UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
JOINT DISCOVERY PLAN PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 26(f) AND LOCAL RULE 16.1
Filed: July 15, 2024
Submitted by counsel for Defendant Solstice Biomedical, Inc. (Calderwood & Harkness LLP) and counsel for Plaintiff Apex Surgical Innovations, Inc. (Hargrove, Tate & Bennington LLP).
I. INTRODUCTION AND PRELIMINARY STATEMENT
Pursuant to Federal Rule of Civil Procedure 26(f), Local Rule 16.1, and the Scheduling Order entered by this Court following the Initial Scheduling Conference held on July 2, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") and Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") (collectively, the "Parties"), by and through their respective undersigned counsel, respectfully submit this Joint discovery Plan for the Court's consideration and approval.
This action is a patent infringement case in which Plaintiff Apex alleges that Defendant Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies infringes three utility patents owned by Apex. Specifically, Plaintiff asserts infringement of U.S. Patent No. 9,814,237 (the "'237 Patent"), U.S. Patent No. 10,271,884 (the "'884 Patent"), and U.S. Patent No. 10,932,105 (the "'105 Patent") (collectively, the "Asserted Patents"). The accused products are the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), the PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), and the PrecisionEdge™ PE-15000 Series (15 mm trocar assembly) (collectively, the "Accused Products").
Plaintiff filed the Complaint in this action on April 22, 2024. Defendant filed its Answer, Affirmative Defenses, and Counterclaims on June 14, 2024, asserting, among other defenses, non-infringement as to all asserted claims, invalidity of the Asserted Patents under 35 U.S.C. §§ 102 and 103, and inequitable conduct during patent prosecution. Defendant also asserted counterclaims for declaratory judgment of non-infringement and declaratory judgment of invalidity as to each of the Asserted Patents.
In accordance with the requirements of Rule 26(f) and Local Rule 16.1, the following counsel met and conferred regarding the discovery plan and related matters:
For Defendant: Marcus Delgado, Esq. and Christy Bauer, Esq. of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801.
For Plaintiff: Victoria Stanton, Esq. and Derek Loomis, Esq. of Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, Delaware 19801.
The Parties held Rule 26(f) conferences on June 26, 2024 and July 10, 2024, during which counsel discussed the nature and basis of the claims and defenses, the scope and timing of discovery, electronically stored information protocols, confidentiality protections, claim construction procedures, expert discovery, and other matters relevant to the efficient and orderly management of this litigation. The Parties have reached agreement on many aspects of the discovery plan, and note certain areas of disagreement as set forth in Section XVII below.
II. IDENTIFICATION OF THE PARTIES AND COUNSEL
A. Plaintiff. Plaintiff Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Apex is engaged in the design, development, manufacture, and sale of minimally invasive surgical instruments and access devices, including laparoscopic trocars and related components.
The following individuals hold key positions relevant to this litigation:
• Gerald K. Whitford — Chief Executive Officer
• Martin Hale — General Counsel
• Dr. Priya Chandrasekaran — Chief intellectual Property Officer
• Dr. Raymond Szabo — Vice President, Engineering, and Named Inventor on all three Asserted Patents
Plaintiff is represented in this action by:
Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-7400 Facsimile: (302) 555-7401
Lead Partner: Victoria Stanton, Esq. Associate: Derek Loomis, Esq.
B. Defendant. Defendant Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware, with Employer Identification Number 84-3291056 and its principal place of business located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice Biomedical, Inc. is the United States operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (Companies Registration Office Number 648217), with its registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland. Solstice is engaged in the development, manufacture, and distribution of surgical access devices and related products, including the Accused Products.
The following individuals hold key positions relevant to this litigation:
• Dr. Fiona Tierney — Chief Executive Officer (parent company, Solstice Biomedical Devices Ltd.)
• Eamon Rourke — General Counsel
• Niamh Cassidy — Vice President, Regulatory Affairs and intellectual Property
• Brendan Molloy — Chief Financial Officer
Defendant is represented in this action by:
Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-9200 Facsimile: (302) 555-9201
Responsible Partner: Marcus Delgado, Esq. Billing Partner: Catherine Bloom, Esq. Lead Associate: Christy Bauer, Esq. Working Associate: Peter Vassiliev, Esq.
III. NATURE AND BASIS OF CLAIMS AND DEFENSES
A. Plaintiff's Claims
Plaintiff asserts claims for patent infringement under 35 U.S.C. § 271 based on the manufacture, use, sale, offer for sale, and importation of the Accused Products. The Asserted Patents, the claims at issue, and the accused products are identified as follows:
1. U.S. Patent No. 9,814,237 (the "'237 Patent")
• Title: "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
• Asserted Claims: Claims 1, 3, 7, and 12
• Issue Date: November 14, 2017
• Expiration Date: June 22, 2035
• Named Inventor: Dr. Raymond Szabo
• Assignee: Apex Surgical Innovations, Inc.
