throbber
IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`TEVA BRANDED PHARMACEUTICAL
`PRODUCTS R&D, INC., and
`AUSPECT PHARMACEUTICALS, INC.,
`
`Civil Action No. 21-cv-13247-FLW-DEA
`
`Scheduling Conference: October 19, 2021
`
`Plaintiffs,
`
`v.
`
`LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`
`Defendants.
`TEVA BRANDED PHARMACEUTICAL
`PRODUCTS R&D, INC., and
`AUSPECT PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`AUROBINDO PHARMA LTD., and
`AUROBINDO PHARMA USA, INC.
`
`Defendants.
`
`Civil Action No. 21-cv-13240-FLW-DEA
`
`Scheduling Conference: October 19, 2021
`
`JOINT PROPOSED DISCOVERY PLAN
`
`Pursuant to Federal Rule of Civil Procedure 26(f), Local Civil Rules 16.1 and 26.1, and
`
`the Court’s September 20, 2021 Order (ECF No. 26) (in 21-cv-13247, “the Lupin Case”) and
`
`September 28, 2021 Order (ECF No. 24) (in 21-cv-13240, “the Aurobindo Case”), Plaintiffs
`
`Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc. (“Auspex”)
`
`(collectively, “Plaintiffs” or “Teva”) and Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc.
`
`(collectively, “Lupin”) and Defendants Aurobindo Pharma Ltd. and Aurobindo Pharma USA,
`
`Inc. (collectively, “Aurobindo”) (together with Lupin, “Defendants”), submit the following
`
`proposed Joint Discovery Plan and proposed joint scheduling order in the above-captioned
`
`matters.
`
`1
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 1
`
`

`

`
`
`
`As a preliminary matter, the parties have proposed to coordinate these cases because they
`
`are both Hatch-Waxman patent litigations involving Teva’s drug AUSTEDO®
`
`(deutetrabenazine). AUSTEDO® is indicated for use in treating chorea associated with
`
`Huntington’s disease and tardive dyskinesia. Both Lupin and Aurobindo have filed Abbreviated
`
`New Drug Applications (“ANDAs”) seeking approval from FDA to market and sell in the United
`
`States the products described therein.
`
`The Aurobindo Case arises from its request to FDA to approve its ANDA prior to the
`
`expiry of six U.S. Patents (collectively, the “Asserted Patents”):
`
` U.S. Patent No. 8,524,733, which includes claims relating to the deutetrabenazine
`
`molecule (the “Drug Patent”);
`
` U.S. Patent Nos. 9,233,959, 9,296,739, and 9,814,708, which include claims relating
`
`to the dosage form (the “Formulation Patents”);
`
` U.S. Patent No. 9,550,780, which include claims relating to the deutetrabenazine
`
`crystal form (the “Polymorph Patent”); and
`
` U.S. Patent No. 10,959,996, which includes claims relating to the use of
`
`deutetrabenazine (the “Use Patent”).
`
`The Lupin Case overlaps in subject matter with the Aurobindo case because it arises from
`
`its request to FDA to approve its ANDA prior to the expiry of the Formulation Patents and the
`
`Polymorph Patent. Lupin has not asked FDA to approve its ANDA prior to the expiry of the
`
`Drug Patent.
`
`1.
`
`
`
`Attorneys
`A.
`
`Counsel for Plaintiffs, Teva
`
`The attorneys for Plaintiffs Teva Branded Pharmaceutical Products R&D, Inc. and
`
`2
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 2
`
`

`

`
`
`Auspex Pharmaceuticals, Inc. are:
`
`Liza M. Walsh
`Katelyn O’Reilly
`William T. Walsh, Jr.
`WALSH PIZZI O’REILLY FALANGA LLP
`100 Mulberry Street, 15th Floor
`Newark, New Jersey 07102
`(973) 757-1100
`
`David I. Berl
`Thomas S. Fletcher
`Shaun P. Mahaffy
`Michaela S. Wilkes Klein
`Julie L. Tavares
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`B.
`
`Counsel for Defendants in the Lupin Case
`
`James S. Richter
`MIDLIGE RICHTER, LLC
`645 Martinsville Road
`Basking Ridge, New Jersey 07920
`(908) 626-0622
`
`Deepro R. Mukerjee
`Lance A. Soderstrom
`Joseph Janusz
`KATTEN MUCHIN ROSENMAN LLP
`575 Madison Avenue
`New York, New York 10022-2585
`
`Jitendra Malik, PhD
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`
`Christopher B. Ferenc
`KATTEN MUCHIN ROSENMAN LLP
`2900 K Street NW, Suite 200 Washington, DC 20007
`
`3
`
`
`
`
`
`
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 3
`
`

