Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 1 of 21 PageID #: 154
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`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., TEVA NEUROSCIENCE, INC., and
`YEDA RESEARCH AND DEVELOPMENT
`CO., LTD.,
`
`
`
`
`
`C.A. No. 14-1171-GMS
`
`
`
`
`
`C.A. No. 14-1172-GMS
`
`
`
`
`
`
`
`
`
`C.A. No. 14-1278-GMS
`
`
`
`Plaintiffs,
`
`
`v.
`
`
`
`SANDOZ INC. AND MOMENTA
`PHARMACEUTICALS, INC.
`
`
`Defendants.
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., TEVA NEUROSCIENCE, INC., and
`YEDA RESEARCH AND DEVELOPMENT
`CO., LTD.,
`
`
`
`Plaintiffs,
`
`
`v.
`
`
`
`DOCTOR REDDY’S LABORATORIES, LTD.
`AND DOCTOR REDDY’S LABORATORIES,
`INC.
`
`
`Defendants.
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., TEVA NEUROSCIENCE, INC., and
`YEDA RESEARCH AND DEVELOPMENT
`CO., LTD.,
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`MYLAN INC. and NATCO PHARMA LTD.,
`
`
`Plaintiffs,
`
`
`v.
`
`Defendants.
`
`
`
`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 2 of 21 PageID #: 155
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`
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`C.A. No. 14-1419-GMS
`
`C.A. No. 15-00124-GMS
`
`
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., TEVA NEUROSCIENCE, INC., and
`YEDA RESEARCH AND DEVELOPMENT
`CO., LTD.,
`
`
`
`Plaintiffs,
`
`
`v.
`
`
`
`SYNTHON PHARMACEUTICALS INC.,
`SYNTHON B.V., and SYNTHON S.R.O.
`
`Defendants.
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., TEVA NEUROSCIENCE, INC., and
`YEDA RESEARCH AND DEVELOPMENT
`CO., LTD.,
`
`
`
`Plaintiffs,
`
`
`v.
`
`
`
`AMNEAL PHARMACEUTICALS LLC,
`
` Defendant.
`
`
`AMENDED JOINT STATUS REPORT
`
`Pursuant to F.R.C.P. 16, D. Del. LR 16.1, and the Court’s January 28, 2015, and February
`
`9, 2015 Oral Orders Scheduling a Rule 16.(b) Scheduling Conference, the parties, by and
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`through their undersigned counsel, jointly submit this Amended Joint Status Report. Counsel for
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`the parties1 participated in a telephone conference pursuant to the Notice of Scheduling
`
`
`1 The Mylan defendants and Natco Pharma have each filed motions to dismiss that are currently
`pending before the Court. C.A. No. 14-1278, D.I. 12, 22. In no way is their participation in this
`report, or in the related hearing, a waiver of any of arguments regarding jurisdiction. C.A. No.
`14-1278, D.I. 13, 23, 25. Mylan and Natco maintain that this Court does not have jurisdiction
`over Mylan Inc., Mylan Pharmaceutical Inc., or Natco Pharma Ltd. for the reasons recited in its
`briefs. C.A. No. 14-1278, D.I. 13, 23, 25. Mylan and Natco understand that the other parties
`have set forth the below schedules.
`
`
`
`2
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 3 of 21 PageID #: 156
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`Conference and as required by Fed. R. Civ. P. 26(f) on February 5, 2015. The following
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`participated in telephone conferences:
`
` Shaw Keller LLP and Goodwin Procter LLP participated on behalf of Plaintiffs
`Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva
`Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively,
`“Plaintiffs”);
`
` Phillips, Goldman & Spence, P.A. and Budd Larner, P.C. participated on behalf
`of Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “DRL”);
`
` Proctor Heyman LLP and Morrison & Foerster LLP participated on behalf of
`Defendants Sandoz, Inc. and Momenta Pharmaceuticals, Inc. (collectively,
`“Sandoz”);
`
` Richards Layton & Finger, P.A. and Perkins Coie LLP participated on behalf of
`Defendants Mylan Inc., Mylan Pharmaceuticals Inc. (collectively, “Mylan”) and
`Natco Pharma Ltd. (“Natco”);
`
` Young Conaway Stargatt & Taylor, LLP and Rothwell Figg Ernst & Manbeck
`P.C. participated on behalf of Defendants Synthon Pharmaceuticals Inc., Synthon
`B.V. and Synthon s.r.o. (collectively, “Synthon”); and
`
` Duane Morris LLP participated on behalf of Defendant Amneal Pharmaceuticals
`LLC (“Amneal”).
