Patent Trial and Appeal Board
`Consolidated Trial Practice Guide
`November 2019
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`ALKERMES EXHIBIT 2001
`Apotex Inc. v. Alkermes Pharma Ireland Limited
`IPR2025-00514
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`TRIAL PRACTICE GUIDE
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`NOVEMBER 2019 EDITION
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`Introduction ............................................................................................................................. 1
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`Background ........................................................................................................................... 2
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`Statutory Requirements ......................................................................................................... 3
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`General Overview of Proceedings ........................................................................................ 5
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`Sequence of discovery ...................................................................................................... 7
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`Sequence of filing responses and motions ........................................................................ 8
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`Summary of the Rules ........................................................................................................... 8
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`I. General Procedures ........................................................................................................ 8
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`A. Jurisdiction and Management of the Record ............................................................... 8
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`1. Jurisdiction ............................................................................................................... 8
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`2. Prohibition on Ex Parte Communications. .............................................................. 9
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`Arranging a conference call with the Board ................................................................. 9
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`Refusal to participate .................................................................................................. 10
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`B. Counsel ...................................................................................................................... 10
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`Need for lead and back-up counsel ............................................................................. 10
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`Power of attorney ........................................................................................................ 10
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`Pro hac vice ................................................................................................................. 11
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`C. Electronic Filing ........................................................................................................ 11
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`D. Mandatory Notices .................................................................................................... 12
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`1. Real Party-in-Interest or Privy ................................................................................ 12
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`2. Related Matters ...................................................................................................... 18
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`3. Identification of service information. .................................................................... 18
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`E. Public Availability and Confidentiality ..................................................................... 19
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`1. Public availability .................................................................................................. 19
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`2. Confidential information ........................................................................................ 19
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`3. Motion to seal ........................................................................................................ 19
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`4. Protective orders .................................................................................................... 19
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`5. Confidential information in a petition .................................................................... 20
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`6. Expungement of confidential information ............................................................. 21
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`7. Derivation .............................................................................................................. 22
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`F. Discovery ................................................................................................................... 22
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`1. Routine discovery .................................................................................................. 23
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`(a) Inconsistent statements ...................................................................................... 23
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`(b) Witness expenses............................................................................................... 23
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`(c) Document Translation ....................................................................................... 24
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`2. Additional discovery .............................................................................................. 24
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`3. Compelled testimony ............................................................................................. 29
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`4. Mandatory Initial Disclosures ................................................................................ 29
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`5. Live testimony ....................................................................................................... 31
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`6. Times and locations for witness cross-examination .............................................. 32
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`7. E-discovery ............................................................................................................ 33
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`G. Expert Testimony ...................................................................................................... 34
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`II. Petitions and Motions Practice .................................................................................. 37
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`A. General Motions Practice Information ...................................................................... 37
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`1. Motions practice..................................................................................................... 37
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`2. Prior authorization ................................................................................................. 37
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`3. Word Count and Page Limits ................................................................................. 38
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`4. Testimony Must Disclose Underlying Facts or Data ............................................. 40
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`5. Tests and Data ........................................................................................................ 41
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`6. Objective Indicia of Nonobviousness .................................................................... 41
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`B. Petition ...................................................................................................................... 41
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`1. Filing date – Minimum Procedural Compliance. ................................................... 41
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`2. Burden of Proof for Statutory Institution Thresholds ............................................ 42
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`3. Specific Requirements for Petition ........................................................................ 42
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`4. Covered Business Method/Technological Invention ............................................. 42
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`5. Claim Charts .......................................................................................................... 44
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`6. Claim Construction ................................................................................................ 44
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`C. Patent Owner Preliminary Response ......................................................................... 49
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`D. Institution of Trial ..................................................................................................... 53