`

`
`
`
`
`2.
`
`C.
`
`Counsel for Defendants in the Aurobindo Case
`
`Karen A. Confoy
`Paul W. Kalish
`FOX ROTHSCHILD LLP
`Princeton Pike Corporate Center
`997 Lenox Drive
`Lawrenceville, NJ 08648
`(609) 844-3033
`
`Timothy H. Kratz
`George J. Barry III
`KRATZ & BARRY LLP
`105 Crown Pointe Parkway, Suite 500
`Atlanta, GA 30338
`(404) 431-6600
`
`Statement of Facts and Legal Issues
`
`The Lupin Case is an action for patent infringement arising out of the filing of an
`
`Abbreviated New Drug Application by Lupin seeking approval from FDA to market and sell in
`
`the United States the product described therein prior to the expiration of the Formulation and
`
`Polymorph Patents.
`
`The Aurobindo Case is an action for patent infringement arising out of the filing of an
`
`Abbreviated New Drug Application by Aurobindo seeking approval from FDA to market and
`
`sell in the United States the product described therein prior to the expiration of the Drug,
`
`Formulation, Polymorph, and Use Patents
`
`Plaintiff Auspex owns the Asserted Patents. Plaintiff Teva licenses the Asserted Patents
`
`and holds the New Drug Application (“NDA”) pursuant to which it markets AUSTEDO® in the
`
`United States. The subject matter of the Asserted Patents are described above.
`
`There is a statutory stay on FDA’s approval of the Defendants’ ANDAs that is in effect
`
`until April 3, 2025.
`
`
`
`4
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 4
`
`

`

`
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Settlement Discussions
`
`The parties have not engaged in settlement discussions.
`
`Rule 26(f) Conference
`
`The parties met pursuant to Fed. R. Civ. P. 26(f) on September 30, 2021.
`
`Fed. R. Civ. P. 26(a)(1) Disclosures
`
`The parties have agreed to exchange their initial disclosures on October 19, 2021.
`
`Problems with Fed. R. Civ. P. 26(a)(1) Disclosures
`
`The parties do not anticipate any issues with Rule 26(a)(1) disclosures.
`
`Third Party Funding
`
`The parties have not filed disclosures of third-party litigation funding as they have
`
`nothing to disclose.
`
`8.
`
`Status of Discovery
`
`The parties have not conducted discovery, with the exception that pursuant to Local
`
`Patent Rule 3.6(a) on August 2, 2021, Lupin produced its ANDA No. 216065 to Teva, and on
`
`October 11, 2021, Aurobindo produced its ANDA No. 215971 to Teva.
`
`9.
`
`Proposed Joint Discovery Plan
`A.
`
`Discovery Needed on the Following Subjects
`
`The parties expect to take discovery on issues raised in Plaintiffs’ Complaints and in any
`
`Defendant’s Answer, Affirmative Defenses and Counterclaims, which could include a need for
`
`physical samples and/or discovery from third parties who may be located abroad.
`
`The Lupin case does not involve the Drug Patent or the Use Patent because Lupin has not
`
`sought FDA approval to market its product prior to the expiry of those patents. However, the
`
`Aurobindo Case does involve those patents and so the scope of discovery outlined below
`
`contemplates discovery concerning those patents.
`
`
`
`5
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 5
`
`

`

`
`
`
`B.
`
`Phased Discovery
`
`Discovery should not be conducted in phases or be limited to particular issues.
`
`C.
`
`Proposed Schedule
`
`The parties respectfully refer the Court to Exhibit A hereto, which sets forth a complete
`
`Joint Proposed Schedule.
`
`D.
`
`Interrogatories
`
`Plaintiffs may serve 10 interrogatories in each of the Lupin and Aurobindo cases. The
`
`Aurobindo and Lupin Defendants will coordinate their efforts in serving interrogatories and may
`
`collectively serve on Plaintiffs up to 12 interrogatories. Aurobindo may also serve on Plaintiffs
`
`up to 5 interrogatories directed to issues pertaining to the Drug and Use Patents.1
`
`E.
`
`Requests for Admission
`
`Plaintiffs may serve up to 20 requests for admission in each of the Lupin and Aurobindo
`
`cases. The Aurobindo and Lupin Defendants will coordinate their efforts in serving requests for
`
`admission and may collectively serve on Plaintiffs up to 30 requests for admission. These limits
`
`do not apply to requests for admission related solely to the authentication of documents.
`
`F.
`
`Depositions
`
`Plaintiffs may take 10 depositions in each of the Lupin and Aurobindo cases. The
`
`Aurobindo and Lupin Defendants will coordinate their efforts in noticing depositions and may
`
`collectively take 12 depositions. The parties reserve their rights to seek additional depositions
`
`for good cause shown.
`
`
`1 If one of the Aurobindo or Lupin cases terminates, via settlement or otherwise, and only the
`other case remains, the number of Interrogatories, Requests for Admission, and Depositions for
`that remaining Defendant will be no more than the number allowed for Plaintiffs. This provision
`shall not affect any discovery already taken.
`
`
`
`6
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 6
`
`

