Page 1 of 72
`
`SENJU EXHIBIT 2016
`LUPIN v. SENJU
`IPR2015-01105
`
`

`
`CONFIDENTIAL
`
`October 30, 20l4
`Page 2
`
`is invalid, unenforceable, and/or will not be infringed by the manufacture, use, sale, offer for
`sale, or importation of Innopharrna’s Bromfenac Product as defined by Innopharma‘s ANDA
`No. 206326.
`
`lnnopharma’s ANDA is for a generic drug product having the established name
`PROLENSATM. The active ingredient in the proposed drug product is bromfenac, which is
`present in the PROLEVSATM ophthalmic solution product in the form of bromfenac sodium
`sesquihydrate. PROLENSATM is supplied as a sterile, aqueous 0.07% solution with a pH of 7.8.
`
`accepted
`The United States Food and Drug Administration (“FDA") has
`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 originally submitted its ANDA under 21 U.S.C. § 355(j)(1) and (2)(A)
`with Paragraph IV certifications to U.S. Patent Nos. 8,129,431 (“the '43! patent”) and the
`8,669,290 (“the ’290 patent"). On September 19, 2014,
`lnnopharma 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 lnnopharma’s belief that
`each of the ’43l 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
`lnnopharma’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 ‘I31 patent, which
`lists as an issuance date on its face of July 17, 2014. Each ofthe ‘I31, '43l and ’290 patents
`is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange
`Book”) in connection with Bausch & Lomb, lnc.’s (“B&L") approved NDA No. 203168 for
`PROLENSATM ophthalmic solution.
`
`Innopharma seeks the FDA’s approval to market its proposed Bromfenac Product
`prior to the expiration of the Orange Book Patents.
`Innopharma alleges, and originally
`certified to the FDA that, to the best of lnnopharma’s knowledge, the '43! 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 Innopharrna’s ANDA.
`lnnophanna
`additionally alleges and has certified to the FDA that,
`to the best of Innophanna’s
`knowledge, the ‘I31 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
`Innopham1a’s ANDA. With regard to the ‘I31 patent, according to the FDA’s Orange Book:
`
`0
`
`the ’t31 patent will expire on January, I6 2024.
`
`to 21 U.S.C.
`Attached as Exhibit A is a detailed statement, made pursuant
`§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 ’ 131 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,
`
`Page 2 of 72
`
`

`
`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 lnnopharma’s ANDA and any supplement(s) thereto. As required by Section
`355{j)(5)(C)(i)(III), Innopharma offers to provide confidentiai access to certain information
`from its ANDA No. 206326 for the sole and exclusive purpose of determining whether an
`infiingement action referred to in Section 355(j)(5)(B)(iii) can be brought.
`
`Section 355{j)(5)(C)(i)(IlI) 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 ofConfidential Access:
`
`(I)
`
`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&[. or any FDA
`counseling,
`litigation, or other work before or involving the FDA. Such
`information (hereinafter, “Confidential
`lnnopharma Information”) shall be
`marked
`with
`the
`legend
`“CONFIDENTIAL
`INNOPHARMA
`INFORMATION.”
`
`The attorneys from the outside law finn representing B&L shall not disclose
`any Confidential
`lnnophanna Information to any other person or entity,
`including B&L employees, outside scientific consultants, andlor other outside
`counsel retained by B&L, without the prior written consent of lnnopharma.
`
`As provided by Section 355(j)(5)(C)(i)([ll), B&L’s outside law firm shall make
`use of the Confidential
`lnnopharma 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
`lnnopharma
`Information, and that all Confidential Innopharma 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
`Page 4
`
`(4)
`
`the
`Innopharma Information disclosed is, and remains,
`The Confidential
`property of
`lnnopharma. By providing said Confidential
`Innophanna
`Information, Innopharrna 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 (35) days from the date that it
`first receives the Confidential lnnopharma Information, return to Innophanna
`all Confidential
`Innopharma Information and any copies thereof. B&L’s
`outside law firm shall
`return all Confidential
`Innopharma Information to
`lnnopharma 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 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 lnnopharma with respect
`to the competency,
`relevance, or
`materiality of any such Confidential
`lnnopharma Infonnation, document, or
`thing. The fact that Innopharma provides Confidential lnnopharma Information
`to B&L upon B&L’s request shall not be construed as an admission by
`Innopharma that such Confidential Innopharrna 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.
`
`The attorneys from B&L’s outside law fin-n shall acknowledge in writing their
`receipt of a copy of these terms and restrictions prior to production of any
`Confidential Innopharma lnfonnation. 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)(lII) 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
`to the extent
`that B&L requests access to
`terms of an enforceable contract.” Thus,
`Confidential
`lnnophanna Information,
`it necessarily accepts the terms and restrictions
`outlined above.
`
`Page 4 of 72
`
`

