Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 1 of 10 PageID #: 136
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`In re Sitagliptin Phosphate ('708 & '921)
`Patent Litigation
`
`C.A. No. 19-md-2902-RGA
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`MERCK SHARP & DOHME CORP.,
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`Plaintiff,
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`V.
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`C.A. No . 19-1489-RGA
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`MYLAN PHARMACEUTICALS INC. ,
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`Defendants.
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`(mQ"POSEDJ: SCHEDULING ORDER
`e~
`I.N ru-r-ed
`This -12._ day of August, 2019, the Ge-art-having conducted an initial Rule l 6(b)
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`scheduling conference pursuant to Local Rule 16.1 (b ), 1 and the parties having determined after
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`discussion that the matter cannot be resolved at this juncture by settlement, voluntary mediation,
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`or binding arbitration;
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`1 This Order follows substantively identical scheduling orders dated June 28, 2019, in related
`actions, C.A. Nos. 19-310-RGA, 19-311-RGA, 19-312-RGA, 19-314-RGA, 19-316-RGA, 19-
`317-RGA, 19-318-RGA, 19-320-RGA, 19-321-RGA, and 19-347-RGA, involving the same
`products and patents. The parties have agreed that the schedule in the related actions should
`apply in this action. This Order thus provides for the same due dates as the scheduling orders in
`the related actions, but has been edited to account for due dates that have already passed.
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`Additionally, on August 8, 2019, the Judicial Panel on Multidistrict Litigation ordered the
`centralization of this action, the related actions, and Merck Sharp & Dahme Corp. v. Mylan
`Pharmaceuticals Inc. et al. , Case No. 19-cv-101-IMK (N. D. W. Va.), to the U.S. District Court
`for the District of Delaware for coordinated and consolidated proceedings. See Transfer Order,
`In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902 (J.P.M.L. Aug. 8,
`2019), ECF No. 56.
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`MEI 31261609v.l
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 1
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`

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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 2 of 10 PageID #: 137
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`IT IS ORDERED that:
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`1.
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`Rule 26(a)(l) Initial Disclosures. The parties have agreed to exchange their initial
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`disclosures pursuant to Federal Rule of Civil Procedure 26(a)(l) and Paragraph 3 of the
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`Delaware Default Standard for Discovery on or before August 20, 2019.
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`2.
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`Joinder of Other Parties and Amendment of Pleadings. All motions to join other
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`parties, and to amend or supplement the pleadings, shall be filed on or before February 14, 2020.
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`3.
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`Discovery.
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`a. Fact Discovery Cut Off. All fact discovery in this case shall be initiated so that it
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`will be completed on or before November 20, 2020.
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`b. Document Production. Document production shall be substantially complete by
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`February 21 , 2020.
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`c. Contentions. The parties shall make their initial disclosures under Paragraphs 3
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`and 4 in accordance with the Court's Default Standard for Discovery, Including Discovery of
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`Electronically Stored Information ("the Default Standard").
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`1.
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`Plaintiff shall make its disclosures under Paragraph 4(a) of the Default
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`Standard by August 20, 2019.
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`11.
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`Defendant shall produce its core technical documents under Paragraph
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`4(b) of the Default Standard by August 23 , 2019. At the same time
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`Defendant produces its core technical documents, Defendant shall also
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`produce the DMF for the sitagliptin API used in its proposed ANDA
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`products, to the extent it is in Defendant's possession, custody, or control,
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`or if Defendant able to obtain the DMF pursuant to a contractual right to
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`the DMF with the DMF holder. If Defendant not in possession, custody,
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`ME I 31261609v. l
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`2
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 2
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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 3 of 10 PageID #: 138
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`or control of the DMF, and is not able to obtain the DMF pursuant to a
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`contractual right with the DMF holder, the Defendant shall inform
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`Plaintiff of that fact and identify the DMF holder at the same time it
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`produces their core technical documents.
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`m.
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`Plaintiff shall make its disclosure under Paragraph 4( c) of the Default
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`Standard within 30 days after receiving Defendant's disclosure under
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`Paragraph 4(b) of the Default Standard;
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`1v.
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`Defendant shall make its disclosures under Paragraph 4(d) of the Default
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`Standard within 30 days after receiving Plaintiff's disclosure under
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`Paragraph 4(c) of the Default Standard.
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`v.
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`The parties shall exchange supplemental infringement and invalidity
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`contentions on October 14, 2020.