`
`The parties attach, for the Court’s consideration, a chart summarizing the parties’
`
`scheduling proposals for this action (Exhibit A). All parties agree that the following actions
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`involving the infringement of Teva’s U.S. Patent Nos. 8,232,250 and 8,399,413—namely, Civil
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`Action Nos. 14-1171-GMS; 14-1172-GMS; 14-1278-GMS (Mylan and Natco each maintain that
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`this Court does not have jurisdiction over any of them); 14-1419-GMS; and 15-00124-GMS—
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`should be consolidated for all purposes, including trial.
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`1. Jurisdiction and Service
`
`These patent infringement suits arise under the Patent Laws of the United States, 35
`
`U.S.C. § 1 et seq. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`
`1338(a). All defendants have been served with process. Synthon, Sandoz, DRL and Amneal
`
`
`
`3
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 4 of 21 PageID #: 157
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`have consented to this Court’s jurisdiction for purposes of these actions. Mylan Inc. and Mylan
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`Pharmaceuticals Inc. filed a motion to dismiss alleging that this Court does not have personal
`
`jurisdiction over them. C.A. No. 14-1278, D.I. 12, 13, 25. Natco Pharma Ltd. also filed a
`
`motion to dismiss alleging that this Court has neither subject matter nor personal jurisdiction
`
`over it. C.A. No. 14-1278, D.I. 22, 23.
`
`2. Substance of Actions
`
`These are actions brought by Plaintiffs for alleged infringement of United States Patent
`
`No. 8,232,250 (“the ’250 patent”) and United States Patent No. 8,399,413 (“the ’413 patent”).
`
`The ’250 and ’413 patents are listed in the FDA publication “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations,” commonly referred to as “the Orange Book” (“Orange
`
`Book”), with respect to COPAXONE® 40 mg/mL injection. These actions are based on
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`Abbreviated New Drug Applications (“ANDAs”) filed with the United States Food and Drug
`
`Administration (“FDA”) that seek approval to manufacture, use, offer for sale, sell in and import
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`into the United States generic versions of COPAXONE® 40 mg/mL injection, prior to the
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`expiration of the ’250 and ’413 patents.
`
`Teva USA is the holder of New Drug Application (“NDA”) number 02-0622, approved
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`by the FDA for the use of glatiramer acetate, marketed as COPAXONE®, for the treatment of
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`patients with relapsing forms of multiple sclerosis such as relapsing-remitting multiple sclerosis.
`
`Teva’s COPAXONE® product is manufactured by Teva Pharmaceutical Industries Ltd., and
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`marketed and sold in the United States by Teva Neuroscience, Inc.
`
`These actions are based on specific ANDAs, which seek approval to manufacture, use,
`
`offer for sale, sell in and import into the United States glatiramer acetate injection, 40 mg/mL
`
`prior to the expiration of the ’250 and ’413 patents. Plaintiffs subsequently filed separate civil
`
`
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`4
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 5 of 21 PageID #: 158
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`actions against each Defendant Group2 alleging that the submission of the ANDAs were an act of
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`infringement under 35 U.S.C. § 271(e)(2)(A). Teva seeks declaratory judgment that
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`manufacture, use, sale, offer for sale, marketing, distribution, and/or importation of each ANDA
`
`Product would infringe, contribute to the infringement of, and induce the infringement of the
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`’250 and ’413 patents.
`
`Synthon, DRL, Sandoz and Amneal have answered the complaints and asserted
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`counterclaims of invalidity and noninfringement. Defendants Sandoz and Synthon filed
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`counterclaims of unenforceability due to inequitable conduct. Mylan and Natco each maintain,
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`as explained in their pending motions to dismiss, that this Court does not have jurisdiction over
`
`them. C.A. No. 14-1278, D.I. 13, 23, 25.
