UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
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`U.S. Patent No. 9,326,945 to Patel et al.
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`Inter Partes Review IPR2018-00892
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`DECLARATION OF KAREN L. CARROLL
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`MYLAN EXHIBIT 1045
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
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`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`U.S. Patent No. 9,326,945 to Patel et al.
`
`Inter Partes Review IPR2018-00892
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`
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`DECLARATION OF KAREN L. CARROLL
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`MYLAN EXHIBIT 1045
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`I, Karen L. Carroll, hereby declare under penalty of perjury:
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`1.
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`I am a partner at Parker Poe Adams & Bernstein LLP and back-up
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`counsel for Mylan Pharmaceuticals Inc. (“Mylan” or “Petitioner”) in the above-
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`captioned inter partes review (“IPR”). I am registered to practice before the
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`United States Patent and Trademark Office (“USPTO”) with registration number
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`50,748. I am a member in good standing of the Bars of the States of Illinois and
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`Georgia. I respectfully submit this declaration in support of Petitioner’s Motion to
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`Correct a Typographical or Clerical Mistake in the Petition Under 37 C.F.R. §
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`42.104(c) and Petitioner’s Motion to File Supplemental Information Pursuant to 37
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`C.F.R. § 42.123(a).
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`2.
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`On December 28, 2016, Mylan filed with the United States Food and
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`Drug Administration (“FDA”), an Abbreviated New Drug Application (“ANDA”)
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`for a generic version of apixaban tablets, 2.5 mg and 5 mg, which is marketed by
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`Bristol-Myers Squibb Company as Eliquis®. Pursuant to 21 U.S.C.
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`§ 355(b)(2)(a)(4), Mylan filed with its ANDA a certification with respect to each
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`patent listed in the Orange Book for Eliquis®, including U.S. Patent No. 9,326,945
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`(“the ’945 patent”), which is the patent-at-issue in this IPR. As a part of its due
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`diligence for its certification, Mylan’s counsel solicited a third party to conduct a
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`prior art search for the ’945 patent, the contents of which are protected under at
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`least under the attorney-work product doctrine.
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`-2-
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`3.
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`As part of that search, the third party provided a chapter – Chapter 10
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`– from the treatise Modern Pharmaceutics, entitled “Tablet Dosage Forms” and
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`authored by E.M. Rudnic and M.K. Kottke. The page numbers of the Chapter 10
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`provided were pages 333-359. The reference was not provided with a cover page,
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`table of contents, or publication date information; however the third-party search
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`provided the following citation: Rudnic, E.M. and M.K. Kottke, “Tablet Dosage
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`Forms,” in Modern Pharmaceutics, 4th ed., G.S. Banker and C.T. Rhodes, eds.,
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`Taylor & Francis Group, Boca Raton, FL, pp. 333-359 (2002). Thus, the third-
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`party prior art search identified the Rudnic reference as from the fourth edition of
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`Modern Pharmaceutics published in 2002. Mylan did not have any basis at that
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`time to doubt either the accuracy of the reference or the corresponding citation
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`provided by the third party prior art search.
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`4.
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`Pursuant to § 505(j)(2)(B) of the Federal Food, Drug and Cosmetic
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`Act and §§ 314.94 and 314.95 of Title 21 of the Code of Federal Regulations,
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`Mylan provided information to Patent Owners via letter, dated March 2, 2017,
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`regarding the filing of Mylan’s ANDA, which included the foregoing citation to
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`the Rudnic reference provided by the third party vendor.
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`5.
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`In preparing the Petition (Paper No. 2) and the Declaration of Kinam
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`Park, Ph.D. (Ex. 1002) (“the Park Declaration”) for this IPR proceeding, Mylan
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`and its counsel similarly relied upon the version of the Rudnic reference and
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`citation provided by the third party vendor, including providing a copy of said
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`reference to Dr. Park for his review and consideration.
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`6. When compiling the references for submission for this IPR
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`proceeding, we reviewed the copy of said reference and instructed our paralegal
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`that it lacked a cover page and publication date information. Accordingly, in
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`reliance of the citation provided by the third party prior art search, our paralegal
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`contacted the law firm’s librarian and requested a cover page and publication date
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`information for the fourth edition of Modern Pharmaceutics. This cover page and
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`publication information was attached to Chapter 10 of the Rudnic reference
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`provided by the third party search firm and was submitted with the Petition and the
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`Park Declaration as Ex. 1010.
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`7.
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`In their Preliminary Response Under 37 C.F.R. § 42.107, Patent
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`Owners challenged Ex. 1010, stating that: “the Table of Contents for the 2002
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`version of Rudnic does not state that Chapter 10: Tablet Dosage Forms begins on
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`page 333. Compare Ex. 2019 at 6 (identifying page 287 as the beginning of
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`Chapter 10: Tablet Dosage Forms), with Ex. 1010 at 333 (identifying page 333 as
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`the beginning of Chapter 10: Tablet Dosage Forms).” (Paper No. 18 at pp. 42-43.)
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`8.
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`As a result of Patent Owners’ allegations in their Preliminary
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`Response, Mylan investigated the Rudnic reference and discovered that, because of
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`the reliance on the incorrect citation provided by the third party prior art search, the
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`incorrect cover page and publication date information was attached to Ex. 1010
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`and an incorrect citation was provided in the Petition and in the Park Declaration.
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`In particular, Mylan obtained a full copy of the fourth edition of Modern
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`Pharmaceutics and confirmed that, although the disclosure was virtually identical,
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`the pagination did not align with the third edition. Accordingly, through further
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`investigation, Mylan determined that the Rudnic reference provided by the third
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`party prior art search and submitted as a part of Ex. 1010 originated from the third
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`edition of Modern Pharmaceutics, which published in 1996, and not the fourth
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`edition published in 2002.
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`-5-
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`9.
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`I declare under penalty of perjury that the foregoing is true and
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`correct. Executed on November 26, 2018, at Atlanta, Georgia.
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`-6-
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