Merchant & Gould
`
`An Intellectual Property Law Firm
`
`
`
`Alexandria, V1rgini:I
`22314 USA
`
`TEL 703.68.f.2500
`
`1900 Duke Strccl
`
`Suue 600
`
`DutttColllJct
`Melissa M. Hayworth
`
`I
`mhayworth@merchantgould.com
`703.684.2522
`
`FA.\ 703.684.2501
`
`wwwmerchamgould com
`A Prol=ni Ci,rpor;,uon
`
`CONFIDENTIAL
`
`15 March 2021
`
`VIA FEDERAL EXPRESS
`
`Salix Pharmaceuticals, Inc.
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Mr. Robert Spurr
`President
`Salix Phannaceuticals, Inc.
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Mr. Joseph Papa
`Chairman and CEO
`Synergy Pharmaceuticals Inc.
`c/o Bausch Health Companies, Inc.
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Christina M. Ackermann, Esq.
`Executive Vice President, General Counsel, Head of Commercial Operations
`Bausch Health Ireland Limited
`c/o Bausch Health Companies, Inc.
`400 Somerset Corporate Boulevard
`Bridgewater, NJ 08807
`
`Keren Tenebaum, Esq.
`VP and Assistant General Counsel, Head of Legal
`Salix Pharmaceuticals, Inc.
`Bausch Health Companies Inc.
`400 Somerset Corporate Blvd
`Bridgewater, NJ 08807
`
`Atbnta
`
`Dmvcr
`
`Knoxville Madison
`
`Minneapohs
`New York
`
`
`
`Washington DC area
`
`Bausch Health Ireland Exhibit 2006, Page 1 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Salix Phannaceuticals Inc.
`
`
`
`Bausch Health Companies, Inc.
`15 March 2021
`Page2
`
`Bausch Health Ireland Limited
`3013 Lake Drive
`Citywest Business Campus
`Dublin, Ireland 34
`
`Re: Notification of Certification oflnvalidity, Unenforceability and/or
`Non-infringement for U.S. Patent Nos. 7,041,786; 9,610,321; 9,616,097;
`9,919,024; 9,925,231; 10,011,637 Pursuant to Section 505(j)(2)(B)(iv)
`of the Federal Food, Drug, and Cosmetic Act
`
`To whom it may concern:
`
`and (iv) of the Federal Food, Drug, and
`Pursuant to Sections 505(j)(2)(B)(i), (ii),
`(iii),
`Cosmetic Act and 21 C.F.R. § 314.95, MSN Laboratories Private Ltd. ("MSN11), MSN House,
`Plot No. C-24, Industrial Estate, Sanath Nagar, Hyderabad, Teleangana, 500018 India, hereby
`provides notice of the following information to Salix Pharmaceuticals Inc. ("Salix"), as holder of
`approved New Drug Application ('1NDA11) N208745 for TRULANCE®, plecanatide; 3 mg, oral
`tablet according to the records of the U.S. Food and Drug Administration (11FDA11), and to
`Bausch Health Ireland Limited, as owner of U.S. Patent Nos. 7,041,786 ("the '786 patent");
`9,610,321 ('1the '321 patent"); and 9,616,097 ("the '097 patent") according to the records of the
`United States Patent and Trademark Office ("USPTO"); and to Synergy Pharmaceuticals Inc.
`("Synergy") as owner of U.S. Patent Nos. 9,919,024 ("the '024 patent"); 9,925,231 (11the '231
`patent"); and 10,011,637 ("the '63 7 patent") according to the records of the US PTO. Salix is a
`wholly-owned subsidiary of Bausch Health Companies Inc. ("Bausch"), and Bausch acquired
`most of Synergy's assets, including all rights to TRULANCE� (plecanatide) and the related
`intellectual property. As such, Salix, Bausch, and Synergy collectively are referred to herein as
`"Salix".
`
`I.
