UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`_____________________________
`
`Case IPR2018-01676
`Patent No. 8,603,044
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.
`OBJECTIONS TO EVIDENCE
`37 CFR §42.64(b)(1)
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`_____________________________
`
`Case IPR2018-01676
`Patent No. 8,603,044
`_____________________________
`
`MYLAN PHARMACEUTICALS INC.
`OBJECTIONS TO EVIDENCE
`37 CFR §42.64(b)(1)
`
`
`
`I.
`
`OBJECTIONS
`Petitioner (“Mylan”) submits the following objections:
`
`1.
`
`EX2001 – Press Release, “Mylan Enhances Partnership
`with Biocon through Strategic Collaboration for Insulin
`Products,” Feb. 13, 2013 (PR Newswire)
`Grounds for objection: FRE 402-403.
`
`EX2001 is offered to show Mylan’s clinical development and
`
`commercialization of a follow-on insulin glargine product. Paper 10, 6. That
`
`Mylan is developing such a product is not relevant to any contested issue in this
`
`proceeding. Thus, EX2001 lacks relevance and risks confusing the issues. To the
`
`extent EX2001 is admitted, its scope should be restricted to the purpose for which
`
`it was originally submitted. FRE 105.
`
`2.
`
`EX2002 – Press Release, “Mylan Commences Phase III
`Clinical Trials for its Generic Version of Advair Diskus®
`and Insulin Analog to Lantus®,” Sept. 16, 2014 (PR
`Newswire)
`Grounds for objection: FRE 402-403.
`
`EX2002 is offered to show Mylan’s clinical development and
`
`commercialization of a follow-on insulin glargine product. Paper 10, 6. That
`
`Mylan is developing such a product is not relevant to any contested issue in this
`
`proceeding. Thus, EX2002 lacks relevance and risks confusing the issues. To the
`
`extent EX2002 is admitted, its scope should be restricted to the purpose for which
`
`it was originally submitted. FRE 105.
`
`-1-
`
`
`
`3.
`
`EX2003 – Press Release, “Mylan and Biocon Present
`Clinical Data on Insulin Glargine at the American Diabetes
`Association’s 77th Scientific Sessions,” June 10, 2017 (PR
`Newswire)
`Grounds for objection: FRE 402-403.
`
`EX2003 is offered to show Mylan’s clinical development and
`
`commercialization of a follow-on insulin glargine product. Paper 10, 6. That
`
`Mylan is developing such a product is not relevant to any contested issue in this
`
`proceeding. Thus, EX2003 lacks relevance and risks confusing the issues. To the
`
`extent EX2003 is admitted, its scope should be restricted to the purpose for which
`
`it was originally submitted. FRE 105.
`
`4.
`
`EX2004 – Complaint for Patent Infringement, Sanofi-
`Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH v. Eli
`Lilly and Company, C.A. No. 1-14-cv-00113-RGA (D. Del.),
`Dkt. No. 1
`Grounds for objection: FRE 402-403.
`
`EX2004 is offered to show that Patent Owner (“Sanofi”) has previously
`
`asserted the ’044 patent against another competitor. Paper 10, 6. Whether the ’044
`
`patent has been previously asserted in litigation is not relevant to any contested
`
`issue in this proceeding. Thus, EX2004 lacks relevance and risks confusing the
`
`issues. To the extent EX2004 is admitted, its scope should be restricted to the
`
`purpose for which it was originally submitted. FRE 105.
`
`-2-
`
`
`
`5.
`
`EX2005 – Complaint for Patent Infringement, Sanofi-
`Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, and
`Sanofi Winthrop Industrie v. Merck Sharp & Dohme Corp.,
`C.A. No. 1-16-cv-00812-RGA (D. Del.), Dkt. No. 1
`Grounds for objection: FRE 402-403.
`
`EX2005 is offered to show that Sanofi has previously asserted the ’044
`
`patent against another competitor. Paper 10, 6. Whether the ’044 patent has been
`
`previously asserted in litigation is not relevant to any contested issue in this
`
`proceeding. Thus, EX2005 lacks relevance and risks confusing the issues. To the
`
`extent EX2005 is admitted, its scope should be restricted to the purpose for which
`
`it was originally submitted. FRE 105.
`
`6.