`
`CONFIDENTIAL
`
`October 30, 2014
`Page 5
`
`Written notice requesting access under this Offer of Confidential Access should be
`made to:
`
`Deepro R. Mukerjee
`Alston & Bird LLP
`90 Park Avenue
`
`New York, New York 10016
`Tel: (212) 210-9400
`Fax: (212) 210-9444
`dccpro.mukc1jcc@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(_i)(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 72
`
`

`
`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
`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(i)(5)(B)(iii) can be brought.
`
`Section 355(j)(5)(C)(i)(Ill) 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.
`
`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
`lnnopharrna 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
`Innophan-na 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 355(j)(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 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
`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.
`
`Page 6 of 72
`
`

`
`EXHIBIT A
`
`Page 7 of 72
`
`

`
`Burtlcrisand
`
`Claim Construction
`
`invalidity Analysis
`
`I.
`
`2..
`3.
`
`4.
`
`OI:-viousness Under 35 U.S.C. § 1133
`
`----nun ---- |I1-ii‘I-Ill-I1-I-I'll-I-I-1-14111141444-
`
`.... ..
`....
`....
`noon-.1--pnnnnonu1-.-"noon-..-.. nu11-..-.-on"...-.-eon-.-.-in-.-.. .
`
`3)
`
`'3)
`
`Bl
`
`Level of Ordinary Skill in the
`
`Scope and Content of the Prior A31 ............................................... .. 6
`
`and the Claimed
`Differences between the Prior Art
`Invention ....................................................................................... ..i5
`
`Obviousness of'S1ri.ieti.ira]ly Similar Compounds ..................................... .. 7-‘
`
`a)
`
`b}
`
`c)
`
`d}
`
`Lead Compound ............................................................................ .. 7
`
`Structural Modifications
`
`Reasonable Expectation of Success
`
`3
`
`9
`
`Objective lndicia of Non-Obvioiisiiess.......,........,.......,................ 10
`
`Infringement
`
`3}
`
`Direct
`
`10
`
`U.S. Patent No. 3,'.r'54,l3I ................................................................................... .. 11
`
`I.
`
`Priority lnfonriation and Related Applications ....................................... .. 11
`
`Claims ofthe ‘I31 Patent.........
`
`.........
`
`........................................ .. ll
`
`Specification oftlte ‘l3l
`
`Prosecution Histories
`
`ill
`
`Pmsecution Histoty ot‘The ‘ I3]
`
`Preliminary
`
`i)
`
`ii}
`
`iii}
`
`iv)
`
`Office Action dated March 13, 20]»-‘I .............................. .. 16
`
`Response dated March 20, 2014 ..................................... .. 17
`
`Notice of Allowance ....................................................... .. 17
`
`Prosecution History ofThe ‘:13! Patent ...................................... .. 17
`
`i}
`
`Preliminary Amendments ............................................... .. I7
`
`15
`
`l6
`
`16
`
`Page 8 of 72
`
`

`
`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
`
`RCE and Rejection .......................................................... .. 23
`
`Response dated March 24, 2010 ..................................... .. 23
`
`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
`
`Response dated September 6, 2011 ................................ .. 25
`
`Notice of Allowance ....................................................... .. 26
`
`Inter Partes Review ......................................................... .. 26
`
`Prosecution History of U.S. Patent No. 8,497,304 ..................... .. 27
`
`Preliminary Amendments, Restriction and Election ....... .. 27
`
`Office Action of August 30, 2012 ................................... .. 27
`
`Response dated January 30, 2013 and Final
`
`Response after Final and Notice of Allowance ............... .. 28
`
`Prosecution history of U.S. Patent 8,669,290 ............................. .. 28
`
`Preliminary Amendment ................................................. .. 28
`
`Office Action dated August 1, 2013 ............................... .. 29
`
`Response dated October 22,
`
`30
`
`Notice of Allowance ....................................................... .. 31
`
`Inter Partes Review ......................................................... .. 31
`
`INVALIDITY OF THE ’131 PATENT .............................................................. .. 31
`1.
`
`Invalidity Analysis ofthe ’13l 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 to Fu et al. ............................ .. 34
`
`Page 9 of 72
`
`