`Pursuant to 21 U.S.C. § 355(j)(2)(B)(iv)(I) and 21 C.F.R. § 314.95(c)(l ), we
`advise you that the FDA has received an Abbreviated New Drug Application ("ANDA") from
`MSN for plecanatide; 3 mg, oral tablet. The ANDA contains the required bioavailability and/or
`bioequivalence data from studies on the plecanatide oral tablet drug product, which is the subject
`of the ANDA. The ANDA was submitted under 21 U.S.C. § 3550)(1) and (2)(A). The ANDA
`includes a paragraph IV certification to obtain approval to engage in the commercial
`manufacture, use and/or sale of plecanatide; 3 mg, oral tablet, before the expiration of the '786,
`1321, '097, '024, '231, and '637 patents, which are listed in the Patent and Exclusivity Information
`Addendum of FD A's publication, Approved Drug 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 the FDA has assigned
`II.
`MSN's ANDA the number 215780.
`
`Bausch Health Ireland Exhibit 2006, Page 2 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Salix Phannaceuticals
`Inc.
`Companies,
`Inc.
`Bausch Health
`15 March 202 I
`Page 3
`
`Pursuant to 21 C.F.R. § 314.95(c)(3), we advise you that MSN has received the
`III.
`paragraph IV acknowledgment letter for the ANDA on 2 March 2021.
`
`Pursuant to 21 C.F.R. § 314.95(c)(4), we advise you that the established name of
`IV.
`the drug product that is the subject of MSN 's ANDA No. 215780 is plecanatide oral tablet.
`
`Pursuant to 21 C.F.R. § 314.95(c)(5), we advise you that the active ingredient in
`V.
`the proposed drug product is plecanatide; the strength of the proposed drug product is 3 mg; and
`the dosage form of the proposed drug product is an oral tablet.
`
`Pursuant to 21 C.F.R. § 314.95(c)(6), we advise you that the patents alleged to be
`VI.
`invalid, unenforceable and/or not infringed in the paragraph IV certification are the '786, '321,
`'097, '024, '231, and '63 7 patents, which are listed in the Orange Book in connection with Salix's
`NDA N208745 for TRULANCE®, plecanatide oral tablet, 3 mg. According to information
`provided by Salix to the FDA that is published in the Orange Book, the '786 patent will expire on
`30 January 2028; the '321 patent will expire on 15 September 2031; the '097 patent will expire on
`20 August 2032; the '024 patent will expire on 15 September 2031; the '231 patent will expire on
`15 September 2031; and the '63 7 patent will expire on 5 June 2034.
`
`It has been certified to the FDA, that in our opinion and to the best of our
`VII.
`knowledge, the '786, '321, '097, '024, '231, and '637 patents are invalid, unenforceable and/or will
`not be infringed by the commercial manufacture, use or sale of the drug product described in
`MSN's ANDA. Therefore, pursuant to 21 U.S.C. § 355G)(2)(B)(iv)(II) and 21 C.F.R.
`§ 314.95(c)(7), detailed statements of the legal and factual bases ofMSN's position for the
`paragraph IV certification set forth in MSN's ANDA is attached hereto and made a part hereof.
`MSN reserves the right to develop additional grounds, reasons, or authorities that any or all of
`the claims of the '786, '321, '097, '024, '231, and '637 patents are invalid or not infringed and/or
`unenforceable.
`
`Pursuant to 21 U.S.C. § 355G)(5)(C) and 21 C.F.R. § 314.95(c)(8), this notice letter
`includes an Offer of Confidential Access to Application. As required by§ 355(j)(5)(C)(i)(III),
`MSN offers to provide confidential access to certain information from its ANDA No. 215780 for
`the sole and exclusive purpose of determining whether an infringement action referred to in
`§ 355G)(5)(B)(iii) can be brought. Requests for access under this Offer of Confidential Access
`should be made to:
`
`Melissa M. Hayworth, Esquire
`Merchant & Gould
`1900 Duke Street
`Suite 600
`Alexandria, Virginia 22314
`Tel: (703) 684.2522
`Fax: (612) 332.9081
`mhayworth@merchantgould.com
`
`Bausch Health Ireland Exhibit 2006, Page 3 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Salix Pharmaceuticals Inc.
`Bausch Health Companies, Inc.
`15 March 2021
`
`The nameand address of the agent in the United States authorized to accept service of
`process for MSN,limited to commencementofa patent infringementsuit based onthis
`notification ofcertification, is also as provided above.
`
`Sincerely,Unt
`
`Melissa M. Hayworth
`Counsel for MSN Laboratories Private Ltd.