`
`EX2006 – Stipulation and Proposed Order, Sanofi-Aventis
`U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-
`SLW (D.N.J. Feb. 5, 2018), Dkt. No. 45
`Grounds for objection: FRE 402-403.
`
`EX2006 is offered to show the joint request for a trial date in the co-pending
`
`district court case. Paper 10, 8; Paper 15, 2. The parties’ request for a trial date in
`
`the district court litigation is not relevant to any contested issue in this proceeding.
`
`Thus, EX2006 lacks relevance and risks confusing the issues. To the extent
`
`EX2006 is admitted, its scope should be restricted to the purpose for which it was
`
`originally submitted. FRE 105.
`
`-3-
`
`
`
`7.
`
`EX2007 – Complaint for Patent Infringement, Sanofi-
`Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-
`cv-09105-SRC-CLW (D.N.J. Oct. 24, 2017), Dkt. No. 1
`Grounds for objection: FRE 402-403.
`
`EX2007 is offered to show that Sanofi has asserted the ’044 patent in the co-
`
`pending district court case. Paper 10, 10. The assertion of the ’044 patent in the
`
`district court case is not relevant to any contested issue in this proceeding. Thus,
`
`EX2007 lacks relevance and risks confusing the issues. To the extent EX2007 is
`
`admitted, its scope should be restricted to the purpose for which it was originally
`
`submitted. FRE 105.
`
`8.
`
`EX2008 – Excerpts from Defendants’ Invalidity
`Contentions, dated Jan. 25, 2018, Sanofi-Aventis U.S. LLC
`et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-
`CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2008 is offered to show that Mylan has referenced overlapping prior art
`
`as a basis for invalidity in the co-pending district court case. Paper 10, 11, 13, 15.
`
`That Mylan has referenced overlapping prior art in its invalidity contentions in the
`
`district court case is not relevant to any contested issue in this proceeding. Thus,
`
`EX2008 lacks relevance and risks confusing the issues. To the extent EX2008 is
`
`admitted, its scope should be restricted to the purpose for which it was originally
`
`submitted. FRE 105.
`
`-4-
`
`
`
`9.
`
`EX2009 – Excerpts from Mylan GMBH’s Amended
`Invalidity Contentions, dated April 25, 2018, Sanofi-Aventis
`U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-
`SRC-CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2009 is offered to show that Mylan has referenced overlapping prior art
`
`as a basis for invalidity in the co-pending district court case. Paper 10, 11. That
`
`Mylan has referenced overlapping prior art in its invalidity contentions in the
`
`district court case is not relevant to any contested issue in this proceeding. Thus,
`
`EX2009 lacks relevance and risks confusing the issues. To the extent EX2009 is
`
`admitted, its scope should be restricted to the purpose for which it was originally
`
`submitted. FRE 105.
`
`10. EX2010 – Excerpts from Mylan GMBH’s Exhibit C to
`Amended Invalidity Contentions, dated April 25, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No.
`2:17-cv-09105-SRC-CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2010 is offered to show that Mylan has referenced overlapping prior art
`
`as a basis for invalidity in the co-pending district court case. Paper 10, 11. That
`
`Mylan has referenced overlapping prior art in its invalidity contentions in the
`
`district court case is not relevant to any contested issue in this proceeding. Thus,
`
`EX2010 lacks relevance and risks confusing the issues. To the extent EX2010 is
`
`admitted, its scope should be restricted to the purpose for which it was originally
`
`submitted. FRE 105.
`
`-5-
`
`
`
`11. EX2011 – Aug. 13, 2018 Service of Sanofi’s Responses to
`Mylan’s Amended Contentions, Sanofi-Aventis U.S. LLC et
`al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW
`(D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2011 is offered to show the date on which Sanofi served its response to
`
`Mylan’s amended invalidity contentions, Paper 10, 15, which is not relevant to any
`
`contested issue in this proceeding. Thus, EX2011 lacks relevance and risks
`
`confusing the issues. To the extent EX2011 is admitted, its scope should be
`
`restricted to the purpose for which it was originally submitted. FRE 105.
`
`12. EX2012 – MP4 file of Sanofi’s Patented Pen animation
`Grounds for objection: FRE 801-804, 901.
`
`EX2012 is offered, without foundation, purportedly to show an animated
`
`operation of an embodiment of the injection pen described in the ’044 patent.
