ALSTON&BlliD LLP
`
`90 Park A venue
`New York, NY 10016
`212-210-9400
`Fax:2!2-210-9444
`www.alston.com
`
`Thomas J. Parker
`
`Direct Dia~ 212-210-9529
`
`E-mail: thomas.parker@alston.com
`
`September 19, 2014
`
`CONFIDENTIAL
`
`VIA FED EX 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 1070
`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 (Bromfenac) Notification of Certification of Noninfringement
`and/or Invalidity for U.S. Patent Nos. 8,129,431 and 8,669,290 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. ("Innopharma") in connection with this
`letter and in connection with any litigation that ensues therefrom.
`Pursuant to
`Section 505G)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.95,
`Innopharma hereby provides notice that it has filed an 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 each of U.S. Patent Nos. 8,129,431 ("the '431 patent") and 8,669,290
`
`I Innopharma 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
`certilication(s) contained within ANDA 206326 (attached as Exhibit B). The assignee's name and address for
`the '431 patent are taken from the USPTO's web-based assignment records accessed on September 19, 2014.
`Assignment data for the '290 patent is not currently available on the USPTO's web-based assignment records.
`
`Atlanta • Charlotte • Dallas • Los Angeles • New York • Research Triangle • Silicon Valley • Ventura County • Washington, D.C.
`Munich (Uaison Barn)
`
`SENJU EXHIBIT 2006
`INNOPHARMA v. SENJU
`IPR2015-00903
`
`Page 1 of 166
`
`

`

`CONFIDENTIAL
`September 19, 2014
`Page2
`
`("the '290 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
`Innopharma's ANDA No. 206326.
`
`Innopharma's ANDA is for a 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 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
`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
`Innopharma's Bromfenac Product that is the subject of the ANDA.
`
`Innopharma submitted its ANDA under 21 U.S.C. § 3550)(1) and (2)(A) with
`Paragraph IV certifications to the '431 and the '290 patents (collectively "the Orange Book
`Patents"), which are 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. According to the FDA's Orange Book:
`
`•
`
`•
`
`the '431 patent will expire on September 11, 2025; and ·
`
`the '290 patent will expire on January 16, 2024.
`
`Innopharma alleges, and has certified to the FDA that, to the best of Innopharma's
`knowledge, each of the Orange Book Patents 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 Innopharma's ANDA.
`
`Attached as Exhibit A is a detailed statement, made pursuant to 21 U.S.C.
`§ 355G)(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 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. § 355G)(5)(C), this notice letter includes an Offer of Confidential
`Access to lnnopharma'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.
`
`Page 2 of 166
`
`

`

`CONFIDENTIAL
`September 19, 2014
`Page 3
`
`Section 355G)(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.
`
`(2)
`
`(3)
`
`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
`(I)
`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 Innopharma Information") shall be
`marked
`with
`the
`legend
`"CONFIDENTIAL
`INNOPHARMA
`INFORMATION."
`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 Innopharma.
`As provided by Section 355G)(5)(C)(i)(III), B&L's outside law firm shall make
`use 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 Innopharma'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
`property of Innopharma. By providing said Confidential
`Innopharma
`Information, Innopharma 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 firm shall, within thirty-five (3 5) days from the date that it
`first receives the Confidential Innopharma Information, return to Innopharma
`all Confidential Innopharma 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
`
`(4)
`
`(5)
`
`Page 3 of 166
`
`

`

`CONFIDENTIAL
`September 19, 2014
`Page4
`
`(6)
`
`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 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 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 Innopharma Information, document, or
`thing. The fact that Innopharma 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 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
`Confidential Innopharma Information. 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 355G)(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 terms and restrictions
`outlined above.
`
`Written notice requesting access under this Offer of Confidential Access should be
`made to:
`
`Thomas J. Parker
`Deepro R. Mukerjee
`Alston & Bird LLP
`90 Park Avenue
`New York, New York 10016
`Tel: (212) 210-9400
`Fax: (212) 210-9444
`thomas.parker@alston.com
`deepro.mukerjee@alston.com
`
`I
`•
`4
`
`4 • 4
`
`4
`4
`~
`
`t • • • • • • • • • • • • • • • • • • •
`
`Page 4 of 166
`
`