`
`Enclosures: Offer of Confidential Access to Application and MSN's Confidential Detailed
`Factual and Legal Bases for its Paragraph IV Certification that U.S. Patent Nos. 7,041,786;
`9,610,321; 9,616,097; 9,919,024; 9,925,231; and 10,011,637 are Invalid, Unenforceable and/or
`Will Not Be Infringed
`
`

`

`Confidential Detailed Factual and Legal Bases for
`Paragraph IV Certification of MSN Laboratories Private Ltd.
`that the Claimed Subiect Matter of U.S. Patent No. 72041,786 is Invalid, Unenforceable
`and/or Not Infringed
`
`Pursuant to Section 505(i)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act and
`21 C.F.R. § 314.95(c)(6), this document is the detailed factual and legal bases for the paragraph
`IV certification of MSN Laboratories Private Ltd. (11MSN11) that, in its opinion and to the best of
`its knowledge, the claimed subject matter of U.S. Patent No. 7,041,786 is 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 MSN's Abbreviated New Drug Application
`("ANDA") No. 215780. MSN reserves its rights to raise any additional defenses relating to
`invalidity, unenforceability, and non-infringement should litigation ensue.
`
`I.
`
`TRULANCE® (plecanatide) Oral Tablets, Exclusi\'ity Information, and Orange
`Book Patents
`
`On January 19, 2017, the FDA approved NDA 208745 held by Salix Pharmaceuticals
`Inc. ("Salix") and related to TRULANCE® (plecanatide) oral tablet (3 mg). Information related
`to TR ULAN CE ® oral tablets is based on the TRULANCE ® prescribing information, as of
`October 2020 ("TRULANCE® Label").
`TRULANCE® (plecanatide) Oral Tablets
`TRULANCE® is indicated in adults for the treatment of chronic idiopathic constipation
`(CIC) and irritable bowel syndrome with constipation (IBS-C).
`
`A.
`
`TRULANCE® (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16
`amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-a-aspartyl­
`L-u-glutamyl-L-cysteinyl-L-a-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L­
`alanyl-L-cysteinyl-L-threonylglycl-L-cysteinyl-, cyclic (4➔ 12), (7➔ 15)-bis(disulfide).
`The molecular formula of plecanatide is C6sH104N1sO26N4 and the molecular weight is
`1682 Daltons. The amino acid sequence for plecanatide is shown below:
`
`.-------s-s-------
`H-Asn
`-Glu3-Cys4-Glu5-Leu6-Cys7-Val8-Asn11-Val10-Ala
`1-Asp2
`11-Cys 12-Thr13-Gly
`16-0 H
`14-Cys 15-Leu
`
`---------s-s-----�
`The solid lines linking cysteines illustrate disulfide bridges.
`
`Plecanatide is an amorphous, white to off-white powder. TRULANCE tablets are
`supplied as 3 mg tablets for oral administration. The inactive ingredients are magnesium stearate
`and microcrystalline cellulose.
`
`Bausch Health Ireland Exhibit 2006, Page 5 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 Is Invalid,
`Unenforceable and/or Not Infringed
`
`B.
`
`Exclusivity Information and Orange Book Patents
`
`TRULANCE® (plecanatide) oral tablet NDA 208745 is associated with a New Chemical
`Entity (NCE) exclusivity that expires on January 19, 2022. TRULANCE® also has a new
`indication exclusivity 1-764 (TREATMENT IN ADULT PATIENTS FOR IRRITABLE
`BOWEL SYNDROME WITH CONSTIPATION (IBS-C)) expiring on January 24, 2021.
`
`There are presently eight (8) U.S. patents listed in the Orange Book with respect to NOA
`208745. The following table summarizes the present patent data for TRULANCE® oral tablets.
`r, ' l.i)&1
`·�
`j �)j) :a>.
`ft]lellsl
`11
`II
` � OS
`l�e '
`1:s.9J;mfssiondl(fe
`kk�uesfedl1
`IGoile
`liJo • ""·
`Feb 14, 2017
`Feb 14, 2017
`Feb 14, 2017
`May 1, 2017
`Mav 1, 2017
`Apr 10, 2018
`Aor 10, 2018
`Julv 19, 2018
`
`U-1964
`U-1999
`U-2230
`
`U-1999
`U-2230
`
`DP
`
`DP
`
`1 1B ·m1·
`..
`,BatfiNo
`..
