Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 1 of 14 PageID #: 1431
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`
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`SANOFI-AVENTIS U.S. LLC,
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`and SANOFI WINTHROP INDUSTRIE,
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`
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`Civil Action No. 1:17-CV-181-IMK
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`Plaintiffs,
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`v.
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`
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`MYLAN N.V., MYLAN GMBH, MYLAN INC.,
`and MYLAN PHARMACEUTICALS INC.,
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`Defendants.
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`
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`INITIAL PLANNING MEETING REPORT AND DISCOVERY PROPOSALS
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`I.
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`INITIAL PLANNING MEETING
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`Pursuant to Fed. R. Civ. P. 16 and 26(f), Local Rule 16.01(b) and (c), and the Court’s
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`December 13, 2017 Order Granting Defendants’ Motion for Expedited Scheduling Conference
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`[Dkt. No. 45] and Motion to Expedite [Dkt. No. 46] (Dkt. No. 60) (“Order”), the parties, by and
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`through their undersigned counsel, jointly submit this report of the parties’ initial planning
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`meeting, which was held by telephone on December 18, 2017. The following persons
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`participated in the initial planning teleconference:
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`• Attorneys from Simmerman Law Office, PLLC and Weil, Gotshal & Manges
`LLP participated on behalf of Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi-Aventis
`Deutschland GmbH, and Sanofi Winthrop Industrie (collectively, “Plaintiffs” or
`“Sanofi”); and
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`• Attorneys from Robinson & McElwee PLLC and Wilson Sonsini Goodrich &
`Rosati P.C. participated on behalf of Defendants Mylan N.V., Mylan GmbH,
`Mylan Inc., and Mylan Pharmaceutical Inc. (collectively, “Defendants”).
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`Sanofi Exhibit 2020.001
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 2 of 14 PageID #: 1432
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`The parties attach, for the Court’s consideration, a chart summarizing the parties’
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`respective scheduling proposals for this action (Exhibit A). Pursuant to the Court’s Order, a
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`scheduling conference is set for January 3, 2018.
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`Sanofi’s Statement:
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`A.
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`Introduction
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`This is a second-filed “protective” Hatch-Waxman action in which Sanofi asserts 18
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`patents against Mylan. Sanofi’s identical first-filed action is proceeding in the District Court for
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`the District of New Jersey—Sanofi’s state of incorporation. See Sanofi-Aventis U.S. LLC, et al.
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`v. Mylan N.V., et al., No. 2:17-09105 (SRC-CLW) (the “New Jersey Action”). This second-filed
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`“protective” suit names the same Mylan entities and asserts the same patents and causes of action
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`as the New Jersey Action. To avoid duplicative, parallel litigation, Sanofi has moved to stay1
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`this second-filed action in view of its first-filed New Jersey Action, which is already well
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`underway. Indeed, discovery is open, and the parties participated in the Rule 16 conference in
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`New Jersey on December 19, where the magistrate judge adopted a schedule for the New Jersey
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`Action and expressly acknowledged the date of expiration of the 30-month stay and its
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`importance to the case. Moreover, two of the patents at issue in this case have also been asserted
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`by Sanofi against Merck in the District of New Jersey, and thus, coordinating claim construction
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`will be more efficient in New Jersey rather than here. See Sanofi-Aventis U.S. LLC, et al. v.
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`Merck Sharp & Dohme Corp., No. 2:17-cv-05914 (D.N.J.). In fact, the magistrate judge in the
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`New Jersey Action has already ordered briefing deadlines for claim construction that will allow
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`for a consolidated claim construction hearing in both cases. Because the New Jersey cases will
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`likely have common issues of claim construction and validity, judicial economy will be better
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`1 Mylan has responded to Sanofi’s motion, Sanofi has replied, and thus, Sanofi’s motion is ripe
`for resolution.
