June 1, 2015
`
`Watson.
`
`Via Certified Mail and/or FedEx®
`
`General Counsel
`Bausch & Lomb
`400 Somerset Corporate Blvd
`Bridgewater, NJ 08807
`
`General Counsel
`Bausch & Lomb
`50 Technology Drive
`Irvine, CA 92618
`
`General Counsel
`Senju Pharmaceutical Co., Ltd.
`2-5-8, Hiranomachi 2-Chome, Chuo-Ku
`Osaka-Shi, Osaka 541-0046, Japan
`
`Warren M. Cheek, Jr., Esq.
`Wenderoth, Lind & Ponack, L.L.P.
`1030 151h St., NW, Suite 400 East
`Washington, DC 20005
`
`HIGHLY CONFIDENTIAL
`
`Re: Notification of Certification for U.S. Patent Nos. 8,129,431, 8,669,290, 8, 754,131,
`8,871,813 and 8,927,606 Pursuant to § 505(i)(2)(B)(iv) of the Federal Food, Drug,
`and Cosmetic Act
`
`Dear Madam or Sir:
`
`Pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act and 21
`C.F.R. § 314.95, Watson Laboratories, Inc. ("Watson") hereby provides notice of the following
`infonnation to: (i) Bausch & Lomb ("Bausch & Lomb"), as the apparent holder of approved New
`Drug Application ("NDA") No. 203168 for Prolensan' (bromfenac sodium) Ophthalmic Solution,
`Eq. 0.07% Acid according to the records of the U.S. Food and Drug Administration ("FDA") and
`Senju Pharmaceutical Co., Ltd ("Senju"), as the record owner of U.S. Patent Nos. 8,129,431,
`8,669,290, 8,754,131, 8,871,813, and 8,927,606 according to the records of the U.S. Patent and
`Trademark Office ("PTO") and/or the face of the patent.
`
`As a courtesy, Watson provides a copy of this Notice Letter and Detailed Statement to
`Warren M. Cheek, Jr., Esq. ofWenderoth, Lind & Ponack, L.L.P. as the correspondent for U.S.
`Patent Nos. 8,129,431; 8,669,290; 8,754,131; 8,871,813; and 8,927,606 according to the records
`
`-1-
`
`Page 1 of 77
`
`SENJU EXHIBIT 2023
`LUPIN v. SENJU
`IPR2015-01100
`
`

`
`Bausch & Lomb
`Senju
`Page2
`
`of the PTO and/or the face of the patent.
`
`Pursuant to 21 C.F .R. § 314.95( e), Watson requested from FDA permission to
`send this notice by means other than registered or certified mail. Specifically, Watson requested
`that it be allowed to send this notice by FedEx®. Consequently, the operative date for
`determining the start of the 45-day clock under 21 U.S.C. § 355G)(5)(B)(iii) began from the
`receipt of this notice, as sent via FedEx® and/or Certified Mail.
`
`I.
`Pursuant to 21 U.S.C. § 355G)(2)(B)(iv)(I) and 21 C.F.R. § 314.95(c)(1),
`we advise you that FDA has received an Abbreviated New Drug Application ("ANDA'') from
`Watson for Bromfenac Ophthalmic Solution, 0.07%. The ANDA contains the required
`bioavailability and/or bioequivalence data and/or bioequivalence waiver. The ANDA was
`submitted under 21 U.S.C. § 3550)(1) and (2)(A), and contains Paragraph IV certifications to
`obtain approval to engage in the commercial manufacture, use or sale of Bromfenac Ophthalmic
`Solution, 0.07%, before the expiration of U.S. Patent Nos. 8,129,431; 8,669,290; 8,754,131;
`8,871,813; and 8,927,606 which are listed in the Patent and Exclusivity Information Addendum
`of FDA's publication, Approved Dmg Products with Therapeutic Equivalence Evaluations
`(commonly known as the "Orange Book").
`
`Pursuant to 21 C.F.R. § 314.95(c)(2), we advise you that FDA has
`II.
`assigned Watson's ANDA the number 206085.
`
`Pursuant to 21 C.F.R. § 314.95(c)(3), we advise you that the established
`III.