`i Ii !t -�1!1,i
`Jan 30, 2028
`7041786
`Jun 9, 2022
`7799897
`Mar 28, 2022
`8637451
`Sept 15, 2031
`9610321
`Aug 20, 2032
`9616097
`Sept 15, 2031
`9919024
`Sept 15, 2031
`9925231
`Jun 5, 2034
`10011637
`
`OS
`
`DS
`
`U-1964 ELEVATION OF INTRACELLULAR COMP RESULTING IN INCREASED INTESTINAL
`FLUID AND ACCELERATED TRANSIT
`U-1999 CHRONIC IDIOPATHIC CONSTIPATION
`U-2230 IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
`
`U.S. Patent No. 7,041,786 ("the 1786 patent") is analyzed herein.
`
`II.
`
`Legal Principles
`
`A.
`
`Infringement under the Hatch-Waxman Act
`
`35 U.S.C. § 27l(e)(2) makes the filing of an ANDA an "artificial" act of infringement to
`facilitate judicial review of patent claims related to the product proposed by the ANDA. Glaxo,
`Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997). Once jurisdiction is established
`under the Hatch-Waxman Act, the substantive determination whether infringement will take
`place is determined by the principles of traditional infringement analysis. Warner-Lambert Co.
`v. Apotex Corp., 316 F.3d 1348, 1365-66 (Fed. Cir. 2003). The only real difference between§
`271(e)(2) and a traditional infringement analysis is the timing- a Hatch-Waxman case may be
`able to proceed earlier because the proper inquiry focuses on what the ANDA applicant will
`likely market if its application is approved rather than having to wait until the launch of the
`product or its imminence. Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1331 (Fed. Cir.
`2003); see also id at 1337 (Schall, J., concurring). The court looks at "whether, if a particular
`drug were put on the market, it would infringe the relevant patent.11 Warner-Lambert, 316 F .3d
`
`CONFIDENTIAL
`
`2
`
`Bausch Health Ireland Exhibit 2006, Page 6 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 Is Invalid,
`Unenforceable and/or Not Infringed
`
`at 1366 (emphasis in original). Section 27l(e)(2) in effect acts as an "umbrella" for claims of
`direct, induced, or contributory infringement. See Allergan, 324 F.3d at 1331-32. "Because drug
`manufacturers are bound by strict statutory provisions to sell only those products that comport
`with the ANDA's description of the drug, an ANDA specification defining a proposed generic
`drug in a manner that directly addresses the issue of infringement will control the infringement
`inquiry." Abbott Labs. v. Torpharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002); see also
`Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271, 1279 (Fed. Cir. 2013).
`
`A valid and enforceable United States patent allows the patentee to exclude others from
`making, using, offering to sell, and/or selling the patented invention in the United States for the
`term of the patent. 35 U.S.C. § 271 (2000). The patent claims, which appear at the end of the
`written description, define the invention and circumscribe the scope of coverage provided by the
`patent. Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en bane),
`ajj'd, 517 U.S. 370 (1996).
`
`Section 271 (a) creates liability for direct infringement for "whoever without authority
`makes, uses, offers to sell, or sells any patented invention, within the United States or imports
`into the United States any patented invention during the term of the patent therefor, infringes the
`patent."
`
`Section 271 (b) states that "whoever actively induces infringement of a patent shall be
`liable as an infringer." 35 U.S.C. § 271(b). "Inducement requires a showing that the alleged
`inducer knew of the patent, knowingly induced the infringing acts, and possessed a specific
`intent to encourage another's infringement of the patent." Vita-Mix Corp. v. Basic Holding, Inc.,
`581 F.3d 1317, 1328 (Fed. Cir. 2006). Induced infringement requires proofofactual direct
`infringement by a third party. Novartis Pharm. Corp. v. Eon Labs Mfg., 363 F.3d 1306, 1308
`(Fed. Cir. 2004). Intent requires more than just knowledge that the induced acts constitute
`infringement; intent requires that the alleged "inducer . . . have an affirmative intent to cause
`direct infringement." DSU Med. Corp. v. JMS Co., 471 FJd 1293, 1304 (Fed. Cir. 2006). An
`alleged inducer's "mere knowledge of possible infringement will not suffice" to establish the
`requisite intent for inducement. Vita-Mix, 581 F.3d at 1328.