`
`Teva anticipates that U.S. Patent Application No. 13/770,677 will issue as U.S. Patent
`
`No. 8,969,302 (“the ’302 patent”) on March 3, 2015. Teva plans to list the ’302 patent in the
`
`Orange Book for the Copaxone® 40 mg/mL product. Teva will discuss this patent with
`
`defendants in an attempt to reach agreement on a procedure for adding it to the case.
`
`3. Identification of the Issues
`
`The legal and factual issues in dispute include at least the following: (a) the scope and
`
`construction of the claims of the patents-in-suit; (b) whether the proposed ANDA products
`
`infringe one or more claims of the patents-in-suit; and (c) whether the claims of the patents-in-
`
`suit are invalid and unenforceable. Additional issues raised include injunctive relief, whether
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`this case is exceptional pursuant to 35 U.S.C. § 285, and whether any party should be awarded its
`
`reasonable attorneys’ fees, costs and disbursements.
`
`
`2 The five current “Defendant Groups” are (a) Sandoz, (b) DRL, (c) Mylan and Natco, (d) Synthon;
`and (e) Amneal.
`
`
`
`5
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 6 of 21 PageID #: 159
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`4. Narrowing of Issues
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`At this time, the parties have reached no agreement regarding the narrowing of issues.
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`5. Relief
`
`As set forth in Plaintiffs’ Complaints, Plaintiffs request a judgment in each case that the
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`patents-in-suit are valid and enforceable. Plaintiffs also request a judgment that the submission
`
`of the relevant ANDAs was an act of infringement and that any manufacture, use, sale, offer for
`
`sale, or importation into the U.S. of the Proposed ANDA Products prior to the expiration of the
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`patents-in-suit will infringe one or more claims of the patents-in-suit. Plaintiffs further request
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`an order decreeing that the effective date of any approval of each ANDA shall be no earlier than
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`the expiration date of the patents-in-suit (including any applicable extensions), that each
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`Defendant be enjoined from the commercial manufacture, use, sale, offer for sale, and
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`importation into the U.S. of the Proposed ANDA Product prior to the expiration of the patents-
`
`in-suit, that this case is exceptional, and that fees and costs incurred in this action be awarded to
`
`Plaintiffs. In addition, Plaintiffs request an award of damages or other monetary relief to
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`compensate Plaintiffs if any Defendant engages in the commercial manufacture, use, offer to sell,
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`sale or marketing or distribution in, or importation into the United States of the relevant ANDA
`
`Product prior to the expiration of the ’250 and ’413 patents.
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`Defendants deny that Plaintiffs are entitled to this relief. Defendants request a judgment
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`in each case that the patents-in-suit are not infringed, invalid, and unenforceable. Defendants
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`oppose any request for injunctive relief that extends beyond the scope of the claims of the
`
`patents-in-suit. Defendants further request an order decreeing that this case is exceptional, and
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`that fees and costs incurred in this action be awarded to Defendants. If Teva is entitled to a 30-
`
`month stay with respect to each Defendant, the first 30-month stay would expire in February
`
`
`
`6
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 7 of 21 PageID #: 160
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`2017. All parties reserve the right to challenge the availability or length of the 30-month stay
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`under 21 U.S.C. §355(j)(5)(B)(iii) or otherwise.
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`Mylan and Natco have not filed any answer or counterclaim because as explained in their
`
`pending motions to dismiss this Court does not have jurisdiction over them. If the motions of
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`Mylan and Natco are denied the relevant defendant(s) will file answer(s) and counterclaim(s)
`
`requesting relief at that time.
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`6. Amendment of Pleadings
`
`The parties’ proposed deadline for amendment to the pleadings is set forth in Exhibit A.
`
`7. Joinder of Parties
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`The parties’ proposed deadline for joinder of additional parties is set forth in Exhibit A.