`name of the drug product that is the subject of Watson's ANDA is Bromfenac Ophthalmic
`Solution, 0.07%.
`
`Pursuant to 21 C.F.R. § 314.95(c)(4), we advise you that the active
`IV.
`ingredient in the proposed drug product is bromfenac sodium; the strength of the proposed drug
`product is 0.07% ofbromfenac; and the dosage form of the proposed drug product is ophthalmic
`solution.
`
`Pursuant to 21 C.F.R. § 314.95(c)(5), we advise you that the patents
`V.
`alleged to be invalid, unenforceable, and/or not infringed in the Paragraph IV certifications are
`U.S. Patent Nos. 8,129,431; 8,669,290; 8,754,131; 8,871,813; and 8,927,606 which are listed in
`the Orange Book in connection with Bausch & Lomb's approved NDA No. 203168 for
`Prolensa™. According to information published in the Orange Book, the patents will expire as
`follows:
`
`U.S. PATENT NO.
`
`EXPIRATION DA'FE
`
`8,129,431
`
`8,669,290
`
`8,754,131
`
`8,871,813
`
`September 11, 2025
`
`January 16, 2024
`
`January 16, 2024
`
`January 16, 2024
`
`Page 2 of 77
`
`

`
`Bausch & Lomb
`Senju
`Page3
`
`U.S. PATENT NO.
`
`EXPIRATION DATE
`
`8,927,606
`
`January 16, 2024
`
`VI. Watson alleges, and has certified to FDA, that in Watson's opinion and to
`the best of its knowledge, U.S. Patent Nos. 8,129,431; 8,669,290; 8,754,131; 8,871,813; and
`8,927,606 are invalid, unenforceable, and/or will not be infringed by the commercial
`manufacture, use or sale of the drug product described in Watson's ANDA. Therefore, pursuant
`to 21 U.S.C. § 355(j)(2){B)(iv)(II) and 21 C.F.R. § 314.95{c)(6), Watson's detailed statement of
`the legal and factual basis for the Paragraph IV certifications set forth in Watson's ANDA is
`attached hereto and made a part hereof.
`
`Pursuant to 21 U.S.C. § 355(j)(5)(C), this notice letter includes an Offer of
`VII.
`Confidential Access to Application. As required by § 355(j)(5)(C)(i)(III), Watson offers to
`provide confidential access to certain information from its ANDA No. 206085 for the sole and
`exclusive purpose of determining whether an
`infringement action
`referred
`to
`in
`§ 355(j)(S)(B)(iii) can be brought.
`
`Section 355(j)(5)(C)(i)(III) allows Watson 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 Watson the right to redact its
`ANDA in response to a request for Confidential Access under this offer.
`
`As permitted by statute, Watson imposes the following terms and restrictions on
`its Offer of Confidential Access:
`
`(1) Watson will permit confidential access to certain information from its proprietary
`ANDA No. 206085 to attorneys from one outside law firm representing Bausch &
`Lomb and one outside law finn representing Senju, provided however that such
`attorneys do not engage, formally or informally, in any patent prosecution for
`Bausch & Lomb or Senju or any FDA counseling, litigation or other work before
`or involving FDA.
`Such information (hereinafter, "Confidential Watson
`Information") shall be marked with the legend "CONFIDENTIAL."
`
`(2)
`
`(3)
`
`The attorneys from the outside law firms representing Bausch & Lomb and/or
`Senju shall not disclose any Confidential Watson Information to any other person
`or entity, including employees of Bausch & Lomb or Senju, outside scientific
`consultants, and/or other outside counsel retained by Bausch & Lomb or Senju,
`without the prior written consent of Watson.
`
`As provided by § 355(j)(S)(C)(i)(III), the outside law firms representing Bausch
`& Lomb or Senju shall make use of the Confidential Watson Information for the
`sole and exclusive purpose of determining whether an action referred to in
`§ 355(j)(5)(B)(iii) can be brought -
`and for no other purpose. By way of
`
`Page 3 of 77
`
`

`
`Bausch & Lomb
`Senju
`Page4
`
`example only, the Confidential Watson Information shall not be used to prepare
`or prosecute any future or pending patent application by Bausch & Lomb or
`Senju; in connection with any filing to, or communication with, FDA relating to
`Watson's ANDA No. 206085; or in connection with any submission to, or
`communication with, the United States Pharmacopeia or any similar organization.