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`1. Statutory Threshold Standards ............................................................................... 53
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`2. Considerations in Instituting a Review .................................................................. 55
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`35 U.S.C. §§ 314(a), 324(a) .................................................................................... 55
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`Parallel Petitions Challenging the Same Patent. ..................................................... 59
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`35 U.S.C. § 325(d). ................................................................................................. 61
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`3. Content of Decision on Whether to Institute ......................................................... 64
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`4. Scheduling Order ................................................................................................... 65
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`E. Initial Conference Call (One Month after Instituting Trial, if Requested) ................ 65
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`F. Patent Owner Response ............................................................................................. 65
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`G. Motions to Amend .................................................................................................... 66
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`1. IPR, PGR, and CBM Amendments........................................................................ 66
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`Motion to Amend ........................................................................................................ 66
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`Motion to Amend Practice .......................................................................................... 67
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`Due Date ..................................................................................................................... 67
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`Evidentiary Standards ................................................................................................. 67
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`Contents of Motion to Amend .................................................................................... 69
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`Claim Construction ..................................................................................................... 70
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`2. Amendments in Derivation Proceedings ............................................................... 70
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`3. General Practice Tips on Amendments.................................................................. 71
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`H. Opposition to a Motion to Amend ............................................................................ 72
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`I. Reply to Patent Owner Response and Reply to Petitioner Opposition to a Motion to
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`Amend; Sur-replies ......................................................................................................... 73
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`J. Other Motions............................................................................................................. 75
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`Motions for Joinder. .................................................................................................... 76
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`K. Challenging Admissibility; Motions to Exclude; Motions to Strike......................... 78
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`Motions to Exclude ..................................................................................................... 79
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`Motions to Strike......................................................................................................... 80
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`L. [DELETED] .............................................................................................................. 81
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`M. Oral Hearing ............................................................................................................. 81
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`Special equipment or needs ........................................................................................ 83
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`Demonstrative exhibits ............................................................................................... 84
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`Live testimony ............................................................................................................ 85
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`No new evidence and arguments ................................................................................ 85
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`N. Settlement.................................................................................................................. 86
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`O. Final Decision ........................................................................................................... 86
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`Remands. ..................................................................................................................... 87
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`P. Rehearing Requests ................................................................................................... 90
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`APPENDIX A-1: Sample Scheduling Order for Inter partes Review, Post-Grant
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`Review, and Covered Business Method Patents Review (based on the trial rules). ....... 91
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`APPENDIX A-2: Sample Scheduling Order for Derivation Proceedings ...................... 99
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`APPENDIX B: Protective Order Guidelines (based on the trial rules) ........................ 107
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`APPENDIX C: Model Order Regarding E-Discovery in Trials Before The Patent Trial
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`and Appeal Board ............................................................................................................... 123
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`APPENDIX D: Testimony Guidelines ............................................................................. 127
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`Introduction
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`This consolidated Office Patent Trial Practice Guide (“Practice Guide”) incorporates the
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`updates from August 2018 and July 2019 into the original August 2012 Practice Guide.
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`In August 2012, the Office published the Practice Guide, concurrent with the promulgation
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`of the AIA Trial Rules. See 77 Fed. Reg. 48,756 (Aug. 14, 2012). The Practice Guide
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`apprised the public of standard practices before the Board during AIA trial proceedings,
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`including inter partes reviews, post-grant reviews, covered business method reviews, and
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`derivation proceedings. The Practice Guide also encouraged consistency of procedures
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`among panels of the Board.
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`The Office has updated the Practice Guide to take into account stakeholder feedback, lessons
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`learned during the years since the first AIA trial, and the natural evolution of the Board’s
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`practices. A first update to the Practice Guide was published on August 13, 2018, and a
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`second update was published on July 16, 2019. This edition incorporates the updates from
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`August 2018 and July 2019 into the original August 2012 Practice Guide so that the most
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`recent versions of all sections of the Practice Guide are available in a single document. It
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`also makes revisions to ensure consistency across the newly consolidated guide. Revisions to
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`reconcile updates and to reflect the Board’s current practices relate to institution of trial after
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`SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018); use of sur-replies in lieu of observations;
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`how parties may contact the Board to request an initial conference call; use of word counts;
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`updates to the sample scheduling order for derivation proceedings; and updates to the default
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`protective order. The Office anticipates making further updates, if needed, on an annual
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`basis. Suggestions regarding the Practice Guide can be sent to
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`PTABAIATrialSuggestions@uspto.gov.
