UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Civ. No. 2:17-09105 (SRC-CLW)
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`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH, and
`SANOFI WINTHROP INDUSTRIE,
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` Plaintiffs,
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`v.
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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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`JOINT PROPOSED DISCOVERY PLAN
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`Pursuant to Federal Rule of Civil Procedure 26(f), Local Civil Rule 26.1(b), and this
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`Court’s Order dated November 14, 2017 (ECF No. 13), Plaintiffs Sanofi-Aventis U.S. LLC,
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`Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie (collectively, “Plaintiffs” or
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`“Sanofi”) and Defendants Mylan N.V., Mylan GmbH, Mylan Inc., and Mylan Pharmaceuticals
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`Inc. (collectively, “Defendants”)1, by their undersigned attorneys, present the following Joint
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`Discovery Plan to the Court.
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`1.
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`Set forth the name of each attorney appearing, the firm name, address and telephone
`number and facsimile number of each, designating the party represented.
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`For Plaintiffs:
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`Liza M. Walsh, Esq.
`Christine I. Gannon, Esq.
`Katelyn O’Reilly, Esq.
`WALSH PIZZI O’REILLY FALANGA LLP
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`1 In compliance with the Court-ordered schedule, Defendants intend to participate in the Rule 16
`Conference subject to and without waiver of their pending motion to dismiss for improper venue
`and lack of subject matter jurisdiction. Plaintiffs dispute the issues presented in Defendants’
`motion to dismiss and believe that venue in this Court is proper and that Defendants’ motion
`should be denied in full, as will be set forth in Sanofi’s forthcoming opposition brief.
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`Sanofi Exhibit 2020.001
`Mylan v. Sanofi
`IPR2018-01676
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`

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`One Riverfront Plaza
`1037 Raymond Blvd., Suite 600
`Newark, NJ 07102
`(973) 757-1100
`lwalsh@walsh.law
`cgannon@walsh.law
`koreilly@walsh.law
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`Of Counsel for Plaintiffs:
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`WEIL, GOTSHAL AND MANGES LLP
`Elizabeth S. Weiswasser
`Anish Desai
`Aaron Pereira
`Priyata Patel
`767 Fifth Avenue
`New York, New York 10153
`(212) 310-8000
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`aaron.pereira@weil.com
`priyata.patel@weil.com
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`Robert T. Vlasis III
`Christopher Pepe
`Matthew Sieger
`2001 M Street NW, Suite 600
`Washington, DC 20036
`(202) 682-7000
`robert.vlasis@weil.com
`christopher.pepe@weil.com
`matthew.sieger@weil.com
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`Audrey L. Maness
`700 Louisiana, Suite 1700
`Houston, TX 77002-2755
`(713) 546-5000
`audrey.maness@weil.com
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`For Defendants:
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`SAIBER LLC
`Arnold B. Calmann
`Jeffrey S. Soos
`Katherine Ann Escanlar
`One Gateway Center
`10th Floor
`Newark, NJ 07102-5311
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`2
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`Sanofi Exhibit 2020.002
`Mylan v. Sanofi
`IPR2018-01676
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`2.
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`(973) 622-3349
`abc@saiber.com
`js@saiber.com
`kae@saiber.com
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`Of Counsel for Defendants:
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`WILSON SONSINI GOODRICH & ROSATI P.C.
`Douglas H. Carsten
`Elham Firouzi Steiner
`Nathaniel R. Scharn
`Alina L. Litoshyk
`12235 El Camino Real
`San Diego, CA 92130
`(858) 350-2300
`dcarsten@wsgr.com
`esteiner@wsgr.com
`nscharn@wsgr.com
`alitoshyk@wsgr.com
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`Set forth a brief description of the case, including the causes of action and
`affirmative defenses asserted.