`The outside law firms representing Bausch & Lomb or Senju agree to take all
`measures necessary to prevent unauthorized disclosure or use of the Confidential
`Watson Information, and that all Confidential Watson Information shall be kept
`confidential and not disclosed in any manner inconsistent with this Offer of
`Confidential Access.
`
`The Confidential Watson Information disclosed is, and remains, the property of
`Watson. By providing the Confidential Watson Information, Watson does not
`grant Bausch & Lomb or Senju and/or their outside law firms any interest in or
`license for the Confidential Watson Information.
`
`The outside law firms representing Bausch & Lomb or Senju shall, within thirty(cid:173)
`five (35) days from the date that it first receives the Confidential Watson
`Information, return to Watson all Confidential Watson Information and any
`copies thereof. Said outside law firm shall return all Confidential Watson
`Information before any infiingement suit is filed by Bausch & Lomb and/or
`Senju, if suit is commenced before this 35-day period expires. In the event that
`Bausch & Lomb and/or Senju opts to file suit, none of the information contained
`in or obtained from any Confidential Watson Information that Watson provides
`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 Watson regarding the validity, enforceability, and/or infringement of any U.S.
`patent. Further, nothing herein shall be construed as an agreement or admission
`by Watson with respect to the competency, relevance, or materiality of any such
`Confidential Watson Information, document, or thing. The fact that Watson
`provides Confidential Watson Information upon request of Bausch & Lomb or
`Senju shall not be construed as an admission by Watson that such Confidential
`Watson Information is relevant to the disposition of any issue relating to any
`alleged infringement of or to the validity or enforceability of U.S. Patent Nos.
`8,129,431; 8,669,290; 8, 754,131 ; 8,871 ,813; and 8,927 ,606.
`
`( 4)
`
`(5)
`
`(6)
`
`(7)
`
`The attorneys from the outside law firms representing Bausch & Lomb or Senju
`shall acknowledge in writing their receipt of a copy of these terms and restrictions
`prior to production of any Confidential Watson Information. Such written
`acknowledgement shall be provided to Watson.
`
`(8)
`
`This Offer of Confidential Access shall be governed by the laws of the State of
`New Jersey.
`
`Page 4 of 77
`
`

`
`Bausch & Lomb
`Senju
`Page 5
`
`Section 355(j)(5)(C)(i)(III) provides that any request for access that Bausch & Lomb or
`Senju makes under this Offer of Confidential Access "shall be considered acceptance of the offer
`of confidential access with the 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 Bausch & Lomb or Senju request access to
`Confidential Watson Information, it necessarily accepts the terms and restrictions outlined
`above. Written notice requesting access under this Offer of Confidential Access should be made
`to:
`
`Brian Anderson, Esq.
`Morris Corporate Center III
`400 Interpace Parkway
`Parsippany, NJ 07054
`(862) 261-8406
`brian.anderson@actavis.com
`
`By providing this Offer of Confidential Access to Application, Watson 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).
`
`Very truly yours,
`
`Watson Laboratories, Inc.
