Report of the Local Patent Rules Committee
`
`Explanatory Notes for 2016 Amendments
`
`
`
`
`
` The Local Patent Rules were implemented in September 2008, and certain
`amendments to the Rules were adopted with the March 2011 revision to the Rules.
`
` Over the course of the last ten months, the Local Patent Rules Advisory Committee
`has once again examined the operation of the Local Patent Rules and, consistent with past
`history, has found that the Rules generally are operating well, and provide a rational and
`reasonably efficient structure for the judicial administration, litigation and trial of patent
`matters in the District of New Jersey.
`
`
`
`
`
` However, as a result of learning from experiences in operating under the Rules
`since they were last amended, certain issues have arisen that led to the Committee’s
`consideration of possible modifications to the Rules. In order to balance and clarify
`certain issues, expedite issues for the Court and Magistrate Judges in particular, and
`attempt to enhance the overall pretrial process, the Committee considered several
`potential amendments to the Rules..
`
`
` Committee Process-- Committee members identified issues of interest or
`potential amendments for consideration by the entire Committee . The Committee then
`identified the issues of highest order of priority. That process resulted in the appointment
`of subcommittees directed to each such issue. Each subcommittee investigated,
`examined and evaluated the issues, and determined whether an amendment or Rule
`revision was necessary.
`
`
` The subcommittees then submitted reports to the Committee as a whole, and those
`reports and any potential amendments to the Rules were then discussed at length by the
`entire Committee. Ultimately, the Committee voted to approve certain amendments.
`
` Amendments -- The following amendments were approved by the Board of
`Judges after submission by the Patent Rules Advisory Committee:
`
` Rule 2.1(a)(6)- With respect to matters to be discussed for the purpose of
`preparing the Joint Discovery Plan for submission to a Magistrate Judge in advance of the
`initial Scheduling Conference, a new subpart is included that expands the topics to be
`discussed between the parties in order to expedite matters, and attempt to avoid more
`protracted disputes later in the discovery process (e.g., availability of invention records,
`product samples, whether there is a 30-month stay and when it ends). The Committee
`recommended encouraging a complete and thorough discussion of issues that need to be
`addressed by the Court at the initial Rule 26 conference.
`
`Sanofi Exhibit 2026.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`
`
`
`
`
` Rule 2.2- The Committee recommended that the Discovery Confidentiality Order
`be submitted in 14 days rather than 30 days subsequent to the initial Scheduling
`Conference in an attempt to expedite the exchange of foundation discovery, which in
`many instances comprises commercially sensitive information.
`
` Rules 3.3(d) (Invalidity Contentions) and 3.4A (Responses to Invalidity
`Contentions- This amendment would require a party asserting invalidity under Sec. 112
`of the Patent Act to set forth the factual basis for that assertion, and would require the
`patent owner to respond with a detailed explanation of how the claim complies with
`Section 101 and 112.
`
` Rule 3.6 (c) and (e)- With regard to Hatch-Waxman matters, the Committee
`recommended that the time for submission of invalidity and noninfringement contentions
`be extended from 14 days to 30 days from the date of the Scheduling Conference. The
`Committee concluded that the current 14-day period presented too compressed a
`schedule, and that the additional time for such submissions would not significantly
`impact overall case management, particularly in light of other changes under these Rules.
`
` Rules 4.1 and 4.2 (Exchange of claim terms for construction)- Pursuant to this
`amendment, parties would be required to explain the meaning of “plain and ordinary”
`assigned to each claim term. The Committee determined that parties often rely on the
`Court to determine what the parties mean by that phrase. The Committee concluded that
`the Local Patent Rule should be amended to require a party to define its understanding of
`the phrase “plain and ordinary meaning” for each claim term for which that phrase is
`asserted.
`
` In May 2016, the Committee submitted the proposed amendments to the Board of
`Judges for their consideration.
`
`
`
`Local Patent Rules Advisory Committee
`
`
`Hon. Stanley R Chesler, U.S.D.J., Chair
`Hon. Jerome B. Simandle, U.S.D.J., Chief Judge, Ex officio
`Hon. Patty Shwartz, U.S.C.J.
`Hon. Mary L. Cooper, U.S.D.J.
`Hon. Douglas E. Arpert, U.S.M.J.
`Hon. Tonianne J. Bongiovanni, U.S.M.J.
`Hon. Michael A. Hammer, U.S.M.J.
`Hon. Lois H. Goodman, U.S.M.J.
`Hon. Joel Schneider, U.S.M.J.
`Hon. Leda D. Wettre, U.S.M.J.
`Hon. Karen M. Williams, U.S.M.J.
