Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 1 of 14 PageID #: 438
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SALIX PHARMACEUTICALS, INC. and
`DR. FALK PHARMA GmbH,
`Plaintiffs/Counter-Defendants,
`CIVIL ACTION NO. 1:15cv109
`(Judge Keeley)
`
`v.
`
`MYLAN PHARMACEUTICALS, INC. and
`MYLAN, INC.,
`Defendants/Counter-Claimants.
`
`SCHEDULING ORDER
`
`On September 9, 2015, the parties filed their meeting report
`and proposed discovery plan. On September 23, 2015, the Court
`conducted a scheduling conference in this matter and, pursuant to
`Fed. R. Civ. P. 16(b), Fed. R. Civ. P. 26(f) and the Local Rules of
`Civil Procedure, as amended on July 20, 2010, ORDERS that the
`following table of dates and deadlines shall govern the further
`preparation of this case1:
`
`TABLE OF DATES AND DEADLINES
`OPENING EXPERT DISCLOSURE (party bearing
`May 2, 2016
`the burden of proof)
`ANSWERING EXPERT DISCLOSURE
`
`June 1, 2016
`
`As noted in this Court’s First Order and Notice Regarding
`1
`Discovery and Scheduling, the report is considered advisory only.
`Accordingly, this Court adopts the proposed discovery plan of the
`parties only to the extent noted.
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SALIX PHARMACEUTICALS, INC. and
`DR. FALK PHARMA GmbH,
`Plaintiffs/Counter-Defendants,
`CIVIL ACTION NO. 1:15cv109
`(Judge Keeley)
`
`v.
`
`MYLAN PHARMACEUTICALS, INC. and
`MYLAN, INC.,
`Defendants/Counter-Claimants.
`
`SCHEDULING ORDER
`
`On September 9, 2015, the parties filed their meeting report
`and proposed discovery plan. On September 23, 2015, the Court
`conducted a scheduling conference in this matter and, pursuant to
`Fed. R. Civ. P. 16(b), Fed. R. Civ. P. 26(f) and the Local Rules of
`Civil Procedure, as amended on July 20, 2010, ORDERS that the
`following table of dates and deadlines shall govern the further
`preparation of this case1:
`
`TABLE OF DATES AND DEADLINES
`OPENING EXPERT DISCLOSURE (party bearing
`May 2, 2016
`the burden of proof)
`ANSWERING EXPERT DISCLOSURE
`
`June 1, 2016
`
`As noted in this Court’s First Order and Notice Regarding
`1
`Discovery and Scheduling, the report is considered advisory only.
`Accordingly, this Court adopts the proposed discovery plan of the
`parties only to the extent noted.
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 1
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 2 of 14 PageID #: 439
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`REBUTTAL EXPERT DISCLOSURE
`EXPERT DISCOVERY
`DAUBERT MOTIONS
`DAUBERT RESPONSE
`COMPLETION OF FACT DISCOVERY
`PRODUCTION OF DOCUMENTS
`PLAINTIFFS PRODUCE THE IND, NDA,
`and FILE HISTORIES
`DEFENDANTS PRODUCE ANDA
`PLAINTIFFS' IDENTIFY ASSERTED
`CLAIMS
`ESI PROTOCOL AND PROTECTIVE ORDER
`SUBSTANTIAL COMPLETION OF DOCUMENT
`PRODUCTION
`MARKMAN EVENTS
`PARTIES IDENTIFY CLAIM TERMS FOR
`CONSTRUCTION
`EXCHANGE PROPOSED CONSTRUCTIONS,
`INCLUDING AN INITIAL IDENTIFICATION
`OF INTRINSIC AND EXTRINSIC EVIDENCE
`TO BE RELIED UPON
`OPENING CLAIM CONSTRUCTION BRIEFS
`RESPONSIVE CLAIM CONSTRUCTION
`BRIEFS
`CLAIM CONSTRUCTION HEARING
`
`DISPOSITIVE MOTIONS
`RESPONSE TO DISPOSITIVE MOTIONS
`REPLY TO DISPOSITIVE MOTIONS
`
`2
`
`July 1, 2016
`August 8, 2016
`August 15, 2016
`August 29, 2016
`April 1, 2016
`
`October 1, 2015
`
`October 1, 2015
`November 4, 2015
`
`October 23, 2015
`December 15, 2015
`
`December 3, 2015
`
`December 17, 2015
`
`January 14, 2016
`February 11, 2016
`
`March 9, 2016
`10:00 a.m.