`
`i)
`
`Interpretation of Independent Claims 1 and 13 ............... .. 38
`
`Obviousness of Claims I and 13 In Light of the ’804
`Publication, the ‘O1 I Patent and Regev ...................................... .. 39
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`Scope and Content of the Prior Art ................................. .. 39
`
`Level of Ordinary Skill in the Art ................................... .. 39
`
`Differences Between the Art and the Claims...............-.... 40
`
`Motivation to Combine the References .......................... .. 42
`
`Obviousness of Claims I and I3 In Light of the ’804
`Publication, the ’0I I Patent, Yuan, and the ’54l Patent ............ .. 44
`
`i)
`
`ii)
`
`iii)
`
`iv)
`
`Scope and Content of the Prior Art ................................. .. 44
`
`Level of Ordinary Skill in the Art ................................... .. 44
`
`Differences Between the Art and the Claims .................. .. 44
`
`Motivation to Combine the References .......................... .. 44
`
`Obviousness of Independent Claim 7
`
`45
`
`Secondary Considerations ........................................................... .. 48
`
`14: Quaternary
`and
`8
`2,
`Obviousness of Claims
`Ammonium Salt .......................................................................... .. 48
`
`Obviousness of Claims 3 and 15: Bromfenac Sodium Salt ........ .. 49
`
`Obviousness of Claim 4: Amount of Tyloxapol ......................... .. 49
`
`Obviousness of Claims 5, II and 17: pH From About 7.5
`To About 8.5 ............................................................................... .. 50
`
`and 24: Specific
`18
`12,
`Obviousness of Clams 6,
`Forrnualtions ............................................................................... .. 51
`
`Obviousness of Claims 9, 19 and 21: Storage Stability .............. .. 53
`
`10, 16 and 22: Amounts of
`Obviousness of Claims
`Bromfenac and Tyloxapol ........................................................... .. 54
`
`Obviousness of Claim 20: Quaternary Salt ................................. .. 55
`
`Obviousness of Claim 23: pH ofAbout 7.5 to About
`
`56
`
`Page 10 of 72
`
`

`
`q]
`
`r)
`
`Ohviuusncss of Claims 15, 215, 2?, 23 and 39: Presewalive
`Efficacy Standard .......................................................................... 56
`
`Olzwiousness of Ciaim EU: Additive ............................................ .. 53
`
`D.
`
`NDP~i—!NFR[HGEMENT OF THE ° l3| FA'l'ENT ............................................... 53
`
`Page 11 of 72
`
`

`
`does not prohibit Innopharma Licensing Inc. (“Innopharma") 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.'
`
`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 PROLENSATM for the treatment of
`postoperative inflammation and reduction of ocular pain in patients who have undergone cataract
`surgery. Exhibit 1, PROLENSA TM Label.
`
`PROLENSATM is formulated as bromfenac sodium sesquihydraie. The USAN name for
`bromfenac sodium sesquihydrate is bromfenac sodium. The standard chemical name for
`bromfenac sodium is sodium [2-amino-3-(4—bromobenzoyl)pli.enyl] acetate sesquihydrate. It has
`an empirical formula of C;5H. ;BrNNaO3-l ‘/2 H30. The structural fonnula for bromfenac sodium
`15.
`
`-Q3
`
`cH3C0gNa
`
`‘ 1 If2H2O
`
`the ’|3l patent; U.S.
`The Orange Book lists the following patents for PROLENSATM:
`Patent No. 8,l28,43| (“the ’43l patent"); and U.S. Patent No. 8,669,290 (“the ‘Z90 patent")
`(collectively, “the Orange Book Patents”). The Orange Book also indicates that PROLENSATM is
`associated with New Drug Application No. 203-168, which is held by B&L, The FDA has
`approved NDA No. 203-168 for PROLENSATM 0.07% ophthalmic solution.
`
`Innopharma reserves its rights to raise any additional defenses relating to invalidity,
`'
`unenforceability, and norrinfringement
`in any and all proceedings
`for alleged patent
`infringement.
`
`Page 12 of 72
`
`

