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`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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`SECOND SUPPLEMENTAL DECLARATION OF KINAM PARK, PH.D.
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`MYLAN EXHIBIT 1044
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`1.
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`I, Kinam Park, Ph.D., have been retained by counsel for Petitioner
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`Mylan Pharmaceuticals Inc. (“Mylan”) and have previously submitted an expert
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`Declaration (Ex. 1002) (“my Original Declaration”) in support of Mylan’s Petition
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`for inter partes review (“IPR”) of U.S. Patent No. 9,326,945 to Patel et al. (“the
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`’945 patent”) (Paper No. 2). I understand that the Patent Trial and Appeal Board
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`(“PTAB”) instituted trial in this IPR on October 15, 2018 (Paper No. 24).
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`2.
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`I further submitted a supplemental expert Declaration (“Supplemental
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`Declaration”) in response to post-institution objections from Patent Owners
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`challenging the authenticity and availability of certain prior art references
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`submitted in Mylan’s Petition and discussed in my Original Declaration. I
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`understand that my Supplemental Declaration was served on Patent Owners in
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`conjunction with other supplemental evidence on November 9, 2018, but has not
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`been filed with the PTAB.
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`3.
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`I submit this Second Supplemental Declaration in support of
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`Petitioner’s Motion to Correct a Typographical or Clerical Mistake in the Petition
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`Under 37 C.F.R. § 42.104(c) and/or Petitioner’s Motion to File Supplemental
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`Information Pursuant to 37 C.F.R. § 42.123(a).
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`I. THE CITATION TO THE RUDNIC REFERENCE CONTAINED IN
`THE PETITION AND MY ORIGINAL DECLARATION
`CONTAINED AN OBVIOUS TYPOGRAPHICAL ERROR
`4.
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`I note that Ex. 1010 as referred in both the Petition and my
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`Declaration (see, e.g., Ex. 1002, header ii and ¶¶140-143) contained an
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`inadvertent typographical error in its citation. The citation referred to Rudnic as
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`being published in the fourth edition of the textbook Modern Pharmaceutics in
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`2002. This is incorrect. The citation should have instead referred to the third
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`edition of Modern Pharmaceutics published in 1996. This inadvertent
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`typographical error resulted from Petitioner being provided with an incorrect
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`citation by a third party which further resulted in the incorrect cover and
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`publishing pages from the fourth edition being placed on the copy of Rudnic
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`supplied to me as Ex. 1010 rather than the correct pages from the third edition.
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`II. REPLACEMENT OF THE RUDNIC REFERENCE TO CORRECT
`THE TYPOGRAPHICAL ERROR DOES NOT CHANGE THE
`SUBSTANCE OF THE RUDIC REFERENCE
`5.
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`I have been provided by counsel with the copy of Chapter 10 from the
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`third edition of Modern Pharmaceutics obtained from Wisconsin TechSearch
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`(“Rudnic –WTS”) and attached as Ex. 1042. I understand supplemental evidence
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`submitted in response to Patent Owners’ post-institution objections establishes
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`that Rudnic – WTS is an authentic copy of Rudnic from the third edition of
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`Modern Pharmaceutics, including the correct cover page. I have reviewed Rudnic
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`- WTS and confirm that Rudnic, submitted as Ex. 1010 to the Petition, is correctly
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`contained therein at the page numbers referenced. In other words, although the
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`citation to Rudnic incorrectly referred to the reference as the fourth edition rather
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`than the third edition, the page numbers cited throughout my Original Declaration
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`correctly corresponded to cited pages of the third edition. This confirms that the
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`error in Ex. 1010 as originally submitted was purely typographical in nature.
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`6.
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`I have further reviewed the fourth edition of Modern Pharmaceutics, a
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`true and accurate copy of which was attached to my Supplemental Declaration as
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`Ex. 1043, and note the same chapter with substantially the same disclosure, albeit
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`at different page numbers and with different formatting, appears in that textbook
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`as well. For example, as I stated in my Original Declaration, Rudnic teaches that
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`“[f]or many drugs, particularly those for which absorption is limited by the rate of
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`dissolution, attainment of therapeutic levels may depend on achieving a small
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`particle size.” (Ex. 1002, ¶ 141). This identical sentence appears on page 335 of
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`the third edition and on page 289 of the fourth edition (Compare Ex. 1042 with
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`Ex. 1043). The only differences between the two sentences are insubstantial and
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`are the uses of “whose” instead of “for which” and “upon” instead of “on.” As
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`further stated in my Original Declaration, Rudnic “lists sodium lauryl sulfate as a
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`lubricant (e.g., antifrictional agent) that is commonly used in tablets and other
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`solid dosage forms” and “further notes that when tablets using sodium lauryl
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`sulfate as a lubricant were compared with those using magnesium stearate as a
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`lubricant, the tablets containing sodium lauryl sulfate exhibited a significantly
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`higher rate of dissolution.” (Ex. 1002, ¶ 142). These identical teachings are
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`found on pages 354-355 of the third edition and on pages 302-303 of the fourth
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`edition. (Compare Ex. 1042 with Ex. 1043). Accordingly, a POSA would have
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`readily recognized the error in the citation provided for Ex. 1010 and would have
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`understood that the disclosure of Ex. 1010 originated from the third edition of
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`Modern Pharmaceutics rather than the fourth edition.
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`7. Moreover, a POSA would also have known that either edition was
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`publicly available well prior to the earliest filing date of the ’945 patent. The
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`publication pages of each of the references show that they were published in 1996
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`and 2002, respectively, by CRC Press and provide an ISBN number. In addition, a
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`POSA, seeking to purchase the third edition online would have noted that vendors
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`selling this text book indicate that the third edition of Modern Pharmaceutics was
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`published in 1996 (see, e.g., Ex. 1042) and the fourth edition was published in
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`2002 (see, e.g., Ex. 1043). Therefore, a POSA would have known that Rudnic was
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`publicly available as of its respective publication dates in the third and fourth
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`editions.
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`5
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`I declare under penalty of perjury under the law of the United States that all
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`statements made herein of my own knowledge are true and that all statements
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`made on information and belief are believed to be true; and further that these
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`statements were made with the knowledge that willful false statements and the like
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`so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`Title 18 of the United States Code.
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`Executed on the 26th day of November, 2018, by:
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`_________________________________
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`Dr. Kinam Park, Ph.D.
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`6
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