`October 7, 2016
`October 28, 2016
`November 14, 2016
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 2
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 3 of 14 PageID #: 440
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`PRETRIAL MEMORANDA
`PLAINTIFF'S FINAL LIST OF WITNESSES AND
`EXHIBITS
`DEFENDANT'S FINAL LIST OF WITNESSES AND
`EXHIBITS
`OBJECTIONS TO FINAL LIST OF WITNESSES
`AND EXHIBITS
`PLAINTIFF'S INTERROGATORIES AND
`DEPOSITIONS TO BE USED AT TRIAL
`DEFENDANT'S INTERROGATORIES AND
`DEPOSITIONS TO BE USED AT TRIAL
`OBJECTIONS TO INTERROGATORIES AND
`DEPOSITIONS
`STIPULATION OF FACTS
`PROPOSED EXPERT WITNESS BIOGRAPHICAL
`SKETCHES
`DESIGNATION OF JOINT EXHIBITS
`PRETRIAL CONFERENCE/FINAL SETTLEMENT
`CONFERENCE
`BENCH TRIAL DATE
`
`February 15, 2017
`February 10, 2017
`
`February 10, 2017
`
`February 17, 2017
`
`February 10, 2017
`
`February 10, 2017
`
`February 17, 2017
`
`February 17, 2017
`February 17, 2017
`
`February 17, 2017
`February 24, 2017
`10:30 a.m.
`March 6, 2017
`9:30 a.m. (first)
`(5 days)
`EXPERT DISCLOSURES: Opening expert disclosures of
`1.
`information required by Fed. R. Civ. P. 26(a)(2)(A) and (B) for
`that issue shall be made by the party bearing the burden of proof
`to all other parties or their counsel no later than May 2, 2016.
`
`3
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 3
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 4 of 14 PageID #: 441
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`Answering disclosures required by Fed. R. Civ. P. 26(a)(2)(A)
`and (B) for that issue shall be made to all other parties or their
`counsel no later than June 1, 2016.
`All parties shall provide the disclosures required by Fed. R.
`Civ. P. 26(a)(2)(A) and (B) if the evidence is intended solely to
`contradict or rebut evidence on the same issue identified by
`another party under Fed. R. Civ. P. 26(a)(2)(B), no later than July
`1, 2016.
`The disclosures described in Fed. R. Civ. P. 26(a)(2)(B) shall
`not be required of physicians and other medical providers who
`examined or treated a party or party’s decedent unless the
`physicians or medical providers will render an expert opinion in
`the case.
`DAUBERT MOTIONS / RESPONSE: Daubert motions shall be
`2.
`filed by August 15, 2016. Any such motions must be supported by a
`memorandum at the time the motion is filed with the Clerk. Response
`to such motions shall be delivered to the Clerk with copies served
`upon opposing counsel on or before August 29, 2016. No reply to the
`response shall be filed.
` FACT AND EXPERT DISCOVERY: All fact discovery shall be
`3.
`completed by April 1, 2016. All expert discovery shall be
`
`4
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 4
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 5 of 14 PageID #: 442
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`completed by August 8, 2016. "Completed discovery" as used in Fed.
`R. Civ. P. 16(b) means that, within the time limits set, all
`discovery, objections, motions to compel, and all other motions and
`replies relating to discovery in this civil action have been filed
`and the party objecting or responding has had sufficient time under
`the Federal Rules of Civil Procedure to make responses. The term
`"all discovery" in the preceding definition of "completed
`discovery" includes the disclosures required by Fed. R. Civ. P.
`26(a)(1) and (2), but does not include the disclosures required by
`Fed. R. Civ. P. 26(a)(3).