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`Background: The Leahy-Smith America Invents Act (AIA) establishes several new trial
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`proceedings to be conducted by the Board including: (1) inter partes review (IPR); (2) post-
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`grant review (PGR); (3) a transitional program for covered business method patents (CBM);
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`and (4) derivation proceedings. The AIA requires the Office to promulgate rules for the
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`proceedings, with the PGR, IPR, and CBM rules to be in effect one year after AIA enactment
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`(September 16, 2012) and the derivation rules to be in effect 18 months after AIA enactment
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`(March 16, 2013).
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`Consistent with the statute, the Office published a number of notices of proposed rulemaking
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`in February of 2012, and requested written comments on the Office’s proposed
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`implementation of the new trial proceedings of the AIA. The Office also hosted a series of
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`public educational roadshows, across the country, regarding the proposed rules. The
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`resulting patent trial regulations lay out a framework for conducting the proceedings aimed at
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`streamlining and converging the issues for decision. In doing so, the Office’s goal is to
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`conduct proceedings in a timely, fair, and efficient manner. Further, the Office has designed
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`the proceedings to allow each party to determine the preferred manner of putting forward its
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`case, subject to the guidance of judges who determine the needs of a particular case and issue
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`procedural and substantive rulings throughout the proceedings.
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`Additionally, the Office published a practice guide based on the proposed trial rules in the
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`Federal Register to provide the public an opportunity to comment. Practice Guide for
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`Proposed Trial Rules, 77 Fed. Reg. 6868 (Feb. 9, 2012) (Request for Comments). In light of
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`the public comments and the final rules, the Office published the original August 2012
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`Practice Guide. Office Patent Trial Practice Guide; Rule, 77 Fed. Reg. 48,756 (Aug. 14,
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`2012). This Practice Guide is intended to advise the public on the general framework of the
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`rules, including the structure and times for taking action in each of the AIA proceedings.
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`Statutory Requirements: The AIA provides certain minimum requirements for each of the
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`proceedings. Provided below is a brief overview of these requirements.
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`Proceedings begin with the filing of a petition to institute a trial. The petition must be filed
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`with the Board consistent with any time period required by statute and be accompanied by
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`the evidence the petitioner seeks to rely upon. See, e.g., 35 U.S.C. §§ 135(a), 311(c); 37
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`C.F.R. § 42.3. For IPR, PGR, and CBM, the patent owner is afforded an opportunity to file a
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`preliminary response. 35 U.S.C. §§ 313, § 323.
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`The Board, acting on behalf of the Director, may institute a trial where the petitioner
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`establishes that the standards for instituting the requested trial are met, taking into account
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`any preliminary response filed by the patent owner. Conversely, the Board may not
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`authorize a trial where the information presented in the petition, taking into account any
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`patent owner preliminary response, fails to meet the requisite standard for instituting the trial.
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`See, e.g., 35 U.S.C. §§ 314, 324. Where there are multiple matters in the Office involving
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`the same patent, the Board may determine how the proceedings will proceed, including
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`providing for a stay, transfer, consolidation, or termination of any such matter. See, e.g., 35
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`U.S.C. §§ 315, 325.
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`The AIA requires that the Board conduct AIA trials and that the Director prescribe
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`regulations concerning the conduct of those trials. 35 U.S.C. §§ 6, 135, 316, 326. For
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`example, for IPR, PGR, and CBM, the AIA mandates the promulgation of rules including
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`motions to seal, procedures for filing supplemental information, standards and procedures for
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`discovery, sanctions for improper use of the proceeding, entry of protective orders, and oral
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`hearings. See, e.g., 35 U.S.C. §§ 316(a), 326. Additionally, the AIA mandates the
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`promulgation of rules for IPR, PGR, and CBM concerning the submission of a patent owner
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`response with supporting evidence and allowing the patent owner a motion to amend the
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`patent. Id. As required by the AIA, the Office has promulgated rules governing the conduct
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`of trials before the Board. See generally 37 C.F.R. § 42.1 et seq.