`

`CONFIDENTIAL
`September 19,2014
`Page 5
`
`By providing this Offer of Confidential Access, Innopharma 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).
`
`Page 5 of 166
`
`

`

`CONFIDENTIAL
`September 19, 2014
`Page 6
`
`Copies of this letter and the attached exhibits are also being provided by U.S.
`Registered mail, return receipt requested.
`
`1]:?~
`
`Thomas J. Parker
`
`Enclosures: Exhibits A & B
`
`.__,
`._J
`a_J
`cJ
`a_J
`a_J
`n-J
`~j
`tf-J
`0~1
`6]
`
`E>
`~-
`
`~-
`
`#,(cid:173)..,-
`
`'#:.(cid:173)
`
`~-
`
`~-.. -
`~-.-
`
`Page 6 of 166
`
`

`

`EXHIBIT A
`EXHIBIT A
`
`1
`
`
`
`Page 7 of 166
`
`Page 7 of 166
`
`

`

`Table of Contents
`
`I.
`II.
`Ill.
`
`Introduction ............................................................... : ......................................................... I
`Summary ......................................................... : ................................................................... 2
`Analysis ............................................................................................................................... 3
`A.
`General Legal Principles ......................................................................................... 3
`
`I.
`2.
`3.
`4.
`
`I.
`
`2.
`
`B.
`
`Burdens and Presumptions ...................................................... : ................... 3
`Claim Construction ..................................................................................... 4
`Invalidity Analysis ...................................................................................... 5
`Obviousness Under 35 U.S.C. § I 03 .......................................................... 5
`a)
`Level of Ordinary Skill in the Art ................................................... 7
`b)
`Scope and Content of the Prior Art ................................................. 7
`c)
`Differences between the Prior Art and the Claimed
`Invention ......................................................................................... 7
`Obviousness of Structurally Similar Compounds ....................................... 8
`a)
`Lead Compound .............................................................................. 8
`b)
`Structural Modifications ................................................................. 9
`Reasonable Expectation ofSuccess .............................................. IO
`c)
`Objective Indicia ofNon-Obviousness ......................................... II
`d)
`Infringement Analysis ............................................................................... II
`a)
`Direct Infringement. ...................................................................... II
`THE LISTED ORANGE BOOK PATENTS FOR PROLENSA™ ..................... 12
`I.
`U.S. Patent No. 8,128,431 ......................................................................... 12
`a)
`Priority Information and Related Applications ............................. 12
`b)
`Claims of the '431 Patent.. ............................................................ 13
`c)
`Specification of the '431 Patent.. .................................................. 15
`d)
`Prosecution History of the '431 Patent ......................................... 15
`i)
`The '006 Application Claims as Filed .............................. 15
`ii)
`Preliminary Amendments Dated February 17, 2005;
`March 20, 2007; and April 3, 2007 ................................... 17
`Restriction Requirement Mailed on May 23, 2007 ........... 19
`Applicants' Response Dated June 4, 2007 ........................ 20
`Restriction Requirement Mailed on July 24, 2007 ........... 20
`Applicants' Response Dated August 20, 2007 ............... :. 21
`
`iii)
`iv)
`v)
`vi)
`
`,1
`•~~1
`
`•=(cid:173)
`
`• =-'
`
`. -·
`
`. :..'
`- -, :J
`t =--' t-j
`• :_I ·(cid:173)·(cid:173)•=-
`•=-. ---·
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`. -· . --... --
`-· . -. ---· . -. -· .----
`• =-' . -. -· .---·
`li.-(cid:173). -·
`li.- -·-·
`... -·
`li.- -
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`·-(cid:173)v-·
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`,_. "'-.
`~=-i
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`t:j
`0.=- ~
`t_J
`t(cid:173)
`t-(cid:173)
`t(cid:173)
`{.1 • •
`
`Page 8 of 166
`
`