`Parties have a continuing obligation to supplement their
`responses beyond the discovery cut-off date, as provided in Fed. R.
`Civ. P. 26(e). The parties should refer to L.R. Civ. P. 5.01, L.R.
`Civ. P. 26.01 -26.04, L.R. Civ. P. 33.01, L.R. Civ. P. 34.01, L.R.
`Civ. P. 36.01, and L.R. Civ. P. 37.01 - 37.02 for further
`instructions on discovery practice.
`The conduct of any discovery which would require a later time
`limit shall be permitted only on the order of the Court or by filed
`stipulation of the parties, and only in cases that will not be
`
`5
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 5
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 6 of 14 PageID #: 443
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`delayed for trial thereby.2 The parties should be aware that a
`stipulation to the continuance of discovery anticipates no
`discovery disputes and, therefore, this Court will not hear
`discovery disputes arising during the stipulated continuance.
`CLAIM CONSTRUCTION PRODUCTION/ANDA: The plaintiff shall
`4.
`produce the IND, NDA, and file histories no later than October 1,
`2015. Plaintiffs shall identify asserted claims by no later than
`November 4, 2015.
`The Defendants shall produce to Plaintiff samples of ANDA
`products for testing, including any amendments or supplements no
`later than October 1, 2015.
`Production of documents shall be substantially completed by no
`later than December 15, 2015.
`ESI PROTOCOL/PROTECTIVE ORDER: The parties shall submit
`5.
`their joint proposed protective order and ESI protocol to the Court
`by no later than October 23, 2015.
`
`Extension of the discovery deadline does not change the
`2
`other deadlines set forth herein nor shall it be a basis for
`seeking extension of those deadlines. In particular, the deadline
`for dispositive motions generally cannot be changed without
`affecting the trial date. In considering to extend discovery, the
`parties should give thought as to any possible impact on
`contemplated dispositive motions.
`
`6
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 6
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 7 of 14 PageID #: 444
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`CLAIM CONSTRUCTION ISSUE IDENTIFICATION: On or before
`6.
`December 3, 2015, the parties shall identify and exchange a list of
`those claim terms that they believe will likely be disputed and
`require construction. On or before December 17, 2015, the parties
`shall exchange their proposed claim constructions, including
`identification of all intrinsic and extrinsic evidence to be relied
`upon.
`
`CLAIM CONSTRUCTION BRIEFING/HEARING: The parties shall
`7.
`file their opening brief on or before January 14, 2016. Responsive
`claim construction briefs shall be filed no later than February 11,
`2016. A hearing on claim construction will be held on March 9,
`2016 at 10:00 a.m., at the Clarksburg, West Virginia point of
`holding court.
`LIMITATIONS ON DISCOVERY: The preemptive limitations on
`8.
`discovery (numbers of interrogatories, requests for admission, and
`depositions) set out in L.R. Civ. P. 26.01(c) apply to this case
`unless otherwise stipulated or ordered.
`DISPOSITIVE MOTIONS: All dispositive motions, as well as
`9.
`deposition transcripts, admissions, documents, affidavits, and any
`other such matters in support thereof, shall be filed by October 7,
`2016. Unless parties have obtained an early briefing schedule from
`
`7
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 7
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 8 of 14 PageID #: 445
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`the Court, all dispositive motions should be filed after the close
`of discovery.
`Any such motion must be supported by a memorandum at the time
`the motion is filed with the Clerk. Memoranda in opposition to
`such motions shall be delivered to the Clerk with copies served
`upon opposing counsel on or before October 28, 2016. Any reply
`memoranda shall be delivered to the Clerk with copies served upon
`opposing counsel on or before November 14, 2016. All dispositive
`motions unsupported by memoranda will be denied without prejudice.
`See L.R. Civ. P. 7.02(a).
`Factual assertions made in memoranda should be supported by
`specific references to affidavits, depositions or other documents
`made a part of the record before the Court. Copies of the
`supporting documents, or relevant portions thereof, should be
`appended to the memoranda. The parties may refer to L.R. Civ. P.
`7.02, L.R. Civ. P. 12.02 and L.R. Civ. P. 78.01 for details on
`motion practice before this Court.
