Case 2:19-cv-16484-CCC-MF Document 34-1 Filed 11/08/19 Page 1 of 12 PageID: 260
`
`Keith J. Miller
`Justin T. Quinn
`Michael J. Gesualdo
`ROBINSON MILLER LLC
`Ironside Newark
`110 Edison Place, Suite 302
`Newark, New Jersey 07102
`(973) 690-5400 (Telephone)
`kmiller@rwmlegal.com
`jquinn@rwmlegal.com
`mgesualdo@rwmlegal.com
`
`Attorneys for Plaintiffs
`Janssen Pharmaceuticals, Inc. and
`Janssen Pharmaceutica NV
`
`Arnold B. Calmann
`Jeffrey Soos
`Katherine A. Escanlar
`SAIBER
`One Gateway Center, 10th Floor
`Newark, New Jersey 07102
`(973) 622-3333 (Telephone)
`abc@saiber.com
`jsoos@saiber.com
`kae@saiber.com
`
`Attorneys for Defendant
`Mylan Laboratories Limited
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`JANSSEN PHARMACEUTICALS, INC. and
`JANSSEN PHARMACEUTICA NV,
`
`
`Plaintiffs,
`
`v.
`
`MYLAN LABORATORIES LIMITED,
`
`
`
`
`
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Civil Action No. 2:19-cv-16484-CCC-
`MF
`
`
`CONFERENCE DATE:
`November 12, 2019 at 11 a.m.
`
`Document Filed Electronically
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`

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`
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`JOINT PROPOSED DISCOVERY PLAN
`
`Pursuant to Federal Rules of Civil Procedure 16(b) and 26(f), Local Civil Rule
`
`26.1(b), the Local Patent Rules, and the Court’s October 7, 2019 Order (ECF No. 28),
`
`counsel for plaintiffs Janssen Pharmaceuticals, Inc. (“JPI”) and Janssen Pharmaceutica NV
`
`(“JPN”) (collectively “Janssen” or “Plaintiffs”) and counsel for defendant Mylan
`
`Laboratories Limited (“Mylan” or “Defendant”), respectfully submit this Joint Discovery
`
`Plan.
`
`I.
`
`NATURE OF CASE
`
`This is a Hatch-Waxman case. Janssen alleges that Mylan has infringed one or more
`
`asserted claims of U.S. Patent No. 9,439,906 (“the ’906 Patent”) by submitting an Abbreviated
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`New Drug Application (“ANDA”) to market a generic version of JPI’s Invega Sustenna®
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`brand paliperidone palmitate extended release suspension products prior to the expiration of
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`the ’906 patent. Mylan denies the allegations of infringement and asserts affirmative defenses
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`and counterclaims alleging that its proposed products do not infringe and/or that the asserted
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`claims are invalid. Thus, the primary legal issues in this case include (1) whether Mylan’s
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`proposed generic products (including the uses thereof) infringe one or more asserted claims of
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`the ’906 patent, and (2) whether the asserted claims are invalid.
`
`Janssen seeks to have this case declared exceptional under 35 U.S.C. §§ 285 and
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`271(e)(4).
`
`II.
`
`DISCOVERY CONDUCTED TO DATE
`
`The parties will exchange Initial Disclosures on November 14, 2019.
`
`The parties will submit a proposed Stipulated Confidentiality Order pursuant to
`
`1.
`
`2.
`
`L. Pat. R. 2.2.
`
`
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`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`
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`3.
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`In accordance with L. Pat. R. 3.6(a), Mylan represents that it has
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`produced its ANDA in its entirety.
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`III. DISCOVERY PROBLEMS ENCOUNTERED TO DATE
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`No discovery problems have been encountered to date.
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`IV.