`John T. O’Brien, Legal Coordinator
`
`Arnold B. Calmann, Esq.
`
`Sanofi Exhibit 2026.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Thomas Curtin, Esq.
`David De Lorenzi, Esq.
`John E. Flaherty, Esq.
`Dennis F. Gleason, Esq.
`Edgar H. Haug, Esq.
`Mary Sue Henifin, Esq.
`Norman E. Lehrer, Esq.
`Charles M. Lizza, Esq.
`Peter Menell, Prof. of Law,
` Univ. of Calif., Berkeley School of Law
`William L. Mentlik, Esq.
`George F. Pappas, Esq.
`Donald Robinson, Esq.
`Robert G. Shepherd Esq.
`Liza M. Walsh, Esq.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

` REPORT
`
`of the
`
`LOCAL PATENT RULES ADVISORY COMMITTEE
`
`May 2016
`
`
`
` The Local Patent Rules were implemented in September 2008, and certain
`
`amendments to the Rules were adopted with the March 2011 revision to the Rules.
`
`
`Over the course of the last ten months, the Local Patent Rules Advisory Committee has
`
` examined the operation of the Local Patent Rules and, consistent with past history, has
`found that the Rules generally are operating well, and provide a rational and reasonably
`efficient structure for the judicial administration, litigation and trial of patent matters.
`
`
`
`
`
` However, we have learned from our further experiences in operating under the
`Rules since they were last amended. As a result, certain issues have arisen that led to the
`Committee’s consideration of possible modifications to the Rules in order to balance and
`clarify certain issues, expedite issues for the Court and Magistrate Judges in particular, and
`attempt to enhance the overall pretrial process.
`
` Committee Process-- Members of the Committee were asked to identify issues of
`interest or potential amendments so that the entire Committee could consider same. The
`Committee then met as a whole, which resulted in a winnowing process where the issues of
`highest order of priority were determined. That process resulted in the appointment of
`subcommittees directed to each such issue. Each subcommittee (usually composed of
`attorney members as well as Judges), met separately to further investigate, examine and
`evaluate the issue, and determine whether an amendment or Rule revision was necessary.
`
` The subcommittees then submitted reports to the Committee as a whole, and those
`reports and any potential amendments to the Rules were then discussed at length at a
`meeting of the entire Committee. At that meeting, the Committee voted to approve certain
`amendments, and also determined that certain other issues were not required to be
`addressed at this time because the process, after further analysis, appeared to be working
`well as to those issues.
`
` Proposed Amendments for consideration by the Board of Judges-- The
`Committee is pleased to report that each of the following proposed amendments were
`approved and adopted by the Committee. The following is a brief identification of the
`proposed amendments to the referenced Rules, followed by a more specific description of
`each for your consideration:
`
`
`
`
`Sanofi Exhibit 2026.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

` Rule 2.1(a)(6)- With respect to matters to be discussed for the purpose of preparing
`the Joint Discovery Plan for submission to a Magistrate Judge in advance of the initial
`Scheduling Conference, a new subpart is proposed that expands the topics to be discussed
`between the parties in order to expedite matters, and attempt to avoid more protracted
`disputes later in the discovery process (e.g., availability of invention records, product
`samples, whether there is a 30-month stay and when it ends, and scheduling order issues,
`etc.).
`
` Rule 2.2- Requiring the Discovery Confidentiality Order to be submitted in 14 days
`rather than 30 days subsequent to the initial Scheduling Conference.
`
` Rules 3.3(d) (Invalidity Contentions) and 3.4A (Responses to Invalidity
`Contentions- This amendment would require a party asserting invalidity under Sec. 112 of
`the Patent Act to set forth the factual basis for that assertion, and would require the patent
`owner to respond with a detailed explanation of how the claim complies with Section 101
`and 112.
`
` Rule 3.6 (c) and (e)- Modifies the obligation in Hatch-Waxman matters from 14
`days to 30 days from the date of the Scheduling Conference within which a party must
`produce non-infringement and invalidity contentions.
`
` Rules 4.1 and 4.2 (Exchange of claim terms for construction)- Parties would be
`required to explain the meaning of “plain and ordinary” assigned to each claim term.
`
`
` The following provides further details regarding these proposed amendments as
`approved by the entire Committee. We look forward to the Board of Judges considering
`these proposals.
`
`
`
`Hon. Stanley R. Chesler, Chair
`Hon. Jerome B. Simandle, U.S.D.J., Chief Judge, Ex officio
`Hon. Patty Shwartz, U.S.C.J.
`Hon. Mary L. Cooper, U.S.D.J.