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`Sanofi’s Response:
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`This is a Hatch-Waxman action involving 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 that Defendants
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`have infringed one or more claims of U.S. Patent Nos. 7,476,652, 7,713,930, 7,918,833,
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`8,512,297, 8,556,864, 8,603,044, 8,679,069, 8,992,486, 9,011,391, 9,233,211, 9,408,979,
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`9,526,844, 9,533,105, 9,561,331, 9,604,008, 9,604,009, 9,610,409, and 9,623,189 (collectively
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`the “patents-in-suit”) by submitting Section 505(b)(2) New Drug Application No. 210605 to
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`market follow-on versions of Sanofi’s Lantus® vial product and Lantus® SoloSTAR® pen
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`3
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`Sanofi Exhibit 2020.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`injectable drug product prior to the expiration of the patents-in-suit. The “FDA mandated 30-
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`month stay” in this action expires on March 18, 2020.
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`Sanofi seeks entry of judgment holding that Mylan has infringed the patents-in-suit, and
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`among other things, the entry of an order pursuant to 35 U.S.C. 271(e)(4)(A), declaring that the
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`effective date of any approval of Mylan’s NDA No. 210605 shall be a date that is not earlier than
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`the last date of the expiration of any of the patents-in-suit or any additional period of exclusivity
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`to which Plaintiffs and/or the patents-in-suit are, or become, entitled.
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`Mylan has filed a motion to dismiss Sanofi’s complaint for alleged improper venue, lack
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`of subject matter jurisdiction, and failure to state a claim against the three Mylan entities that are
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`not identified on Mylan’s Notice Letter (Mylan NV, Mylan Inc., and Mylan Pharmaceuticals
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`Inc.) leaving only Mylan GmbH, which Mylan agrees is a proper defendant (but contests venue
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`for this entity).
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`Sanofi maintains that venue is proper and that each of the named Mylan entities is a
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`proper defendant in this case. Notwithstanding Sanofi’s position, in an effort to avoid undue
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`motion practice and continue to move this case forward on the merits, Sanofi proposed a
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`stipulation that would dismiss the non-Mylan GmbH entities in exchange for Mylan withdrawing
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`its Motion to Dismiss and consenting to venue in New Jersey as to the Mylan GmbH entity.
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`Sanofi’s proposed stipulation would also require that the terminated Mylan entities cooperate in
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`discovery and be bound by any relief issued by this Court as if they were named defendants.
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`There would be no dispute as to proper defendants or subject matter jurisdiction of Sanofi’s
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`declaratory judgment claims, as the stipulation proposed by Sanofi would obviate those issues.
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`Sanofi’s proposed stipulation would thus serve to quickly resolve Mylan’s motion and thereby
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`expedite these proceedings. Mylan never responded to Sanofi’s proposed stipulation.
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`4
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`Sanofi Exhibit 2020.004
`Mylan v. Sanofi
`IPR2018-01676
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`

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`Separately, in an effort to resolve the factual disputes presented in Mylan’s Motion,
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`Sanofi requested that Mylan consent to limited, expedited discovery on the issues raised therein
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`while proceeding with discovery on the merits of the case in parallel, but Mylan refused to
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`provide any such discovery. Accordingly, in Sanofi’s response to Mylan’s motion to dismiss,
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`Sanofi intends to request this limited discovery in the event that the Court does not deny Mylan’s
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`motion outright. Permitting limited discovery is common practice in venue disputes post TC-
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`Heartland, and Sanofi’s requests will be narrowly tailored and specifically targeted at the factual
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`issues raised by Mylan in its motion and declaration, namely, (i) Mylan’s presence in New
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`Jersey, (ii) the interconnectedness of the Mylan entities, and (iii) the proper defendants in this
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`case. Sanofi’s request will thus help the Court resolve the issues in dispute.
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`Sanofi has also commenced a second-filed “protective” suit against the same Mylan
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`entities asserting the same patents and causes of action in the United States District Court for the
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`Northern District of West Virginia. Sanofi-Aventis U.S. LLC, et al. v. Mylan N.V., et al., No.