`
`Section 271(c) requires that an infringer sell a product for use in an infringing
`composition, "which use constitutes a material part of the invention, knowing that the [product]
`is especially made or adapted for use in infringing the patent," and that the product does not have
`a substantial non-infringing use. C.R. Bard v. Advanced Cardiovascular Sys., Inc., 911 F.2d 670,
`673 (Fed. Cir. 1990). Contributory infringement also requires proof of actual direct infringement
`by a third party. Novartis Pharm. Corp., 363 F.3d at 1308.
`
`Both induced infringement and contributory infringement require, among other things,
`knowledge of infringement. Commil USA, LLC v. Cisco Sys .• 135 S. Ct. 1920, 2015 LEXIS 3406
`at *12 (May 26, 2015).
`
`CONFIDENTIAL
`
`3
`
`Bausch Health Ireland Exhibit 2006, Page 7 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 1s Invalid,
`Unenforceable and/or Not Infringed
`
`B.
`
`· Claim Interpretation
`
`"An infringement analysis involves two steps. First, the court detennines the scope and
`meaning of the patent claims asserted ... and then the properly construed claims are compared to
`the allegedly infringing device .... " Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1454 (Fed. Cir.
`1998), en bane. Accordingly, claim construction (i.e., determining the meaning of a claim) is a
`threshold inquiry in any assessment of infringement. Athletic Alternatives v. Prince Mfg., 73
`F.3d 1573, 1578 (Fed. Cir. 1996); citing Markman v. Westview Instruments, Inc., 52 F.3d 967,
`979 (Fed. Cir. 1995), en bane. Claim interpretation is a question of law, exclusively within the
`province of the courts. Cybor Corp., 138 F.3d at 1455; Vitronics Corp. v. Conceptronic, Inc., 90
`F.3d 1576, 1582 (Fed. Cir. 1996).
`
`A claim is interpreted by first examining the language of the claims themselves, the
`patent specification, and the prosecution history. Rhodia Chimie v. PPG Indus., 402 F.3d 1371,
`1377 (Fed. Cir. 2005); Markman, 52 F.3d at 979. The words of the claim are given their
`ordinary meaning to one skilled in the art unless it appears unequivocally from the patent and
`prose�ution history that the words were used differently by the inventors, e.g., by an inventor's
`own definition of a claim term in the patent specification. Merck & Co. v. Teva Pharms. USA,
`Inc., 395 F.3d 1364, 1370 (Fed. Cir. 2005); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d
`1364, 1367 (Fed. Cir. 2003); Multiform Desiccants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1477
`(Fed. Cir. 1998). Vitronics Corp., 90 F.3d at 1582 (Fed. Cir. 1996). Common words, unless the
`context suggests otherwise, should be accorded their ordinary and customary meaning in the art.
`Desper Prods. v. QSound Lab, 157 F.3d 1325, 1336 (Fed. Cir. 1998); see also Hockerson­
`Halberstadt, Inc. v. Avia Group Int'/, 222 F.3d 951, 955 (Fed. Cir. 2000).
`
`Claims must be read in view of the specification, which is the written description of the
`invention. Phillips, 415 F.3d at 1316; accord, Microsoft Corp. v. Multi-Tech Sys., 357 F.3d
`1340, 1347 (Fed. Cir. 2004); Ultimax Cement Mfg. Corp. v CTS Cement Corp., 587 F.3d 1339,
`1347 (Fed. Cir. 2009). The specification is a primary tool of claim construction, acting as a
`dictionary, explaining the invention and defining the claim terms. Rhodia Chimie, 402 FJd at
`1377; Mifutoyo Corp. v. Cent Purchasing LLC, 499 F. 3d 1284, 1290 (Fed. Cir 2007) (the
`specification is the "single best guide to the meaning of a disputed term").
`
`One important purpose for examining the specification is to determine if the patentee has
`limited the scope of his claims. Abbott Labs v. Sandoz, Inc. 566 F.3d 1282, 1288 (Fed. Cir.
`2009); Microsoft Corp., 357 F.3d at 1347 (quoting Watts v. XL Sys., 232 F.3d 877, 882 (Fed. Cir.