`
`By:(],)"' ,L.,..,., 0t.i.kt...,
`
`J yce Anne Delgaudio
`Executive Director, Regulatory Affairs
`
`Enclosure: Watson's Detailed Factual and Legal Basis for Its Paragraph IV Certifications that
`U.S. Patent Nos. 8,129,431, 8,669,290, 8,754,131, 8,871,813, and 8,927,606 are
`Invalid, Unenforceable and/or Not Infringed by the Bromfenac Product Described in
`Watson's ANDA No. 206085
`
`Page 5 of 77
`
`

`
`ENCLOSURE
`
`WATSON'S DETAILED FACTUAL AND LEGAL BASIS
`FOR ITS PARAGRAPH IV CERTIFICATIONS THAT U.S. PATENT NOS. 8,129,431;
`8,669,290; 8,754,131; 8,871,813; AND 8,927,606 ARE INVALID, UNENFORCEABLE
`AND/OR NOT INFRINGED BY THE BROMFENAC PRODUCT
`DESCRIBED IN WATSON'S ANDA NO. 206085
`
`Pursuant to § 505(j)(2)(8)(iv)(II) of the Federal Food, Drug, and Cosmetic Act and 21
`C.F.R. § 314.95(c)(6), the following infonnation comprises the detailed factual and legal basis
`for the Paragraph IV certifications of Watson Laboratories, Inc. (Watson) that, in its opinion
`and to the best of its knowledge, U.S. Patent Nos. 8,129,431 ("the '431 patent"), 8,669,290
`("the '290 patent"), 8,754,131 ("the '131 patent"), 8,871,813 ("the '813 patent"), and 8,927,606
`("the '606 patent") are invalid, unenforceable and/or will not be infringed by the commercial
`manufacture, use, sale, offer for sale or importation of the drug product described in Watson's
`ANDA No. 206085 ("Watson's ANDA Product" or "the Watson ANDA Product"). Watson
`reserves all rights to raise additional defenses relating to invalidity, unenforceability and/or non(cid:173)
`infringement should litigation ensue.
`
`I. WATSON'S ANDA PRODUCT
`
`The Watson ANDA Product is an ophthalmic solution containing 0.07 mglmL of
`bromfenac.
`
`The composition of Watson's ANDA Product may be disclosed pursuant to the tenns set
`forth in the Offer of Confidential Access.
`
`II. THE ORANGE BOOK LISTED PATENTS
`
`U.S. PATENT
`NO.
`
`EXPIRATION DATE
`
`8,129,431
`
`8,669,290
`
`8, 754,131
`
`8,871,813
`
`8,927,606
`
`September 11, 2025
`
`January 16, 2024
`
`January 16, 2024
`
`January 16, 2024
`
`January 16, 1 024
`
`1
`
`Page 6 of 77
`
`

`
`III. APPLICABLE LEGAL STANDARDS
`
`A. Infringement
`
`Direct infringement occurs when a person or entity makes, uses, offers to sell or sells in
`the United States a product that is covered by an unexpired patent without the authorization of
`the patent owner. 35 U.S.C. §27l(a).
`
`The courts have held that all infringement analysis involves two steps. The first step
`involves interpreting the claims to determine their meaning and scope. North Am. Vaccine, Inc.
`v. Am. Cyanamid Co., 7 F.3d 1571, 1574 (Fed. Cir. 1993), cert. denied, 511 U.S. 1069 (1994).
`The Supreme Court has held that this first step - claim interpretation - is an issue of law
`exclusively within the province of the court. Markman v. Westview Instruments, Inc., 517 U.S.
`3 70 (1996). Proper claim interpretation involves consideration of the claim itself, the
`specification, other claims, the prosecution history and extrinsic evidence, if necessary. See
`Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995), (en bane) aff'd,
`517 u.s. 370 (1996).
`
`The second step involves comparing the properly construed claims to the accused
`product or process to determine whether the properly construed claims "read on" the accused
`subject matter. North Am. Vaccine, 7 F.3d at 1574. This second step is a factual determination.
`Hormone Research Found., Inc. v. Genentech, Inc., 904 F.2d 1558, 1562 (Fed. Cir. 1990), cert.
`dismissed, 499 U.S. 955 (1991). The Federal Circuit has explained that "[i]n order for there to
`be infringement, each and every limitation set forth in a patent claim must be found in the
`accused product, either literally or under the doctrine of equivalents." CVI/Beta Ventures, Inc.
`v. Tura LP, 112 F.3d 1146, 1161 (Fed. Cir. 1997); see also Tanabe Seiyalm Co., Ltd., v. United
`States Int 'I Trade Comm 'n, 109 F.3d 726, 731 (Fed. Cir. 1997), cert. denied, 522 U.S. 1027
`(1997) ("The patent owner must show that every limitation of the patent claim asserted is found
`in the accused process or product, either literally or under the doctrine of equivalents.").