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`1:17-cv-00181 (N.D.W. Va.) (“West Virginia Action”). Sanofi filed the West Virginia Action
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`because Sanofi had correctly anticipated that Mylan would move to dismiss this New Jersey
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`action based on venue grounds. In particular, because FDA regulations provide that the
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`aforementioned 30-month stay is lost if the corresponding patent action is dismissed, in the event
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`that Mylan’s motion to dismiss is successful, the 30-month stay would otherwise be lifted absent
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`the existence of the second-filed West Virginia Action. See 21 C.F.R. § 314.107 (2016). Second-
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`filed “protective” suits like the West Virginia Action are thus common in Hatch-Waxman
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`litigation particularly again Mylan.
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`Sanofi has moved to stay the West Virginia Action to avoid duplicative parallel litigation,
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`and Mylan has opposed a stay, arguing this Court will not resolve the litigation within the 30-
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`month stay period (expiring no later than March 18, 2020). See Exhibit B, Mylan Opp. to Mtn. to
`5
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`Sanofi Exhibit 2020.005
`Mylan v. Sanofi
`IPR2018-01676
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`

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`Stay at 10-11, 13 (“[T]here is no reason to believe that the New Jersey case is likely to move
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`forward much beyond the pleading stage any time soon. . . . New Jersey has a longer median
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`time from filing to trial . . . . [T]he New Jersey action is an uncertain and moving target. . . .
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`[T]he New Jersey action is virtually stagnant and likely to continue to lag behind this Court. . . .
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`[S]haring the same judges with the Merck New Jersey Action would scarcely provide any benefit
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`to judicial economy.”). Mylan also opposes the stay because Mylan believes it will be prejudiced
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`if it does not obtain final FDA approval prior to March 23, 2020, which is the “transition date”
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`on which the FDA will begin to apply new approval procedures for insulin glargine drug
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`products.2 Id. Sanofi’s reply explains that this Court is well-equipped to adjudicate this case in
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`the timeframe of the 30-month stay and that this case has already progressed further than the
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`West Virginia Action. Sanofi further explained that the 30-month stay expires no later than
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`March 18, 2020, in advance of the “transition date,” and that this patent litigation will thus not
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`preclude FDA final approval prior to the transition date. Nothing prevents Mylan from working
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`with the FDA now (while the stay is pending) on any regulatory issues to ensure timely final
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`approval of its application prior to the transition date. Assuming that Mylan is diligent in doing
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`so, as of the expiration of the stay (prior to the transition date), there will be no patent barriers to
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`FDA approval. In short, there are regulatory steps that Mylan can and should take while the stay
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`is pending to ensure timely approval of its NDA irrespective of this lawsuit or any patent
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`barriers.
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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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`2 The new procedures were established by the Biologics Price Competition and Innovation Act
`(“BPCIA”).
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`6
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`Sanofi Exhibit 2020.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

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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’ Response:
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`Defendants assert that venue in this District is improper, as set forth in detail in
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`Defendants’ motion to dismiss (ECF Nos. 10-11). It is undisputed that no Defendant resides in
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`New Jersey. Additionally, the sole act of infringement—Mylan GmbH’s NDA submission—did
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`not occur here, and Defendants have no regular and established place of business in this District.
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`Plaintiffs’ proposed stipulation of dismissal suggests that Plaintiffs understand that Mylan
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`GmbH, the applicant, is the only proper and relevant defendant here (as also detailed in
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`Defendants’ motion). However, Plaintiffs have conditioned their proposal on Defendants’
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`agreement to forego their venue challenge. The two issues are unrelated. Plaintiffs’ proposal
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`would not “quickly resolve” Defendants’ motion, as Plaintiffs suggest. Rather, it would lead to
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`the action proceeding in the improper venue, which Defendants cannot reasonably agree to.
