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,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01676
`U.S. Patent No. 8,603,044
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`PATENT OWNER’S SUR-REPLY IN SUPPORT OF
`PATENT OWNER’S PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`Page
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`THE DISTRICT COURT CASE WILL CONCLUDE BY MARCH
`2020 ................................................................................................................. 1 
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`IN THIS CASE WILL NOT
`EXERCISING DISCRETION
`BROADLY IMPACT HATCH-WAXMAN LITIGANTS ............................. 3 
`
`PETITIONER IS ASSERTING DUPLICATIVE GROUNDS IN THIS
`IPR AND THE DISTRICT COURT CASE .................................................... 4 
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`I. 
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`II. 
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`III. 
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`i
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`Exhibit #
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`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`EXHIBIT LIST
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`Description
`Press Release, “Mylan Enhances Partnership with Biocon through
`Strategic Collaboration for Insulin Products”, Feb. 13, 2013 (PR
`Newswire), available at http://newsroom.mylan.com/press-
`releases?item=122834
`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), available at
`http://newsroom.mylan.com/press-releases?item=123251
`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), available at
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-
`Present-Clinical-Data-on-Insulin-Glargine-at-the-American-
`Diabetes-Associations-77th-Scientific-Sessions
`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
`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
`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
`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
`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.)
`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.)
`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.)
`ii
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`Exhibit #
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`2011
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`2012
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`2013
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`2014
`2015
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`2016
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`2017
`2018
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`2019
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`2020
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`2021
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`2022
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`2023
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`2024
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`Description
`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.)
`MP4 file of Sanofi’s Patented Pen animation
`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.)
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp &
`Corp., Case No. 16-cv-812-RGA (D. Del.), Dkt. No. 192
`International Patent WO 99/3855
`Excerpt from Joint claim construction statement, Ex. A, dated
`October 8, 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.)
`Animation depicting Møller’s first embodiment
`Animation depicting Møller’s second embodiment
`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
`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.)
`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
`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
`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
`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
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`iii
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`Exhibit #
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`2025
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`2026
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`2027
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`Description
`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.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes for
`2016 Amendments
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
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`iv
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`Patent Owner respectfully submits this sur-reply on the issue of whether the
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`Board should exercise discretion under 35 U.S.C. § 314(a) and deny institution. As
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`detailed below and in Patent Owner’s Preliminary Response, the specific facts of
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`this case warrant the exercise of that discretion.
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`I.
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`THE DISTRICT COURT CASE WILL CONCLUDE BY MARCH 2020
`Petitioner’s assertion that the “district-court timeline is speculative” can be
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`rejected out of hand. From the outset of the District Court case in October 2017,
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`Petitioner has demanded an expeditious trial of all issues of validity and
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`infringement well in advance of March 2020, when the 30-month stay in the District
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`Court case expires and when a so-called “transition date” occurs. This “transition
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`date” is unique to the insulin space and is the date in March 2020 when insulins will
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`be governed by the biologics statute (BPCIA) and no longer by the Hatch-Waxman
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`Act. Indeed, Petitioner has repeatedly asserted that “the transition date makes the
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`timeline in this case more urgent than in a typical Hatch-Waxman case.” Ex. 2019
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`at 1 (emphasis added); see also Ex. 2020 at 19 (“[i]n view of the unique issues in
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`this case relating to regulatory approval and the BPCIA, the timeline in this case is
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`more urgent than in a typical Hatch-Waxman case.”); Ex. 2021 at 1 (“[T]his case
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`presents a unique timing issue that requires diligent adherence to litigation timelines
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`sufficient to allow the Court plenty of time to issue a decision prior to the expiration
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`of the FDA’s 30-month stay.”).
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`1
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`Thus, at the outset of the case, Petitioner sought to have the case resolved in
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`West Virginia rather than New Jersey, asserting that “[i]t is vital to Defendants’
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`interests that this case proceed as quickly as possible.” Ex. 2022 at 1; Ex. 2023 at
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`7-8 (“[T]here is a heightened need to efficiently litigate this case to allow the Court
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`sufficient time to issue a decision prior to the expiration of the stay in this matter.”);
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`id. at 12 (“[T]he timeline in this case is more urgent than in a typical Hatch-Waxman
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`case”).
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`In deciding to stay the West Virginia action and allow the case to proceed in
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`New Jersey, the District Court Judge in West Virginia specifically recognized that
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`the District of New Jersey and Judge Chesler were known to resolve Hatch-Waxman
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`cases expeditiously and in advance of stay expiration:
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`I really would be out of my league to suggest that the judges—the
`district judges in New Jersey can’t efficiently handle a pharmaceutical
`patent case like this and in my years on the Bench, I have bowed to their
`knowledge and experience in patent work generally. . . . [T]he court has
`a long standing history of experience trying these cases. I have no
`reason to believe that the District Judge in New Jersey, Judge
`Chesler, will not make a decision on this as quickly as is reasonable.
`Ex. 2024 at 31:15-32:3 (emphasis added). Petitioner thus agreed to proceed in New
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`Jersey on the condition that the parties jointly propose a trial date in October 2019.
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`Ex. 2006, ¶ 8.
