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Rule 16 Scheduling Order - ANDA — Magistrate Judge Eleanor G Tennyson

D. Del. Judge Practices (Magistrate Judge Eleanor G Tennyson) · Magistrate Judge Eleanor G Tennyson

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE [PLAINTIFF], ) ) Plaintiff, ) ) v. ) C.A. No. 00-0000 (EGT) ) [DEFENDANT], ) ) Defendant. ) [PROPOSED] SCHEDULING ORDER [PATENT, ANDA] This day of , 20_____, [the Court having conducted an initial scheduling conference pursuant to Local Rule 16.1(b), and] the parties having determined after discussion that the matter cannot be resolved at this juncture by settlement, voluntary mediation or binding arbitration; IT IS HEREBY ORDERED that: 1. Rule 26(a)(l) Initial Disclosures and E-Discovery Default Standard. Unless otherwise agreed to by the parties, the parties shall make their initial disclosures pursuant to Federal Rule of Civil Procedure 26(a)(l) within five (5) days of the date this Order is entered by the Court. If they have not already done so, the parties are to review the Court’s Default Standard for Discovery, Including Discovery of Electronically Stored Information (“ESI”), which is posted at https://www.ded.uscourts.gov (see Other Resources, Default Standard for Discovery) and is incorporated herein by reference. 2. Joinder of Other Parties and Amendment of Pleadings. All motions to join other parties, and to amend or supplement the pleadings, shall be filed on or before [DATE]. Unless otherwise ordered by the Court, any motion to join a party or motion to amend the pleadings shall be made pursuant to the procedures set forth in Paragraphs 8(g) and 9 below. 3. Application to Court for Protective Order. Should counsel find it will be necessary to apply to the Court for a protective order specifying terms and conditions for the disclosure of confidential information, counsel should confer and attempt to reach an agreement on a proposed form of order and submit it to the Court within ten (10) days from the date the Court enters this Order. If counsel are unable to reach an agreement on a proposed form of protective order, counsel must follow the provisions of Paragraph 8(g) below. Any proposed protective order must include the following paragraph: 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 party subject to this order who becomes subject to a motion to disclose another party’s information designated “confidential” [the parties should list any other level of designation, such as “highly confidential,” which may be provided for in the protective order] 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. 4. Papers Filed Under Seal. In accordance with section G of the Revised Administrative Procedures Governing Filing and Service by Electronic Means, a redacted version of any sealed document must be filed electronically within seven (7) days of the filing of the sealed document. Should any party intend to request to seal or redact all or any portion of a transcript of a court proceeding (including a teleconference), such party should expressly note that intent at the start of the court proceeding. Should any party subsequently choose to make a request for sealing or redaction, it must, promptly after the completion of the transcript, file with the Court a motion for sealing/redaction, and include as attachments (1) a copy of the complete transcript highlighted so the Court can easily identify and read the text proposed to be sealed/redacted and (2) a copy of the proposed redacted/sealed transcript. With such request, the party seeking redactions must 2 demonstrate why good cause exists for the redactions and why disclosure of the redacted material would work a clearly defined and serious injury to the party seeking redaction. 5. Courtesy Copies. The parties shall provide to the Court two (2) courtesy copies of all briefs and any other document filed in support of any briefs (i.e., appendices, exhibits, declarations, affidavits, etc.). This provision also applies to papers filed under seal. All courtesy copies shall be double-sided. Exhibits and attachments must be separated by tabs, and the parties should highlight the portions of the exhibits and attachments that they wish the Court to read. 6. ADR Process. This matter is NOT referred to a magistrate judge to explore the possibility of alternative dispute resolution. 7. Disclosures. Absent agreement among the parties and approval of the Court: (a) Identification of Accused Products and Asserted Patents. On or before [DATE], Plaintiff shall identify the accused product(s) [or method(s)] and asserted patent(s). On the same date, Plaintiff shall also produce the prosecution history for each asserted patent. (b) ANDA [or NDA] and Related Documents. On or before [DATE], Defendant shall produce the Abbreviated New Drug Application(s) [or New Drug Application(s) under 355 U.S.C. § 355(b)(2)], including any amendments, supplements or FDA correspondence relating thereto, that form the basis of the infringement allegations in this litigation, as well as any Drug Master Files. (c) Infringement Contentions. On or before [DATE], Plaintiff shall provide its initial infringement contentions for each asserted claim. On or before [DATE], Defendant shall provide its initial non-infringement contentions in response to Plaintiff’s initial contentions. On or before [DATE], Plaintiff shall provide its final infringement contentions. On or before [DATE], 3 Defendant shall provide its final non-infringement contentions in response to Plaintiff’s final contentions. (d) Invalidity Contentions. On or before [DATE], Defendant shall provide its initial invalidity contentions for each asserted claim and the related invalidating references. On or before [DATE], Plaintiff shall provide its initial validity contentions in response to Defendant’s initial contentions. On or before [DATE], Defendant shall provide its final invalidity contentions. On or before [DATE], Plaintiff shall provide its final validity contentions in response to Defendant’s final contentions. (e) All final contentions (i.e., infringement, non-infringement, invalidity, validity) must include a party’s contentions under its proposed claim construction(s), as well as under the opposing claim construction(s) (if such an alternative contention exists). 