`
`The patent owner bears the burden to prove infringement by a preponderance of the
`evidence. Id. at 731. This standard applies to both literal infringement and infiingement under
`the doctrine of equivalents. Lemelson v. United States, 752 F.2d 1538, 1547 (Fed. Cir. 1985).
`The burden to prove infringement rests at all times on the patent owner and must be established
`by accurate, scientific methods. Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1050
`(Fed. Cir. 2001 ).
`
`1. Claim Construction
`
`The courts construe the claims of each patent according to the hierarchy of evidence
`articulated in Markman, looking first to the intrinsic evidence of the patent. Mar/,:man, 52 F.3d
`at 979, quoting Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir. 1991) ("To
`ascertain the meaning of claims, we consider three sources: The claims, the specification, and
`the prosecution history.") The court begins with the language of the disputed claims, which
`define the scope of the invention and the rights of the patentee. Markman, 517 U.S. at 373-74;
`Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en bane), cert. denied, 126 S.Ct.
`
`2
`
`Page 7 of 77
`
`

`
`1332 (Feb. 21, 2006). The court may consider not only the language of the disputed claims
`themselves, but also the language of the unasserted claims. Phillips, 415 F.3d at 1314-15.
`Claims should be construed as they would be by a person of ordinary skill in the art. Phillips,
`415 F.3d at 1313-14; Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1302 (Fed. Cir. 1997).
`Moreover, the court must construe the words of the claim as of the time of the invention or
`when the application was first filed. Phillips, 415 F.3d 1313; Leggett & Platt, Inc. v. Hick01y
`Springs Mfg. Co., 285 F.3d 1353, 1357 (Fed. Cir. 2002). Thus, the focus in construing disputed
`claim tenns is not the subjective intent of the inventor or examiner; rather, it is the objective test
`of what one of ordinary skill in the art at the time of the invention would have understood a
`claim tenn to mean. See Marh.-man, 52 F.3d at 986; Phillips, 415 F.3d at 1313.
`
`Each and every word in a claim must be construed to have meaning. Exxon Chem.
`Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557 (Fed. Cir. 1995). Claim tenns generally are
`given their ordinary and customary meaning as of the date of the application for the patent.
`Phillips, 415 F.3d at 1313; Kopykake Enters., Inc. v. Lucks Co. , 264 F.3d 1377, 1383 (Fed. Cir.
`2001). They also must "be read in accordance with the precepts of English grammar." In re
`Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983). This strong presumption "in favor of the ordinary
`meaning of claim language as understood by one of ordinary skill in the art" may be overcome
`where: 1) the patentee has chosen to become his or her own lexicographer by clearly and
`explicitly defining the claim tenn; or 2) a claim tenn would "deprive[] the claim of clarity such
`that there is 'no means by which the scope of the claim may be ascertained from the language
`used."' Bell At/. Network Servs., Inc. v. Covad Comms. Group, Inc., 262 F.3d 1258, 1268 (Fed.
`Cir. 2001) (internal citations omitted). When a patentee chooses to be his or her own
`lexicographer and uses tenns in a manner other than their ordinary meaning, the intended
`definition of the tenn must be "clearly stated in the patent specification or file history!'
`Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir 1996); see also Novo
`Nordisk of N. Am., Inc. v. Genentech, Inc., 77 F .3d 1364, 1368 (Fed. Cir. 1996); Intellicall, Inc.
`v. Phonometries, Inc., 952 F.2d 1384, 1387 (Fed. Cir. 1992).
`
`The court should look to the specification and the file history to see if the inventor
`varied the ordinary meaning of particular claim tenns or if a claim tenn is unclear. Phillips, 415
`at 1315, 1317; Phonometries, Inc. v. N. Telecom Inc., 133 F.3d 1459, 1466 (Fed. Cir. 1998).