`
`Paper 10, 18. The animation is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions. In addition, EX2012
`
`lacks sufficient support to show that it is what Sanofi purports it to be.
`
`13. EX2013 – Excerpt from Defendants’ opening claim
`construction brief, dated October 12, 2018, Sanofi-Aventis
`U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-
`SRC-CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2013 is offered to suggest that the parties agree that the same claim
`
`constructions should apply for all patents asserted in the co-pending district court
`
`-6-
`
`
`
`case. Paper 10, 23-24 n.10. The quoted language is taken out of context and does
`
`not support this assertion. Thus, EX2013 lacks relevance, risks confusing the
`
`issues, is misleading, and is prejudicial to Mylan.
`
`14. EX2014 – Memorandum Opinion, Sanofi-Aventis U.S. LLC
`v. Merck Sharp & Dohme Corp., Case No. 16-cv-812-RGA
`(D. Del.), Dkt. No. 192
`Grounds for objection: FRE 402-403.
`
`EX2014 is offered to show a claim construction (“main housing”) adopted
`
`by a district court in a prior litigation not involving Mylan. Paper 10, 25-26. A
`
`district court’s construction in an unrelated case is not relevant to any contested
`
`issue in this proceeding. Thus, EX2014 lacks relevance, risks confusing the issues,
`
`and is prejudicial to Mylan.
`
`15. EX2017 – Animation depicting Møller’s first embodiment
`Grounds for objection: FRE 801-804, 901.
`
`EX2017 is offered, without foundation, to show an animated operation of an
`
`embodiment of the injection pen described in Møller. Paper 10, 47, 52, 54. The
`
`animation is hearsay because it is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions. In addition, EX2017 lacks sufficient
`
`support to show that it is what Sanofi purports it to be.
`
`16. EX2018 – Animation depicting Møller’s second embodiment
`Grounds for objection: FRE 801-804, 901.
`
`-7-
`
`
`
`EX2018 is offered, without foundation, to show an animated operation of an
`
`embodiment of the injection pen described in Møller. Paper 10, 52, 54. The
`
`animation is hearsay because it is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions. In addition, EX2018 lacks sufficient
`
`support to show that it is what Sanofi purports it to be.
`
`17. EX2019 – Defendants’ Opposition to Plaintiffs’ Motion to
`Stay dated Nov. 22, 2017, Sanofi-Aventis U.S. LLC et al. v.
`Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W.
`Va.), Dkt. No. 44
`Grounds for objection: FRE 402-403.
`
`EX2019 is offered to show statements made by the parties regarding the
`
`timeline of the co-pending district court case. Paper 15, 1. These statements are
`
`not relevant to the issues in this proceeding. Thus, EX2019 lacks relevance and
`
`risks confusing the issues. To the extent EX2019 is admitted, its scope should be
`
`restricted to the purpose for which it was originally submitted. FRE 105.
`
`18. EX2020 – Joint Proposed Discovery Plan dated Dec. 14,
`2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`EX2020 is offered to show statements made by the parties regarding the
`
`timeline of the co-pending district court case. Paper 15, 1, 3-4. Thus, EX2020
`
`lacks relevance and risks confusing the issues. To the extent EX2020 is admitted,
`
`-8-
`
`
`
`its scope should be restricted to the purpose for which it was originally submitted.
`
`FRE 105.
`
`19. EX2021 – Letter from A. Calmann to Judge Waldor dated
`Apr. 24, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V.
`et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.), Dkt. No.
`90
`Grounds for objection: FRE 402-403.
`
`EX2021 is offered to show statements made by the parties regarding the
`
`timeline of the co-pending district court case. Paper 15, 1. These statements are
`
`not relevant to the issues in this proceeding. Thus, EX2021 lacks relevance and
`
`risks confusing the issues. To the extent EX2021 is admitted, its scope should be
`
`restricted to the purpose for which it was originally submitted. FRE 105.
`
`20. EX2022 – Motion to Expedite Defendants’ Motion
`Requesting an Expedited Scheduling Conference dated Nov.
`22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt. No. 46
`Grounds for objection: FRE 402-403.