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`Plaintiffs also intend to delay resolution of Defendants’ venue challenge by requesting
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`suspension of briefing on Defendants’ motion to pursue unnecessary, burdensome, and irrelevant
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`discovery purportedly relating to venue. For example, Plaintiffs’ so-called “narrowly tailored”
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`proposed discovery is in fact not narrowly-tailored at all in view of the legal issue to be decided
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`and the factors required to consider it. Plaintiffs’ proposed discovery includes depositions and
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`written discovery pertaining to: (1) the list of directors and officers at each Mylan entity; (2)
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`Apicore (a non-Defendant with no connection to the NDA or this case); (3) New Jersey leases
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`and terminations; (4) what Plaintiffs’ mistakenly purport to be “Mylan’s” New Jersey clinical
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`trials; (4) individuals who participated in meetings related to the decision to pursue an insulin
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`glargine product and any meeting notes; (5) agreements between Defendants and third parties
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`relating to the proposed products; and (6) documents related to any agreements that may exist.
`7
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`Sanofi Exhibit 2020.007
`Mylan v. Sanofi
`IPR2018-01676
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`

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`Plaintiffs have failed to provide any basis whatsoever for how or why how the proposed
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`discovery is relevant to Defendants’ motion in light of TC Heartland LLC v. Kraft Foods Grp.
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`Brands LLC, 137 S. Ct. 1514 (2017) and In re Cray, 871 F.3d 1355 (Fed. Cir. 2017). Contrary
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`to Plaintiffs’ assertion, discovery is not common practice in venue disputes after the above
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`rulings, particularly where, like here, a party has provided a detailed declaration to support its
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`assertion that venue is improper due to no infringing act taking place in the district and the lack
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`of any regular and established place of business in the district.
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`With respect to the case schedule, this case is unique and presents issues different from
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`those in a typical Hatch-Waxman case. The products at issue here are currently subject to
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`approval under the Hatch-Waxman Act. However, as of March 23, 2020, these products will be
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`subject to approval under the BPCIA. FDA has stated that any applications for these products
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`pending as of March 23, 2020, will never be approved. Plaintiffs attempt to minimize the unique
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`timing constraints presented in this case by suggesting that it is possible for Mylan GmbH to
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`obtain final approval of its application in the two business days between the expiry of the 30-
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`month stay and the BPCIA transition date. That hypothetical ignores the realities of FDA’s
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`regulatory approval process and Hatch-Waxman litigation. Approval as Mylan GmbH’s NDA is
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`not automatic upon expiry of the 30-month stay and will require further action by FDA—action
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`that is unlikely to happen in two business days. Thus, there is a heightened need to efficiently
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`litigate this case to allow the Court sufficient time to issue a decision prior to the expiration of
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`the stay in this matter. For this reason, Defendants respectfully request the Court to depart from
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`its typical practice and set a date certain for trial, or at least a trial ready date, that will remain on
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`calendar but for exceptional circumstances requiring its adjustment.
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`3.
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`No settlement discussions have taken place.
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`8
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`Sanofi Exhibit 2020.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`4.
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`5.
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`6.
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`The parties will exchange the information required by Fed. R. Civ. P. 26(a)(1) on
`December 19, 2017.
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`The parties do not anticipate any problems in connection with completing
`the disclosures required by Fed R. Civ. P. 26(a)(l).
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`A description of all discovery conducted by the parties to date:
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`Defendants have produced a copy of the 505(b)(2) New Drug Application pursuant to L.
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`Pat. R. 3.6(a).
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`7.
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`The parties met pursuant to Fed. R. Civ. P. 26(f) on November 28, 2017.
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`Participating in the conference were the following attorneys:
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`For Plaintiffs:
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`Liza M. Walsh
`Christine I. Gannon
`Katelyn O’Reilly
`WALSH PIZZI O’REILLY FALANGA LLP
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`Elizabeth S. Weiswasser
`Robert T. Vlasis III
`Audrey L. Maness
`Christopher Pepe
`Priyata Patel
`Matthew Sieger
`WEIL, GOTSHAL & MANGES LLP
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`For Defendants:
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`Elham Firouzi Steiner
`Nathaniel R. Scharn
`Alina L. Litoshyk
`WILSON SONSINI GOODRICH & ROSATI P.C.