`2000)); Hakim v. Cannon Avent Group., PLC, 479 F. 3d 1313, 1317 (Fed Cir. 2007); SciMed
`Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 1341 (Fed. Cir. 2001) (quoting Watts,
`232 FJd at 882) accord, Phillips, 415 F.3d at 1316. When a patentee clearly disclaims a feature
`of the invention in the specification, he cannot later try to recapture the feature in his claims.
`SciMed Life Sys., 242 F.3d at 1341-42. Further, a claim term will be limited where the patentee
`described in the specification a particular feature as "important" to the invention. Sentry Prof.
`Prods. v. Eagle Mfg. Co., 400 F.3d 910, 915 (Fed. Cir. 2005); see also Inpro II Licensing,
`S.A.R.L. v. T-A1obile USA, Inc., 450 F.3d 1350, 1354-55 (Fed. Cir. 2006).
`
`CONFIDENTIAL
`
`4
`
`Bausch Health Ireland Exhibit 2006, Page 8 of 32
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 Is Invalid,
`Unenforceable and/or Not Infringed
`
`The prosecution history is also relevant to claim construction because it contains
`exchanges between a patent applicant and the U.S. Patent and Trademark Office. Ultimax
`Cement, 587 F.3d at 1347; Phillips, 415 F.3d at 1317; Schumer v. Lab. Computer Sys., Inc., 308
`F.3d 1304, 1312-13 (Fed. Cir. 2002) (quoting Vitronics, 90 F.3d at 1582); Digital Biometrics, v.
`ldentix, Inc., 149 F.3d 1335, 1344 (Fed. Cir. 1998). In these exchanges, the patent applicant may
`disavow or disclaim certain claim coverage, which serves to preclude any claim interpretation
`that would encompass the disavowed or disclaimed subject matter. See Hakim, 479 F.3d at
`1317; Phillips, 415 F.3d at 1317; Rhodia Chimie, 402 F.3d at 1384. For example, failure of the
`patentee to object to an examiner's interpretation of a claim ordinarily disclaims a broader
`interpretation. Inverness Med. Switz. GmbHv. Warner Lambert Co., 309 F.3d 1373, 1380 (Fed.
`Cir. 2002); CP Salazar v. Procter & Gamble Co., 414 F.3d 1342, 1346-47 (Fed. Cir. 2005). The
`prosecution history is also helpful to determine if the patentee intended any special meaning for
`his claim terms. Teleflex, Inc. v. Ficosa N Am. Corp., 299 F.3d 1313, 1326 (Fed. Cir. 2002);
`Biovail Corp. Inl'l v. Andrx Pharms., Inc., 239 F.3d 1297, 1300-01 (Fed. Cir. 2001).
`
`When the patent and the prosecution history unambiguously describe the scope and
`meaning of the claimed invention, there is no need to rely on extrinsic evidence. Brookhill-Wilk
`1, LLC v. lnluitive Surgical, Inc., 334 F.3d 1294, 1304 (Fed. Cir. 2003); Biovail Corp., 239 F.3d
`at 1300. Such recourse may in fact be improper. Vitronics, 90 F.3d at 1583. However, dictionary
`definitions may provide a basis for determining the ordinary meaning of a disputed term.
`Phillips, 415 F.3d at 1322; Vitronics, 90 F.3d. at 1580, n.6; Tex. Digital Sys. v. Te/egenix, Inc.,
`308 F.3d 1193, 1202 (Fed. Cir. 2002); accord, Superguide Corp. v. DirecTV Enters., 358 F.3d
`870, 875 (Fed. Cir. 2004). Thus, a court may use a technical or general purpose dictionary in
`order to begin to understand the meaning of a particular claim term, and then review the patent to
`see how the term is used in that context. Id. A non-scientific dictionary may not be proper for
`defining a technical term. See, e.g., Phillips, 415 F.3d at 1322; Gemstar-TV Guide Int'/, Inc. v.
`ITC, 383 F.3d 1352, 1366 (Fed. Cir. 2004). Furthermore, expert testimony and declarations are
`useful to confirm that the construed meaning is consistent with the denotation ascribed by those
`in the field of the art. Phillips, 415 F.3d at 1316; Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d
`1314, 1332 (Fed. Cir. 2003). There is no magic formula for construing claims, nor is a court
`precluded from using any particular sources in any particular order, so long as those sources do
`not contradict the intrinsic evidence. Phillips, 415 F .3d at 1324.