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`FURTHER DISCOVERY NEEDS
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`The parties anticipate seeking discovery on all the issues raised in the Complaint, the
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`Answer and Counterclaims, and the Answer to Counterclaims in this case. The parties
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`contemplate seeking written discovery, including requests for the production of documents
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`and things, interrogatories, and requests for admission. The parties also anticipate taking
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`depositions of both party and non-party witnesses. The parties propose that expert discovery
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`will take place following the close of fact discovery. The parties do not believe that any
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`phasing of discovery is appropriate.
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`Plaintiffs may request samples of Mylan’s proposed generic paliperidone palmitate
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`extended release suspension products and the active pharmaceutical ingredient for those
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`products. Mylan does not concede that samples of its proposed generic paliperidone
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`palmitate extended release suspension products and/or the active pharmaceutical ingredients
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`for those products are relevant to the issues in the case or that the production of such samples
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`is appropriate in the context of the instant litigation. The parties agree to discuss requests for
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`samples in good faith and to bring any issues concerning the production of samples to the
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`Court’s attention when appropriate. The parties do not believe that the Court needs to enter a
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`separate formal date at this time for production of samples.
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`V.
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`PROPOSED DISCOVERY SCHEDULE
`
`
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`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`
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`The parties propose the schedule set forth below. The parties have agreed to revisit
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`the schedule and approach the Court for an earlier trial date, subject to the Court’s
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`availability, should the parties agree to forego dispositive motions at a later date.
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`Event
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`Proposed Date
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`Exchange of initial disclosures
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`November 14, 2019
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`Plaintiffs disclose asserted claims
`
`November 19, 2019
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`Parties file proposed Stipulated
`Confidentiality Order
`
`November 26, 2019
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`Defendant’s Invalidity and Non-infringement
`Contentions and accompanying documents
`
`December 20, 2019
`
`Plaintiffs’ Infringement Contentions and accompanying
`documents
`
`February 7, 2020
`
`Plaintiffs’ response to Invalidity Contentions
`
`February 7, 2020
`
`Deadline for joining parties without leave of Court
`
`February 10, 2020
`
`Deadline for amending pleadings without leave
`of Court
`
`October 16, 2020
`
`Parties exchange list of claim terms in need of
`construction
`
`February 21, 2020
`
`exchange
`Parties
`constructions and
`extrinsic evidence
`
`proposed
`preliminary
`identify
`intrinsic and
`
`Parties exchange intrinsic and extrinsic
`evidence that each party intends to rely on to
`oppose any other party’s proposed construction
`
`March 13, 2020
`
`March 27, 2020
`
`Joint Claim Construction and Prehearing
`Statement
`
`April 10, 2020
`
`Deadline to complete fact discovery relating to
`claim construction
`
`June 12, 2020
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`
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`
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`Opening Claim Construction Submissions
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`June 26, 2020
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`Parties Complete Expert Discovery Relating to
`Opening Markman Submissions
`
`July 17, 2020
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`Responsive Claim Construction Submissions
`
`August 10, 2020
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`Parties confer and propose a schedule for claim
`construction hearing
`
`By August 24, 2020
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`Plaintiffs and Defendant Substantially
`Complete Document Production
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`Close of fact discovery
`
`Exchange of Opening Expert Reports (on issues for
`which a party bears the burden of proof)
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`Exchange of Rebuttal Expert Reports
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`Exchange of Reply Expert Reports (limited to
`secondary considerations)
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`Close of expert discovery
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`Deadline for filing dispositive motions
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`Deadline for filing final pretrial briefs
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`Pretrial Conference
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`Trial
`
`End of 30 Month Stay
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`VI.
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`EXPERT DISCOVERY
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`September 11, 2020
`
`November 13, 2020
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`November 18, 2020
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`January 8, 2021
`
`January 22, 2021
`
`February 19, 2021
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`February 26, 2021
`
`TBD
`
`TBD
`
`June 2021 or at the Court’s
`convenience
`January 2, 2022
`
`The parties expect that expert testimony will be required. The parties’ proposed dates for
`
`expert reports and deposition discovery are set forth above.