`Specifications can be "the single best guide to the meaning of a disputed tenn" and, therefore,
`are always "highly relevant to the claim construction analysis." Phillips, 415 F.3d at 1315. A
`patentee need not deliberately or precisely define a tenn in a lexicographical manner, but may
`provide a definition by implication. Vitronics, 90 F.3d at 1582. Thus, the Federal Circuit has
`"specifically held that the written description of the preferred embodiments 'can provide
`guidance as to the meaning of the claims'" that are to be construed, "even if the guidance is not
`provided in explicit definitional fonnat." Bell At/. Network, 262 F.3d at 1268 (quoting SciMed
`Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed. Cir. 2001)).
`
`The prosecution history of a patent ordinarily should be considered during a claim
`construction analysis. Markman, 52 F.3d at 980 ("The court has broad power to look as a
`matter of law to the prosecution history of the patent in order to ascertain the true meaning of
`language used in the patent claims ... "). The prosecution history is intrinsic evidence and is
`"often of critical significance in detennining the meaning of the claims." Vitronics, 90 F.3d at
`
`3
`
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`
`

`
`1582; Phillips, 415 F.3d 1317. In addition, prior art considered by the United States Patent and
`Trademark Office ("USPTO") during prosecution of a patent comprises intrinsic evidence for
`claim construction. Vitronics, 90 F.3d at 1583.
`
`"In most situations, an analysis of the intrinsic evidence alone will resolve any
`ambiguity in a disputed claim term." !d. When the meaning cannot be determined by intrinsic
`evidence, a court may tum to extrinsic evidence to construe the claims in a patent. Phillips, 415
`F.3d at 1317-18; Vitronics, 90 F.3d at 1584. "Extrinsic evidence consists of all evidence
`external to the patent and prosecution history, including expert and inventor testimony,
`dictionaries, and learned treatises" and may be useful to show "the state of the art at the time of
`the invention." Markman, 52 F.3d at 980. "The court may, in its discretion, receive extrinsic
`evidence in order 'to aid the court in coming to a correct conclusion' as to the 'true meaning of
`the language employed' in the patent." !d. (internal citations omitted); see also Key Plzarms. v.
`Hereon Labs. Corp., 161 F.3d 709, 716 (Fed. Cir. 1998) (holding that a trial court can hear
`extrinsic evidence to educate itself about patent and relevant technology, but may not use
`extrinsic evidence to vary or contradict claim terms). When consideration of extrinsic evidence
`is necessary to understand the meaning of claim terms, the court may consider testimony on
`how a person skilled in the art would understand technical terms in the claims. Cybor Corp. v.
`FAS Teclzs., Inc., 138 F.3d 1448, 1475 (Fed. Cir. 1998) ("The objective of claim interpretation
`is to discern the meaning of the claim terms to one of ordinary skill in the art at the time of
`invention.") Where the intrinsic evidence unambiguously describes the scope of the patent,
`however, it is improper to rely on extrinsic evidence to alter the meaning of the claims. See
`Vitronics, 90 F.3d at 1584. Thus, in most instances, a thorough consideration of the intrinsic
`evidence alone will resolve any ambiguity in a disputed claim term, and the court may not rely
`on extrinsic evidence to construe the scope of a claim term unless the court first finds that the
`term is ambiguous even in light of the intrinsic evidence. See !d. at 1583-85.
`
`2. Literal Infringement
`
`To determine literal infringement, the relevant inquiry is whether all the elements
`contained in the claim appear in the product under consideration. A product that has all of the
`claimed elements is said to be a literal infringement. For open-ended claims, with the word
`"comprising" in the preamble, it typically does not matter that the product has elements in
`addition to the ones specified in the claim. The product is said to infringe literally when it has
`everything mentioned in the claim. See Litton Sys., Inc. v. Honeywell, Inc., 140 F.3d 1449,
`1454 (Fed. Cir. 1998) ("Literal infringement requires that the accused device contain each
`limitation of the claim exactly; any deviation from the claim precludes a finding of literal
`infringement."); Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1476-77 (Fed. Cir. 1998) ("To
`establish literal infringement, a plaintiff must demonstrate that every limitation in the claim is
`literally met by the accused device."). On the other hand, a product that does not have each and
`every element recited in the claim should not be considered a literal infringement. Mas(cid:173)
`Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1211 (Fed. Cir. 1998).