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`Katherine Ann Escanlar
`SAIBER LLC
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`Proposed joint discovery plan:
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`(a)
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`Discovery is needed on the following subjects:
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`8.
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`9
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`Sanofi Exhibit 2020.009
`Mylan v. Sanofi
`IPR2018-01676
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`

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`The parties intend to take discovery concerning the subject matter of the claims set forth
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`in Plaintiffs’ Complaint, and the defenses and counterclaims Defendants may set forth (as
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`identified in Defendants’ answer and Mylan GmbH’s counterclaims in the West Virginia action)
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`should their motion to dismiss be denied and they are required to file an answer in this case.
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`Plaintiffs’ Response:
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`Plaintiffs expect to take discovery on the issues raised in the Complaint, Mylan’s Motion
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`to Dismiss and supporting declarations and exhibits filed November 13, 2017, and any
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`Counterclaims and Answers that Mylan may file, including, but not limited to, the following
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`topics: (a) Mylan’s decision to file its insulin glargine follow-on 505(b)(2) NDA; (b) Mylan’s
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`follow-on 505(b)(2) NDA and related Drug Master Files and correspondence with the FDA; (c)
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`Mylan’s proposed insulin glargine follow-on vial and pen products, including samples of
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`Mylan’s proposed follow-on vial and pen products; (d) all research and development related to
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`Mylan’s proposed insulin glargine follow-on vial and pen products; (e) all marketing plans
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`relating to Mylan’s proposed insulin glargine follow-on vial and pen products and uses of the
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`follow-on vial and pen products; (f) any contentions that Mylan may make that any claim of the
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`patents-in-suit is invalid, unenforceable, and/or not infringed by the commercial manufacture,
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`use, sale, offer for sale, or importation into the United States of Mylan’s proposed insulin
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`glargine follow-on vial and/or pen products; (g) information underlying or relating to the
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`allegations in Mylan’s Paragraph IV Notice letter regarding the patents-in-suit; (h) information
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`underlying or relating to any defenses and counterclaims that Mylan may raise; (i) information
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`underlying or relating to Mylan’s contention that venue is improper in the District of New Jersey;
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`(j) information underlying or relating to Mylan’s contention that Sanofi has failed to state a claim
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`for which relief may be granted against Mylan N.V., Mylan Inc., and Mylan Pharmaceuticals Inc.;
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`and (k) Mylan’s contention that the court lacks subject matter jurisdiction over Plaintiff’s
`10
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`Sanofi Exhibit 2020.010
`Mylan v. Sanofi
`IPR2018-01676
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`

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`infringement claims under § 271(a)-(c). On the November 28 Rule 26(f) conference, Mylan
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`represented that it did not know where its product samples are located, the identity of the
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`custodian(s) of such samples, the quantity of samples available for production, or when such
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`samples will be available for production. During the Rule 26(f) conference, Plaintiffs explained
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`that they foresee no issues with producing invention records or records relating to the date of
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`conception and reduction to practice for the patents-in-suit.
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`Defendants’ Response:
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`Defendants do not believe that discovery purportedly relating to their motion to dismiss
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`is necessary or relevant in view of recent decisions relating to venue, including TC Heartland
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`and In re Cray. Regarding the remainder of subjects identified above, without waiving any
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`objections to the production of information, Defendants trust that Plaintiffs will make good faith
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`efforts to ensure that any discovery sought by them is relevant, non-privileged, and proportional
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`to the needs of the case. At present, Defendants expect to require discovery on all issues raised
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`in the Complaint and in Defendants’ Answer and Counterclaims in the West Virginia action,
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`including at least the following topics: (a) the research and development of the Lantus® vial
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`product and Lantus® SoloSTAR® pen injectable drug product; (b) the conception and reduction
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`to practice of the claimed subject matter of the patents-in-suit; (c) the prosecution of the patents-
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`in-suit and any related applications, continuations, divisionals, issued patents, and any foreign
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`counterparts and/or equivalents; (f) research and development regarding NDA No. 21-081 and
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`any related IND applications; (g) Plaintiffs’ communications with FDA regarding NDA No. 21-
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`081 and any related IND applications; (h) any agreements by, among, or between Plaintiffs and a
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`third party relating to the Lantus® vial product and Lantus® SoloSTAR® pen injectable drug
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`product; (i) prior art to the patents-in-suit; (j) pleadings and discovery in litigation involving the
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`Lantus® vial product and Lantus® SoloSTAR® pen injectable drug product; (k) licensing of the
`11
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`Sanofi Exhibit 2020.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`patents-in-suit; (l) any alleged secondary indicia of nonobviousness; (m) any prior public use or
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`offer for sale of the claim inventions; and (n) any additional discovery that may be identified as
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`the case progresses.