`
`8. Discovery
`
`(a)
`
`The parties anticipate that discovery will be needed regarding the infringement,
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`validity, and unenforceability of the ’250 and ’413 patents. The parties anticipate
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`needing the following forms of discovery: (i) written discovery, including but not limited
`
`to requests for documents, requests for admission, and interrogatories; (ii) depositions of
`
`fact witnesses, including but not limited to deposition testimony pursuant to Federal Rule
`
`of Civil Procedure 30(b)(6); and (iii) expert discovery, including but not limited to expert
`
`reports and depositions.
`
`(b)
`
`Given the number of defendants and the possibility of individual disputes, the
`
`parties request an increase in the number of discovery dispute teleconferences with the
`
`Court to six (6), with any further teleconferences only upon a showing of good cause.
`
`
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`7
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 8 of 21 PageID #: 161
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`(c)
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`The parties propose that they adhere to the limitations on discovery set forth in the
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`Federal Rules of Civil Procedure, the Local Rules, and the Court’s Default Standard for
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`Discovery, except that:
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`i. Requests for Admission: Plaintiffs shall be limited to forty (40) requests for each
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`Defendant Group, except for the purpose of authenticity. Each Defendant Group
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`shall be limited to forty (40) requests for admission, except for the purpose of
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`authenticity.
`
`ii.
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`Interrogatories: Plaintiffs shall be permitted to serve twenty (20) interrogatories,
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`including distinct and separate subparts, per each Defendant Group. Each Defendant
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`Group shall be permitted to serve ten (10) interrogatories, including distinct and
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`separate subparts, on Plaintiffs. Further, Defendants collectively shall be permitted to
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`serve twenty (20) common interrogatories, including distinct and separate subparts.
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`iii.
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`Fact Depositions:
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`Number of depositions:
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`1.Plaintiffs shall be permitted to take five (5) fact depositions for each
`
`defendant group. Defendants collectively shall be permitted to take up to
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`thirteen (13) fact depositions of Plaintiffs. Where multiple defendant
`
`groups seek to take the deposition of the same fact witness, the witness
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`shall be offered only once, at a time agreeable to all parties. If additional
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`depositions are needed, and if good cause is shown, the parties may take
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`additional depositions upon agreement of the parties or by leave of court.
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`30(b)(6) depositions:
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`2.Seven hours of deposition testimony taken pursuant to Federal Rule of
`
`Civil Procedure 30(b)(6) shall count as a single deposition toward the
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`
`
`8
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 9 of 21 PageID #: 162
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`deposition limit, no matter how many deposition topics are included in the
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`notice, and no matter how many witnesses are assigned by a party to
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`testify about the deposition topics. Any party may designate more than
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`one person to testify pursuant to Rule 30(b)(6). Each day of deposition
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`testimony under Rule 30(b)(6) will not be longer than seven (7) hours. If
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`a witness is presented in both an individual and Rule 30(b)(6) capacity, the
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`parties will work together to determine a reasonable length for the
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`deposition of that witness.
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`3.Notwithstanding the foregoing, the Defendants may take a Rule 30(b)(1)
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`deposition of the sole inventor of the patents-in-suit for up to ten (10)
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`hours.
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`Location of depositions:
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`4.Plaintiffs’ Proposal: Reasonable location to be determined on a witness-
`
`by-witness basis.
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`5.Defendants’ Proposal: Any party or representative (officer, director, or
`
`managing agent) of a party filing a civil action in this district court must
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`ordinarily be required, upon request, to submit to a deposition at a place
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`designated within this district, or at another location in the United States
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`convenient for the witness, subject to the ability of any foreign national to
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`obtain visa approval for entry into the United States within the deposition
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`period. Exceptions to this general rule may be made by order of the Court.
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`All parties will make reasonable requests to their respective former non-
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`U.S. employees to attend depositions in the United States.
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`
`
`9
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 10 of 21 PageID #: 163
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`Miscellaneous issues related to fact depositions that the parties agree on:
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`6.For any deposition conducted in a language other than English with use of
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`an interpreter, each hour of testimony will be counted as one half hour for
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`purposes of the limits described in Fed. R. Civ. P. 30.
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`7.The parties will discuss and work together in good faith concerning any
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`requests to adjust the length of any particular deposition in excess of the
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`limits described above. The parties each reserve their right to seek relief
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`from the Court to limit the length of any particular deposition or take
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`depositions in excess of the number and time limits described above.