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`2
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`Sanofi Exhibit 2020.002
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 3 of 14 PageID #: 1433
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`served through adjudication in New Jersey, as a stay will avoid the obvious risk of inconsistent
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`rulings here. In summary, Sanofi maintains that this case should be stayed in view of (i) its
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`preference to proceed in its home state of New Jersey, (ii) the overlapping legal issues pending in
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`the Merck litigation in New Jersey, and (iii) to avoid the waste of judicial and party resources
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`from litigating both cases at the same time.
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`B.
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`Case Overview
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`By way of background, both cases involve Sanofi’s insulin glargine (rDNA origin) vial
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`and pen injectable drug products, which are prescribed and sold in the United States under the
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`trademarks Lantus® and Lantus® SoloSTAR®, respectively. Both products are indicated for the
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`treatment of adults with type 2 diabetes and adults and pediatric patients (children 6 years and
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`older) with type 1 diabetes for the control of high blood sugar. Sanofi alleges in both cases that
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`Defendants have infringed one or more claims of U.S. Patent Nos. 7,476,652, 7,713,930,
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`7,918,833, 8,512,297, 8,556,864, 8,603,044, 8,679,069, 8,992,486, 9,011,391, 9,233,211,
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`9,408,979, 9,526,844, 9,533,105, 9,561,331, 9,604,008, 9,604,009, 9,610,409, and 9,623,189
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`(collectively the “patents-in-suit”) by submitting Section 505(b)(2) New Drug Application No.
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`210605 to market follow-on versions of Sanofi’s Lantus® vial product and Lantus® SoloSTAR®
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`pen injectable drug product prior to the expiration of the patents-in-suit. The “FDA mandated
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`30-month stay” in this action expires on March 18, 2020.
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`Sanofi seeks entry of judgment in both cases, holding that Mylan has infringed the
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`patents-in-suit, and among other things, the entry of an order pursuant to 35 U.S.C. 271(e)(4)(A),
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`declaring that the effective date of any approval of Mylan’s NDA No. 210605 shall be a date that
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`is not earlier than the last date of the expiration of any of the patents-in-suit or any additional
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`period of exclusivity to which Plaintiffs and/or the patents-in-suit are, or become, entitled.
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`3
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`Sanofi Exhibit 2020.003
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 4 of 14 PageID #: 1434
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`C. Motion to Stay
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`Sanofi filed this second action because Sanofi had correctly anticipated that Mylan would
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`move to dismiss the New Jersey Action based on venue grounds.2 In particular, because FDA
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`regulations provide that the aforementioned 30-month stay is lost if the corresponding patent
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`action is dismissed, in the event that Mylan’s motion to dismiss is successful, the 30-month stay
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`would otherwise be lifted absent the existence of this second-filed case. See 21 C.F.R. § 314.107
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`(2016). Second-filed “protective” suits like this action are thus common in Hatch-Waxman
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`litigation, particularly against Mylan. Stays of second-filed suits are likewise common in suits
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`against Mylan in this District. See, e.g., D.I. 42 at 4 n. 2 (listing stayed cases involving Mylan).
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`But Mylan has opposed a stay, contending that the New Jersey Court will not resolve the
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`litigation within the 30-month stay period (expiring no later than March 18, 2020). As explained
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`in Sanofi’s reply brief, however, the New Jersey Court is well-equipped to adjudicate the case in
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`the timeframe of the 30-month stay, and the New Jersey Action has already progressed further
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`than this case. Indeed, as mentioned above, at the Rule 16 conference in the New Jersey Action,
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`the magistrate judge emphasized the District’s extensive experience with Hatch-Waxman cases
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`and the importance of the date of expiration of the 30-month stay. Mylan cites statistics
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`concerning the average time to trial in New Jersey and West Virginia, but those are for all civil
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`cases, not Hatch-Waxman cases subject to the 30-month stay. Indeed, Judge Chesler—the
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`presiding Judge over the New Jersey Action—has presided over fifty Hatch-Waxman cases and
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`has been instrumental in the development of rules to timely adjudicate Hatch-Waxman cases
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`within the 30-month stay time period.
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`2 Plaintiffs dispute the issues presented in Defendants’ motion to dismiss and believe that venue
`in New Jersey is proper and that Defendants’ motion should be denied in full.
