidity Analysis ...................................................................................... 4
`Obviousness Under 35 U.S.C. § 103 .......................................................... 5
`a)
`Level of Ordinary Skill in the Art ................................................... 6
`
`b)
`
`c)
`
`Scope and Content of the Prior Art ................................................. 6
`
`Differences between the Prior Art and the Claimed
`Invention ......................................................................................... 7
`
`5.
`
`Obviousness of Structurally Similar Compounds ....................................... 7
`
`a)
`
`b)
`
`c)
`
`d)
`
`Lead Compound .............................................................................. 8
`
`Structural Modifications ................................................................. 8
`
`Reasonable Expectation ofSuccess .............................................. 1 0
`
`Objective Indicia of Non-Obviousness ......................................... 10
`
`6.
`
`Infringement Analysis ............................................................................... 10
`
`a)
`
`b)
`
`Direct Infringement... .................................................................... 10
`
`Infringement under the Doctrine of Equivalents .......................... 11
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`v)
`
`vi)
`
`The Tri-Partite Test (Triple Identity Test) ........................ 12
`
`The All Elements Rule ...................................................... 12
`
`Prosecution History Estoppel.. .......................................... 13
`
`Festo Exception: Foreseeable Equivalents ........................ 14
`
`Festo Exception: Tangential Relationship ........................ 14
`
`Festo Exception: The "Some Other Reason" .................... 14
`
`B.
`
`U.S. Patent No. 8,871,813 ..................................................................................... 15
`
`1.
`
`2.
`
`3.
`
`4.
`
`Priority Information and Related Applications ......................................... 15
`
`Claims of the '813 Patent.. ........................................................................ 15
`Specification of the '813 Patent.. .............................................................. l9
`Prosecution Histories ................................................................................ 20
`
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`Page 7 of 74
`
`

`
`a)
`
`Prosecution History of The '813 Patent... ..................................... 20
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`Preliminary Amendment.. ................................................. 20
`
`Office Action dated July 24, 2014 .................................... 20
`
`Response dated July 31, 2014 ........................................... 20
`
`Notice of Allowance ......................................................... 20
`
`b)
`
`Prosecution History of The '431 Patent... ..................................... 21
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`v)
`
`vi)
`
`Preliminary Amendments ................................................. 21
`
`Office Action dated September 27, 2007 .......................... 21
`
`Response dated March 26, 2008 ....................................... 23
`
`Office Action dated July 18, 2008 .................................... 25
`
`Response dated January 15,2009 ..................................... 26
`
`Office Action dated June 3, 2009 ..................................... 27
`
`vii)
`
`RCE and Rejection ............................................................ 27
`
`viii) Response dated March 24, 2010 ....................................... 27
`
`ix)
`
`x)
`
`xi)
`
`Office Action dated June 24,2010 ................................... 28
`
`Response dated October 25, 2010 ..................................... 28
`
`Office Action of May 6, 2011 and Interview of
`September 1, 2011 ............................................................ 29
`
`xii)
`
`Response dated September 6, 2011 .................................. 3 0
`
`xiii) Notice of Allowance ......................................................... 30
`
`xiv)
`
`Inter Partes Review ........................................................... 31
`
`c)
`
`Prosecution History of U.S. Patent No. 8,497,304 ....................... 31
`
`i)
`
`ii)
`
`iii)
`
`Preliminary Amendments, Restriction and Election ......... 31
`
`Office Action of August 30, 2012 ..................................... 31
`
`Response dated January 30, 2013 and Final
`rejection ............................................................................. 32
`
`iv)
`
`Response after Final and Notice of Allowance ................. 32
`
`d)
`
`Prosecution history of U.S. Patent 8,669,290 ............................... 32
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`v)
`
`Preliminary Amendment... ................................................ 33
`
`Office Action dated August 1, 2013 ................................. 33
`
`Response dated October 22, 2013 ..................................... 34
`
`Notice of Allowance ......................................................... 35
`
`Inter Partes Review ........................................................... 36
`
`11
`
`Page 8 of 74
`
`