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`During the parties’ Rule 26(f) conference, Defendants’ counsel told Plaintiffs that they
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`were investigating the status of samples of the proposed products. On the same conference,
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`Plaintiffs did not provide any information with respect to when they would produce invention
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`records or the date of conception and reduction to practice for the patents-in-suit.
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`(b) Whether discovery should be conducted in phases or limited to particular
`issues?
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`Plaintiffs’ Response:
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`Plaintiffs believe that the Court can deny Mylan’s Motion to Dismiss based on the
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`current record. But in the event the Court is inclined to grant Mylan’s Motion to Dismiss, prior
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`to any such ruling, Sanofi should be afforded the opportunity to conduct limited, expedited
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`discovery concerning the issues raised in Mylan’s Motion to Dismiss while proceeding with
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`discovery on the merits of the case in parallel. To date, Mylan has refused to agree to any
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`framework for providing any discovery to Sanofi on an expedited timeframe that would allow
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`Sanofi to review any such discovery in advance of the December 19 deadline for Sanofi to file
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`its opposition to Mylan’s Motion to Dismiss.
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`Mylan has not provided sufficient evidence to support the allegations contained in the
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`declaration that accompanies its motion to dismiss. To the contrary, the declaration is
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`inconsistent with both confidential and publicly available information, and other portions of the
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`declaration support Sanofi’s position that venue is proper in this District. The requested
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`discovery, if granted, will thus be highly relevant to Mylan’s allegations and has routinely been
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`granted in venue-related disputes post TC-Heartland.
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`12
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`Sanofi Exhibit 2020.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`Plaintiffs believe that all other discovery should be conducted together and during the
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`normal course as provided by the rules.
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`Defendants’ Response:
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`Defendants have moved to dismiss Plaintiffs’ Complaint for improper venue, lack of
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`subject matter jurisdiction, and/or failure to state a claim. Defendants’ motion is supported by a
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`detailed declaration from one of Defendants’ high-level employees. The facts set forth in the
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`sworn declaration contradict Plaintiffs’ unsupported allegations in their Complaint.
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`Notwithstanding that fact, Plaintiffs have indicated that they intend to seek discovery
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`purportedly related to Defendants’ motion. However, Plaintiffs have failed to articulate any
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`basis for why the broad-reaching discovery they have requested is relevant or necessary in view
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`of the governing legal precedents. The discovery Plaintiffs seek is a fishing expedition, which
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`will unduly burden Defendants, while in the end providing nothing to undermine the fact that
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`venue is improper here under Section 1400(b) in view of recent Supreme Court and Federal
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`Circuit decisions. Plaintiffs’ request should be denied at least because it will otherwise result in
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`a waste of the Court’s and the parties’ resources.