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`4
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`Sanofi Exhibit 2020.004
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 5 of 14 PageID #: 1435
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`Mylan also opposes the stay because Mylan believes it will be prejudiced if it does not
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`obtain final FDA approval prior to March 23, 2020, which is the “transition date” on which the
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`FDA will begin to apply new approval procedures for insulin glargine drug products.3 But as
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`Sanofi explained in its reply, the 30-month stay expires no later than March 18, 2020, in advance
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`of the “transition date,” so this patent litigation will thus not preclude FDA final approval prior
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`to the transition date. Indeed, nothing prevents Mylan from working with the FDA now (while
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`the stay is pending) on any regulatory issues to ensure timely final approval of its application
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`prior to the transition date. Assuming that Mylan is diligent in doing so, as of the expiration of
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`the stay (prior to the transition date), there will be no patent barriers to FDA approval. In short,
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`there are regulatory steps that Mylan can and should take while the stay is pending to ensure
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`timely approval of its NDA irrespective of this lawsuit or any patent barriers.
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`D.
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`Related Litigation
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`Sanofi further advises the Court that claim terms of certain of the patents-in-suit have
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`been construed in two orders from Plaintiffs’ prior suit against Eli Lilly & Company in the
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`District of Delaware. See Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., No. 14-113-RGA-MPT,
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`2015 U.S. Dist. LEXIS 5946 (D. Del. Jan 20, 2015); id. at 2015 U.S. Dist. LEXIS 57877 (D. Del.
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`Apr. 27, 2015). Claim terms of certain of the patents-in-suit are also anticipated to be construed
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`in Plaintiffs’ current suit against Merck Sharp & Dohme Corp. (“Merck”) in the District of
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`Delaware where claim construction briefing has been completed and a Markman hearing was
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`conducted on November 6, 2017, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No.
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`16-812-RGA-MPT (D. Del.). And as mentioned above, Sanofi anticipates that claim terms will
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`be construed for two of the patents-in-suit in the Merck litigation pending in the District of New
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`3 The new procedures were established by the Biologics Price Competition and Innovation Act
`(“BPCIA”).
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`5
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`Sanofi Exhibit 2020.005
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 6 of 14 PageID #: 1436
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`Jersey. The parties agree to meet and confer regarding the applicability of prior constructions
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`but have not yet reach any agreements.
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`Finally, on December 13, 2017, the Patent Trial and Appeal Board (PTAB) issued
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`decisions to institute an inter partes review (“IPR”) under 37 C.F.R. § 42.108 of claims 1–25 of
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`the asserted ’652 Patent and claims 1–20 of the asserted ’930 Patent. The case numbers are
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`IPR2017-01526 and IPR2017-01528, and the PTAB’s final written decisions concerning the
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`validity of the claims are due on or before December 13, 2018.
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`Defendants’ Statement:
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`As set forth in detail in Defendants’ opposition to Sanofi’s motion to stay this action
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`(Dkt. No. 44), this case is unique and presents issues different from those in a typical Hatch-
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`Waxman case. The products at issue here are currently subject to approval under the Hatch-
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`Waxman Act. However, as of March 23, 2020, these products will be subject to approval under
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`the BPCIA. FDA has stated that any applications for these products pending as of March 23,
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`2020, will never be approved.
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`Sanofi attempts to minimize the unique timing constraints presented in this case by
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`suggesting that it is possible for Mylan GmbH to obtain final approval of its application in the
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`two business days between the expiry of the 30-month stay and the BPCIA transition date. That
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`hypothetical ignores the realities of FDA’s regulatory approval process and Hatch-Waxman
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`litigation. Approval of Mylan GmbH’s NDA is not automatic upon expiry of the 30-month stay
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`and will require further action by FDA within two business days.