`

`vii) Non-Final Office Action Mailed September 27,
`2007 ................................................................................... 21
`Interview Summary Mailed March 20, 2008 .................... 24
`Applicants' Response Dated March 26, 2008 ................... 24
`
`viii)
`ix)
`
`x)
`
`Non-Final Office Action Mailed July 18, 2008 ................ 33
`
`Interview Summary Mailed December 23, 2008 .............. 37
`xi)
`xii) Applicants' Response Dated January I5, 2009 ................. 37
`
`xiii)
`
`Final Rejection Mailed June 3, 2009 ................................ 43
`
`xiv) Applicants' Response and Request for Continued
`Examination Dated October 5, 2009 ................................. 45
`
`Interview Summary Mailed October 8, 2009 ................... 47
`xv)
`xvi) Non-Final Office Action Mailed December 24,
`2009 ................................................................................... 47
`
`xvii) Applicants' Response Dated March 24, 2010 ................... 49
`
`xviii) Final Rejection Mailed June 24, 20I 0 .............................. 55
`
`xix) Applicants' Response and Request for Continued
`Examination Dated October 25, 2010 ............................... 57
`Interview Summary Mailed January 20, 20I 1 .................. 61
`
`xx)
`
`xxi) Non-Final Office Action Mailed May 6, 2011 ................. 61
`
`xxii) Applicants' Response Dated September 6, 2011 .............. 62
`xxiii) Final Office Action Mailed November 15, 2011 .............. 65
`
`xxiv)
`Interview Summary Mailed November I 5, 2011 ............. 65
`xxv) Notice of Allowance and Examiner's Amendment
`mailed December 23, 2011 ............................................... 66
`Issuance of the '431 Patent on March 6, 2012 .................. 67
`U.S. Patent No. 8,669,290 ......................................................................... 67
`
`xxvi)
`
`2.
`
`a)
`
`b)
`
`c)
`
`d)
`
`Priority Information and Related Applications ..................................................... 67
`
`Claims of the '290 Patent ...................................................................................... 68
`
`Specification of the '290 Patent... ......................................................................... 72
`
`Prosecution History of the '290 Patent.. ............................................................... 72
`
`i)
`
`ii)
`iii)
`
`iv)
`
`The '242 Application Claims as Filed and Track I Request .................... 72
`
`Preliminary Amendment Dated November 28, 20I2 ............................... 72
`Restriction Requirement Mailed on March 25, 20 I 3 ................................ 81
`
`Applicants' Response Dated April9, 20I3 ............................................... 8I
`
`11
`
`Page 9 of 166
`
`