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`d. Samples. At the same time Defendant produces its core technical documents,
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`Defendant shall also disclose to Plaintiff whether it is able to produce reasonable quantities of
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`unexpired samples (unexpired as of the entry of this Scheduling Order) of its ANDA products
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`and API to the extent such samples are in Defendant' s possession, custody, or control, or if
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`Defendant can obtain such samples pursuant to a contractual right with a supplier. On or before
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`August 27, 2019, Defendant shall produce reasonable quantities of unexpired samples (unexpired
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`as of the entry of this Scheduling Order) of the ANDA products and API to the extent such
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`samples are in Defendant's possession, custody, or control, or if Defendants can obtain such
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`samples due to a contractual right with a supplier. To the extent that Defendant is unable to
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`produce such samples on or before August 27, 2019, Defendant shall inform Plaintiff at the same
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`time Defendant produces its core technical documents and confer with Plaintiff as to a
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`MEI 31261609v.1
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`3
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 3
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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 4 of 10 PageID #: 139
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`reasonable extension of time to produce such samples. For clarity, if Defendant does not have
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`unexpired samples (unexpired as of the entry of this Scheduling Order) of their ANDA Product
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`and API in their possession, custody, or control, and cannot obtain such samples pursuant to a
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`contractual right with a supplier, Defendant shall inform Plaintiff of those facts at the same time
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`it produces its core technical documents.
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`e. Requests for Admission. Plaintiff may serve up to 15 requests for admission on
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`the Defendant Groups collectively. 2 To the extent that a request for admission is served on the
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`Defendant Groups collectively, that request for admission shall count as one request for
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`admission even if multiple parties provide a distinct response. The Defendant Groups
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`collectively may jointly serve up to 15 requests for admission on Plaintiff. In addition, each
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`Defendant Group may serve on Plaintiff up to 15 individualized requests for admission, and
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`Plaintiff may serve on each Defendant Group up to 15 individualized requests for admission.
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`Any additional requests for admission may only be served with leave of Court. Any requests for
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`admission directed to the authentication of documents are excluded from the limitations above.
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`f.
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`Interrogatories. Plaintiff may serve up to 15 interrogatories on the Defendant
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`Groups collectively. To the extent that an interrogatory is served on the Defendant Groups
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`collectively, that interrogatory shall count as one interrogatory even if multiple parties provide a
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`distinct response. The Defendant Groups collectively may jointly serve up to 15 interrogatories
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`2 The Defendant Groups (in this action and the related actions) are: (1) Alvogen Pine Brook
`LLC F/K/A Alvogen Pine Brook, Inc. and Alvogen Malta Operations Ltd.; (2) Anchen
`Pharmaceuticals, Inc. and Par Pharmaceutical, Inc. ; (3) Apotex Inc. and Apotex Corp.; (4) Lupin
`Limited and Lupin Pharmaceuticals, Inc.; ( 5) Macleods Pharmaceuticals Limited and Macleods
`Pharma USA, Inc.; (6) Mylan Pharmaceuticals, Inc .; (7) Sandoz Inc.; (8) Sun Pharma Global
`FZE and Sun Pharmaceutical Industries Ltd.; (9) Teva Pharmaceuticals USA, Inc. ; ( 10) Torrent
`Pharmaceuticals Limited and Torrent Pharma Inc.; (11 ) Watson Laboratories, Inc. and Teva
`Pharmaceuticals USA, Inc.; (12) Wockhardt Bio AG and Wockhardt USA LLC; and (13) Zydus
`Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.
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`MEI 3126 1609v.1
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`4
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 4
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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 5 of 10 PageID #: 140
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`on Plaintiff. In addition, each Defendant Group may serve on Plaintiff up to 10 individualized
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`interrogatories, and Plaintiff may serve on each Defendant Group up to 10 individualized
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`interrogatories. Any additional interrogatories may only be served with leave of Court.
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`g. Depositions.
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`1.
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`Limitation on Hours for Deposition Discovery. Plaintiff is limited to 50
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`hours of taking fact deposition testimony upon oral examination per Defendant Group, including
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`testimony of former Defendant Group employees. 3 The Defendant Groups collectively are
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`limited to 130 hours of taking fact deposition testimony upon oral examination, including
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`testimony of former Plaintiff employees. Any deposition lasting less than 5 hours will count as 5
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`hours against the total time of the side taking the deposition. These hour limits on fact
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`depositions may be increased by Court order upon good cause shown. Depositions of inventors
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`of the patents-in-suit who are designated as 30(b)(6) witnesses will be limited to 10 hours per
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`inventor. Depositions of inventors of the patents-in-suit who are not designated as 30(b)(6)
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`witnesses will be limited to 7 hours per inventor. Separate and apart from these hour limits on
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`fact depositions, Plaintiff may depose each witness offered as an expert by a Defendant Group,
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`and the Defendant Groups collectively may depose each witness offered as an expert by Plaintiff.