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`Sanofi’s allegation that staying second-filed “protective suits” is common practice in
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`Hatch-Waxman litigations is wrong, particularly under the unique circumstances here. Although
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`nothing in the Hatch-Waxman Act requires or condones the filing of duplicative suits, Sanofi
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`6
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`Sanofi Exhibit 2020.006
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 7 of 14 PageID #: 1437
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`concedes that it intentionally initiated both this action and a related action in the District of New
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`Jersey. Sanofi’s complaint affirmatively alleges that this Court has competent jurisdiction to
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`preside over this matter. Thus, there is no reason to not proceed in this Court.
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`The pending Merck litigation in New Jersey referenced above by Sanofi is irrelevant.
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`The Merck New Jersey action shares no common defendants and involves only two of the
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`eighteen patents-in-suit in the present case. Venue is not an issue in the Merck New Jersey
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`action, and Merck has not moved to dismiss the complaint on any ground. The instant action
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`shares more common ground with the Merck Delaware action, which involves ten of the same
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`patents-in-suit. Given the gap in subject matter and issues, sharing the same judges with the
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`Merck New Jersey action would scarcely provide any benefit to judicial economy.
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`Although the New Jersey court held a Scheduling Conference on December 19, 2017,
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`that case is not well underway, as Sanofi states. Pleadings are not settled, and the parties are
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`briefing Defendants’ motion to dismiss. Also, in keeping with practice, the New Jersey court
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`declined to set a trial date. It is unlikely the New Jersey action will reach trial before the end of
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`the BPCIA’s transition period while this Court is likely to set trial well in advance of the
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`transition date. See Federal Court Management Statistics, June 2017 – District Courts, United
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`States Courts (June 30, 2017),4 (31.4 months in New Jersey compared to 19.1 months in this
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`Court per the most recently available statistics for each court).
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`Thus, there 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. Defendants’
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`proposed schedule is reasonable and in line with other similar matters proceeding in this Court.
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`4 http://www.uscourts.gov/sites/default/files/data_tables/fcms_na_distprofile0331.2017.pdf
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`7
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`Sanofi Exhibit 2020.007
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 8 of 14 PageID #: 1438
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`Accordingly, Defendants respectfully request the Court enter Defendants’ proposed schedule,
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`including a date certain for trial.
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`II.
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`INITIAL DISCLOSURES
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`Pursuant to the Court’s Order, the parties will exchange initial discovery disclosures on
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`or before January 10, 2017.
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`III. DISCOVERY PLAN
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`The parties jointly propose the following discovery plan.
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`A.
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`Discovery Subjects
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`Discovery will be needed on the following subjects:
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`1. Claims alleged in the Complaint (Dkt. No. 1) or any amended or supplemental
`pleading;
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`2. Defenses alleged in the First Amended Answer (Dkt. No. 43) or any amended or
`supplemental pleading; and
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`3. Claims alleged in the First Amended Counterclaims (Dkt. No. 43) or any
`amended or supplemental pleading.
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`4. Sanofi’s answer to Mylan GmbH’s Counterclaims (Dkt. No. 59) or any amended
`or supplemental pleading.
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`B.
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`Discovery Confidentiality and Electronically Stored Information
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`The parties anticipate exchanging highly sensitive information in this action, including,
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`inter alia, confidential research, development, business, and financial information relevant to the
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`parties’ claims and defenses. To protect such sensitive information, the parties seek to enter a
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`protective order. The parties will jointly prepare and submit a proposed protective order for this
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`Court’s consideration. Further, because the parties anticipate exchanging electronically stored
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`information (“ESI”), the parties will also jointly prepare for this Court’s consideration a
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`proposed stipulated ESI agreement. Pending entry of a protective order and stipulated ESI
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`8
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`Sanofi Exhibit 2020.008
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 9 of 14 PageID #: 1439
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`agreement, discovery and disclosures deemed confidential by a party shall be produced to the
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`adverse party on an “Outside Counsel Eyes Only” basis.
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`C.