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`Claim Construction
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`(c)
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`Claim terms of certain of the patents-in-suit have been construed in two orders from
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`Plaintiffs’ prior suit against Eli Lilly & Company in the District of Delaware. See Sanofi-Aventis
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`U.S. LLC v. Eli Lilly & Co., No. 14-113-RGA-MPT, 2015 U.S. Dist. LEXIS 5946 (D. Del. Jan
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`20, 2015); id. at 2015 U.S. Dist. LEXIS 57877 (D. Del. Apr. 27, 2015). Claim terms of certain
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`of the patents-in-suit are also anticipated to be construed in Plaintiffs’ current suit against Merck
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`Sharp & Dohme Corp. (“Merck”) in the District of Delaware where claim construction briefing
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`has been completed and a Markman hearing was conducted on November 6, 2017, Sanofi-
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`Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-812-RGA-MPT (D. Del.). The
`13
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`Sanofi Exhibit 2020.013
`Mylan v. Sanofi
`IPR2018-01676
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`parties agree to meet and confer regarding the applicability of prior constructions but have not
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`yet reach any agreements.
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`Plaintiffs also commenced suit on August 8, 2017 in this Court against Merck, asserting
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`infringement of the ’652 and ’930 Patents, Sanofi-Aventis U.S. LLC, et al. v. Merck Sharp &
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`Dohme Corp., No. 2:17-cv-05914 (D.N.J.) and expect that claim terms will be construed in that
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`action as well. For the Court’s reference, the Scheduling Order from the Merck New Jersey
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`litigation is attached hereto as Exhibit C. A Markman hearing is currently scheduled in that case
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`for the week of September 10, 2018, subject to the Court’s availability. Should the Court be
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`inclined to consolidate the Markman hearing in the Merck action with that in the instant action,
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`the parties have proposed a schedule in Exhibit A that would enable the Court to hold a
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`consolidated hearing.
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`(d)
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`Exchange of Discovery, Deadlines to Amend, and Dispositive Motions
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`(1) Maximum number of interrogatories by each party to each other
`party:
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`Plaintiffs’ Response:
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`Sanofi originally proposed a limit of 25 interrogatories with the understanding that any
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`discovery concerning Mylan’s Motion to Dismiss would not count toward these limits. Mylan
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`rejected this proposal. Thus, in the event the Court grants Sanofi the opportunity to take discovery
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`on Mylan’s Motion to Dismiss, Sanofi proposes that a maximum of 35 interrogatories are
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`permitted for Sanofi directed towards all Defendants for both merits and Motion to Dismiss
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`related discovery, and a maximum of 35 interrogatories are permitted for Defendants collectively
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`directed towards Sanofi. Alternatively, in the event the Court adopts Mylan’s proposed limit of
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`25 interrogatories, Sanofi’s position is that any discovery requests concerning Mylan’s Motion to
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`Dismiss shall not count against this limit, subject to the proposals Sanofi described above. Sanofi
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`14
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`Sanofi Exhibit 2020.014
`Mylan v. Sanofi
`IPR2018-01676
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`submits that either approach is necessary so that Sanofi’s efforts to pursue discovery on the
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`Motion to Dismiss do not prejudice its ability to pursue discovery on the merits.
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`Defendants’ Response:
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`As originally agreed by the parties, a maximum of 25 interrogatories are permitted for
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`Sanofi directed towards all Defendants, and a maximum of 25 interrogatories are permitted for
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`Defendants collectively directed towards Sanofi. There is no reason to deviate from the default
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`number of interrogatories allowed pursuant to the Federal Rules of Civil Procedure.
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`(2) Maximum number of requests for admission by each party to each
`other party:
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`A maximum of 100 requests for admission are permitted for Sanofi directed towards all
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`Defendants, and a maximum of 100 requests for admission are permitted for Defendants
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`collectively directed towards Sanofi. These limitations do not apply to any requests for
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`admission for the purpose of authentication or for establishing that a document is a business
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`record or a learned treatise.
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`(3) Maximum number of depositions to be taken by each side:
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`Plaintiffs’ Response:
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`Sanofi originally proposed a limit of 75 hours of deposition time with the understanding
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`that any discovery concerning Mylan’s Motion to Dismiss would not count toward these limits.