`PRETRIAL MEMORANDA: A pretrial memorandum shall be
`10.
`submitted to the Court not later than February 15, 2017. The
`pretrial memorandum shall contain at least those matters provided
`for under L.R. Civ. P. 16.04(b).
`
`8
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 8
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 9 of 14 PageID #: 446
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`B.
`
`The pretrial memorandum shall contain for each party, a list
`of all witnesses who will be called at the trial:
`A.
`Each list of witnesses should include the
`witnesses' addresses and a statement of the general
`subject matter of their testimony. It is NOT
`sufficient to designate the witness simply "fact,"
`"medical," or "expert." The list must also include
`an indication in good faith of those witnesses who
`WILL be called in the absence of reasonable notice
`to opposing counsel to the contrary and of those
`witnesses who MAY be called.
`This restriction does not apply to rebuttal
`witnesses or documents when necessity cannot be
`reasonably anticipated. Furthermore, in the case of
`expert witnesses, counsel shall certify that they
`have exchanged expert reports or have otherwise
`exchanged expert information. Expert witnesses
`whose reports have not been furnished to opposing
`counsel will not be permitted to testify nor shall
`experts be permitted to testify to opinions not
`included in the reports timely furnished.
`Except for good cause shown, the Court will not
`permit any witness to testify unless with respect
`to such witness there has been complete compliance
`with all provisions of this Order and prior court
`orders.
`The witness lists submitted to this Court as part of the pre-
`trial order shall include all of a party's potential witnesses and
`exhibits and no party shall be permitted to add to these lists
`after the pretrial order is submitted to the Court. Following the
`pretrial conference, this Court shall enter the final pretrial
`order which shall be modified only to prevent manifest injustice.
`
`C.
`
`9
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 9
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 10 of 14 PageID #: 447
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`11. FINAL LIST OF WITNESSES AND EXHIBITS AND OBJECTIONS:
`Pursuant to Fed. R. Civ. P. 26(a)(3), on or before February 10,
`2017, plaintiff shall file with the Clerk a final list of those
`exhibits and witnesses that he or she actually intends to use or
`call at trial. Prior to that, he shall either forward copies of the
`proposed exhibits or make them available to all other counsel for
`examination. On or before February 10, 2017 defendant shall file
`a list of proposed exhibits to be used and witnesses to be called
`at trial after having forwarded copies of them or having them
`available for examination to all other counsel. All exhibits shall
`be appropriately marked in numerical sequence (not lettered).
`Exhibit markers may be obtained from the Clerk.
`By each of the dates set forth above, each counsel shall
`tender to the Clerk two sets (preferably in binders and on disk) of
`copies of the exhibits to be used at trial. These should be indexed
`for easy reference and each paper exhibit should be individually
`tabbed. One of the binders will be for the Court’s use and the
`other is for use by the witness. Counsel should have their own
`copy of each exhibit and should furnish opposing counsel with a
`copy of each exhibit. Original exhibits shall be submitted to the
`
`10
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 10
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 11 of 14 PageID #: 448
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`Clerk at trial and should not be tendered to the Clerk prior to
`trial.
`Any objection to any proposed witness or exhibit must be filed
`in writing no later than February 17, 2017, shall include a copy of
`the exhibit where possible, and shall include authority supporting
`the ground for objection. Failure to comply with this paragraph may
`constitute a waiver of objection or may result in the Court’s
`denying any objection to the admission of an affected exhibit or
`witness.
`INTERROGATORIES AND DEPOSITIONS TO BE USED AT TRIAL AND
`12.
`OBJECTIONS: Pursuant to Fed. R. Civ. P. 26(a)(3), on or before
`February 10, 2017, plaintiff shall file with the Clerk any
`interrogatories, answers thereto, depositions, etc., specifying the
`appropriate portions thereto that plaintiff intends to offer in
`this case. Defendant shall do the same on or before February 10,
`2017. Before designating these discovery materials, the parties
`shall meet and agree as to the elimination of all irrelevant and
`repetitive matter, and all colloquy between counsel in the
`depositions. In addition, the parties shall, in good faith, attempt
`to resolve all objections to testimony. Any objections to the
`testimony that cannot be amicably resolved and the grounds for the
`
`11
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 11
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 12 of 14 PageID #: 449
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`objections shall be filed in writing by each of the parties no
`later than February 17, 2017, or such objection shall be deemed to
`have been waived. The objections shall include appropriate
`statement of authorities in support of the party's position. This
`paragraph does not apply to discovery materials that will be used
`at trial solely in cross-examination or for impeachment.