`

`v)
`
`vi)
`
`Non-Final Office Action Mailed August 8, 2013 ..................................... 81
`
`Applicants' Response and Terminal Disclaimers Submitted
`October 22, 2013 ....................................................................................... 86
`
`vii)
`
`Interview Summary Mailed January 15, 2014 .......................................... 91
`
`viii) Notice of Allowance and Examiner's Amendment mailed January
`15, 2014 ..................................................................................................... 91
`
`C.
`
`INVALIDITY OF THE ORANGE BOOK LISTED PATENTS ......................... 93
`
`1.
`
`2.
`
`3.
`
`Invalidity of the '431 Patent ..................................................................... 93
`
`Invalidity Analysis ofthe '431 Patent ...................................................... 94
`
`The Scope and Content of the Prior Art .................................................... 94
`
`a)
`
`b)
`
`c)
`
`d)
`
`e)
`
`f)
`
`g)
`
`h)
`
`i)
`
`j)
`
`k)
`
`U.S. Patent No. 4,910,225 to Ogawa eta!. ................................... 94
`
`WO 02/13804 to Kapin eta!. ....................................................... .'96
`
`U.S. Patent No. 5,414,011 toFu eta!. .......................................... 97
`
`WO 00/57887 to Shull et a!. ......................................................... 98
`
`Regev and Zana, Journal of Colloid and Interface Science
`(210) 8-17 (1999). ········································································ 98
`Yuan eta!., J. Phys. Chei:n. B 2001, 105,4611-4615 ................... 99
`
`U.S. Patent No. 2,454,541 to Bock eta!. .................................... 100
`
`U.S. Patent No. 6,107,343 to Sallmann eta!... ............................ 100
`
`U.S. Patent No. 6,274,609 to Yasueda eta!. ............................... 101
`
`Hara, Yoshiyuki, Clinics & Drug Therapy 2002, 19:1014-
`1015 ............................................................................................. 102
`
`Differences between the Prior Art and the Claims of the
`'431 Patent .................................................................................. l 03
`
`i)
`
`ii)
`
`iii)
`
`Independent Claim 1 of the '431 Patent is obvious
`under 35 U.S.C. § 103 over the '225 Patent in view
`of the '804 Publication, the '011 Patent, and Regev ....... I 03
`
`Independent Claim 1 of the '431 Patent is obvious
`under 35 U.S.C. § 103 over the '225 Patent in view
`of the '804 Publication, the 'Oil Patent, Yuan, and
`the '541 patent... .............................................................. I 08
`
`Independent Claim 1 of the '431 Patent is obvious
`· under 35 U.S. C. § 103 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 and Hara ....................................................... I 09
`
`iii
`
`Page 10 of 166
`
`

`

`iv)
`
`v)
`
`vi)
`
`vii)
`
`Dependent Claim 2 of the '431 Patent is obvious
`under 35 U.S.C. § I 03, over (A) the '225 Patent in
`view of the '804 Publication, the '011 Patent, and
`Regev or alternatively, (B) the '225 Patent in view
`of the '804 Publication, the '011 Patent, Yuan, and
`the '541 patent, or alternatively, (C) the '225 Patent
`in view the '343 Patent and the '609 Patent, or
`alternatively, (D) the '343 Patent in view of the
`'225 Patent and Hara ....................................................... 113
`Dependent Claims 3-5 and ll of the '431 Patent are
`obvious under 35 U.S.C. § 103 over (A) the '225
`Patent in view of the '804 Publication, the '011
`Patent, and Regev or alternatively, (B) the '225
`Patent in view of the '804 Publication, the '011
`Patent, Yuan, and the '541 patent, or alternatively,
`(C) the '225 Patent in view the '343 Patent and the
`'609 Patent, or alternatively, (D) the '343 Patent in
`view of the '225 Patent and Hara .................................... 114
`
`Dependent Claims 6, 12 and 15 of the '431 Patent
`are obvious under 35 U.S.C. § 103 over (A) the
`'225 Patent in view of the '804 Publication, the
`'Oil Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'541 patent, or
`'011 Patent, Yuan, and
`the
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 115
`
`Dependent Claims 7, 8, 13, 14, 16 and 17 of the
`'431 Patent are obvious under 35 U.S.C. § 103 over
`(A) the '225 Patent in view of the '804 Publication,
`the '011 Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'541 patent, or
`'011 Patent, Yuan, and
`the
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 117
`
`viii) Dependent Claims 9 and I 0 of the '431 Patent are
`obvious under 35 U.S. C. § 103 over (A) the '225
`Patent in view of the '804 Publication, the '011
`Patent, and Regev or alternatively, (B) the '225
`Patent in view of the '804 Publication, the '011
`Patent, Yuan, and the '541 patent, or alternatively,
`(C) the '225 Patent in view the '343 Patent and the
`'609 Patent, or alternatively, (D) the '343 Patent in
`view of the '225 Patent and Hara .................................... 118
`
`IV
`
`Page 11 of 166
`
`

