IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`
`Inter Partes Review No.: IPR2020-00040
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`
`Inter Partes Review No.: IPR2020-00040
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Pharmaceuticals Inc. (“Mylan”
`
`or “Petitioner”) timely objects under the Federal Rules of Evidence (“FRE”) to the
`
`admissibility of Exhibits 2002, 2003, 2004, 2005, 2011, 2012 and 2013 (and
`
`accompanying appendices). Collectively, these exhibits (“Challenged Evidence”)
`
`were served by Merck, Sharpe & Dohme Corp. (“Merck” or “Patent Owner”) with
`
`its Patent Owner Complete Response filed on February 14, 2020.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because
`
`they are being filed and served within ten business days. Petitioner files these
`
`objections to provide notice to Patent Owner that Petitioner may move to exclude
`
`the Challenged Evidence under 37 C.F.R. § 42.64(c), unless timely cured by Patent
`
`Owner.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS FOR
`
`OBJECTIONS
`
`A. Multiple Exhibits Are Inadmissible as Being Irrelevant, and/or
`Containing Hearsay, and Are Therefore More Prejudicial Than
`Probative as to Any Fact of Consequence.
`
`1. Exhibit 2002:
`
`Petitioner objects to Exhibit 2002 in its entirety as inadmissible hearsay and
`
`hearsay within hearsay under FRE 801 and 802 because it is relied upon for the
`
`truth of the matter asserted (POR at 35, 37-39) and Petitioner has not had the
`
`opportunity to subject the declarant (Vicky K. Vydra) to cross-examination.
`
`2
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`Petitioner also objects to the Appendices of Exhibit 2002 under FRE 901 for lack
`
`of authentication and
`
`lack of foundation because
`
`there
`
`is no evidence
`
`authenticating or providing foundation for Appendices A & B. Petitioner further
`
`objects to Exhibit 2002 and Appendices A and B under FRE 602 and 901 because
`
`there is no evidence that declarant is competent to testify regarding events that
`
`occurred 18 years ago and Patent Owner has not provided evidence sufficient to
`
`support a finding that Appendix A “is what [Patent Owner] claims it is.” See FRE
`
`901. Petitioner further objects to Appendix B as inadmissible hearsay and hearsay
`
`within hearsay under FRE 801, 802 and/or 805. Appendix B is relied upon for the
`
`truth of the matter asserted (POR at 35, 37-39; EX2002 at ¶ 21) and Petitioner has
`
`not had the opportunity to subject Michael Palucki to cross-examination.
`
`Petitioner also objects to Appendices A & B of EX2002 under FRE106 because the
`
`documents are improper compilations and incomplete. Finally, Petitioner objects
`
`to the Declaration of Vicky K. Vydra as improper expert opinion under FRE 702.
`
`2. Exhibit 2003:
`
`Petitioner objects to Exhibit 2003 in its entirety as inadmissible hearsay
`
`under FRE 801 and 802 because it is relied upon for the truth of the matter asserted
`
`(POR at 35, 37-39) and Petitioner has not had the opportunity to subject the
`
`declarant (Robert M. Wenslow) to cross-examination. In addition, the Declaration
`
`of Dr. Wenslow further cites to other materials or individuals for the truth of the
`
`3
`
`
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`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`matter asserted. Therefore, Petitioner objects to the extent EX2003 contains
`
`hearsay with hearsay under FRE 801, 802 and/or 805. Petitioner also objects to the
`
`Appendices of Exhibit 2003 under FRE 901 for lack of authentication and lack of
`
`foundation because there is no evidence authenticating or providing foundation for
`
`the materials contained therein. Petitioner objects to Exhibit 2003 in its entirety
`
`under FRE 602 because there is no evidence that declarant is competent to testify
`
`regarding events that occurred 18 years ago.
`
`Petitioner objects to Appendix A in Exhibit 2003 as inadmissible hearsay
`
`under FRE 801,802 and/or 805. The document is relied upon for the truth of the
`
`matter asserted (POR at 35-39; EX2003 at ¶ 12) and Petitioner has not had the
`
`opportunity to subject Leigh Shultz to cross-examination. Petitioner also objects to
`
`Appendix A under FRE 901 because Patent Owner has not provided evidence
`
`sufficient to support a finding that Appendix A “is what [Patent Owner] claims it
`
`is.” See FRE 901. In addition, Dr. Wenslow, in ¶ 12 of Exhibit 2003, relies on
`
`Appendix A for the truth of the matter asserted, and is therefore inadmissible under
`
`FRE 801, 802, and 805.