`
`e)
`
`i)
`ii)
`
`Prosecution History of The' 131 Patent.. ...................................... 36
`Preliminary Amendment ................................................... 36
`•
`Office Action dated March 13, 2014 ................................ 36
`Response dated March 30,2014 ....................................... 36
`iii)
`Notice of Allowance ......................................................... 36
`iv)
`INVALIDITYOFTHE'813PATENT ................................................................ 36
`Invalidity Analysis of the '813 Patent ...................................................... 37
`a)
`The Scope and Content of the Prior Art ........................................ 37
`i)
`U.S. Patent No. 4,910,225 to Ogawa eta!. ....................... 37
`
`C.
`
`1.
`
`v)
`
`ii)
`iii)
`iv)
`
`WO 02/13804 to Kapin eta!. ............................................ 38
`U.S. Patent No. 5,414,011 toFu eta!. .............................. 39
`Regev and Zana, Journal of Colloid and Interface
`Science (21 0) 8-17 (1999) ................................................ 41
`Yuan et a!., J. Phys. Chern. B, 2001, 105, 4611-
`4615 ................................................................................... 42
`U.S. Patent No. 2,454,541 to Bock eta!. .......................... 42
`vi)
`Claim Interpretation ...................................................................... 42
`i)
`Interpretation oflndependent Claims 1 and 13 ................. 42
`Obviousness of Claims 1 and 13 In Light of the '804
`Publication, the '011 Patent and Regev ........................................ 44.
`
`i)
`Scope and Content of the Prior Art ................................... 44
`Level of Ordinary Skill in the Art ..................................... 45
`ii)
`Differences Between the Art and the Claims .................... 45
`iii)
`iv) Motivation to Combine the References ............................ 47
`Obviousness of Claims 1 and 13 In Light of the '804
`Publication, the '011 Patent, Yuan, and the '541 Patent .............. 49
`i)
`Scope and Content of the Prior Art ................................... 49
`ii)
`Level of Ordinary Skill in the Art ..................................... 49
`
`Differences Between the Art and the Claims .................... 49
`iii)
`iv) Motivation to Combine the References ............................ 49
`Obviousness of Independent Claim 7 ........................................... 50
`Secondary Considerations ............................................................. 53
`Obviousness of Claims 2, 8 and 14: Sodium Sulfite .................... 53
`Obviousness of Claims 3 and 15: Bromfenac Sodium Salt.. ........ 54
`
`111
`
`b)
`
`d)
`
`e)
`
`f)
`
`g)
`h)
`i)
`
`..
`
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`Page 9 of 74
`
`

`
`j)
`
`k)
`
`I)
`
`m)
`
`n)
`
`o)
`
`Obviousness of Claim 4: Amount ofTyloxapol.. ......................... 54
`
`Obviousness of Claims 5, 11 and 17: pH From About 7.5 •
`To About 8.5 ................................................................................. 55
`
`Obviousness of Claims 9, 19 and 20: Storage Stability ................ 55
`
`Obviousness of Claims 10, 16 and 22: Amounts of
`Bromfenac and Tyloxapol. ............................................................ 56
`
`Obviousness of Claim 22: pH of About 7.5 to About 8.5 ............. 57
`
`Obviousness of Claim 27: Additives ............................................ 57
`
`D.
`
`NON-INFRINGEMENT OF THE '813 PATENT ............................................... 58
`
`1.
`
`2.
`
`An Invalid Claim Cannot Be Infringed ..................................................... 58
`
`There Is No Literal Infringement.. ............................................................ 58
`
`a)
`
`b)
`
`Claims 6, 12, 18 And 23: Specific Formulations .......................... 59
`
`Claims 24, 25 And 26: Absence of a Preservative ........................ 60
`
`3.
`
`There Is No Infringement Under the Doctrine Of Equivalents ................. 60
`
`a)
`
`b)
`
`Claims 6, 12, 18 and 23: Specific Formulations ........................... 60
`
`Claims 24, 25 And 26: Absence of a Preservative ........................ 61
`
`IV
`
`Page 10 of 74
`
`