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` A
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` petitioner and a patent owner may terminate the proceeding with respect to the petitioner
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`by filing a written agreement with the Board, unless the Board has already decided the merits
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`of the proceeding before the request for termination is filed. See, e.g., 35 U.S.C. §§ 317, 327.
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`If no petitioner remains in the proceeding, the Board may terminate the review or proceed to
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`a final written decision. For derivation proceedings, the parties may arbitrate issues in the
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`proceeding, but nothing precludes the Office from determining the patentability of the
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`claimed inventions involved in the proceeding. 35 U.S.C. § 135. Where a trial has been
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`instituted and not dismissed, the Board will issue a final written decision with respect to the
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`challenged claims. 35 U.S.C. §§ 135, 318, 328.
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`For IPR, PGR, and CBM, the AIA requires that the Office consider the effect of the
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`regulations on the economy, the integrity of the patent system, the efficient administration of
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`the Office, and the ability of the Office to timely complete the proceedings. 35 U.S.C.
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`§§ 316, 326. In developing the general trial rules, as well as the specific rules for the
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`individual proceedings, the Office has taken these considerations into account. Further, the
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`specific rules for the individual proceedings take into account the jurisdictional and timing
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`requirements for the particular proceedings.
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`General Overview of Proceedings: Generally, the proceedings begin with the filing of a
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`petition that identifies all of the claims challenged and the grounds and supporting evidence
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`on a claim-by-claim basis. Within three months of notification of a filing date, the patent
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`owner in an IPR, PGR, or CBM proceeding may file a preliminary response to the petition,
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`including a simple statement that the patent owner elects not to respond to the petition. The
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`Board acting on behalf of the Director will determine whether to institute a trial within three
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`months of the date the patent owner’s preliminary response was due or was filed, whichever
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`is first.
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`In instituting a trial, the Board will either (1) institute as to all claims challenged in the
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`petition and on all grounds in the petition, or (2) institute on no claims and deny institution.
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`The Board will not institute on fewer than all claims or all challenges in a petition. See SAS
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`Institute Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891
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`F.3d 1354, 1359–62 (Fed. Cir. 2018); and Adidas AG v. Nike, Inc., 894 F.3d 1256, 1258
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`(Fed. Cir. 2018). If a trial is instituted, the Board generally will provide analysis of the
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`strengths and weaknesses of all challenges in the petition in order to provide guidance to the
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`parties for the upcoming trial. A party dissatisfied with the Board’s determination to institute
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`a trial may request rehearing as to points believed to have been overlooked or
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`misapprehended. See 37 C.F.R. §§ 42.71(c), (d).
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`The Board will enter a Scheduling Order (see, e.g., Appendix A) concurrent with the decision
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`to institute a trial. The Scheduling Order will set due dates for the trial taking into account
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`the complexity of the proceeding but ensuring that the trial is completed within one year of
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`institution.
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`For example, a Scheduling Order for an IPR or PGR might, consistent with 37 C.F.R.
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`§§ 42.120 and 42.220, provide a three month deadline for patent owner discovery and for
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`filing a patent owner response and motion to amend. Once the patent owner’s response and
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`motion to amend have been filed, the Scheduling Order might provide the petitioner with
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`three months for discovery and for filing a petitioner’s reply to the response and the
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`petitioner’s opposition to the amendment. The Scheduling Order might then provide the
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`patent owner with one month for discovery and for filing a patent owner reply to petitioner’s
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`opposition to a patent owner amendment. A sample timeline is provided below:
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`For another sample timeline, see “Appendix 1A (PO Reply Timeline),” Notice Regarding a
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`New Pilot Program Concerning Motion to Amend Practice and Procedures in Trial
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`Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 84
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`Fed. Reg. 9497, 9506 (Mar. 15, 2019) (presenting a pilot timeline for scheduling orders
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`issued in AIA trials instituted on or after March 15, 2019, indicating, for example, that a
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`petitioner has 6 weeks to file a reply to a patent owner’s response to the petition, and a patent
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`owner has 6 weeks to file a sur-reply in response to that reply).