`
`4
`
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`

`
`3. The Doctrine of Equivalents
`
`Even if a device or method does not infringe literally, infringement still can be found
`under the doctrine of equivalents. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S.
`605, 609 (1950). The Supreme Court has confirmed that "the doctrine of equivalents must be
`applied to individual elements of the claim, not to the invention as a whole." Warner-Jenkinson
`Co., Inc. v. Hilton Davis Chern. Co., 520 U.S. 17 (1997). Thus, to infringe a claim, each claim
`element must be present in the accused subject matter literally or by equivalents. See London v.
`Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991); Dolly Inc. v. Spalding &
`Evenjlo Cos., 16 F.3d 394, 397 (Fed. Cir. 1994). Conversely, "[t]here can be no infringement as
`a matter of law if a claim limitation is totally missing from the accused device." London, 946
`F.2d at 1539.
`
`The determination of equivalents should be applied as an objective inquiry on an
`element-by-element basis. RF Delaware, Inc. v. Pacific Keystone Techs., Inc., 326 F.3d 1255,
`1266-67 (Fed. Cir. 2003 ); Pennwalt C01p. v. Durand- Wayland Inc., 833 F .2d 931, 935 (Fed.
`Cir. 1987) (en bane) (overruled on other grounds) (infringement under the doctrine of
`equivalents requires the presence of the equivalent of each claim element or limitation). The
`Supreme Court has left it to the Federal Circuit to refine the formulation of the test for
`equivalents on a case by case basis. In Hilton Davis Chern. Co. v. Warner-Jenkinson Co., 62
`F.3d 1512, 1518 (Fed. Cir. 1995) (en bane), rev'd on other grounds, 520 U.S. 17 (1997), the
`Federal Circuit held that "application of the doctrine of equivalents rests on the substantiality of
`the differences between the claimed and accused products or processes, assessed according to
`an objective standard." One way of determining "substantiality" under the doctrine of
`equivalents is if the accused product or process performs substantially the same function, in
`substantially the same way, to achieve substantially the same results as the claims. See id., see
`also Goodwa/1 Constr. Co. v. Beers Cons11·. Co., 991 F.2d 751,757-58 (Fed. Cir. 1993).
`
`Several principles restrict the applicability of the doctrine of equivalents. One such restriction
`is the doctrine of claim vitiation. The doctrine of claim vitiation applies when a patentee
`attempts to argue that the doctrine of equivalents can be used to entirely eliminate a claim
`element. If the patentee argues that the allegedly infringing product infringes a claim under the
`doctrine of equivalents because it accomplishes the same results in the same manner, but does
`not prove the existence of an equivalent for each and every claim element, then the patentee has
`violated the doctrine of claim vitiation. The United States Supreme Court has stated: "[i]t is
`important to ensure that the application of the doctrine [of equivalents], even as to an individual
`element, is not allowed such broad play as to effectively eliminate that element in its entirety."
`Warner-Jenldnson, 520 U.S. at 29. Thus, "the 'all elements rule' provides that the doctrine of
`equivalents does not apply if applying the doctrine would vitiate an entire claim limitation."
`Asyst Teclts., Inc. v. Erntrak, Inc., 402 F.3d 1188, 1195 (Fed. Cir. 2005).
`
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`B. Validity
`
`Under 35 U.S.C. §282, patents are presumed valid and a party asserting invalidity must
`overcome this presumption by clear and convincing evidence establishing facts which support
`the conclusion of invalidity. Texas Instruments Inc. v. U.S. Int'l Trade Comm 'n, 988 F.2d 1165,
`1177 (Fed. Cir. 1993). Once a challenger has presented a prima facie case of invalidity, the
`burden shifts to the patentee to go forward with rebuttal evidence. See Mas-Hamilton Group v.
`LaGard, Inc., 156 F.3d 1206, 1216 (Fed. Cir. 1998).
`
`1. Obviousness
`
`Under 35 U.S.C. § 103(a), a patent claim is obvious, and therefore invalid, "if the
`differences between the subject matter ... patented and the prior art are such that the subject
`matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains." A party challenging the
`validity of a claim under § 103 must "prove by clear and convincing evidence that the claimed
`invention would have been obvious in view of the prior art." Kahn v. General Motors C01p.,
`135 F.3d 1472, 1479-80 (Fed. Cir. 1998); Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253 (Fed.