`
`Petitioner objects to Appendix B in Exhibit 2003 as inadmissible hearsay
`
`under FRE 801, 802 and/or 805. The document is relied upon for the truth of the
`
`matter asserted (POR at 35-39; EX2003 at ¶ 13) and Petitioner has not had the
`
`opportunity to subject Yun Liu to cross-examination. Petitioner also objects to
`
`4
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`Appendix B under FRE 901 because Patent Owner has not provided evidence
`
`sufficient to support a finding that Appendix B “is what [Patent Owner] claims it
`
`is.” See FRE 901. In addition, Dr. Wenslow, in ¶ 13 of Exhibit 2003, relies on
`
`Appendix B for the truth of the matter asserted and is therefore inadmissible under
`
`FRE 801, 802, and 805.
`
`Petitioner objects to Appendix C in Exhibit 2003 as inadmissible hearsay
`
`under FRE 801,802 and/or 805. The document is relied upon for the truth of the
`
`matter asserted (POR at 35-39; EX2003 at ¶ 15) and Petitioner has not had the
`
`opportunity to subject Cindy Starbuck to cross examination. Petitioner also objects
`
`to Appendix C under FRE 901 because Patent Owner has not provided evidence
`
`sufficient to support a finding that Appendix C “is what [Patent Owner] claims it
`
`is.” See FRE 901. No exception applies. In addition, Dr. Wenslow, in ¶ 15 of
`
`Exhibit 2003, relies on Appendix C for the truth of the matter asserted, and is
`
`therefore inadmissible under FRE 801, 802, and 805.
`
`Petitioner objects to Appendix D in Exhibit 2003 as inadmissible hearsay
`
`under FRE 801,802 and/or 805. The document is relied upon for the truth of the
`
`matter asserted (POR at 35-39; EX2003 at ¶ 16) and Petitioner has not had the
`
`opportunity to subject Cindy Starbuck to cross examination. Petitioner also objects
`
`to Appendix D under FRE 901 because Patent Owner has not provided evidence
`
`sufficient to support a finding that Appendix D “is what [Patent Owner] claims it
`
`5
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`is.” See FRE 901. No exception applies. In addition, Dr. Wenslow, in ¶ 15 of
`
`Exhibit 2003, relies on Appendix D for the truth of the matter asserted. Exhibit
`
`2003 is therefore inadmissible under FRE 801, 802, and 805.
`
`Petitioner also objects to the Appendices of EX2003 under FRE106 because
`
`the documents are improper compilations and incomplete. Finally, Petitioner
`
`objects to the Declaration of Robert M. Wenslow as improper expert opinion under
`
`FRE 702.
`
`3. Exhibit 2004:
`
`Petitioner objects to Exhibit 2004 under FRE 602 because there is no
`
`evidence that declarant is competent to testify regarding events that occurred 18
`
`years ago. Petitioner also objects to Exhibit 2004 in its entirely under FRE 901
`
`because Patent Owner has not provided evidence sufficient to support a finding
`
`that Exhibit 2004 “is what [Patent Owner] claims it is,” and as hearsay under FRE
`
`801, 802, and 805 because Patent Owner relies on Exhibit 2004 for the truth of the
`
`matter asserted (POR at 40) and Petitioner has not had the opportunity to subject
`
`the declarant (Russell R. Ferlita) to cross-examination.
`
`Appendix A to Exhibit 2004 is inadmissible under FRE 401 and 402.
`
`Appendix A purports to be a copy of Conditions of Employment and is unsigned.
`
`Appendix A is not relevant to any issue in the IPR proceeding. Therefore,
`
`Appendix A is inadmissible as being irrelevant. Petitioner also objects to Appendix
`
`6
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`A under FRE 901 because Patent Owner has not provided evidence sufficient to
`
`support a finding that EX2004 “is what [Patent Owner] claims it is.” See FRE 901.
`
`Petitioner also objects to the Appendix A of EX2004 under FRE106 because the
`
`documents are as incomplete and unsigned. Petitioner also objects to the Appendix
`
`A of EX2004 under FRE 901 for lack of authentication and lack of foundation
`
`because there is no evidence authenticating or providing foundation for the
`
`document contained therein.