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`Discovery Timing
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`Sanofi’s position is that a schedule is not necessary while Sanofi’s motion to stay is
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`pending. If the court denies Sanofi’s motion to stay, then Sanofi’s position on the proposed
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`deadlines is set forth in Exhibit A. Sanofi’s proposed dates in Exhibit A are consistent with
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`those already entered in the New Jersey Action, but Defendants have not agreed here to several
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`of the deadlines that have already been ordered in New Jersey. These include dates for
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`exchanging contentions, dates for completing fact and expert discovery relating to claim
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`construction, and dates for amending pleadings. Sanofi submits that in the event the New Jersey
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`Action is dismissed and this case proceeds, the most efficient course of action is to continue to
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`proceed on the agreed dates, including for deadlines that were entered based on the New Jersey
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`local patent rules. Such deadlines will enable the parties to develop their respective positions
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`and disclose information critical to patent cases on a timely basis.
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`Mylan contends below that “Sanofi has declined to agree to expedite the New Jersey
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`Action,” but to the contrary, Sanofi has proposed a schedule that will allow for final resolution of
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`Sanofi’s complaint well within the 30-month timeframe. For example, it was Sanofi (not Mylan)
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`who proposed an expedited Markman schedule so that claim construction can be coordinated
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`with the Merck action also pending in New Jersey. Mylan has not requested that Sanofi
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`“expedite” the New Jersey Action, other than by proposing unrealistic deadlines that depend on
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`the Court issuing a Markman ruling just 10 months from now and within 30 days of a Markman
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`hearing that has not even been scheduled.
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`Defendants have also deviated in many additional respects from the New Jersey schedule
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`by, for example, proposing inconsistent dates for the completion of document production and
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`9
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`Sanofi Exhibit 2020.009
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 10 of 14 PageID #: 1440
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`discovery. Sanofi proposed that the parties agree to the same deadlines that were set in New
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`Jersey for these events, but Defendants did not agree.
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`Defendants’ position is as follows: Defendants’ proposed deadlines for discovery are set
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`forth in Exhibit A. Any benefit to the parties of coordination of the schedules does not justify
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`holding hostage the timely resolution of this case. This is particularly true as Sanofi has declined
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`to agree to expedite the New Jersey Action, and the New Jersey court has declined to set a trial
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`date. Defendants maintain their original proposals because those dates allow this case to proceed
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`to trial in the second quarter of 2019. Defendants will use good faith in cooperating in discovery
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`but Sanofi has provided no reason why the parties are required to comply with the local patent
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`rules of the District of New Jersey, including adhering to the reverse order of disclosure of
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`contentions and the requirement that those contentions be considered final.
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`D.
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`Interrogatories
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`Sanofi shall be permitted to serve twenty-five (25) interrogatories directed towards all
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`Defendants. Defendants collectively shall be permitted to serve twenty-five (25) interrogatories
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`directed towards Sanofi.
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`E.
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`Requests for Admission
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`Sanofi shall be limited to one hundred (100) requests for admission directed towards all
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`Defendants. Defendants collectively shall be limited to one hundred (100) requests for
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`admission directed towards Sanofi. These limitations do not apply to any requests for admission
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`for the purpose of authentication or for establishing that a document is a business record or a
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`learned treatise.
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`F.
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`Depositions of Fact Witnesses
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`Sanofi is permitted a maximum of seventy-five (75) hours of deposition time on the
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`record directed towards all Defendants and any third parties. Defendants collectively are
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`10
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`Sanofi Exhibit 2020.010
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 11 of 14 PageID #: 1441
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`permitted a maximum of seventy-five (75) hours of deposition time on the record directed
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`towards Sanofi and any third parties. These time limits include 30(b)(6) depositions. For any
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`depositions requiring interpreters, interpreter speaking time shall not count toward the individual
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`or total time limit.
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`G.
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`Expert Discovery
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`As stated previously, Sanofi’s position is that a schedule is not necessary while its motion
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`to stay is pending. If the Court is inclined to enter a schedule, the parties’ proposed schedule in
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`Exhibit A includes dates for expert discovery pursuant to Fed. R. Civ. P. 26(a)(2) and Fed. R.