`
`C.
`
`Non-Infringement
`
`An infringement analysis requires two separate steps. First, the asserted claims must be
`interpreted by the court as a matter of law to determine their meaning and scope. Cybor Corp.,
`138 F.3d at 1454. Once the claims have been properly construed, the next step is to compare the
`properly construed claims with the accused method to determine whether any of the claims are
`infringed. Id. A determination of infringement, both literal and pursuant to the doctrine of
`equivalents, is a question of fact. See, e.g., Phillips Petroleum Co. v. Huntsman Polymers Corp.,
`157 F.3d 866, 876 (Fed. Cir. 1998). Literal infringement requires that every limitation recited in
`the claim is found in the accused method. Dawn Equip. Co . .v. Kentud.y Farms, Inc., 140 F.3d
`1009, 1014 (Fed. Cir. 1998).
`
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`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 Is Invalid,
`Unenforceable and/or Not Infringed
`
`The patent owner has the burden of proving by a preponderance of the evidence that
`"every limitation of the patent claim asserted to be infringed is found in the accused [method],
`either literally or by an equivalent." Smithkline Diag, Inc. v. Helena Lab. Corp., 859 F.2d 878,
`889 (Fed. Cir. 1988), afrd, 926 F.2d 1 161 (Fed. Cir. 1991). Detennination of infringement,
`either literally or under the doctrine of equivalents, is a question of fact. Bai v. L & L Wings,
`Inc., 160 F .3d I 350, 1353 (Fed. Cir. 1998).
`
`Even if a claim does not literally read on an accused product or process, infringement
`may still be found under the doctrine of equivalents. Cybor Corp., 138 F.3d at 1459. Application
`of the doctrine of equivalents involves a judicial balancing of the purpose of preventing patents
`from being unjustly circumvented against the purpose of providing clear boundaries to the scope
`of patent claims. Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1 480 (Fed.
`Cir. 1 998).
`
`However, "there are limits to the application of the doctrine of equivalents aside from the
`question of insubstantiality of the differences." Eagle Comtronics v. Arrow Commun. Labs., 305
`F.3d 1303, 13 I 5 (Fed. Cir. 2002). "First, prosecution history estoppel can prevent a patentee
`from relying on the doctrine of equivalents when the patentee relinquishes subject matter during
`the prosecution of the patent, either by amendment or argument. Second, the question of
`insubstantiality of the differences is inapplicable if a claim limitation is totally missing from the
`accused device." Id. Citations omitted.
`
`Accordingly, the doctrine of equivalents is limited by the rule of prosecution history
`estoppel. Cybor Corp., 138 F.3d at 1460. Traditionally, prosecution history estoppel has
`excluded from the range of equivalents subject matter surrendered during prosecution of the
`application. Cybor Corp., 138 F.3d at 1460� Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
`Co., 122 S. Ct. 1831 (2002). Festo follows Warner-Jenkinson, which placed the burden of proof
`on the patent owner to show that an amendment was not made for a reason that would give rise
`to estoppel, and increases the burden on the patent owner, who now must also show that the
`amendment did not surrender the particular equivalent in question.
`
`In certain instances, infringement under the doctrine of equivalents is not permitted as a
`matter of law. Subject matter disclosed in the specifcation but not claimed is dedicated to the
`public, and cannot be recaptured under the doctrine of equivalents. Johnson & Johnston Assocs.
`v. R.E. Serv. Co., 285 F.3d I 046, 1054 (Fed. Cir. 2002) (citing Charles Greiner & Co. v. Mari­
`
`Med Mfg., Inc., 962 F .2d I 031, 1036 (Fed. Cir. 1992). Subject matter in the prior art to a patent
`
`cannot infringe the claims of that patent either literally or under the doctrine of equivalents.
`Bristol-Myers Squibb Co. v. Ben-Venue Labs., Inc., 246 F.3d 1368, 1378 (Fed. Cir. 2001).
`
`Moreover, "[t]he doctrine of equivalents cannot be used to erase meaningful structural
`and functional limitations of the claim on which the public is entitled to rely in avoiding
`infringement. 11 Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d at I 054. Further, the
`doctrine of equivalents cannot be employed in a manner that wholly vitiates a claim limitation.
`Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 1 7, 29-30 (1997). For example,
`a claim term would be vitiated when the doctrine of equivalents would require omitting or
`
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`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 Is Invalid,
`Unenforceable and/or Not Infringed
`
`ignoring that term. Moore US.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1105-1106
`(Fed. Cir. 2000).
`
`The Federal Circuit has noted "[o]ne may infringe an independent claim and not infringe
`a claim dependent on that claim. The reverse is not true. One who does not infringe an
`independent claim cannot infringe a claim dependent on (and thus containing all the limitations
`ot) that claim.11 Wahpeton Canvas Company, Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed.
`Cir. 1989); see also 3M v. Chemque, Inc., 303 F.3d 1294, 1299 (Fed. Cir. 2002).
`
`D.
`
`lm•alidity
`
`Claims must be construed in the same way for determining both infringement and
`validity. Kim v. ConAgra Foods, Inc., 465 F.3d at 1324; Eaton Corp. v. Rockwell Int'! Corp.,
`323 F.3d 1332, 1343 (Fed. Cir. 2003). By statute, an issued patent is presumed valid, and each
`claim is presumed valid independent of the validity of other claims. 35 U.S.C. § 282.
`Innovention Toys v. MGA Entm't, Inc., 665 F. Supp. 2d 636 (E.D. La. 2009). Section 282 also
`requires an independent analysis of the validity of each claim asserted to be invalid. Dayco
`Prods .. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1370-71 (Fed. Cir. 2003); see also Xerox
`Corp. v. 3Com Corp., 458 F.3d 1310, 1315 (Fed. Cir. 2006).
`
`The standard of proof required to establish invalidity of a patent claim is clear and
`convincing evidence. Microsoft Corp. v. i4i Ltd. P'Ship, 131 S. Ct. 2238, 2251 (2011);
`Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013) cert.
`denied 134 S.Ct. 1501 (2014); Abbott Labs. v. Baxter Pharni. Prods., 471 F.3d 1363, 1367 (Fed.
`Cir. 2006); ConAgra Foods, 465 F.3d at 1324 ( citing Honeywell v. Hamilton Sundstrand Corp.,
`370 F.3d 1131, 1145 (Fed. Cir. 2004)). Further, a determination of patent invalidity must be
`objectively based on prior art or other requirements of patentability. Norian Corp. v. Stryker
`C01p., 363 F.3d 1321, 1329 (Fed. Cir. 2004). "Introspection and speculation into the examiner's
`understanding of the prior art or the completeness or correctness of the examination process is
`not part of the objective review of patentability." Id. at 1329. While the presumption of validity
`may be weakened in cases where the invalidity evidence includes information that was not
`considered by the Examiner during patent prosecution, the standard of proof remains clear and
`convincing evidence, Microsoft Corp., 131 S. Ct. at 2241.
`
`A claimed invention in an issued patent is invalid if it would have been obvious to one
`of ordinary skill in the art at the time the invention was made when viewed in light of the prior
`art. 35 U.S.C. § 103. Obviousness is a question of law, based on underlying factual issues.
`Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). These factual issues (i.e., the so-called
`Graham factors) are: (1) the scope and content of the prior art; (2) the differences between the
`prior art and the claimed invention; (3) the level of ordinary skill in the art; and {4) objective
`indicia of non-obviousness (also known as secondary considerations), which includes but is
`not limited to unexpected results and commercial success. KSR Int'/ Co. v. Teleflex, Inc., 550
`U.S. 398, 405 (2007).
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`Confidential Detailed Factual and Legal Bases that U.S. Patent No. 7,041,786 1s Invalid,
`Unenforceable and/or Not Infringed
`
`KSR reaffinned that the Graham analysis was proper; however, the Supreme Court
`detennined that the Federal Circuit had interpreted Graham incorrectly by requiring that
`differences between the prior art and the invention could only be obvious in cases where the
`prior art contained a specific teaching, suggestion or motivation to make the changes needed to
`arrive at the claimed invention (the "TSM test"). The Supreme Court held that the TSM test was
`based on an improperly rigid reading of Graham, and that an obviousness analysis can also take
`account of the inferences and creative steps that a person of ordinary skill in the art would
`employ.
`
`According to the Court, the Graham factors are factual findings
`upon which a legal conclusion of obviousness must be based.
`Graham, 383 U.S. at I 7. The Court also clarified that an
`obviousness