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`If a deponent testifies wholly or substantially through an interpreter, the party taking the
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`deposition shall be permitted, on a pro rata basis, two hours of deposition time for each hour
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`spent testifying through the interpreter. For clarity, the hour limitations described in this
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`paragraph do not apply to depositions of third-parties or expert witnesses.
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`11.
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`Location of Depositions. The parties shall meet and confer regarding the
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`locations of depositions, taking into account convenience for the deponent.
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`3 To the extent the same individual is deposed for more than one Defendant Group, there shall be
`a single deposition.
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`ME I 31261609v.l
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`5
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 5
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`

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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 6 of 10 PageID #: 141
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`h. Discovery Matters and Disputes Relating to Protective Orders . Should counsel
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`find they are unable to resolve a discovery matter or a dispute relating to a protective order, the
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`parties involved in the discovery matter or protective order dispute shall contact the Court 's Case
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`Manager to schedule an in-person conference/argument. Unless otherwise ordered, by no later
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`than forty-eight hours prior to the conference/argument, the party seeking relief shall file with
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`the Court a letter, not to exceed three pages, outlining the issues in dispute and its position on
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`those issues. By no later than twenty-four hours prior to the conference/argument, any party
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`opposing the application for relief may file a letter, not to exceed three pages, outlining that
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`party' s reasons for its opposition. Should any document(s) be filed under seal, a courtesy copy
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`of the sealed document(s) must be provided to the Court within one hour of e-filing the
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`document(s).
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`If a discovery-related motion is filed without leave of the Court, it will be denied
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`without prejudice to the moving party's right to bring the dispute to the Court through the
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`discovery matters procedures set forth in this Order.
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`4.
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`Application to Court for Protective Order. Should counsel find it will be
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`necessary to apply to the Court for a protective order specifying terms and conditions for the
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`disclosure of confidential information, counsel should confer and attempt to reach an agreement
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`on a proposed form of order and submit it to the Court within twenty-one (21) days from the date
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`of this Order. Should counsel be unable to reach an agreement on a proposed form of order,
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`counsel must follow the provisions of Paragraph 3(f) abo ve.
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`Any proposed protective order must include the following paragraph:
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`Other Proceedings: By entering this order and limiting the
`disclosure of information in this case, the Court does not intend to
`preclude another court from finding that information may be
`relevant and subject to disclosure in another case. Any person or
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`MEI 3 1261609v. l
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`6
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 6
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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 7 of 10 PageID #: 142
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`party subject to this order who becomes subject to a motion to
`disclose another party's information designated as confidential
`pursuant to this order shall promptly notify that party of the motion
`so that the party may have an opportunity to appear and be heard
`on whether that information should be disclosed.
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`5.
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`Papers Filed Under Seal. When filing papers under seal, counsel shall deliver to
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`the Clerk an original and one copy of the papers. A redacted version of any sealed document
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`shall be filed electronically within seven days of the filing of the sealed document.
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`6.
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`Courtesy Copies. The parties shall provide to the Court two courtesy copies of all
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`briefs and one courtesy copy of any other document filed in support of any briefs (i.e.,
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`appendices, exhibits, declarations, affidavits etc.). This provision also applies to papers filed
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`under seal.
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`7.
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`Claim Construction Issue Identification. On or before January 24, 2020, the
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`parties shall exchange a list of those claim term(s)/phrase(s) that they believe need construction
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`and their proposed claim construction of those term(s)/phrase(s). This document will not be filed
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`with the Court. Subsequent to exchanging that list, the parties will meet and confer to prepare a
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`Joint Claim Construction Chart to be filed no later than February 14, 2020. The Joint Claim
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`Construction Chart, in Word or WordPerfect format, shall be e-mailed simultaneously with filing
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`to rga_civil@ded.uscourts.gov. The parties ' Joint Claim Construction Chart should identify for
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`the Court the term(s)/phrase(s) of the claim(s) in issue, and should include each party's proposed
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`construction of the disputed claim language with citation( s) only to the intrinsic evidence in
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`support of their respective proposed constructions. A copy of the patent(s) in issue as well as
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`those portions of the intrinsic record relied upon shall be submitted with this Joint Claim
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`Construction Chart. In this joint submission, the parties shall not provide argument.
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`ME I 31261609v. l
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`7
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 7
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`

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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 8 of 10 PageID #: 143
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`8.
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`Claim Construction Briefing. Plaintiff shall serve, but not file, their opening.
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`brief, not to exceed 20 pages, on March 20, 2020. Defendants shall serve, but not file, their
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`answering brief, not to exceed 30 pages, on May 1, 2020.4 Plaintiff shall serve, but not file, their
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`reply brief, not to exceed 20 pages, on June 5, 2020. Defendants shall serve, but not file, their
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`sur-reply brief, not to exceed 10 pages, on July 10, 2020. No later than July 17, 2020, the parties
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`shall file a Joint Claim Construction Brief. The parties shall copy and paste their unfiled briefs
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`into one brief, with their positions on each claim term in sequential order, in substantially the
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`form below.