8. Discovery. Unless otherwise ordered by the Court or agreed to by parties, the limitations on discovery set forth in the Federal Rules shall be strictly observed. (a) Fact Discovery Cutoff. All fact discovery in this case shall be initiated so that it will be completed on or before [DATE]. (b) Document Production. Document production shall be substantially complete by [DATE]. (c) Requests for Admission. A maximum of ___ requests for admission are permitted for each side. (d) Interrogatories. (i) A maximum of ___ interrogatories, including contention interrogatories, are permitted for each side. 4 (ii) The Court encourages the parties to serve and respond to contention interrogatories early in the case. In the absence of agreement among the parties, contention interrogatories, if served, shall first be addressed by the party with the burden of proof. The adequacy of all interrogatory answers shall be judged by the level of detail each party provides (i.e., the more detail that a party provides, the more detail the party shall receive). (e) Depositions. (i) Limitation on Hours for Deposition Discovery. Each side is limited to a total of ___ hours of taking testimony by deposition upon oral examination. (ii) Location of Depositions. Any party or representative (officer, director, or managing agent) of a party filing a civil action in this district court must ordinarily be required, upon request, to submit to a deposition at a place designated within this district. Exceptions to this general rule may be made by order of the Court. A defendant who becomes a counterclaimant, cross-claimant, or third-party plaintiff shall be considered as having filed an action in this Court for the purpose of this provision. (f) Disclosure of Expert Testimony. (i) Expert Reports. For the party who has the initial burden of proof on the subject matter, the initial Federal Rule of Civil Procedure 26(a)(2) disclosure of expert testimony is due on or before [DATE]. The supplemental disclosure to contradict or rebut evidence on the same matter identified by another party is due on or before [DATE]. Reply expert reports from the party with the initial burden of proof are due on or before [DATE]. No other expert reports will be permitted without either the consent of all parties or leave of the Court. Along with the submissions of the expert reports, the parties shall advise of the dates and times of their experts’ availability for deposition. 5 (ii) Expert Report Supplementation. The parties agree that they [will] [will not] permit expert declarations to be filed in connection with motions briefing. (iii) Objections to Expert Testimony. To the extent that any objection to expert testimony is made pursuant to the principles announced in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), as incorporated in Federal Rule of Evidence 702, it shall be made by motion no later than fourteen (14) days after the close of expert discovery, unless otherwise ordered by the Court. Briefing will be presented pursuant to the Court’s Local Rules. (iv) Expert Discovery Cutoff. All expert discovery in this case shall be initiated so that it will be completed on or before [DATE]. (g) Discovery Matters and Disputes Relating to Protective Orders. (i) Any discovery motion filed without first complying with the following procedures will be denied without prejudice to renew pursuant to these procedures. (ii) Should counsel find that, after reasonable efforts pursuant to Local Rule 7.1.1, they are unable to resolve a discovery matter or a dispute relating to a protective order, the moving party (i.e., the party seeking relief from the Court) should file a Motion for Teleconference to Resolve a Discovery or Protective Order Dispute. The text for this motion can be found in the “Forms” section of Magistrate Judge Tennyson’s portion of the Court’s website. (iii) After reviewing the motion, the Court will issue an order setting a discovery conference and outlining the specific dispute procedure to be used. On the date set by court order, generally not less than seventy-two (72) hours prior to the conference, the party seeking relief shall file with the Court a letter not to exceed three (3) pages in 12-point font outlining the issues in dispute and that party’s position on those issues. This submission shall include as exhibits (1) a proposed order that identifies with specificity the relief sought on an issue- 6 by-issue basis and (2) copies of any discovery requests and responses relating to the dispute. On the date set by court order, generally not less than forty-eight (48) hours prior to the conference, any party opposing the application for relief may file a letter not to exceed three (3) pages in 12- point font outlining that party’s reason for its opposition. (iv) Should the Court find further briefing necessary upon conclusion of the conference, the Court will order it. Alternatively, the Court may choose to resolve the dispute prior to the conference and will, in that event, cancel the conference. 9. Motions to Amend / Motions to Strike. (a) Any motion to amend (including a motion for leave to amend) a pleading or any motion to strike any pleading or other document shall be made pursuant to the discovery dispute procedure set forth in Paragraph 8(g) above. (b) Any such motion shall attach the proposed amended pleading (as well as a “redline” comparison to the prior pleading) or the document proposed to be stricken. 10. Technology Tutorials. Although technology tutorials are not required by the Court, they are appreciated and, if any party chooses to file such a tutorial, it shall be submitted on or before the date that the joint claim construction brief is filed. 