`
`VII. LIMITATIONS ON DISCOVERY
`
`A.
`
`Written Discovery
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
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`
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`The parties agree that each side in each case shall be permitted a maximum number
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`of twenty-five (25) interrogatories served on the other side in that case. Each discrete subpart
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`shall be counted as a separate interrogatory. The parties agree that each side in each case
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`should be limited to 60 Requests for Admission, exclusive of any such requests pertaining
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`solely to the authentication of documents, which shall not be limited, but may be subject to a
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`claim of undue burden, and that each side in each case may serve an unlimited number of
`
`requests for production. The parties agree that all of these limits are subject to the parties
`
`reaching a future agreement, in writing, modifying these limits or the Court entering an order
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`modifying these limits for good cause shown.
`
`The parties consent to electronic service pursuant to Federal Rule of Civil Procedure
`
`5(b)(2)(E).
`
`B.
`
`1.
`
`Depositions
`
`Number of Depositions: The parties agree that discovery should be
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`conducted in accordance with the parameters set forth in the Federal Rules of Civil Procedure
`
`and the Local Rules of this Court except as described below.
`
`(i)
`
`Plaintiffs are limited to a total of 70 hours of taking 30(b)(1) and 30(b)(6)
`
`testimony by deposition upon oral examination of Defendant (including any depositions of
`
`third parties who have discoverable information related to that defendant). Defendant is
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`limited to a total of 70 hours of taking 30(b)(1) and 30(b)(6) testimony by depositions upon
`
`oral examination of Plaintiffs. The parties agree that every expert may be deposed and such
`
`depositions do not count against the limit of 70 hours.
`
`
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`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`(ii)
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`The parties agree that each deposition day shall not extend beyond seven (7) hours
`
`of deposition tape time unless there is agreement between the parties or an Order of the Court.
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`(iii) Deposition time for witnesses testifying through an interpreter shall be discounted
`
`by 50% for the purpose of calculating aggregate deposition time.
`
`2.
`
`To the extent a party reasonably believes that additional deposition time is
`
`necessary, the parties shall meet and confer in good faith in an attempt to achieve resolution.
`
`If the parties are unable to achieve resolution, a party may seek relief from the Court, and the
`
`remaining parties will not oppose a reasonable request for an expedited briefing schedule.
`
`3.
`
`The parties have not reached agreement on whether a witness who appears
`
`on a trial witness list (or as a declarant in any motion practice) who has not been deposed will
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`be deposable and whether the deposition of such witness/declarant counts toward the total
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`hour limits on depositions in Section VII(B)(1)(i). Janssen maintains that such
`
`witness/declarant is deposable notwithstanding the total hour limits. The parties agree,
`
`however, that this disagreement does not relieve any party from the duty of disclosing
`
`relevant fact and expert witnesses during discovery.
`
`4.
`
`Locations of Depositions: Unless the parties agree otherwise, all
`
`depositions of witnesses who are current employees of a party or are a third party represented
`
`by counsel for Plaintiffs or Defendant, and reside in the U.S., will take place in the U.S. For
`
`witnesses who are current employees of a party or are a third party represented by counsel for
`
`Plaintiffs or Defendant, that reside outside the U.S., the parties will cooperate in good faith
`
`and attempt to arrange depositions in the United States to the extent possible. To the extent a
`
`party intends to bring a witness to the United States for trial, that witness will be made
`
`available for deposition in the United States. If a deposition does occur outside of the U.S.,
`
`
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`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`

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`
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`the parties agree that the U.S. discovery rules will apply.
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`5.
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`ESI: The parties anticipate requesting production of electronically stored
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`information. The parties will agree separately on a format for production of electronically
`
`stored information. The parties do not anticipate currently that restoration of deleted or
`
`archived digital information will be necessary.
`
`6.