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`8.For clarity, depositions of experts do not count against the limit on the
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`number of depositions of fact witnesses.
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`iv. Third-Party Subpoenas: Any party which serves a subpoena upon a third party
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`will simultaneously serve a copy of such subpoena upon every other party. Any
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`party that receives documents from a third party pursuant to a subpoena will
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`produce those documents to the other parties within ten (10) days. To the extent
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`that third party subpoenas will reveal the identity of business partners for any
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`party, the party serving the subpoena will mark the subpoena with the highest
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`level of confidentiality under the protective order in this case when it is served on
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`the other Defendants.
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`(d)
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`Electronically Stored Information: The parties will continue to meet and confer
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`on electronic discovery and electronically stored information.
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`
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`10
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 11 of 21 PageID #: 164
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`(e)
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`Protective Order: The parties agree that a protective order will be necessary due
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`to confidential business and financial information that will need to be exchanged in this action.
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`The parties expect to present a stipulated protective order to the Court for its consideration.
`
`(f)
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`Discovery Schedule: The parties’ proposed schedule for discovery and other
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`dates are set forth in Exhibit A.
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`9. Estimated Trial Length
`
`The parties estimate a five- to seven-day trial if all related actions filed in this Court are
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`consolidated for trial.
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`10. Jury Trial
`
`The parties agree that at present there are no issues triable by a jury and request a bench
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`trial in this action.
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`11. Settlement
`
`There have not been settlement discussions to date.
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`12. Mylan and Natco’s Proposal: Such other matters as counsel considered conducive
`to the just, speedy and inexpensive determination of this action.
`
`There are presently two pending motions filed in these related actions. First, Mylan
`
`Pharmaceuticals Inc. and Mylan Inc. have filed a motion to dismiss Case No. 14-1278-GMS for
`
`lack of personal jurisdiction. See Civ. No. 14-1278, D.I. 12. The motion has been fully briefed.
`
`In addition, Natco Pharma Ltd. has also filed a motion to dismiss Case No. 14-1278-GMS for
`
`lack of personal and subject matter jurisdiction. See Civ. No. 14-1278, D.I. 22. This motion will
`
`be fully briefed by February 20, 2015. Mylan and Natco submit that resolution of these motions
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`would be conducive to the just, speedy, and/or inexpensive determination of these actions.
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`
`
`
`
`11
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 12 of 21 PageID #: 165
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`13. Related Proceedings
`
`On February 7, 2015, Mylan Pharmaceuticals Inc. filed separate petitions for inter partes
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`review for each of the two patents-in-suit in this case.
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`14. Confirmation of Rule 26(f) Conference
`
`Counsel for the parties have conferred about each of the above matters.
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`
`
`12
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`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 13 of 21 PageID #: 166
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`Respectfully submitted,
`
`
`
`
`/s/ John W. Shaw
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James
`GOODWIN PROCTER LLP
`901 New York Ave. NW
`Washington, DC 20001
`(202) 346-4000
`
`Attorneys for Plaintiffs Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries,
`Ltd., Teva Neuroscience, Inc. and Yeda (Case
`Nos. 14-cv-1172, 14-cv-1278 and 14-cv-1419)
`
`
`
`
`
`
`
`Dated: March 3, 2015
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 14 of 21 PageID #: 167
`
`
`
`/s/ Stephen B. Brauerman
`Richard D. Kirk (rk0922)
`Stephen B. Brauerman (sb4952)
`Vanessa R. Tiradentes (vt5398)
`Sara E. Bussiere (sb5725)
`BAYARD, P.A.