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`2
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`The Magistrate Judge in the New Jersey Action has recognized the importance
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`of resolving Petitioner’s validity challenges well before the 30-month stay ends. See,
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`e.g., Ex. 2025 at 6:17-24 (encouraging parties to resolve their disputes to maintain
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`the October trial date). The District Court Judge—Judge Chesler—in the New Jersey
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`Action, has presided over 50 Hatch-Waxman cases and is the Chair of the Local
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`Patent Rules Committee for the District of New Jersey. Ex. 2026 at 2. In 2016, that
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`committee amended New Jersey Local Patent Rule 2.1 to require parties in Hatch-
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`Waxman cases to address the 30-month stay in their case planning conference and
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`joint discovery plan, explaining that the amendment was made “in order to expedite
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`matters.” Id. at 1. Thus, even if the trial date shifts to later in 2019, there is simply
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`no basis to suggest that the District Court will not resolve all of the issues in this
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`case, including validity, before the March 2020 transition date and expiration of the
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`stay.
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`II. EXERCISING DISCRETION IN THIS CASE WILL NOT BROADLY
`IMPACT HATCH-WAXMAN LITIGANTS
`Petitioner claims that Patent Owner’s arguments would create a “sector-
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`specific nullification of § 315(b) for ANDA suits” by purportedly preventing all
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`Hatch-Waxman defendants from using the full one-year statutory period to file an
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`IPR. Reply at 6. This argument is refuted by Petitioner’s own repeated assertions in
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`District Court that “the unique issues in this case relating to regulatory approval and
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`the BPCIA, the timeline in this case is more urgent than in a typical Hatch-Waxman
`3
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`case.” Ex. 2020 at 19. These “unique issues” are the transition date and the
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`commitment by the parties and the court to resolve the case in advance of the March
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`2020 stay expiration and transition date. Other facts specific to this case make it
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`appropriate for denial under § 314(a). Petitioner asserts the same invalidity grounds
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`in the Petition and the District Court, which results in unnecessary duplicative
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`litigation in two forums. See NHK Spring, IPR2018-00752, Paper 8 (P.T.A.B. Sept.
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`12, 2018). These case-specific circumstances arise from Petitioner’s selection of
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`invalidity grounds and the timing of the petitions relative to the District Court case.
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`Moreover, these factors are not unique to Hatch-Waxman cases, as evidenced by
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`NHK Spring, which was not such a case. Thus, it is Petitioner that improperly seeks
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`“sector-specific” treatment for Hatch-Waxman cases by asking the Board to exempt
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`such cases from the Board’s discretion under § 314 and NHK Spring.
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`III. PETITIONER IS ASSERTING DUPLICATIVE GROUNDS IN THIS
`IPR AND THE DISTRICT COURT CASE
`The invalidity grounds in the Petition are also asserted in Petitioner’s District
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`Court invalidity contentions. See Paper 10 at 11. Nonetheless, Petitioner apparently
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`contends that because its District Court invalidity positions have not “been
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`developed” to the same degree as its IPR arguments, it is not clear that the District
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`Court ultimately will decide the same issues. Ex. 2027 at 13:10-14:3. Not once,
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`however, has Petitioner affirmed to the Board that it will not continue to assert the
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`same grounds against the challenged claims in the District Court case. Nor has
`4
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`Petitioner affirmed that it will ultimately present a different theory of obviousness
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`based on the same prior art references to the District Court, or even suggested how
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`it could present different, non-overlapping theories of obviousness to the Board and
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`the District Court based on the same prior art. Thus, even accepting arguendo
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`Petitioner’s claim that the invalidity arguments in the District Court case are not
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`fully developed, Petitioner has provided no assurances that it will not invite the
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`District Court to adjudicate the same invalidity grounds after receiving an institution
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`decision in this proceeding.1 It therefore remains that the invalidity grounds asserted
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`in the Petition are still asserted in the District Court case, and instituting a trial would
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`result in duplicative litigation over the same grounds, with the District Court case
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`resolving before the Board’s final written decision is due.
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`*
`*
`*
`For these reasons and those set forth in Patent Owner’s Preliminary Response,
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`Patent Owner respectfully requests that the Board exercise its discretion under § 314
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`to deny institution.
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`1 Given that Petitioner can still tailor its District Court invalidity grounds to address
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`weaknesses identified in the Patent Owner’s Preliminary Response or the institution
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`decision, the potential tactical advantage also merits denial.
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`5
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`

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`Dated: February 12, 2019
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`
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`Respectfully submitted,
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`(Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Sudip K. Kundu (Reg. No. 74,193)
`Kathryn M. Kantha (Reg. No. 70,371)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`sudip.kundu@weil.com
`kathryn.kantha@weil.com
`
`William S. Ansley (Reg. No. 67,828)
`Matthew D. Sieger (Reg. No. 76,051)
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`
`Adrian C. Percer (Reg. No. 46,986)
`Brian C. Chang (Reg. No. 74,301)
`Weil, Gotshal & Manges LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Phone: 650-802-300
`adrian.percer@weil.com
`brian.chang@weil.com
`
`Sanofi.IPR.Service@weil.com
`
`
`6
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on February 12, 2019, the foregoing
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`PATENT OWNER’S SUR-REPLY IN SUPPORT OF PATENT OWNER’S
`
`PRELIMINARY RESPONSE and EXHIBITS 2019 – 2027 were served via
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`electronic mail upon the following:
`
`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Wilson Sonsini Goodrich & Rosati
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006-3817
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`
`Douglas Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`
`Franklin Chu
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Ste. 5100
`Seattle, WA 98104
`ychu@wsgr.com
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`7
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`
`Lorelei Westin
`Wilson Sonsini Goodrich & Rosati
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
`
`Nicole W. Stafford
`Wilson Sonsini Goodrich & Rosati
`900 South Capital of Texas Highway
`Las Cimas, IV Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`
`
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`
`
`Timothy J. Andersen
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`timothy.andersen@weil.com
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`8
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