`Hon. Douglas E. Arpert, U.S.M.J.
`Hon. Tonianne J. Bongiovanni, U.S.M.J.
`Hon. Michael A. Hammer, U.S.M.J.
`Hon. Lois H. Goodman, U.S.M.J.
`Hon. Joel Schneider, U.S.M.J.
`Hon. Leda D. Wettre, U.S.M.J.
`Hon. Karen M. Williams, U.S.M.J.
`John T. O’Brien, Legal Coordinator
`
`Arnold B. Calmann, Esq.
`Thomas Curtin, Esq.
`David De Lorenzi, Esq.
`
`Sanofi Exhibit 2026.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`John E. Flaherty, Esq.
`Dennis F. Gleason, Esq.
`Edgar H. Haug, Esq.
`Mary Sue Henifin, Esq.
`Norman E. Lehrer, Esq.
`Charles M. Lizza, Esq.
`Peter Menell, Prof. of Law,
` Univ. of Calif., Berkeley School of Law
`William L. Mentlik, Esq.
`George F. Pappas, Esq.
`Donald Robinson, Esq.
`Robert G. Shepherd Esq.
`Liza M. Walsh, Esq.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`Rule 2.1(a)(6) – Initial Scheduling Conference
`
`
`
` Committee Statement- New subpart (6), set forth below, identifies a number of
`topics for discussion during the meet and confer process leading to the preparation of the
`Joint Discovery Plan for submission to the Magistrate Judge in advance of the initial
`Scheduling Conference. Many of the topics that are included in this proposed new
`provision have been the subject of separate discovery disputes, often later in the
`proceedings, and have many times led to delays in the resolution of the dispute, and
`delays in the pretrial schedule. For example, many disputes have arisen over the location
`and identification of inventor laboratory notebooks, delays in obtaining product samples,
`completion of document production dates, foreign witness availability, etc.
`
` As everyone is aware, under the Local Civil Rules, the parties have an obligation
`to meet and confer in a good faith effort to attempt to resolve by agreement any discovery
`or other pretrial issue in advance of bringing a dispute to the Court. By requiring the
`parties to discuss these issues early in the process, the expectation is that the parties will
`attempt to satisfy their meet and confer obligations and potentially resolve some if not all
`of the issues. If they are unable to do so, the issues can be set forth in the Joint Discovery
`Plan and submitted to the Magistrate Judge for discussion and possible resolution at the
`initial Scheduling Conference, thereby expediting the entire process.
`
` The parties may or may not agree during this process, but at least the topics will be
`discussed and possibly resolved, narrowed or more sharply defined for presentation to the
`Magistrate Judge. The practical, real world theory underlying this proposal is essentially,
`“how can it hurt to discuss these issues?”
`
` Accordingly, this proposal was discussed, amended in Committee principally to
`accommodate certain concerns by a few members as to a single subpart, and then adopted
`by the Committee. The proposed Rule follows:
`
`
`2.1 Governing Procedures
`
`(a) Initial Scheduling Conference. When the parties confer pursuant to Fed.
`R. Civ. P. 26(f), the parties shall discuss and address in the
`Discovery Plan submitted pursuant to Fed. R. Civ. P. 26(f) and L.
`Civ. R. 26.1(b)(2) the topics set forth in those rules and the
`following topics:
` . . .
`
`
`(6) The availability and timing of production of invention records
`(including inventor laboratory notebooks and analytical test results);
`
`The availability and timing of production of ANDA product research and
`development documents;
`
`Sanofi Exhibit 2026.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`The availability and timing of production of ANDA product samples;
`
`The date of conception and the date of reduction to practice for each
`patent asserted in the action;
`
`Each inventor’s availability for deposition in the matter;
`
`Availability of foreign witnesses for deposition and foreign documents;
`
`Whether there is a 30-month stay and if so, when it ends;
`
`Whether the Judge in his/her discretion consistent with L. Pat. R. 1.3,
`should consider issuing a Scheduling Order that contains two dates for
`amendments under L. Pat. R. 3.7 and for adding parties, the first date of
`which shall be without the need for leave of Court, and second date for
`which amendments would be permitted only upon application to the Court
`under customary procedures;*
`
` A
`
` date for substantial completion of document production and a method
`for determining compliance;
`
`Any other issues or matters that a party believes are time sensitive.
`
`
`
` *
`
` Inclusion of this item for discussion does not indicate any endorsement
`by the Committee of this procedure.