`
`
`
`4. Exhibit 2005:
`
`Petitioner objects to Exhibit 2005 in its entirety under FRE 602 because
`
`there is no evidence that declarant is competent to testify regarding events that
`
`occurred 18 years ago, has personal knowledge of any such events, or was even
`
`present during the events underlying the documents attached as in Appendices A-O
`
`of Exhibit 2005. Petitioner also objects to Exhibit 2005 under FRE 901 because
`
`Patent Owner has not provided evidence sufficient to support a finding that Exhibit
`
`2005 “is what [Patent Owner] claims it is,” and as hearsay under FRE 801, 802,
`
`and 805 because Patent Owner relies on Exhibit 2005 for the truth of the matter
`
`asserted and Petitioner has not had the opportunity to subject the declarant (Joanne
`
`Diddle) to cross-examination.
`
`Petitioner objects to Appendices A-O in Exhibit 2005 as inadmissible
`
`hearsay and hearsay within hearsay under FRE 801, 802 and/or 805. Appendices
`
`7
`
`
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`A-O are relied upon for the truth of the matter asserted (POR at 40-41; EX2005 at
`
`¶¶ 4-19) and Petitioner has not had the opportunity to subject Scott D. Edmondson,
`
`Michael H. Fisher, Dooseop Kim, Malcolm MacCoss, Emma R. Parmee, Ann E.
`
`Weber, Jinyou Xu, Stephen H. Cypes, Minhua (Alex) Chen, Russell R. Ferlita,
`
`Karl B. Hansen, Ivan Lee, Vicky K. Vydra, and/or Robert M. Wenslow to cross
`
`examination. Petitioner also objects to Appendices A-O under FRE 901 because
`
`Patent Owner has not provided evidence sufficient to support a finding that
`
`Appendices A-O “is what [Patent Owner] claims it is.” See FRE 901.
`
`In addition, Joanne Diddle, in ¶¶ 4-19 of Exhibit 2005, relies on Appendices
`
`A-O for the truth of the matter asserted. EX2005 is therefore inadmissible under
`
`FRE 801, 802, and 805. Petitioner also objects to the Appendices A-O of EX2005
`
`to the extent any of them are found to be incomplete under FRE106. To that end,
`
`at least the document provided as Appendix J is incomplete and unsigned.
`
`Petitioner also objects to the Appendices A-O of EX2005 under FRE 901 for lack
`
`of authentication and
`
`lack of foundation because
`
`there
`
`is no evidence
`
`authenticating or providing foundation for the document contained therein.
`
`
`
`5. Exhibit 2011:
`
`Exhibit 2011 is inadmissible under FRE 401 and 403. Exhibit 2011 purports
`
`to be a U.S. Patent published August 1, 2017. Exhibit 2011 is not relevant to any
`
`issue in the IPR proceeding because the purported date of the document is after the
`
`8
`
`
`
`filing date of the ’708 patent. Therefore, Exhibit 2011 is inadmissible as being
`
`IPR2020-00040
`U.S. Patent No. 7,326,708
`
`irrelevant.
`
`6. Exhibit 2012:
`
`Exhibit 2012 is inadmissible under FRE 401 and 403. Exhibit 2012 purports
`
`to be a U.S. Patent published April 5, 2011. Exhibit 2012 is not relevant to any
`
`issue in the IPR proceeding because the purported date of the document is after the
`
`filing date of the ’708 patent. Therefore, Exhibit 2012 is inadmissible as being
`
`irrelevant.
`
`7. Exhibit 2013:
`
`Exhibit 2013 is inadmissible under FRE 401 and 403. Exhibit 2013 purports
`
`to be a U.S. Patent published November 10, 2015. Exhibit 2013 is not relevant to
`
`any issue in the IPR proceeding because the purported date of the document is after
`
`the filing date of the ’708 patent. Therefore, Exhibit 2013 is inadmissible as being
`
`irrelevant.
`
`DATE: May 27, 2020
`
`Respectfully submitted,
`
`Katten Muchin Rosenman LLP
`
`By: /Alissa M. Pacchioli/
`Alissa M. Pacchioli
`Reg. No. 74,252
`
`9
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on May 27, 2020, a complete copy of the foregoing Objections to
`
`Evidence, was served via email to Patent Owner’s counsel at:
`
`sfisher@wc.com
`
`jberniker@wc.com
`
`smahaffy@wc.com
`
`asheh@wc.com
`
`bgenderson@wc.com
`
`ebaumgarten@wc.com
`
`azolan@wc.com
`
`Respectfully submitted,
`
`Katten Muchin Rosenman LLP
`By: /Alissa M. Pacchioli/
`Alissa M. Pacchioli
`Reg. No. 74,252
`
`
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