`
`Privilege Protocol: The parties will confer regarding the management
`
`of attorney-client privilege and work product protection, and are negotiating a privilege
`
`protocol that will be incorporated into the parties’ Stipulated Confidentiality Order.
`
`7.
`
`Experts: The protections provided by Federal Rule of Civil Procedure
`
`26(b)(4) relating to experts apply to this litigation. In addition, (1) Rule 26(b)(4)(C) shall be
`
`interpreted to apply to communications between an expert and a party as well as between an
`
`expert and a party’s attorney, and (2) no notes or other types of preliminary work created by
`
`or for an expert will be the subject of discovery or inquiry at trial. Notwithstanding the
`
`foregoing, all documents provided or made known to an expert, other than those generated
`
`for the purpose of the litigation and/or for the purpose of communicating with the expert,
`
`which are considered by and relied upon by the expert in formulating his or her opinion are
`
`discoverable and may be the subject of questioning at deposition and trial.
`
`VIII. CLAIM CONSTRUCTION PROCEEDINGS
`
`The parties have conferred and have set forth in Section V a proposed schedule
`
`governing the scope and timing of claim construction discovery. However, the parties believe
`
`that other matters concerning claim construction proceedings, including the format of the
`
`claim construction hearing and whether and how the parties intend to educate the Court on the
`
`technology underlying the patent at issue, should be discussed after the parties exchange their
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`

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`
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`preliminary proposed constructions and the intrinsic and extrinsic evidence that the parties
`
`intend to rely on. The parties will promptly inform the Court of their proposals on these
`
`additional matters after such discussions have occurred.
`
`IX. ADDITIONAL ITEMS
`
`a. The availability and timing of production of invention records (including
`inventor laboratory notebooks and analytical test results);
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(a), the parties agree that to the extent
`
`production of invention records (including inventor laboratory notebooks and analytical test
`
`results) is relevant to any party’s claims or defenses and proportional to the needs of the case, and
`
`such materials are timely requested, Plaintiff will produce any non-privileged invention records
`
`within the possession or control of Plaintiff and pursuant to a reasonable search when required by
`
`L. Pat. R. 3.2 and prior to the deadline for the substantial completion of document production set
`
`forth in Section V.
`
`b. The availability and timing of production of ANDA product research and
`development documents;
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(b), the parties agree that to the extent
`
`production of ANDA product research and development documents is relevant to the parties’
`
`claims or defenses and proportional to the needs of the case, and to the extent such materials are
`
`timely requested, Defendant will produce any non-privileged ANDA product research and
`
`development documents within the possession or control of Defendant and pursuant to a
`
`reasonable search when required by L. Pat. R. 3.2 and prior to the deadline for the substantial
`
`completion of document production set forth in Section V.
`
`c. The date of conception and the date of reduction to practice for the patent
`asserted in the action, if applicable;
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(d), the parties agree that to the extent
`
`the date of conception and date of reduction to practice for the patent asserted in this action is
`
`relevant to any party’s claims or defenses and proportional to the needs of the case, documents
`
`evidencing the date of conception and date of reduction to practice for the patent asserted in this
`
`case will be provided when required by L. Pat. R. 3.2 and prior to the deadline for the substantial
`
`completion of document production.
`
`d. Each inventor’s availability for deposition in the matter;
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(e), Plaintiff will investigate the
`
`inventors’ availability for deposition and work in good faith to report to Defendant by February 7,
`
`2020. The parties note that these depositions will not occur until after the date for substantial
`
`completion of document production identified in Section V.
`
`e. Availability of foreign witnesses for deposition and foreign documents;
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(f), the parties will confer regarding the
`
`availability of foreign witnesses for deposition within the United States and foreign documents
`
`and work in good faith to resolve any disputes relating thereto.
`
`f. Whether there is a 30-month stay and if so, when it ends;
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(g), there is a 30-month stay which ends
`
`on January 2, 2022.