`Cir. 2012); i4i Ltd. Partnership v. Microsoft Corp., 598 F.3d 831, 848 (Fed. Cir. 2010), affd
`131 S.Ct. 2238 (June 9, 2011).
`
`The obviousness analysis includes an assessment of (1) the level of ordinary skill in the
`pertinent art, (2) the scope and content of the prior art, (3) the differences between the prior art
`and the claimed subject matter, and ( 4) any objective evidence of nonobviousness, often
`referred to as secondary considerations.
`In re Cyclobenzaprine Hydrochloride Extended(cid:173)
`Release Capsule Patent Litigation, 676 F.3d 1063, 1068-69 (Fed. Cir. 2012); Graham v. John
`Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966). The "secondary considerations" relating
`to the obviousness inquiry include commercial success, long felt but unsolved need and failure
`of others. Id.
`
`In order to determine obviousness, a court can look to: 1) "interrelated teachings of
`multiple patents;" 2) "the effects of demands known to the design community or present in the
`marketplace;" and 3) "the background knowledge possessed by a person having ordinary skill in
`the art." The determination should be based upon "whether there was an apparent reason to
`combine the known elements in the fashion claimed by the patent at issue." KSR Intern. Co. v.
`Telejlex Inc., 127 S.Ct. 1727, 1740-41 (2007). The analysis of obviousness "need not seek out
`precise teachings directed to the specific subject matter of the challenged claim"- a court can
`take into account "inferences and creative steps that a person of skill in the art would employ."
`Id. at 1741.
`
`In deciding obviousness, neither the actual motivation nor the purported motivation of
`the patentee controls. Rather, the objective reach of the claim is what matters. If the claim
`extends to what is obvious, then it is invalid under§ 103. "One of the ways in which a patent's
`subject matter can be proved obvious is by noting that there existed at the time of invention a
`
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`known problem for which there was an obvious solution encompassed by the patent's claims."
`ld. at 1742.
`
`IV. The '431 Patent, Aqueous Liquid Preparation Containing 2-amino-3-(4-
`bromobenzoyl)phenylacetic Acid
`
`The application that became the '431 patent was filed with the USPTO on March 28,
`2005 and assigned Serial No. 10/525,006 ("the '431 patent application"). The '431 patent
`application was the U.S. national stage entry of International Application No. PCT/JP04/00350,
`filed January 16, 2004.
`
`The named inventors of the '431 patent are Shirou Sawa and Shuhei Fujita. The '431
`patent is assigned on its face to Senju Pharmaceutical Co., Ltd. of Osaka, Japan.
`
`The claims of the '431 patent, which issued on March 6, 2012, are reproduced below:
`
`1. An aqueous liquid preparation consisting essentially of the
`following two components, wherein the first component is 2-
`amino-3-( 4-bromobenzoyl)phenylacetic acid or a
`pharmacologically acceptable salt thereof or a hydrate thereof,
`wherein the hydrate is at least one selected from a 112 hydrate, 1
`hydrate, and 3/2 hydrate and the second component is tyloxapol,
`wherein said liquid preparation is formulated for ophthalmic
`administration, and wherein when a quaternary ammonium
`compound is included in said liquid preparation, the quaternary
`ammonium compound is benzalkonium chloride.
`
`2. The aqueous liquid preparation according to claim 1, wherein
`the first component is a 2-amino-3-( 4-
`bromobenzoyl)phenylacetic acid sodium salt.
`
`3. The aqueous liquid preparation according to claim 1, wherein
`the second component is tyloxapol and the pharmacologically
`acceptable salt of2-amino-3-(4-bromobenzoyl)phenylacetic acid
`is a sodium salt, wherein the concentration of the tyloxapol is
`from about 0.01 w/v% to about 0.5 w/v %; and
`wherein the first component is a 2-arnino-3-(4-
`bromobenzoyl)phenylacetic acid sodium salt, wherein the
`concentration