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`JOINT CLAIM CONSTRUCTION BRIEF
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`I.
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`Agreed-upon Constructions
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`II. Disputed Constructions
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`A.
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`B.
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`[TERM l]
`1. Plaintiffs Opening Position
`2. Defendants' Answering Position
`3. Plaintiffs Reply Position
`4. Defendants' Sur-Reply Position
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`[TERM 2]
`1. Plaintiffs Opening Position
`2. Defendants' Answering Position
`3. Plaintiffs Reply Position
`4. Defendants ' Sur-Reply Position
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`4 To clarify, any Defendant Group that proposes the same claim constructions shall collectively
`serve and file joint claim construction briefs for those claim terms. If any individual Defendant
`Group(s) seeks construction of a term that other Defendant Groups do not, or has a need to assert
`a construction that is different from the other Defendant Groups, that Defendant Group(s) may
`serve a brief, not to exceed five pages, in addition to the collective joint answering claim
`construction brief, and Plaintiff will then have the right to serve separate reply briefs to those
`individual briefs, each additional brief not to exceed five pages, and the Defendant Group may
`serve a sur-reply brief not to exceed 3 pages.
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`ME I 3 1261609v.l
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`8
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 8
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`

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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 9 of 10 PageID #: 144
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`Etc. The parties need not include any general summaries of the law relating to claim
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`construction. If there are any materials that would be submitted in an appendix, the parties shall
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`submit them in a Joint Appendix.
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`9.
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`Hearing on Claim Construction/Status Conference. Beginning at 9:00 a.m. on
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`August 18, 2020, the Court will hear argument on claim construction. Absent prior approval of
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`the Court (which, if it is sought, must be done so by joint letter submission no later than the date
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`on which answering claim construction briefs are due), the parties shall not present testimony at
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`the argument, and the argument shall not exceed a total of three hours. At the same hearing, the
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`Parties will discuss the need for infringement trials .
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`10.
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`Disclosure of Expert Testimony.
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`a.
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`Expert Reports. For the party who has the initial burden of proof on the
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`subject matter, the initial Federal Rule 26(a)(2) disclosure of expert testimony is due on or before
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`January 22, 2021. Plaintiff's responsive reports, including Plaintiff's expert reports regarding
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`objective indicia of nonobviousness, and Defendants ' responsive reports are due on or before
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`March 19, 2021. Reply expert reports are due on or before May 7, 2021. No other expert reports
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`will be permitted without either the consent of all parties or leave of the Court. The parties shall
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`advise of the dates and times of their experts' availability for deposition by May 14, 2021.
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`Depositions of experts shall be completed on or before July 2, 2021 .
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`b.
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`Objections to Expert Testimony. To the extent any objection to expert
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`testimony is made pursuant to the principles announced in Daubert v. Merrell Dow Pharm., Inc.,
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`509 U.S. 579 (1993), as incorporated in Federal Rule of Evidence 702, it shall be made by
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`motion no later July 23, 2021 , unless otherwise ordered by the Court.
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`ME! 3126 1609v.l
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`9
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 9
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`..
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`'
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`Case 1:19-md-02902-RGA Document 15 Filed 08/23/19 Page 10 of 10 PageID #: 145
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`11.
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`Case Dispositive Motions. There being no issues triable to a jury in this case at
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`this time, a party may only file a motion for summary judgment if that party first obtains
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`permission from the Court to do so.
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`12.
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`Applications by Motion. Except as otherwise specified herein, any application to
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`the Court shall be by written motion. Any non-dispositive motion should contain the statement
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`required by Local Rule 7 .1 .1.
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`13 .
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`Pretrial Conference. To be detennined.
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`14. Motions in Limine. To be determined.
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`15.
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`Trial. A three-day bench trial is conditionally scheduled to begin on December
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`13, 2021.
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`16.
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`ADR Process. This matter is referred to a magistrate judge to explore the
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`possibility of alternative dispute resolution.
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`17.
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`Service By E-Mail. The parties consent to service by e-mail, in accordance with
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`Rule 5(b)(2)(E) of the Federal Rules of Civil Procedure. The parties agree that service on any
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`party by e-mail shall be made on both Delaware and Lead counsel for that party.
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`IT IS SO ORDERED this J3 day of Autrf:
`, 2019.
`~~~
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`MEI 3126 1609v.1
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`10
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`Merk Sharp & Dohme Corp. Exhibit 2006
`Mylan Pharmaceuticals Inc. v. Merk Sharp & Dohme Corp.
`IPR2020-00040
`Page 10
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