11. Claim Construction Issue Identification. On [DATE], the parties shall exchange a list of claim term(s)/phrase(s) that they believe need construction and their proposed claim construction of those term(s)/phrase(s). This document will not be filed with the Court. Subsequent to exchanging that list, the parties will meet and confer to prepare a joint claim construction chart to be submitted two weeks prior to service of the opening claim construction brief. The parties’ joint claim construction chart must identify for the Court the term(s)/phrase(s) of the claim(s) at issue and must include each party’s proposed construction of the disputed claim 7 language with citation(s) only to the intrinsic evidence in support of their respective proposed constructions. All joint claim construction charts shall be in substantially the same form as the sample joint claim construction chart found in the “Forms” section of Magistrate Judge Tennyson’s portion of the Court’s website. Intrinsic evidence (including copies of the patent(s) at issue) shall NOT be attached to the joint claim construction chart and, instead, the parties shall include a joint appendix with the joint claim construction brief, and the joint appendix shall include a copy of the patent(s) at issue and portions of all relevant intrinsic evidence, as well as any additional evidence cited in the parties’ briefing. 12. Claim Construction Briefing. Plaintiff shall serve, but not file, its opening brief, not to exceed 20 pages, on [DATE]. Defendant shall serve, but not file, its answering brief, not to exceed 30 pages, on [DATE]. Plaintiff shall serve, but not file, its reply brief, not to exceed 20 pages, on [DATE]. Defendant shall serve, but not file, its sur-reply brief, not to exceed 10 pages, on [DATE]. No later than [DATE], the parties shall file a joint claim construction brief. The parties shall copy and paste their unfiled briefs into one brief, with their positions on each claim term in sequential order, in substantially the form below. If the joint brief as submitted is more than 80 pages, the parties must certify that the page limits in the Scheduling Order have not been violated and provide a brief explanation (e.g., formatting issues, listing of agreed-upon terms, etc.) as to why the brief is longer than 80 pages. JOINT CLAIM CONSTRUCTION BRIEF I. Agreed-Upon Constructions II. Disputed Constructions [TERM 1] 1. Plaintiff’s Opening Position 2. Defendant’s Answering Position 8 3. Plaintiff’s Reply Position 4. Defendant’s Sur-Reply Position [TERM 2] 1. Plaintiff’s Opening Position 2. Defendant’s Answering Position 3. Plaintiff’s Reply Position 4. Defendant’s Sur-Reply Position The parties should not include any general summaries of the law relating to claim construction. If there are any materials that would be submitted in an index, the parties shall submit them in a joint appendix accompanying the joint claim construction brief. 13. Hearing on Claim Construction. Beginning at __________ on [DATE], the Court will hear argument on claim construction. The parties need not include any general summaries of the law relating to claim construction in their presentations to the Court. On or before the date on which the joint claim construction brief is filed, the parties shall file a joint letter indicating the amount of time they are requesting for the hearing and whether they are requesting leave to present testimony at the hearing. 14. Case Dispositive Motions. Absent agreement between the parties and prior approval from the Court, the Court will not hear case dispositive motions in ANDA cases. 15. Applications by Motion. Except as otherwise specified herein, any application to the Court shall be by written motion. Any non-dispositive motion must contain the statement required by Local Rule 7.1.1. 16. Motions in Limine. Motions in limine shall not be separately filed. All in limine requests and responses thereto shall be set forth in the proposed pretrial order. Each SIDE shall be limited to three (3) in limine requests, unless otherwise permitted by the Court. The in limine 9 request and any response shall contain the authorities relied upon; each in limine request may be supported by a maximum of three (3) pages of argument, may be opposed by a maximum of three (3) pages of argument, and the side making the in limine request may add a maximum of one (l) additional page in reply in support of its request. If more than one party is supporting or opposing an in limine request, such support or opposition shall be combined in a single three (3) page submission (and, if the moving party, a single one (1) page reply). No separate briefing shall be submitted on in limine requests unless otherwise permitted by the Court. 17. Pretrial Conference. On [DATE], the Court will hold an in-person pretrial conference with counsel beginning at ____. Not later than seven (7) days before the pretrial conference, the parties shall file a joint proposed final pretrial order in compliance with Federal Rule of Civil Procedure 26(a)(3) and Local Rule 16.3(c) & (d)(4). Unless otherwise ordered by the Court, the parties shall comply with the timeframes set forth in Local Rule 16.3(d) for the preparation of the joint proposed final pretrial order. The parties shall provide the Court two (2) double-sided courtesy copies of the joint proposed final pretrial order and all attachments. The proposed final pretrial order shall contain a table of contents and the paragraphs must be numbered. 18. Trial. This matter is scheduled for a ______ day bench trial beginning at 9:30 a.m. on [DATE], with the subsequent trial days beginning at 9:00 a.m. The trial will be timed, as counsel will be allocated a total number of hours in which to present their respective cases. 19. Post-Trial Briefing. The parties will address the post-trial briefing schedule and page limits in the proposed final pretrial order. UNITED STATES MAGISTRATE JUDGE 10
Official source: https://www.ded.uscourts.gov/sites/ded/files/chambers/Rule%2016%20Scheduling%20Order%20-%2 · retrieved 2026-07-23