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`Evid. 702 and 703. For the avoidance of doubt, any purported objective indicia of
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`nonobviousness will be addressed in Plaintiffs’ rebuttal expert report(s) and Defendants’ reply
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`expert report(s).
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`H.
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`Rule 26(e) Supplementation
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`The parties have an ongoing duty to make supplemental disclosures pursuant to Fed. R.
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`Civ. P. 26(e), but in any event shall make such disclosures no later than the close of discovery.
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`IV. OTHER ITEMS
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`A. Pursuant to the Court’s Order, a scheduling conference is set for January 3, 2018.
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`B. The parties’ proposed schedule includes dates to join additional parties and to
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`amend pleadings.
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`C. Defendants’ proposed schedule includes a date for filing dispositive motions
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`pursuant to Fed. R. Civ. P. 56. There are 18 patents-in-suit, and Defendants
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`believe that dispositive motions will allow the Court to streamline the issues for
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`trial. Sanofi does not believe that the instant suit is amenable to summary
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`disposition. Since this is a bench trial, Sanofi respectfully submits that any issues
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`raised at the summary disposition phase will be more efficiently resolved after the
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`11
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`Sanofi Exhibit 2020.011
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 12 of 14 PageID #: 1442
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`parties present their evidence and arguments during trial. Accordingly, Sanofi
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`does not agree that deadlines for dispositive motions are appropriate, and Sanofi
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`has therefore not proposed any such dates in the proposed schedule.
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`D. There have not been settlement discussions to date.
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`E. The parties’ proposed schedule includes a date for pretrial submissions and a
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`proposed date for the final pretrial conference.
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`F. Defendants’ proposed schedule includes a proposed date for a bench trial.
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`Defendants submit that in view of the unique issues in this case relating to
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`regulatory approval and the BPCIA, the timeline in this case is more urgent than
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`in a typical Hatch-Waxman case. Thus, Defendants request that trial occur at the
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`Court’s convenience on a date certain in the Second Quarter of 2019 to allow the
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`Court sufficient time to issue a decision prior to the expiration of the stay in this
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`matter. Specifically, Defendants request a trial date in late April 2019 or at the
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`Court’s earliest convenience thereafter to allow sufficient time for post-trial
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`briefing and a decision without exposing the Court and the parties to the
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`possibility of a preliminary injunction motion. Plaintiffs request that the Court set
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`a conditional trial date in November or December 2019, subject to the Court’s
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`availability. This trial date will be three to four months in advance of the
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`expiration of the 30-month stay, which Plaintiffs respectfully submit is more than
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`adequate to accommodate any post-trial briefing and a final decision.
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`Defendants’ proposed trial date presumes that the Court will be available to hold a
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`Markman hearing on the date indicated in Exhibit A, and that the Court will issue
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`a Markman ruling within 30 days thereafter. Indeed, each of Defendants’
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`12
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`Sanofi Exhibit 2020.012
`Mylan v. Sanofi
`IPR2018-01675
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`

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`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 13 of 14 PageID #: 1443
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`proposed dates depends upon that narrow turn-around time for the Court’s
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`availability and Markman decision. In contrast, Plaintiffs’ proposed schedule
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`provides ample time for the Court to issue a Markman ruling, while still allowing
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`for final resolution of Sanofi’s complaint well within the 30-month timeframe.
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`G. The parties make additional LR Civ. P. 16.01 disclosures as directed by the
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`Court’s Order:
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`a. The parties agree that at this time this case should not be designated as
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`complex pursuant to LR Civ. P. 16.01(b)(1).
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`b. The parties will continue to discuss whether they can agree upon the
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`disputed facts that have been alleged in the pleadings.
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`c. The parties do not consent to trial by a magistrate judge.
`
`d. The parties believe alternative dispute resolution processes would be
`
`premature at this time.
`
`e. Agenda for the January 3, 2018 scheduling conference: The parties wish to
`
`discuss (i) the status of the New Jersey Action, (ii) Sanofi’s motion to stay
`
`these proceedings, and (iii) the schedule and trial date in this action.