`

`
`
`
`G.
`
`Dispositive Motions
`
`The parties do not expect to file dispositive motions.
`
`H.
`
`Pretrial Conference
`
`The parties propose that the final pretrial conference take place in or around April 2024,
`
`on a date set by the Court.
`
`I.
`
`Trial
`
`The parties propose that trial take place in May 2024, at a date set by the Court. A
`
`proposed trial in May 2024 is eleven (11) months prior to the expiration of the statutory stay on
`
`April 3, 2025.
`
`J.
`
`Special Discovery Mechanisms
`
`The parties do not anticipate needing to use any special discovery mechanisms at this
`
`time.
`
`K.
`
`Special Discovery Needs
`
`The parties do not anticipate any special discovery needs at this time.
`
`10.
`
`Electronic Discovery
`
`The parties have begun to discuss electronic discovery issues, and they intend to reach an
`
`agreement concerning the scope and format of discovery of electronically stored information.
`
`The parties will meet and confer regarding any issues that arise concerning electronic discovery.
`
`The parties will cooperate to produce electronically stored information in mutually agreeable
`
`formats and media and will endeavor to promptly reach agreement concerning the extent, scope,
`
`and handling of electronic discovery. The parties agree to produce English translations of
`
`documents in any other language, along with the original document, to the extent such
`
`translations existed prior to the commencement of these actions.
`
`
`
`7
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 7
`
`

`

`
`
`11.
`
`Discovery Confidentiality Order
`
`The parties anticipate that a Discovery Confidentiality Order will be needed and have
`
`begun to meet and confer and will submit a joint proposed Discovery Confidentiality Order. The
`
`parties propose that the Discovery Confidentiality Order be submitted by November 3, 2021.
`
`12.
`
`Anticipated Discovery Problems
`
`The parties do not anticipate any other discovery problems at this time.
`
`13.
`
`Alternative Dispute Resolution
`
`The parties respectfully submit that they have substantial experience with patent litigation
`
`and the resolution of patent litigation. The parties believe that this case is not appropriate for
`
`voluntary arbitration, mediation, appointment of a special master, or other special procedure at
`
`this time.
`
`14.
`
`Bifurcation
`
`The parties do not believe bifurcation of the any of the issues in these cases is
`
`appropriate.
`
`15.
`
`Interim Status/Settlement Conference
`
`The parties do not believe that a settlement conference should be scheduled at this time.
`
`However, the parties will notify the Court if they believe that a settlement conference would aid
`
`in resolution of these actions at a later time. The parties understand the Court will conduct
`
`interim status conferences on a regular basis.
`
`16.
`
`Trial by Magistrate Judge
`
`The parties do not consent to trial before a magistrate judge.
`
`17.
`
`Any Other Issues
`
`The parties are aware of no other issues to be addressed at the Rule 16 Scheduling
`
`Conference.
`
`
`
`8
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 8
`
`