`
`EX2022 is offered to show statements made by the parties regarding the
`
`timeline of the co-pending district court case. Paper 15, 2. These statements are
`
`not relevant to the issues in this proceeding. Thus, EX2022 lacks relevance and
`
`risks confusing the issues. To the extent EX2022 is admitted, its scope should be
`
`restricted to the purpose for which it was originally submitted. FRE 105.
`
`-9-
`
`
`
`21. EX2023 – Initial Planning Meeting Report and Discovery
`Proposals dated Dec. 22, 2017, Sanofi-Aventis U.S. LLC et
`al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D.
`W. Va.), Dkt. No. 61
`Grounds for objection: FRE 402-403.
`
`EX2023 is offered to show statements made by the parties regarding the
`
`timeline of the co-pending district court case. Paper 15, 2. These statements are
`
`not relevant to the issues in this proceeding. Thus, EX2023 lacks relevance and
`
`risks confusing the issues. To the extent EX2023 is admitted, its scope should be
`
`restricted to the purpose for which it was used. FRE 105.
`
`22. EX2024 – Transcript of Motion/Scheduling Conference
`dated Jan. 3, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan
`N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.), Dkt.
`No. 64
`Grounds for objection: FRE 402-403.
`
`EX2024 is offered to show statements made by a West Virginia District
`
`Court Judge regarding the District of New Jersey. Paper 15, 2. These statements
`
`are not relevant to the issues in this proceeding. Thus, EX2024 lacks relevance
`
`and risks confusing the issues. To the extent EX2024 is admitted, its scope should
`
`be restricted to the purpose for which it was originally submitted. FRE 105.
`
`23. EX2025 – Excerpts from Transcript, Conference Call dated
`Aug. 2, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Grounds for objection: FRE 402-403.
`
`-10-
`
`
`
`EX2025 is offered to show comments of the magistrate judge in the co-
`
`pending district court case regarding resolution of disputes in the litigation. Paper
`
`15, 3. These comments are not relevant to any contested issues in this proceeding.
`
`Thus, EX2025 lacks relevance and risks confusing the issues. To the extent
`
`EX2025 is admitted, its scope should be restricted to the purpose for which it was
`
`originally submitted. FRE 105.
`
`24. EX2026 – Report of the Local Patent Rules Committee,
`Explanatory Notes for 2016 Amendments
`Grounds for objection: FRE 402-403.
`
`EX2026 is offered to establish the patent rules specific to the United States
`
`Court for the District of New Jersey. Paper 15, 3. The District of New Jersey’s
`
`local patent rules are irrelevant to the issues in this proceeding. Thus, EX2026
`
`lacks relevance and risks confusing the issues. To the extent EX2026 is admitted,
`
`its scope should be restricted to the purpose for which it was originally submitted.
`
`FRE 105.
`
`25. EX2027 – Transcript, Conference Call for Case IPR2018-
`01675, -01676, -01678, -01680 (PTAB Feb. 5, 2019)
`Grounds for objection: FRE 402-403.
`
`EX2027 is offered to show statements made by the parties regarding the
`
`status of issues before the district court in the co-pending litigation. Paper 15, 4.
`
`These statements are not relevant to the issues in this proceeding. Thus, EX2027
`
`lacks relevance and risks confusing the issues. To the extent EX2027 is admitted,
`
`-11-
`
`
`
`its scope should be restricted to the purpose for which it was originally submitted.
`
`FRE 105.
`
`Dated: 16 April 2019
`
`Respectfully submitted,
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`
`-12-
`
`
`
`CERTIFICATE OF SERVICE
`I certify that today I caused a true and correct copy of Mylan
`
`Pharmaceuticals Inc. Objections to Evidence, on the Patent Owner at the email
`
`correspondence addresses of the Patent Owner as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`Sundip K. Kundu
`
`Kathryn M. Kantha
`
`William S. Ansley
`
`Matthew D. Sieger
`
`Adrian C. Percer
`
`Brian C. Chang
`
`anish.desai@weil.com
`
`sundip.kundu@weil.com
`
`kathryn.kantha@weil.com
`
`sutton.ansley@weil.com
`
`matthew.sieger@weil.com
`
`adrian.percer@weil.com
`
`brian.chang@weil.com
`
`WEIL, GOTSHAL & MANGES LLP
`
`Sanofi.IPR.Service@weil.com
`
`Dated: 16 April 2019
`
`Respectfully submitted,
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`
`-13-
`
`
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