`
`13
`
`Sanofi Exhibit 2020.013
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 1:17-cv-00181-IMK Document 61 Filed 12/22/17 Page 14 of 14 PageID #: 1444
`
`
`
`
`Respectfully Submitted,
`
`By: /s/Chad L. Taylor
`Frank E. Simmerman, Jr. (WVSB# 3403)
`Chad L. Taylor (WVSB# 10564)
`SIMMERMAN LAW OFFICE, PLLC
`254 East Main Street
`Clarksburg, WV 26301-2170
`Phone: (304) 623-4900
`Fax: (304) 623-4906
`fes@simmermanlaw.com
`clt@simmermanlaw.com
`trey@simmermanlaw.com
`
`OF COUNSEL:
`WEIL, GOTSHAL & MANGES LLP
`Elisabeth S. Weiswasser
`Anish Desai
`Aaron Pereira
`767 Fifth Avenue
`New York, NY 10153
`(212) 310-8000
`anish.desai@weil.com
`aaron.pereira@weil.com
`
`Robert T. Vlasis III
`Christopher Pepe
`1300 Eye Street NW, Suite 900
`Washington, DC 20005-3314
`(202) 682-7000
`robert.vlasis@weil.com
`christopher.pepe@weil.com
`
`Audrey L. Maness
`700 Louisiana, Suite 1700
`Houston, TX 77002-2755
`(713) 546-5000
`audrey.maness@weil.com
`
`Attorneys for Plaintiffs
`Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH,
`and Sanofi Winthrop Industrie
`
`
`
`Dated: December 22, 2017
`
`By: /s/Jeffrey A. Kimble
`Jeffrey A. Kimble
`(W. Va. State Bar No. 4928)
`E. Ryan Kennedy
`(W. Va. State Bar No. 10154)
`ROBINSON & MCELWEE PLLC
`140 W. Main Street, Suite 300
`Clarksburg, West Virginia 26301
`(304) 622-5022
`jak@ramlaw.com
`erk@ramlaw.com
`
`OF COUNSEL:
`Douglas H. Carsten (pro hac vice)
`Elham Firouzi Steiner (pro hac vice)
`Nathaniel R. Scharn (pro hac vice)
`Alina L. Litoshyk (pro hac vice)
`WILSON SONSINI GOODRICH & ROSATI P.C.
`12235 El Camino Real
`San Diego, CA 92130
`Tel: 858.350.2300
`dcarsten@wsgr.com
`esteiner@wsgr.com
`nscharn@wsgr.com
`alitoshyk@wsgr.com
`
`Attorneys for Defendants Mylan N.V., Mylan
`GmbH, Mylan Inc., and Mylan
`Pharmaceuticals Inc.
`
`14
`
`Sanofi Exhibit 2020.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 1:17-cv-00181-IMK Document 61-1 Filed 12/22/17 Page 1 of 3 PageID #: 1445
`
`
`
`
`EXHIBIT A
`
`Event
`Parties exchange Rule 26(a)(1) disclosures
`
`Defendants’ Date
`Plaintiffs’ Date
`January 10, 2018
`
`Sanofi to produce file histories of patents-in-suit
`and disclosure of asserted claims
`
`Defendants to serve Initial Invalidity Contentions
`and Noninfringement Contentions
`
`Sanofi to produce Initial Claim Chart relating
`each accused product to the asserted claim(s)
`
`Parties submit proposed protective order and
`stipulated ESI agreement to the Court
`
`January 10, 2018
`
`January 18, 2018
`
`N/A
`
`N/A
`
`January 18, 2018
`
`January 24, 2018
`
`Defendants to serve Initial Invalidity Contentions
`
`N/A
`
`February 22, 2018
`
`Plaintiffs to serve Initial Disclosure of
`Infringement Contentions and Responses to
`Invalidity Contentions
`
`Parties exchange claim terms for construction
`
`Parties exchange proposed claim constructions
`and support therefor
`
`Parties exchange lists of intrinsic and extrinsic
`evidence that each party will use to oppose the
`other party’s constructions
`
`March 5, 2018
`
`N/A
`
`March 13, 2018
`
`March 27, 2018
`
`April 10, 2018
`
`Meet & confer to limit claim construction terms
`
`April 13, 2018
`
`Motions to join other parties, and to amend or
`supplement the pleadings, without leave
`
`All motions to join other parties, and to amend or
`supplement the pleadings
`
`June 29, 2018
`
`N/A
`
`December 1, 20181
`
`May 15, 2018
`
`Substantial completion of document production
`
`September 27, 20182
`
`June 1, 2018
`
`Completion of fact discovery relating to claim
`construction, including depositions of nonexpert
`witnesses identified prior to claim construction
`
`Parties file and serve opening Markman briefs
`and supporting evidence
`
`May 22, 2018
`
`N/A
`
`June 5, 2018
`
`
`1 Sanofi originally proposed December 1, 2018 for this deadline, and the New Jersey Court has
`set the deadline for August 13, 2018. Sanofi has proposed that the parties likewise agree to
`August 13 here.