• Accused Products: PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and PrecisionEdge™ PE-12000 Series (12 mm trocar assembly)
Plaintiff contends that the accused PE-5000 Series and PE-12000 Series trocar assemblies each incorporate a locking seal assembly that meets every element of the asserted claims of the '237 Patent, including the claimed configuration of a compressible seal member, a locking ring, and a spring-biased retention mechanism that cooperates with the housing to maintain a gas-tight seal during laparoscopic procedures.
2. U.S. Patent No. 10,271,884 (the "'884 Patent")
• Title: "Retractable Blade Deployment Mechanism for Trocar Systems"
• Asserted Claims: Claims 1, 2, 5, 9, and 14
• Issue Date: April 30, 2019
• Expiration Date: September 15, 2036
• Named Inventor: Dr. Raymond Szabo
• Assignee: Apex Surgical Innovations, Inc.
• Accused Products: PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), and PrecisionEdge™ PE-15000 Series (15 mm trocar assembly)
Plaintiff contends that all three accused PrecisionEdge™ product lines incorporate a retractable blade deployment mechanism that satisfies each limitation of the asserted claims of the '884 Patent, including the claimed spring-loaded obturator blade, the cam-actuated retraction assembly, and the safety lockout mechanism that prevents inadvertent blade deployment.
3. U.S. Patent No. 10,932,105 (the "'105 Patent")
• Title: "Integrated Insufflation Valve and Seal for Laparoscopic Trocar"
• Asserted Claims: Claims 1, 4, and 8
• Issue Date: March 2, 2021
• Expiration Date: January 10, 2038
• Named Inventor: Dr. Raymond Szabo
• Assignee: Apex Surgical Innovations, Inc.
• Accused Products: PrecisionEdge™ PE-12000 Series (12 mm trocar assembly) and PrecisionEdge™ PE-15000 Series (15 mm trocar assembly)
Plaintiff contends that the accused PE-12000 Series and PE-15000 Series incorporate an integrated insufflation valve and seal that practices each element of the asserted claims of the '105 Patent, including the claimed unitary valve body, the dual-stage insufflation pathway, and the self-sealing elastomeric membrane.
All three Asserted Patents name Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole inventor, and all three patents have been assigned to Apex Surgical Innovations, Inc. The Asserted Patents are part of a broader patent family (the "Apex Trocar Patent Family") that includes a total of fourteen (14) issued United States patents and six (6) pending continuation applications before the United States Patent and Trademark Office.
B. Defendant's Defenses and Counterclaims
Defendant has asserted the following affirmative defenses and counterclaims:
1. Non-Infringement. Defendant denies that any of the Accused Products infringes any asserted claim of the '237 Patent, the '884 Patent, or the '105 Patent, either literally or under the doctrine of equivalents. Defendant contends that the PrecisionEdge™ products were independently developed and employ materially different structures and mechanisms from those claimed in the Asserted Patents.
2. Invalidity. Defendant contends that each asserted claim of the Asserted Patents is invalid under 35 U.S.C. § 102 (anticipation) and/or 35 U.S.C. § 103 (obviousness) in view of prior art references, including prior art patents, published patent applications, printed publications, and prior public uses or sales. Defendant's invalidity contentions will identify the specific prior art references and the bases for anticipation and obviousness with respect to each asserted claim.
3. Inequitable Conduct. Defendant asserts that the Asserted Patents are unenforceable due to inequitable conduct during prosecution before the USPTO, specifically alleging that material prior art references were withheld from the Patent Examiner with the intent to deceive.
4. Counterclaims. Defendant has asserted counterclaims seeking declaratory judgments of non-infringement and invalidity as to each of the Asserted Patents pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202.
IV. PROPOSED DISCOVERY SCHEDULE
The Parties propose the following discovery schedule, subject to modification by the Court. Unless otherwise specified, all dates refer to calendar days, and any deadline falling on a weekend or federal holiday shall be extended to the next business day.
A. Fact discovery
With respect to interrogatories, Plaintiff anticipates serving an initial set of approximately eighteen (18) interrogatories, and Defendant anticipates serving an initial set of approximately fifteen (15) interrogatories. Each side shall be limited to no more than twenty-five (25) interrogatories per set, inclusive of all discrete subparts, consistent with the default limit under Federal Rule of Civil Procedure 33(a)(1). With respect to requests for production, Plaintiff's initial set is anticipated to include approximately forty-two (42) requests, and Defendant's initial set is anticipated to include approximately thirty-eight (38) requests.