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302) 655-5000
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James
`GOODWIN PROCTER LLP
`901 New York Ave. NW
`Washington, DC 20001
`(202) 346-4000
`
`Attorneys for Plaintiffs Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries,
`Ltd., Teva Neuroscience, Inc. and Yeda (Case
`No. 14-cv-1171)
`
`
`
`
`
`
`
`
`
`
`

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`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 15 of 21 PageID #: 168
`
`/s/ David A. Bilson
`John C. Phillips, Jr. (No. 110)
`David A. Bilson (No. 4986)
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`1200 North Broom Street
`Wilmington, DE 19806
`jcp@pgslaw.com
`dab@pgslaw.com
`
`Constance S. Huttner
`Beshoy M. Sharoupim
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 315-4430
`
`Attorneys for DRL Defendants
`
`/s/ Dominick T. Gattuso
`Dominick T. Gattuso (No. 3630)
`PROCTOR HEYMAN LLP
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`DGattuso@proctorheyman.com
`
`Rachel Krevans
`Matthew I. Kreeger
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105-2482
`(415) 268-7000
`
`Grant J. Esposito
`David J. Austin
`MORRISON & FOERSTER LLP
`250 West 55th Street
`New York, NY 10019-9601
`(212) 468-8000
`
`Brian M. Kramer
`MORRISON & FOERSTER LLP
`12531 High Bluff Drive, Suite 100
`San Diego, California 92130-2040
`(858) 720-5100
`
`Attorneys for Defendants Sandoz Inc.
`and Momenta Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 16 of 21 PageID #: 169
`
`
`
`/s/ Frederick L. Cottrell, III
`Frederick L. Cottrell, Ill (No. 2555)
`RICHARDS, LAYTON, & FINGER, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`Cottrell@rlf.com
`
`Shannon M. Bloodworth
`PERKINS COIE LLP
`700 13th St. NW
`Washington, DC 20005
`Telephone: (202) 654-6204
`
`Attorneys for Mylan Inc., Mylan
`Pharmaceuticals Inc. and Natco Pharma Ltd.
`
`
`
`
`
`
`
`/s/ Robert M. Vrana
`Melanie K. Sharp (No. 2501)
`Robert M. Vrana (No. 5666)
`Samantha G. Wilson (No. 5816)
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6681
`msharp@ycst.com
`
`E. Anthony Figg
`Sharon L. Davis
`R. Elizabeth Brenner-Leifer
`Seth E. Cockrum
`Jennifer Nock
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`(202) 783-6040
`
`Attorneys for Synthon Pharmaceuticals Inc.,
`Synthon B.V, and Synthon s.r.o.
`
`
`
`
`
`
`
`
`
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 17 of 21 PageID #: 170
`
`s/ Richard L. Renck
`Richard L. Renck (No. 3893)
`DUANE MORRIS LLP
`222 Delaware Avenue, Suite 1600
`Wilmington, DE 19801-1659
`(302) 657-4900
`
`Anthony J. Fitzpatrick
`Vincent L. Capuano, Ph.D.
`Christopher S. Kroon
`Carolyn A. Alenci
`DUANE MORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`(857) 488-4200
`
`Attorneys for Amneal Pharmaceuticals LLC
`
`
`
`
`
`
`
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 18 of 21 PageID #: 171
`
`Exhibit A
`
`
`
`
`
`
`
`
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 19 of 21 PageID #: 172
`
`TEVA’S PROPOSED
`DATES
`February 5, 2015
`
`DEFENDANTS’
`PROPOSED DATE
`February 5, 2015
`
`
`
`Item
`
`Joint Status Report
`
`Amended Joint Status Report
`
`March 3, 2015
`
`Rule 16.2b Scheduling Conference
`
`March 6, 2015
`
`Rule 26(a) Initial Disclosures
`
`Initial Disclosures pursuant to
`Paragraph 3 of the default standard
`for electronic discovery
`
`Parties to produce their respective
`ANDAs and NDAs, including
`amendments and supplements, and
`bases for approval.