`
`lnnopharma 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 ’43l and ’29O patents and set
`forth the factual and legal bases for
`|nnopharma’s certification that the ’43l 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
`
`.
`.
`.
`.
`.
`‘J
`Innopharma’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:'
`
`The ‘[31 Patent
`
`As set forth in detail below, Innophanna cannot infringe claims 1-30 of the ’43l patent
`because each of these claims is invalid under 35 U.S.C. § 103 as follows:
`
`0 Each of claims 1-30 of US. 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 O2/13804
`(“the ’804 publication”); U.S. Patent Number 5,414,011 (“the ‘U11 patent"); and
`Regev, Journal ofColloid 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
`ofthe’225 patent in view of the ‘S04 publication; the ‘O1 1 patent; Yuan et al., J.
`Phys. Chem. B 2001, 105, 4611-4615 (“Yuan”) and U.S. Patent No. 2,454,541
`(the ’541 patent).
`
`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 patcnt’s invalidity. Sec, c.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
`c.g., Apotcx 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, [nnopharrna incorporates by
`reference, and reserves the right to assert, any invalidity positions set forth in any inter partes
`review related to any parent at issue.
`
`Page 13 of 72
`
`

`
`Sollac & 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. Demenr, 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. Pltillips 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., Pliillips, 415 F.3d at 1312; Vi'trouic.s' Corp. v. COI1C€pt.'l’0HlC,
`Inc, 90 F.3d 1576, 1582
`(Fed. Cir. 1996); Markmcm v. Westvicw Instruments, Inc, 52 F.3d 967, 979-80 (Fed. Cir. 1995)
`(en banc) ("Mm'lrmm1 I"). 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; Vi!roru'cs, 90 F.3d at 1582-33. Usually, analysis of the intrinsic
`evidence suffices to enable one to determine the meaning of claim terms. Vitt-onics, 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., Mantech Envtl.
`Corp, V. Hurlson Em/tl. Servs., 152 F.3d 1368, 1373 (Fed. Cir. 1998); Bell & Howell Document
`Mgmt. Prods. Ca. V. Altck .S'ys., 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.,
`Scr'Med Life Sys., Inc. v. Advrmced 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
`claim language by explicitly limiting statements made therein. See, e.g., Watts v. XL Sys., Inc,
`232 F.3d 877, 882 (Fed. Cir. 2000); 0.1. Corp. v. Tekmar Co., 115 F.3d 1576, 1531 (Fed. Cir.
`1997); Wang Lab, Inc. v. Am. Onliue, Inc., 197 F.3d 1377, 1332-33 (Fed. Cir. 1999).
`
`Where the specification contains nothing to indicate that phrases are to be given anything
`other than their ordinary meanings, then those are the meanings the court must give them. See,
`e.g., Vitrom'cs, 90 F.3d at 1582. Thus, a technical term used in a patent document is interpreted
`as having the meaning that it would be given by persons experienced in the field of the patent,
`unless it is apparent from the specification or the prosecution history that the patentee used the
`term with a different meaning. See, c.g., C VIfBe!a Vc'nture.s'. Inc. v, Tum Lp, 112 F.3d 1146,
`1153 (Fed. Cir. I997) (citation omitted) (“[i]t is always necessary to review the specification to
`
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`detennine whether the inventor has used any terms in a manner inconsistent with their ordinary
`meaning”). In addition, unambiguous claim language controls over alternative contradictory
`interpretations found in the specification. See, e.g., Elckta Instrumem‘ S.A. v. UR Scieirafic lntl.
`Inc., 214 F.3d 1302, 1308 (Fed. Cir. 2000).
`
`in claim construction, which
`A court may also look to extrinsic evidence to assist
`includes any evidence which is external to the patent and prosecution history, such as expert
`testimony, inventor testimony, dictionaries, technical treatises and articles. la'.; Vltronic.s', 90 F.3d
`at 1584. While extrinsic evidence may be usefiil in shedding light on the relevant prior art, a
`reviewing court is limited in relying on extrinsic evidence for claim interpretation purposes.
`Phillips, 415 F.3d at 1317-18. Thus,
`if the intrinsic evidence (specification, claims, and
`prosecution history) resolves any ambiguity in a disputed claim, extrinsic evidence cannot be
`used to contradict the established meaning of the claim language. See, e.g., Mantecl: Envtl. Corp.
`v. Hudson Envtl. Servsz, 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). In addition, while use of expert
`testimony to explain an invention is admissible, courts may only rely upon extrinsic evidence to
`construe a claim term when the claim language remains genuinely ambiguous after consideration
`of the intrinsic evidence. See, e.g., Phillips, 415 F.3d at 1318; Bell & Howell, 132 F.3d at 706.
`Any expert testimony which is inconsistent with unambiguous intrinsic evidence, therefore,