`

`
`
`18.
`
`Local Patent Rule 2.1(a):
`
`Pursuant to Local Patent Rule 2.1(a), the parties report that parties engaged in
`
`preliminary discussions during the Rule 26(f) conference regarding the following topics. The
`
`parties’ discussions are ongoing and they do not anticipate discussing these issues during the
`
`Rule 16 Scheduling Conference at this time. To the extent the parties request a modification of
`
`the proposed schedule set forth in Exhibit A to accommodate certain deadlines identified below,
`
`they will make an appropriate request to the Court.
`
`(1) Proposed modification of the obligations or deadlines set forth in these Local
`Patent Rules to ensure that they are suitable for the circumstances of the
`particular case (see L. Pat. R. 1.3);
`
`The parties have addressed this issue in the proposed schedule attached hereto as Exhibit
`
`A.
`
`A.
`
`(2) The scope and timing of any claim construction discovery including disclosure of
`and discovery from any expert witness permitted by the Court;
`
`The parties have addressed this issue in the proposed schedule attached hereto as Exhibit
`
`(3) The format of the Claim Construction Hearing, including whether the Court will
`hear live testimony, the order of presentation, and the estimated length of the
`hearing;
`
`The parties will submit this information in the Joint Claim Construction and Prehearing
`
`Statement on the date set forth in Exhibit A.
`
`(4) How the parties intend to educate the Court on the patent(s) at issue;
`
`The parties will submit this information in the Joint Claim Construction and Prehearing
`
`Statement on the date set forth in Exhibit A.
`
`(5) The need for any discovery confidentiality order and a schedule for presenting
`certification(s) required by L. Civ. R. 5.3(b)(2).
`
`The parties will submit a proposed discovery confidentiality order by the date set forth in
`
`
`
`9
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 9
`
`

`

`
`
`Exhibit A.
`
`(6) The availability and timing of production of invention records (including
`inventor laboratory notebooks and analytical test results);
`
`Plaintiffs will produce documents required under L. Pat. R. 3.2 in accordance with the
`
`schedule set forth in Exhibit A.
`
`(7) The availability and timing of production of ANDA product research and
`development documents;
`
`Other than documents that Defendants are already required to produce pursuant to L. Pat.
`
`R. 3.6(a) and 3.6(j), Defendants will produce non-privileged ANDA product research and
`
`development documents within their possession or control and pursuant to a reasonable search in
`
`accordance with the schedule set forth in Exhibit A.
`
`(8) The availability and timing of production of ANDA product samples;
`
`The parties have not yet discussed this topic, but will endeavor to resolve this issue in
`
`accordance with the schedule set forth in Exhibit A.
`
`(9) The date of conception and the date of reduction to practice for each patent
`asserted in the action, if applicable;
`
`The parties have not yet discussed this topic, but will endeavor to resolve this issue in
`
`accordance with the schedule set forth in Exhibit A.
`
`(10) Each inventor’s availability for deposition in the matter;
`
`The parties have not yet discussed this topic, but will endeavor to resolve this issue in
`
`accordance with the schedule set forth in Exhibit A.
`
`(11) Availability of foreign witnesses for deposition and foreign documents;
`
`The parties have not yet discussed this topic, but will endeavor to resolve this issue in
`
`accordance with the schedule set forth in Exhibit A.
`
`(12) Whether there is a 30-month stay and if so, when it ends;
`
`
`
`10
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 10
`
`

`

`There is a 30-month stay which ends on April 3, 2025.
`
`(13) A date for substantial completion of document production and a method for
`determining compliance;
`
`A date for substantial completion of document production is set forth in Exhibit A.
`
`(14) Any other issues or matters that a party believes are time sensitive.
`
`None at this time.
`
`WALSH PIZZI O’REILLY FALANGA LLP
`
`
`/s/Liza M. Walsh
`Liza M. Walsh
`Katelyn O’Reilly
`William T. Walsh, Jr.
`100 Mulberry Street, 15th Floor
`Newark, New Jersey 07102
`(973) 757-1100
`
`Attorneys for Plaintiffs Teva Branded
`Pharmaceutical Products R&D, Inc. and
`Auspex Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`Dated: October 12, 2021
`
`
`
`
`
`OF COUNSEL:
`David I. Berl
`Thomas S. Fletcher
`Shaun P. Mahaffy
`Michaela S. Wilkes Klein
`Julie L. Tavares
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`Attorneys for Plaintiffs Teva Branded
`Pharmaceutical Products R&D, Inc. and
`Auspex Pharmaceuticals, Inc.
`
`
`/s/James S. Richter
`James S. Richter
`MIDLIGE RICHTER, LLC
`645 Martinsville Road
`Basking Ridge, New Jersey 07920
`(908) 626-0622
`
`Deepro R. Mukerjee
`Lance A. Soderstrom
`Joseph Janusz
`KATTEN MUCHIN ROSENMAN LLP
`575 Madison Avenue
`New York, New York 10022-2585
`
`
`
`11
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 11
`
`