`
`Plaintiff Shall Specifically Identify
`the Accused Product(s) and the
`asserted patent(s) they allegedly
`infringe, and Produce the File
`History for Each Asserted Patent
`
`Each defendant shall produce to
`the plaintiff the core technical
`documents related to the accused
`product(s), including but not
`limited to operation manuals,
`product literature, schematics, and
`specifications
`
`Deadline for Motions to Join
`Parties
`
`Plaintiffs shall produce to each
`defendant an initial claim chart
`relating each accused product to
`the asserted claims each product
`allegedly infringes
`
`Substantial Completion of
`Document Production Deadline
`
`
`
`March 3, 2015
`
`March 6, 2015
`
`March 13, 2015
`
`March 13, 2015
`
`March 13, 2015
`
`March 13, 2015
`
`None
`
`March 18, 2015
`
`March 13, 2015
`
`March 13, 2015
`
`April 13, 2015
`
`April 13, 2015
`
`None
`
`April 30, 2015
`
`May 13, 2015
`
`May 13, 2015
`
`None
`
`June 5, 2015
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 20 of 21 PageID #: 173
`
`TEVA’S PROPOSED
`DATES
`June 12, 2015
`
`DEFENDANTS’
`PROPOSED DATE
`June 12, 2015
`
`January 22, 2016
`
`June 26, 2015
`
`July 17, 2015
`
`July 24, 2015
`
`August 3, 2015
`
`June 26, 2015
`
`July 17, 2015
`
`July 24, 2015
`
`August 14, 2015
`
`August 14, 2015
`
`September 11, 2015
`
`September 11, 2015
`
`October 2, 2015
`
`October 2, 2015
`
`October 2, 2015
`
`October 2, 2015
`
`Item
`
`
`
`Each defendant shall produce to
`the plaintiffs its initial invalidity
`contentions for each asserted
`claim, as well as the related
`invalidating references (e.g.,
`publications, manuals and patents)
`
`Fact Discovery Completed
`
`Exchange Proposed Terms for
`Claim Construction
`
`Exchange Proposed Constructions
`
`Meet and Confer regarding Claim
`Terms for Construction
`
`File Final Joint Claim Construction
`Statement
`
`File Opening Claim Construction
`Briefs
`
`File Answering Claim
`Constructions Briefs
`
`Joint Appendix of Intrinsic
`Evidence
`
`Markman Hearing
`
`October __, 2015
`
`October __, 2015
`
`November 13, 2015
`
`November 13, 2015
`
`March 4, 2016
`
`April 8, 2016
`
`September 25, 2015
`
`October 23, 2015
`
`May 6, 2016
`
`November 19, 2015
`
`Deadline to File Motions to
`Amend Pleadings
`
`Opening Expert Reports
`
`Rebuttal Expert Reports (including
`Plaintiffs’ presentation of
`Objective Indicia of
`Nonobviousness)
`
`Reply Expert reports (limited to
`Objective Indicia of
`Nonobviousness)
`
`
`
`

`
`Case 1:14-cv-01171-GMS Document 18 Filed 03/03/15 Page 21 of 21 PageID #: 174
`
`TEVA’S PROPOSED
`DATES
`June 30, 2016
`
`DEFENDANTS’
`PROPOSED DATE
`January 21, 2016
`
`30 days before Pre-Trial
`Conference
`
`30 days before Pre-Trial
`Conference
`
`September __, 2016 (or at
`the convenience of the
`Court)
`
`October __, 2016 (or at the
`convenience of the Court)
`
`March 2016 (or at the
`convenience of the Court)
`
`Mid-March to Mid-April
`2016 (or at the convenience
`of the Court)
`
`30 days following
`completion of trial
`
`30 days following
`completion of trial
`
`Item
`
`
`
`Expert Discovery Completed
`
`Submission of Joint Pretrial Order
`
`Pre-trial Conference
`
`Trial
`
`Post-Trial Briefs
`
`Expiration of FDA Exclusivity
`
`January 28, 2017
`
`N/A
`
`Expiration of 30 Month Stay3
`
`
`
`DRL: Feb. 6, 2017
`Sandoz: Feb. 28, 2017
`Mylan: Feb. 28, 2017
`Synthon: Apr. 9, 2017
`Amneal: July 26, 2017
`
`DRL: Feb. 6, 2017
`Sandoz: Feb. 28, 2017
`Mylan: Feb. 28, 2017
`Synthon: Apr. 9, 2017
`Amneal: July 26, 2017
`
`
`3 All parties reserve the right to challenge the availability or length of the 30-month stay under 21 U.S.C.
`§355(j)(5)(B)(iii) or otherwise.