`2 The New Jersey Court has set this deadline for August 1, 2018, Sanofi has requested that
`Mylan agree to August 1 here too.
`
`
`
`
`Sanofi Exhibit 2020.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 1:17-cv-00181-IMK Document 61-1 Filed 12/22/17 Page 2 of 3 PageID #: 1446
`
`
`
`
`Event
`Completion of Expert Discovery Relating to
`Opening Markman submissions
`
`Plaintiffs’ Date
`July 10, 2018
`
`Defendants’ Date
`N/A
`
`Parties file and serve responding Markman briefs
`and supporting evidence
`
`August 2, 2018
`
`Parties propose a schedule for Markman hearing
`
`August 10, 2018
`
`Close of fact discovery
`
`Markman hearing
`
`February 11, 20193
`
`August 31, 2018
`
`Week of September
`10, 2018 (subject to
`the Court’s
`availability)4
`
`Week of September
`3, 2018 (subject to
`the Court’s
`availability)
`
`Opening expert reports due on those issues for
`which the parties bear the burden of proof
`
`Rebuttal expert reports due, including any
`secondary considerations of nonobviousness
`
`Reply expert reports due
`
`Close of expert discovery
`
`30 days after the
`issuance of a claim
`construction order
`
`60 days after the
`issuance of a claim
`construction order
`
`90 days after the
`issuance of a claim
`construction order
`
`120 days after the
`issuance of a claim
`construction order
`
`Deadline to file dispositive motions
`
`Dispositive motion opposition briefs due
`
`Dispositive motion reply briefs due
`
`Hearing on dispositive motions (if requested by
`the Court)
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`October 11, 2018
`
`November 29, 2018
`
`December 20, 2018
`
`January 31, 2019
`
`February 13, 2019
`
`March 6, 2019
`
`March 19, 2019
`
`April 2019 (subject
`to the Court’s
`direction and
`availability)
`
`Parties submit Final Pretrial Order to the Court
`
`One week before pretrial conference (LR
`16.04(b))
`
`
`3 The New Jersey Court has set this deadline for December 7, 2018. Sanofi has requested that
`Mylan agree to December 7 here too.
`4 Sanofi submits that Defendants agreed to this date in the New Jersey Action but have proposed
`an inconsistent date here. Defendants agreed to this date in the New Jersey Action to conserve
`the Court’s resources as that is the proposed date in the Merck New Jersey Action. To the extent
`Defendants’ motion to dismiss the New Jersey Action is granted, Sanofi cannot maintain the
`same date in both Courts.
`
`2
`
`Sanofi Exhibit 2020.016
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 1:17-cv-00181-IMK Document 61-1 Filed 12/22/17 Page 3 of 3 PageID #: 1447
`
`
`
`
`Event
`Final pretrial conference
`
`Bench trial
`
`Plaintiffs’ Date
`October 2019,
`subject to Court’s
`availability
`
`November or
`December 2019,
`subject to Court’s
`availability
`
`Defendants’ Da