`should be accorded no weight. Phillips, 415 F.3d at 1318.
`
`3.
`
`Invalidity Analysis
`
`Once the claims have been properly construed, in the case of an invalidity analysis, the
`second step requires the properly construed claims to be compared to the prior art reference(s) to
`determine whether the claim limitations are present in the prior art, either expressly or inherently.
`See, e.g., Iron Grip Barbell C0,, Inc. v. USA Sports. Inc., 392 F.3d 1317, 1323 (Fed. Cir. 2004);
`In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Whether a limitation is present in a prior
`art reference is a factual determination and thus may be submitted to a jury if the case is not tried
`to the court. See Rapoporr, 254 F.3d at 1060. However, whether a claim is obvious in view of the
`prior art is a question of law that is subject to underlying factual determinations. Id. at 1057-58.
`The disclosure of the specification must also be examined with respect to each construed claim
`to detennine if it meets the legal standards for written description. Uiiiversity ofRocl1ester v.
`G.D. Searle & Co., Inc., 358 F.3d 916, 921 (Fed. Cir. 2004).
`
`4.
`
`Obviozrsiaess Under 35 U.S.C. § 103
`
`Under 35 U.S.C. § 103, an applicant is not entitled to a patent “if the differences between
`the claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having ordinary
`skill in the art to which the claimed invention pertains.” The Supreme Court set the standard for
`obviousness in Graham v. John Deere, 383 U.S.
`I (1966), identifying the factual inquiries for
`determining obviousness. The relevant factual inquiries include:
`
`(a)
`
`(b)
`
`detennining the scope and contents of the prior art;
`
`ascertaining the differences between the prior art and the claims in issue;
`
`4
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`Page 15 of 72
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`To establish (I prima fircic case of obviousness, th.ree basic criteria must be met. First,
`there must be some reason to modify or combine the prior art references. See, e.g., Takeda Chem.
`Indus. Ltd. v. Alpliapharm Pty., Ltd., 492 F.3d I350, 1356-57 (Fed. Cir. 2007). This motivation
`need not come from the references themselves nor must it be explicitly stated, but may reside in
`the knowledge generally known to one of ordinary skill in the art. Id. at 1357 (citing KSR, 550
`U.S. at 40!). For chemical compounds, a prima facie case of obviousness further requires
`“structural similarity between claimed and prior art subject matter...where the prior art gives
`reason or motivation to make the claimed compositions.” In re Mayne, 104 F.3d 1339, 1342
`(Fed. Cir. 1997) (citation omitted).
`
`there must be a reasonable expectation of success. See, e.g., PharmaStcm
`Second,
`T/Ierrrtpeutics, Inc. v. V:'aCeIl, Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007) (citing KSR, 550 U.S. at
`417). This expectation, however, need not be guaranteed or amount to absolute predictability. In
`re 0'FarrelI, 853 F.2d 894, 903-904 (Fed. Cir. I988) (citation omitted).
`
`Third, the prior art reference (or references when combined), or the combination of the
`prior art references with the knowledge of an ordinary artisan, must teach or suggest all the claim
`limitations. See, e.g., Dam: v. Johnston, 425 U.S. 219, 230 (l976).
`
`In the KS}? case, the Supreme Court rejected the Federal Circuit’s rigid rule of requiring
`that there be an explicit teaching, suggestion, or motivation to combine references to make the
`claimed invention. 550 U.S. at 415. Instead, the Court found that other factors, including the
`availability of design or market pressures, may provide the motivation to make the claimed
`invention. “When there is a design need or market pressure to solve a problem and there are a finite
`number of identified, predictable solutions, a person of ordinary skill has good reason to pursue”
`known options available to make the claimed invention. Id. at 421. The Court in KSR also held that if
`a combination or improvement
`is no more than a predictable use of prior art elements,
`that
`combination would have been obvious to one of ordinary skill in the art. Id. at 416. The Court
`recognized the creativity of an ordinary practitioner, and that a skilled artisan may “be able to fit the
`teachings of multiple patents together like pieces of a puzzle.” Id. at 420. “A person of ordinary skill
`is also a person of ordinary creativity, not an automaton." Id. at 421.
`
`Accordingly, simple substitution of known elements for another, or use of known
`techniques to improve a method in a similar way, such that the substitution or techniques are
`“obvious to try” to one of ordinary skill
`in the art, may form the basis of establishing
`obviousness. Id.
`
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`
`a)
`
`Level of Ordinary Skill in the Art
`
`The hypothetical person of ordinary skill in the an is not an extraordinarily