`STIPULATION OF FACTS: Counsel are encouraged to meet and
`13.
`enter into stipulations of facts in this case and any such
`stipulation shall be reduced to writing, signed by counsel and
`filed with the Court and with opposing counsel by February 17,
`2017.
`
`14. BIOGRAPHICAL SKETCHES: Biographical sketches of any
`proposed expert witnesses shall be filed with the Court and with
`opposing counsel by February 17, 2017.
`DESIGNATION OF JOINT EXHIBITS: The parties should
`15.
`consider designating a list of joint exhibits and should file any
`list of exhibits to be jointly designated by February 17, 2017.
`PRETRIAL CONFERENCE/FINAL SETTLEMENT CONFERENCE: A pre-
`16.
`trial conference shall be held at 10:30 a.m. on February 24, 2017,
`at the Clarksburg, West Virginia point of holding court. Lead trial
`counsel for each represented party must attend. Counsel and
`
`12
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 12
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 13 of 14 PageID #: 450
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`parties should be prepared to participate fully and to discuss all
`aspects of the case, including the matters set forth in the pre-
`trial order. Persons with full authority to settle the case for
`each party shall be present in person.
`TRIAL: A bench trial in this action shall be held on
`17.
`March 6, 2017 at 9:30 a.m. at the Clarksburg, West Virginia point
`of holding court. This case is presently the first case on the
`trial docket for that week.
`SETTLEMENT AUTHORITY AND SANCTIONS: At least one of the
`18.
`attorneys for each party participating in any conference before
`trial shall have authority to make decisions as to settlement,
`stipulations and admissions on all matters that participants
`reasonably anticipate may be discussed. Counsel and parties are
`subject to sanctions for failures and lack of preparation specified
`in Fed. R. Civ. P. 16(f) and L.R. Civ. P. 37.01 respecting pre-
`trial conferences or orders.
`DEADLINES FINAL: The time limitations set forth above
`19.
`shall not be altered except as set forth in L.R. Civ. P. 16.01(f).
`All dates for submissions, deliveries and filings with the
`Clerk or the Court refer to the date the materials must be actually
`received not the mailing date.
`
`13
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 13
`
`
`
`Case 1:15-cv-00109-IMK Document 51 Filed 09/28/15 Page 14 of 14 PageID #: 451
`
`SALIX V. MYLAN
`
`1:15CV109
`
`SCHEDULING ORDER
`
`FAILURE ON THE PART OF COUNSEL TO APPEAR AT THE
`PRETRIAL CONFERENCE OR TO COMPLY WITH THE REQUIREMENTS OF
`THIS ORDER WILL SUBJECT THE PARTY OR ATTORNEY TO
`APPROPRIATE SANCTIONS UNDER THE RULES, AND MAY RESULT IN
`DISMISSAL OR STRIKING OF ALL PLEADINGS OF THE FAILING
`PARTY OR PERSON. COMPLIANCE WITH THIS ORDER INCLUDES
`TIMELY AND GOOD FAITH EFFORT BY ALL PARTIES TO MEET AND
`JOINTLY PREPARE THE FINAL PRETRIAL ORDER AND OTHER ITEMS
`DESCRIBED ABOVE.
`It is so ORDERED.
`The Court directs the Clerk to transmit copies of this
`Scheduling Order to counsel of record.
`DATED: September 28, 2015
`
`/s/ Irene M. Keeley
`IRENE M. KEELEY
`UNITED STATES DISTRICT JUDGE
`
`14
`
`Dr. Falk Ex. 2004
`Mylan v. Dr. Falk IPR2016-01386
`Page 14
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