`
`
`
`
` The eighth item under proposed new subpart (6) relates to the parties having the
`opportunity to discuss whether to have two dates in the pretrial schedule to amend
`pleadings, contentions and to add parties, i.e., one date on which the parties would be
`freely able to do so without the need for formal motion practice, and a second date that
`would require compliance with customary procedures. The Chair has authorized the
`objectors to this single provision to submit a minority report on this issue.
`
` From the Committee’s perspective, and as presented by the subcommittee that
`proposed this amendment, it can be helpful to the efficiency of the pretrial process to
`discuss this type of issue with the possibility that the parties can reach an accord on the
`issue. Early in the pretrial schedule, contentions may have been exchanged but the
`parties have not obtained any substantial discovery as yet, there are no expert reports in
`the case and experts may not even have been retained as yet. It was presented in
`Committee that motion practice is intensive enough without having to unnecessarily
`impose on the Court and the parties the need for formal motion practice when early in the
`
`Sanofi Exhibit 2026.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`process, a claim of prejudice might be problematical. While it is not anticipated that the
`use of two dates for amendments under L. Pat. R. 1.3 will be routinely authorized, there
`may be cases where one or more parties and/or the Court believe such a procedure will be
`beneficial, and therefore discussion between the parties is warranted.
`
` L. Pat. R. 1.3 specifically requires in advance of the submission of any request for
`a modification of the Rules that parties “shall meet and confer for purposes of reaching
`an agreement, if possible, upon any modification.” That is directly what the Committee’s
`proposal achieves early in the process, thereby leaving it to the discretion of the Court in
`the event the parties cannot agree on a proposal.
`
` Accordingly, the Committee believes that requiring a discussion regarding not
`just the subject issue but with regard to all the issues in proposed subpart (6) will be
`beneficial to the judicial process and helpful to the parties, and requests that the Board of
`Judges adopt the proposal as presented.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`
`Rule 2.2- Discovery Confidentiality Order
`
`
`
`
` Committee Statement- This Rule requires the submission to the Court of the
`Discovery Confidentiality Order (“DCO”), “[w]ithin 30 days after the initial Scheduling
`Conference.”
`
` As part of an effort to provide additional time for the parties in Hatch-Waxman
`matters to submit non-infringement and invalidity contentions (see proposed amendments
`to Rule 3.6 (c) and (e) that follow), and in an attempt to balance the present structured
`schedule under the Local Patent Rules, it is proposed that the 30 days under this Rule be
`reduced to 14 days. While that may result in further pressure upon the parties to
`promptly submit the DCO, it provides additional time for parties to prepare their opening
`contentions.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.010
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`
`
`
`
`
`
`
`
`Rules 3.3(d) (Invalidity Contentions) and 3.4A (Responses)
`
` Committee Statement- This amendment would require a party asserting
`invalidity under Sec. 112 of the Patent Act to set forth the factual basis for that assertion,
`and would require the patent owner to respond with a detailed explanation of how the
`claim complies with Section 101 and 112. Presently, the Rules do not specifically cover
`these issues.
`
` The following amendments are proposed:
`
` Rule 3.3. Invalidity Contentions.
`
` * * * *
`
` (d) Any grounds of invalidity based on 35 U.S.C. § 101, indefiniteness under 35
`U.S.C. § 112(2) 112(b) or enablement or written description under 35 U.S.C. § 112(1)
`112(a) of any of the asserted claims including a detailed explanation of the bases for the
`asserted grounds.
`
` Rule 3.4A Responses to Invalidity Contentions.
`
` * * * *
`
` (d) For each asserted grounds of invalidity under L. Par. R. 3.3(d), a detailed
`explanation of how the asserted claim complies with 35 U.S.C. § 101 or 35 U.S.C. § 112;
`and
`
` (e)(d) The production or the making available for inspection and copying of any
`document or thing that the party intends to rely on in support of its Responses herein.
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Rule 3.6- Disclosures Arising Under the Hatch-Waxman Act
`
`
`
`
`
`
`
`
`
` Committee Statement- Presently, Rules 3.6(c) and (e) respectively, require the
`submission of a party’s non-infringement and invalidity contentions in Hatch-Waxman
`matters within 14 days after the initial Scheduling Conference. That two week time
`frame has been the subject of a number of complaints from parties. This provision is
`intended to provide additional time for a party to submit its contentions by modifying the
`obligation in Hatch-Waxman matters from 14 days to 30 days from the date of the
`Scheduling Conference. This proposal was paired with the proposed amendment to Rule
`2.2 to attempt to balance the impact of providing additional time for parties to provide
`their opening contentions.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`
`
`
`Rules 4.1 and 4.2 (Exchange of claim terms for construction)
`
`
`
`
`
`
` Committee Statement- Rules 4.1 governs the exchange of proposed terms for
`construction, and Rule 4.2 governs the exchange of preliminary claim constructions and
`extrinsic evidence. Often a party will assert that the meaning of a particular claim term is
`“plain and ordinary,” but little or no explanation is provided regarding the meaning of that
`assertion. Under the proposed amendment, parties would be required to explain the
`meaning of “plain and ordinary” that is assigned to each claim term, and provide any
`evidence in support thereof, consistent with the obligations under the Rules..