`

`
`
`
`
`Jitendra Malik, PhD
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`
`Christopher B. Ferenc
`KATTEN MUCHIN ROSENMAN LLP
`2900 K Street NW, Suite 200 Washington, DC 20007
`
`Attorneys for Defendants Lupin Ltd.., and Lupin Pharmaceuticals, Inc.
`
`
`s/ Karen A. Confoy
`Karen A. Confoy
`Paul W. Kalish
`kconfoy@foxrothschild.com
`pkalish@foxrothschild.com
`FOX ROTHSCHILD LLP
`Princeton Pike Corporate Center
`997 Lenox Drive
`Lawrenceville, NJ 08648
`(609) 844-3033
`
`Timothy H. Kratz
`George J. Barry III
`KRATZ & BARRY LLP
`105 Crown Pointe Parkway, Suite 500
`Atlanta, GA 30338
`(404) 431-6600
`
`
`Attorneys for Aurobindo Pharma Ltd. And Aurobindo Pharma USA, Inc.
`
`
`
`
`
`12
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 12
`
`

`

`
`
`
`
`
`Exhibit A: Joint Proposed Schedule
`
`
`Proposed Date
`Tuesday, October 12, 2021
`
`Tuesday, October 19, 2021
`Tuesday, October 19, 2021
`Wednesday, November 3, 2021
`
`Wednesday, November 17, 2021
`
`February 11, 2022
`
`Friday, April 22, 2022
`
`Friday, May 20, 2022
`
`Thursday, June 23, 2022
`
`Thursday, July 21, 2022
`
`Thursday, August 25, 2022
`
`Friday, September 9, 2022
`
`Thursday, September 22, 2022
`
`Friday, October 28, 2022
`
`Friday, November 4, 2022
`
`Event
`Parties to submit joint discovery plan and proposed
`scheduling order (L. R. 26.1(b))
`Initial scheduling conference
`Parties to serve Rule 26(a)(1) Initial Disclosures
`Parties shall submit proposed discovery
`confidentiality order (L. Pat. R. 2.2)
`Plaintiffs shall serve their “Disclosure of Asserted
`Claims” (L. Pat. R. 3.6(b))
`Defendants shall serve their “Invalidity
`Contentions,” “Noninfringement Contentions,” and
`underlying documents (L. Pat. R. 3.6(c)-(f))
`Plaintiffs shall serve their “Disclosure of
`Infringement Contentions,” “Responses to Invalidity
`Contentions,” and underlying documents (L. Pat. R.
`3.6(g)-(i))
`Parties shall exchange proposed terms for
`construction (L. Pat. R. 4.1(a)-(b))
`Parties shall exchange preliminary claim
`constructions and supporting intrinsic and extrinsic
`evidence (L. Pat. R. 4.2(a)-(b))
`Parties shall exchange an identification of all
`intrinsic and extrinsic evidence that each party
`intends to rely upon to oppose any other party’s
`proposed construction (L. Pat. R. 4.2(c))
`Parties shall file a Joint Claim Construction and
`Prehearing Statement (L. Pat. R. 4.3)
`Completion of Claim Construction Discovery (other
`than depositions of experts) (L. Pat. R. 4.4)
`Parties shall file Opening Markman Submissions (L.
`Pat. R. 4.5(a))
`Deadline for substantial completion of document
`production
`Completion of expert discovery relating to Opening
`Markman Submissions (L. Pat. R. 4.5(b))
`
`13
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 13
`
`

`

`
`
`
`
`
`
`
`Parties shall file responding Markman briefs and
`supporting documents (L. Pat. R. 4.5(c))
`Parties shall propose a Markman Hearing date (L.
`Pat. R. 4.6)
`Markman Hearing
`Deadline for amendment of pleadings and joinder of
`parties
`Close of fact discovery
`Parties shall exchange opening expert reports on
`issues for which the party bears the burden of proof
`Parties shall exchange rebuttal expert reports
`Parties shall exchange reply expert reports
`Close of expert discovery
`Final Pretrial Conference
`Trial
`
`Thursday, November 17, 2022
`
`Friday, December 2, 2022
`
`TBD
`Wednesday, March 8, 2023
`
`Wednesday, April 12, 2023
`Wednesday, June 28, 2023
`
`Wednesday, September 13, 2023
`Wednesday, November 1, 2023
`Wednesday, January 31, 2024
`(April 2024)
`(May 2024)
`
`14
`
`Auspex Exhibit 2023
`Apotex v. Auspex
`IPR2021-01507
`Page 14
`
`

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