`

`ix)
`
`x)
`
`xi)
`
`Independent Claim 18 of the '431 Patent is 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.. ......................... 119
`
`Independent Claim 18 of the '431 Patent is obvious
`under 35 U.S.C. § I 03 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 and Hara ....................................................... 122
`Dependent Claim 19 of the '431 Patent is obvious
`under 35 U.S.C. § 103 over (A) the '225 Patent in
`view of the '804 Publication, the '011 Patent, and
`Regev or alternatively, (B) the '225 Patent in view
`of the '804 Publication, the '011 Patent, Yuan, and
`the '541 patent, or alternatively, (C) the '225 Patent
`in view the '343 Patent and the '609 Patent, or
`alternatively, (D) the '343 Patent in view of the
`'225 Patent and Hara ....................................................... 123
`
`xii)
`
`Dependent Claim 20 of the '431 Patent is obvious
`under 35 U.S.C. § 103 over (A) the '225 Patent in
`view of the '804 Publication, the '011 Patent, and
`Regev or alternatively, (B) the '225 Patent in view
`of the '804 Publication, the '011 Patent, Yuan, and
`the '541 patent, or alternatively, (C) the '225 Patent
`in view the '343 Patent and the '609 Patent, or
`alternatively, (D) the '343 Patent in view of the
`'225 Patent and Hara ....................................................... 124
`xiii) Dependent Claims 21 and 22 of the '446 Patent are
`obvious under 35 U.S.C. § '103 over (A) the '225
`Patent in view of the '804 Publication, the '011
`Patent, and Regev or alternatively, (B) the '225
`Patent in view of the '804 Publication, the '011
`Patent, Yuan, and the '541 patent, or alternatively,
`(C) the '225 Patent in view the '343 Patent and the
`'609 Patent, or alternatively, (D) the '343 Patent in
`view of the '225 Patent and Hara .................................... 125
`
`4.
`5.
`
`Secondary Considerations ofNonobviousness ....................................... 126
`
`Invalidity of U.S. Patent No. 8,669,290 .................................................. 127
`
`a)
`
`Invalidity Analysis of the '290 Patent ........................................ 127
`
`i)
`
`The Scope and Content of the Prior Art .......................... 127
`
`b)
`
`Differences between the Prior Art and the Claims of the
`'290 Patent .................................................................................. 127
`
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`Page 12 of 166
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`

`

`i)
`
`ii)
`
`iii)
`
`iv)
`
`v)
`
`vi)
`
`vii)
`
`Independent Claims I and 14 of the '290 Patent are
`obvious under 35 U.S.C. § 103 over the '225 Patent
`in view of the '804 Publication, the '0 II Patent, and
`Regev .............................................................................. 127
`
`Independent Claims I and 14 of the '290 Patent are
`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 ............................................... 132
`
`Independent Claims 1 and 14 of the '290 Patent are
`obvious under 35 U.S.C. § 103 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 and Hara ....................................................... 133
`
`Independent Claim 8 of the '290 Patent is 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.. ......................... 137
`
`Independent Claim 8 of the '290 Patent is obvious
`under 35 U.S. C. § 103 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 and Hara ....................................................... 139
`
`Dependent Claims 10, 20 and 22 of the '290 Patent
`are obvious under 35 U.S.C. § 103 over (A) the
`'225 Patent in view of the '804 Publication, the
`'Oil Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'011 Patent, Yuan, and
`the
`'541 patent, or
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 140
`
`Dependent Claims 2, 9, 15 and 21 ofthe '290 Patent
`are obvious under 35 U.S. C. § 103 over (A) the
`'225 Patent in view of the '804 Publication, the
`'Oil Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'Oil Patent, Yuan, and
`the
`'541 patent, or
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 141
`
`viii) Dependent Claims 3 and 16 of the '290 Patent are
`obvious under 35 U.S.C. § 103 over (A) the '225
`
`VI
`
`Page 13 of 166
`
`