`
`EXHIBIT A
`DETAILED STATEMENT OF THE FACTUAL AND LEGAL BASIS FOR
`INNOPHARMA LICENSING INC.'S CERTIFICATION THAT U.S. PATENT Ne>.
`8,871,813 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. 8,871,813 ("the '813 patent")
`does not prohibit Innopharma Licensing Inc. ("Innophanna") from manufacturing, using, selling,
`offering for sale, or importing Innopharma'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 PROLENSA ™. 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 ™ is fonnulated 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 C15HnBrNNa03•1 Yz H20. The structural formula for bromfenac sodium
`lS:
`
`The Orange Book lists the following patents for PROLENSA™: the '813 patent; U.S.
`Patent No. 8,754,131 ("the '131 patent"); U.S. Patent No. 8,128,431 ("the '431 patent"); and
`U.S. Patent No. 8,669,290 ("the '290 patent"); and U.S. Patent No. 8,927,606 ("the '606 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 ™ 0.07% ophthalmic solution.
`
`1 Innopharma reserves the right to raise any additional defenses relating to invalidity,
`unenforceability, and non-infringement in any and all proceedings.
`
`1
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`Page 11 of 74
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`Innophanna hereby incorporates by reference: 1) 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
`lnnophanna'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 Innopharma's
`Bromfenac Product as defined by ANDA No. 206-326; 2) the Notification letter dated October
`30, 2014 and related exhibits, the combined contents of which provided notice to the NDA
`holder and assignee of the '131 patent and set forth the factual and legal bases for Innophanna' s
`certification that the '131 patent 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; and 3) the Notification letter dated March 25, 2015 and related
`exhibits, the combined contents of which provided notice to the NDA holder and assignee of the
`'606 patent and set forth the factual and legal bases for Innopharma's certification that the '606
`patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, sale, offer
`for sale, or importation oflnnopharma's Bromfenac Product as defined by ANDA No. 206-326.
`
`II.
`
`Summary
`
`Innopharma's manufacture, use, sale, offer for sale, or importation of its Bromfenac
`Product will not infringe any of the claims of the '813 patent for at least the following reasons: 2
`
`The '813 Patent
`
`As set forth in detail below, Innopharma cannot infringe claims 1-27 of the '813 patent
`because each of these claims is invalid under 35 U.S.C. § 103 or Innopharma's Bromfenac
`Product does meet each and every limitation of the claims as follows:
`
`• As set forth in detail below, each of claims 1-5, 7-11, 13-17, 19-22, and 27 of the
`'813 patent 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 No.
`5,414,011 ("the '011 patent"); and Regev, Journal of Colloid and interface
`Science 210, 8-17 (1999) ("Regev").
`
`• As set forth in detail below, each of claims 1-3, 5, 7-9, 10, 11, 13-15, 17, 19, 20,
`and 27 of the '813 patent is invalid as obvious in light of the '225 patent in view
`of the '804 publication; the '011 patent; Yuan et al., J. Phys. Chern. B 2001, 105,
`4.611-15 ("Yuan") and U.S. Patent No. 2,454,541 (the '541 patent).
`
`•
`
`Innopharma cannot infringe claims 6, 12, 18, and 23-26 of the '813 patent,
`literally or under the doctrine of equivalents, because none of these claims
`encompasses Innopharma's Bromfenac Product. Specifically, each of these claims
`
`2 In addition to the reasons of invalidity set forth in this Exhibit A, Innopharma 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 12 of 74
`
`

`
`•
`
`excludes benzalkonium chloride and Innophanna's Bromfenac Product contains
`benzalkonium chloride.
`
`•
`Innopharma cannot infringe claims 6, 12,18, and 23 of the '813 patent, literally or
`under the doctrine of equivalents, because none of these claims encompasses
`Innophanna's Bromfenac Product. Specifically, each of these claims requires
`"EDTA sodium salt," which Innophanna's Bromfenac Product does not contain.
`
`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 of validity includes a "presumption of nonobviousness 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).
`
`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 Pharma L.P. v. Paulding, Inc., 230 F.3d 1320, 1329 (Fed. Cir. 2000); AK Steel Corp. v.
`Sollac & Ugine, 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. 199-5)
`(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; Vitronics, 90 F.3d at 1582-83. Usually, analysis of the intrinsic
`
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`evidence suffices to enable one to determine the meaning of claim tenns. Vitronics, 90 F.3d at
`1582. If the int