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`Mylan rejected this proposal. Thus, in the event the Court grants Sanofi the opportunity to take
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`discovery on Mylan’s Motion to Dismiss, Sanofi proposes that a maximum of 85 hours of
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`deposition time is permitted for Sanofi directed towards all Defendants and any third parties for
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`both merits and Motion to Dismiss related discovery, and a maximum of 85 hours of deposition
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`time is permitted for Defendants collectively directed towards Sanofi and any third parties.
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`Alternatively, in the event the Court adopts Mylan’s proposed limit of 75 hours of deposition
`
`15
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`Sanofi Exhibit 2020.015
`Mylan v. Sanofi
`IPR2018-01676
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`time, Sanofi’s position is that any depositions concerning Mylan’s Motion to Dismiss shall not
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`count against this limit. Sanofi submits that either approach is necessary so that Sanofi’s efforts
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`to pursue discovery on the Motion to Dismiss do not prejudice its ability to pursue discovery on
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`the merits. These time limits include 30(b)(6) depositions but exclude depositions of expert
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`witnesses. For any depositions requiring interpreters, interpreter speaking time shall not count
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`toward the individual or total time limit.
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`Defendants’ Response:
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`As originally agreed by the parties, a maximum of 75 hours of deposition time is
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`permitted for Sanofi directed towards all Defendants and any third parties, and a maximum of 75
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`hours of deposition time is permitted for Defendants collectively directed towards Sanofi and
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`any third parties. These time limits include 30(b)(6) depositions but exclude depositions of
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`expert witnesses. For any depositions requiring interpreters, interpreter speaking time shall not
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`count toward the individual or total time limit.
`
`(4)
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`Plaintiffs’ proposed discovery requests concerning Mylan’s Motion to
`Dismiss:
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`Plaintiffs’ Response: Any discovery requests concerning Mylan’s Motion to Dismiss
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`shall not count against the above limits, subject to the proposals Sanofi described above.
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`Defendants’ Response: Any discovery requests propounded by the parties shall count
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`against the above limits.
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`(5)
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`Amendments to the pleadings without leave of the Court shall be filed
`or served by the date listed in Exhibit A.
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`(6) Motions to amend with leave of the Court or to add parties shall be
`filed by the date listed in Exhibit A.
`
`(7)
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`(8)
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`The parties will produce documents on a rolling basis and will
`substantially complete document production by the date listed in
`Exhibit A.
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`Factual discovery is to be completed by the date listed in Exhibit A.
`16
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`Sanofi Exhibit 2020.016
`Mylan v. Sanofi
`IPR2018-01676
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`(9)
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`Plaintiffs’ expert reports:
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`Plaintiffs’ opening expert reports with respect to all issues on which Plaintiffs bear the
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`burden of proof, e.g., infringement, shall be due on the date listed in Exhibit A. Plaintiffs’
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`rebuttal expert reports responding to Defendant’s invalidity reports are due on the date listed in
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`Exhibit A. Any purported objective indicia of nonobviousness must be addressed in Plaintiffs’
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`rebuttal expert reports. Reply expert reports with respect to all issues on which Plaintiffs bear the
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`burden of proof, e.g., infringement, shall be due on the date listed in Exhibit A.
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`
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`(10) Defendants’ expert reports:
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`Defendants’ opening expert reports with respect to all issues on which Defendants bear
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`the burden of proof or production, e.g., invalidity, shall be due on the date listed in Exhibit A.
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`Defendants’ rebuttal expert reports responding to Plaintiffs’ infringement reports are due on the
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`date listed in Exhibit A. Reply expert reports with respect to all issues on which Defendants bear
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`the burden of proof, e.g., invalidity, and secondary considerations of nonobviousness shall be due
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`on the date listed in Exhibit A.
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`(11) Expert discovery to be completed by the date listed in Exhibit A.
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`(12) Dispositive motions:
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`Plaintiffs’ Response: Plaintiffs do not believe the instant suit is amenable to summary
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`disposition. Since this is a bench trial, consistent with past practice of this Court, Plaintiffs
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`respectfully submit that any issue