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`Sequence of discovery. Once instituted, absent special circumstances, discovery will proceed
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`in a sequenced fashion. For example, the patent owner may begin deposing the petitioner’s
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`declarants once the proceeding is instituted. After the patent owner has filed a patent owner
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`response and any motion to amend the claims, the petitioner may depose the patent owner’s
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`declarants. Similarly, after the petitioner has filed a reply to the patent owner’s response and
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`an opposition to an amendment, the patent owner may depose the petitioner’s declarants and
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`file a sur-reply in support of its response and a reply in support of its motion to amend
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`claims. Where the patent owner relies upon new declaration evidence in support of its
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`motion to amend, the petitioner will be authorized to depose the declarants and submit a sur-
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`reply. Once the time for taking discovery in the trial has ended, the parties will be authorized
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`to file motions to exclude evidence believed to be inadmissible. Admissibility of evidence is
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`generally governed by the Federal Rules of Evidence.
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`Sequence of filing responses and motions. A party may request that an initial conference call
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`be held about one month from the date of institution to discuss the motions that the parties
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`intend to file and to determine if any adjustment needs to be made to the Scheduling Order.
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`The patent owner may file a patent owner’s response and/or a motion to amend the claims by
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`the time set in the Scheduling Order. The petitioner may then file a reply to the patent
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`owner’s response and any opposition to the patent owner’s motion to amend. Each party
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`may file a sur-reply (i.e., to a reply to a patent owner’s response or to a reply to an opposition
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`to a motion to amend). Both parties will then be permitted an opportunity to file motions to
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`exclude an opponent’s evidence believed to be inadmissible. After all motions have been
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`filed, the parties will be afforded an opportunity to have an oral argument at the Board.
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`Summary of the Rules: The following is a general summary of the rules for the
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`proceedings.
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`I. General Procedures: The rules are to be construed so as to ensure the just, speedy, and
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`inexpensive resolution of a proceeding and, where appropriate, the rules may be modified to
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`accomplish these goals. 37 C.F.R. §§ 42.1(b), 42.5(a), (b).
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`A. Jurisdiction and Management of the Record
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`1. Jurisdiction: 35 U.S.C. § 6(b) provides that the Board is to conduct derivation
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`proceedings, inter partes reviews, and post-grant reviews. The Board also conducts the
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`transitional program for covered business method reviews, which are subject to Board review
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`under 35 U.S.C. §§ 6(b), 326(c), and Pub. L. 112-29, § 18. The Board therefore will have
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`exclusive jurisdiction within the Office over every application and patent that is involved in a
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`derivation, IPR, PGR, or CBM proceeding. Ex parte reexamination proceedings and inter
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`partes reexamination proceedings are not “involved” patents (as defined in 37 C.F.R. § 42.2)
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`in derivation, IPR, PGR, and CBM proceedings and are thus treated separately except as
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`ordered by the Board.
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`2. Prohibition on Ex Parte Communications: All substantive communications with the
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`Board regarding a proceeding must include all parties to the proceeding, except as otherwise
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`authorized. 37 C.F.R. § 42.5(d). The prohibition on ex parte communications does not
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`extend to: (1) ministerial communications with support staff (for instance, to arrange a
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`conference call); (2) conference calls or hearings in which opposing counsel declines to
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`participate; (3) informing the Board in one proceeding of the existence or status of a related
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`Board proceeding; or (4) reference to a pending case in support of a general proposition (for
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`instance, citing a published opinion from a pending case or referring to a pending case to
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`illustrate a systemic problem).