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2026.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`MINORITY REPORT OF THE
`LOCAL PATENT RULES ADVISORY COMMITTEE
`May 25, 2016
`
`
`Preliminary Statement
`
`
` As requested by Judge Chesler, we have revised the May 23, 2016 Minority
`Report to set forth the critical issue of dispute over the proposed amendments to Local
`Patent Rule 2.1(a).
`
`Proposed Amendments to Local Patent Rule 2.1(a)
`
`
` The Committee is not unanimous on the inclusion of the following subsection in
`proposed Rule 2.1(a)(6):
`
`Whether the Judge in his/her discretion consistent with L. Pat. R. 1.3, should
`consider issuing a Scheduling Order that contains two dates for amendments
`under L. Pat. R. 3.7 and for adding parties, the first date of which shall be
`without the need for leave of Court, and second date for which amendments
`would be permitted only upon application to the Court under customary
`procedures;*
`* Inclusion of this item for discussion does not indicate any endorsement by
`the Committee of this procedure.
`
`First, this proposal requires parties to discuss two dates for amending contentions
`– one without leave of court – and makes that discussion part of the Joint Discovery Plan.
`However, Local Patent Rule 3.7, which is a hallmark of this District’s Local Patent Rules,
`governs the timing and substantive requirements for amending contentions under the
`rules. To have the parties be “required” by this new rule to discuss and negotiate these
`“double dates” (one without good cause) is (1) inconsistent with the express language of
`Local Patent Rule 3.7 and (2) inconsistent with the Committee’s virtually unanimous vote
`rejecting this concept (see Proposed Amendments to Rules 2.2 and 3.6).
`
`Second, although the proposal cites to the discretion reflected in Local Patent
`Rule 1.3, nothing in the current rules prevents courts from exercising that discretion at
`any time. See L. Pat. R. 1.3 (Court may modify obligations set forth in Local Patent
`Rules based on circumstances of any case). In short, the proposed paragraph seeks to fix
`a problem that does not exist and may create additional problems. As the Rules stand
`now, without this unnecessary amendment, the parties may still reach agreement on
`specific procedures relevant to the needs of their case, and the Magistrate Judge may use
`his or her discretion in approving any such agreement. Requiring the parties to discuss
`two dates for amending contentions – one without good cause – may give rise to
`unnecessary disputes and protract the litigation. The Local Patent Rules should not
`become a vehicle for rigorous micromanagement by attempting to dictate every topic that
`the parties must discuss, especially a topic such as amending contentions, which the
`Rules already address fully.
`
`Sanofi Exhibit 2026.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`
`Third, the Committee reached a compromise position to amend Local Patent
`Rules 3.6(c) and (e) to provide additional time for defendants in Hatch-Waxman cases to
`serve their Non-Infringement and Invalidity Contentions (see Proposed Amendment to
`Rule 3.6 (allowing 30 days, instead of 14 for defendants in Hatch-Waxman cases to serve
`their contentions)). This compromise was reached after the Committee rejected a
`proposal to amend the Local Patent Rules to provide a date for amending contentions
`without leave of court. This proposed subparagraph would undermine the purpose of that
`compromise and is contrary to the Committee’s consensus that Local Patent Rule 3.7
`should not be modified.
`
`*
`*
`*
`In short, the proposed amendment to Rule 2.1(a) would create greater uncertainty
`and could protract the process. We believe the Local Patent Rules have been working
`well and see no reason to add the disputed subparagraph at this time.
`
`With respect to the proposed revisions to Local Patent Rules 2.2 and 3.6, we
`believe the language in the Report of the Local Patent Rules Advisory Committee should
`be revised to reflect the official Committee Minutes and the November 13, 2015
`Subcommittee Report and have provided the proposed alternative language in the May
`23, 2016 version of the Minority Report.
`
`Respectfully submitted,
`John E. Flaherty, Esq.
`Dennis F. Gleason, Esq.
`Edgar H. Haug, Esq.
`Charles M. Lizza, Esq.
`George F. Pappas, Esq.
`
`
`
`
`
`Sanofi Exhibit 2026.015
`Mylan v. Sanofi
`IPR2018-01676
`
`