`
`g. A date for substantial completion of document production and a method
`for determining compliance;
`
`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(h), a date for substantial completion of
`
`document production is set forth in Section V. The parties will confer in good faith to ensure
`
`compliance with this deadline.
`
`h. Any other issues or matters that a party believes are time sensitive.
`
`
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`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`Joint Response: With respect to L. Pat. R. 2.1(a)(6)(i), the parties are presently unaware of
`
`any issues or matters that are time sensitive.
`
`X.
`
`SPECIAL DISCOVERY NEEDS
`
`Certain documents relevant to this litigation may be in a foreign language and require
`
`translation. Certain depositions may also require a translator. In addition, certain information
`
`may need to be redacted to comply with foreign privacy and data protection laws, as well as
`
`third party confidentiality.
`
`XI.
`
`TRIAL BY MAGISTRATE JUDGE
`
`The parties do not consent to a trial by a Magistrate Judge.
`
`XII. ARBITRATION AND MEDIATION
`
`The parties believe that, to the extent voluntary arbitration, mediation, or other
`
`special procedure is appropriate, the parties’ participation would be more productive after
`
`expert discovery has been completed.
`
`
`
`Dated: November 8, 2019
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
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`

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`
`
`s/ Keith J. Miller
`Keith J. Miller (kmiller@rwmlegal.com)
`Justin T. Quinn (jquinn@rwmlegal.com)
`Michael Gesualdo
`(mgesualdo@rwmlegal.com)
`ROBINSON MILLER LLC
`One Newark Center, 19th Floor Newark,
`New Jersey 07102
`(973) 690-5400 (Telephone)
`(973) 466-2760 (Facsimile)
`
`OF COUNSEL:
`Barbara L. Mullin (bmullin@pbwt.com)
`Aron Fischer (afischer@pbwt.com)
`Gregory Diskant (gldiskant@pbwt.com)
`Zhiqiang Liu (zliu@pbwt.com)
`A. Robert Quirk (rquirk@pbwt.com)
`Jeffrey Hughes (jhughes@pbwt.com)
`J. Jay Cho (jcho@pbwt.com)
`Meghan Larywon (mlarywon@pbwt.com)
`PATTERSON BELKNAP WEBB &
`TYLER LLP
`1133 Avenue of the Americas
`New York, New York 10036
`(212) 336-2000 (Telephone)
`(212) 336-2222 (Facsimile)
`
`Attorneys for Plaintiffs
`Janssen Pharmaceuticals, Inc.
`and Janssen Pharmaceutica
`NV
`
`
`
`s/ Arnold B. Calmann
`Arnold B. Calmann (abc@saiber.com)
`Jeffrey Soos (jsoos@saiber.com)
`Katherine A. Escanlar (kae@saiber.com)
`SAIBER
`One Gateway Center, 10th Floor
`Newark, New Jersey 07102
`(973) 622-3333 (Telephone)
`(973) 286-2465 (Facsimile)
`
`OF COUNSEL:
`Deepro R. Mukerjee
`(deepro.mukerjee@katten.com)
`Lance A. Soderstrom
`(lance.soderstrom@katten.com)
`KATTEN MUCHIN ROSENMAN LLP
`575 Madison Avenue
`New York, NY 10022
`(212) 940-6330 (Telephone)
`(212) 940-8776 (Facsimile)
`
`Guylaine Haché, Ph.D.
`(guylaine.hache@katten.com)
`KATTEN MUCHIN ROSENMAN LLP
`525 West Monroe Street
`Chicago, IL 60661
`(312) 902-5200 (Telephone)
`
`Alissa Pacchioli
`(alissa.pacchioli@katten.com)
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202
`(704) 444-2000 (Telephone)
`
`Attorneys for Defendant
`Mylan Laboratories Limited
`
`
`
`
`
`
`
`Janssen Ex. 2004
`Mylan v. Janssen
`IPR2020-00440
`
`