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`Arranging a conference call with the Board. The Board encourages the use of conference
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`calls to raise and resolve issues in an expedited manner. Prior to making a request for a
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`conference call, the parties should meet and confer to resolve any disputes. If attempts to
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`resolve the dispute fail, a party may request a conference call with the Board. The Board
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`envisions that most of the procedural issues arising during a proceeding will be handled
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`during a conference call or shortly thereafter, i.e., in a matter of days. When arranging a
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`conference call, parties should be prepared to discuss with a Trial Section paralegal why the
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`call is needed and what materials may be needed during the call, e.g., a particular exhibit.
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`When contacting the Board to arrange a conference call, a party to a proceeding should notify
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`the Board if it intends to provide a court reporter for the call. If a court reporter is present for
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`the conference call, the party that retained the court reporter should notify the panel at the
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`beginning of the call that a reporter is on the line, and shall file the transcript of the call as an
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`exhibit to the proceeding within one week of receiving the transcript.
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`Refusal to participate. The Board has the discretion to permit a hearing or conference call to
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`take place even if a party refuses to participate. In such cases, the Board may order as a
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`condition for the call additional safeguards, such as the recording of the communication and
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`the entry of the recording into the record.
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`B. Counsel
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`Need for lead and back-up counsel. A party represented by counsel must designate both a
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`lead as well as a back-up counsel who can conduct business on behalf of the lead counsel, as
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`instances may arise where lead counsel may be unavailable. 37 C.F.R. § 42.10(a).
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`Power of attorney. A power of attorney must be filed with the designation of counsel, unless
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`the designated counsel is already counsel of record. 37 C.F.R. § 42.10(b).
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`Pro hac vice. The Board may recognize counsel pro hac vice during a proceeding upon a
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`showing of good cause, and subject to the requirement that lead counsel is a registered
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`practitioner. 37 C.F.R. § 42.10(c). The Board may impose other considerations as well. Id.
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`Proceedings before the Office can be technically complex. For example, it is expected that
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`amendments to a patent will be sought. The grant of a motion to appear pro hac vice is a
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`discretionary action taking into account the specifics of the proceedings. Similarly, the
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`revocation of pro hac vice is a discretionary action taking into account various factors,
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`including incompetence, unwillingness to abide by the Office’s Rules of Professional
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`Conduct, and incivility.
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`The Office expects that lead counsel will, and back-up counsel may, participate in all
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`hearings and conference calls with the Board and will sign all papers submitted in the
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`proceeding. In addition, the role of back-up counsel is to conduct business with the Office on
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`behalf of lead counsel when lead counsel is not available. Actions not conducted before the
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`Office (e.g., taking of deposition) may be conducted by lead or back-up counsel.
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`C. Electronic Filing
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`Electronic filing is the default manner in which documents are to be filed with the Board. 37
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`C.F.R. § 42.6(b). Electronic filing of legal documents is being implemented across the
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`country in state and federal courts. The use of electronic filing aids in the efficient
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`administration of the proceeding, improves public accessibility, and provides a more
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`effective document management system for the Office and parties. Electronic submission
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`information is provided on the Board’s Web site (www.uspto.gov/PTAB).
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`Paper filing may be used where appropriate, but must be accompanied by a motion
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`explaining the need for non-electronic filing. 37 C.F.R. § 42.6(b). Based upon experience,
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`the Board does not expect to receive many requests to file paper submissions. Circumstances
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`where a paper filing may be warranted include those occasions where the Office’s electronic
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`filing system is unable to accept filings. Alternatively, if a problem with electronic filing
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`arises during normal business hours, a party may contact the Board and request a one-day
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`extension of time for due dates that are set by rule or orders of the Board. 37 C.F.R. § 42.5.
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`In the unlikely event that an administrative patent judge is not available to rule on the
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`extension, the Board may grant an extension the day after the paper is due, which includes
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`situations where electronic filing problems are