`

`ix)
`
`x)
`
`xi)
`
`xii)
`
`Patent in view of the '804 Publication, the '011
`Patent, and Regev or alternatively, (B) the '225
`Patent in view of the '804 Publication, the '011
`Patent, Yuan, and the '541 patent, or alternatively,
`(C) the '225 Patent in view the '343 Patent and the
`'609 Patent, or alternatively, (D) the '343 Patent in
`view of the '225 Patent and Hara .................................... 142
`
`Dependent Claims 4, 11, 17 and 23 of the '290
`Patent are obvious under 35 U.S.C. § 103 over (A)
`the '225 Patent in view of the '804 Publication, the
`'01 1 Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'01 1 Patent, Yuan, and
`the
`'541 patent, or
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 142
`
`Dependent Claim 5 of the '290 Patent is obvious
`under 35 U.S.C. § I 03 over (A) the '225 Patent in
`view of the '804 Publication, the '011 Patent, and
`Regev or alternatively, (B) the '225 Patent in view
`of the '804 Publication, the '011 Patent, Yuan, and
`the '541 patent, or alternatively, (C) the '225 Patent
`in view the '343 Patent and the '609 Patent, or
`alternatively, (D) the '343 Patent in view of the
`'225 Patent and Hara ....................................................... 144
`
`Dependent Claims 6, 12, 18 and 24 of the '290
`Patent are obvious under 35 U.S.C. § 103. over (A)
`the '225 Patent in view of the '804 Publication, the
`'011 Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'011 Patent, Yuan, and
`the
`'541 patent, or
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 144
`
`Dependent Claims 7, I 3, 19, and 25 of the '290
`Patent are obvious under 35 U.S.C. § 103 over (A)
`the '225 Patent in view of the '804 Publication, the
`'0 I I Patent, and Regev or alternatively, (B) the
`'225 Patent in view of the '804 Publication, the
`'011 Patent, Yuan, and
`the
`'541 Patent, or
`alternatively, (C) the '225 Patent in view the '343
`Patent and the '609 Patent, or alternatively, (D) the
`'343 Patent in view of the '225 Patent and Hara ............ 145
`
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`Page 14 of 166
`
`

`

`xiii) Dependent Claims 26-30 of the '290 Patent are
`obvious under 35 U.S.C. § I 03 over (A) the '225
`Patent in view of the '804 Publication, the 'Oil
`Patent, and Regev or alternatively, (B) the '225
`Patent in view of the '804 Publication, the '011
`Patent, Yuan, and the '541 Patent, or alternatively,
`(C) the '225 Patent in view the '343 Patent and the
`'609 Patent, or alternatively, (D) the '343 Patent in
`view of the '225 Patent and Hara .................................... 147
`
`c)
`
`Secondary Considerations ofNonobviousness ........................... 149
`
`D.
`
`E.
`
`NON-INFRINGEMENT OF THE '431 PATENT ............................................. 149
`
`NON-INFRINGEMENT OF THE '290 PATENT ............................................. 149
`
`vm
`
`Page 15 of 166
`
`

`

`EXHIBIT A
`DETAILED STATEMENT OF THE FACTUAL AND LEGAL BASIS FOR
`INNOPHARMA LICENSING INC.'S CERTIFICATION
`THAT U.S. PATENT NOS. 8,128,431 AND 8,669,290 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
`
`For at least the reasons set forth below, U.S. Patent Nos. 8,128,431 ("the '431 patent")
`and 8,669,290 ("the '290 patent") do not prohibit Innopharma Licensing Inc ("Innophanna")
`from manufacturing, using, selling, offering for sale, or importing Innopharmas'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 pai