B. Claim Construction
The Parties anticipate that up to nine (9) claim terms will be disputed and submitted for construction, drawn from across all three Asserted Patents. The claim construction proceedings will address terms relevant to infringement, non-infringement, and invalidity, and will be conducted in accordance with the procedures set forth in the Court's Scheduling Order and the Default Standard for discovery, Including discovery of Electronic Documents, issued by this Court.
C. Expert discovery
The staggered schedule for opening expert reports reflects the Parties' agreement that Defendant's invalidity and non-infringement experts should serve their reports first, followed by Plaintiff's infringement experts and then damages experts on both sides, to promote efficiency and minimize the need for supplementation.
D. Dispositive Motions and Trial
The Parties will comply with all pre-trial deadlines as set by the Court in connection with the pre-trial conference and any pre-trial order.
V. WRITTEN DISCOVERY — SCOPE AND LIMITATIONS
A. Interrogatories. Interrogatories shall be governed by Federal Rule of Civil Procedure 33. Each Party shall be limited to twenty-five (25) interrogatories per set, including all discrete subparts, consistent with the default limit under Rule 33(a)(1). The Parties reserve the right to seek leave of Court or agreement of the opposing Party for additional interrogatories beyond the twenty-five (25) per set limit if warranted by the circumstances of this case.
The Parties anticipate that interrogatory topics will include, but are not limited to, the following subjects:
(a) Infringement contentions and non-infringement contentions, including identification of claim limitations that are disputed and the factual basis for each Party's position;
(b) Invalidity contentions, including identification of prior art references relied upon and the specific claim elements to which each reference is asserted to apply;
(c) Prosecution history of the Asserted Patents, including any communications or submissions to the USPTO relevant to Defendant's inequitable conduct defense;
(d) Inventorship, including the nature and scope of Dr. Raymond Szabo's contributions to the subject matter of the Asserted Patents and the identification of any other individuals who may have contributed to the inventive subject matter;
(e) Damages theories and methodologies, including the factual bases for any reasonable royalty calculations, lost profits claims, and apportionment analyses;
(f) Identification of persons with knowledge of facts material to the claims and defenses in this action; and
(g) Licensing history for the Asserted Patents and other patents within the Apex Trocar Patent Family, including identification of all licensees, the terms of each license, and any royalty payments received.
B. Requests for Production
Requests for production shall be governed by Federal Rule of Civil Procedure 34. The Parties have not agreed to any specific numeric limitation on requests for production beyond the general requirements of reasonableness and proportionality under Rule 26(b)(1). As noted above, Plaintiff's initial set is anticipated to include approximately forty-two (42) requests, and Defendant's initial set is anticipated to include approximately thirty-eight (38) requests.
The Parties anticipate that the categories of documents to be requested will include, but are not limited to, the following:
(a) Patent prosecution files for U.S. Patent Nos. 9,814,237, 10,271,884, and 10,932,105, including the complete prosecution histories of all related continuation, divisional, and reissue applications within the Apex Trocar Patent Family;
(b) Technical documentation for the Accused Products (PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series), including design files, engineering drawings, specifications, testing records, design verification and validation records, manufacturing process documents, and quality control records;
(c) Sales and financial data for the Accused Products, including revenue data by individual product line and time period, for United States sales for calendar years 2021 through 2024 (and, as disputed, potentially worldwide sales data — see Section XVII.1 below);
(d) Prior art references identified in any prior art searches conducted by or on behalf of either Party, including search reports and analyses;
(e) License agreements involving any patents in the Apex Trocar Patent Family, including any licenses, covenants not to sue, settlement agreements containing license grants, and related correspondence;
(f) Communications between the named inventor, Dr. Raymond Szabo, and patent prosecution counsel during prosecution of the Asserted Patents, to the extent such communications are not protected by the attorney-client privilege or work-product doctrine;
(g) Marketing materials, promotional materials, product literature, and product comparisons relating to the Accused Products and any competing Apex products;
(h) Defendant's freedom-to-operate analyses, opinions of counsel, and non-infringement analyses, to the extent that Defendant has waived the attorney-client privilege or work-product protection as to any such materials (Defendant has not made any such waiver as of the date of this filing);
(i) Damages-related documents, including financial statements (both audited and unaudited), cost data, gross margin analyses, contribution margin analyses, profit and loss statements for accused product lines, research and development expenditures allocable to the Accused Products, and any market analyses or financial projections relating to the Accused Products.
C. Depositions. Each side shall be entitled to a maximum of ten (10) fact depositions during the fact discovery period. Each deposition shall be limited to seven (7) hours of testimony on the record in one day, consistent with Federal Rule of Civil Procedure 30(d)(1), absent agreement of the Parties or order of the Court extending such time.
Plaintiff's anticipated fact deponents include:
(a) Dr. Raymond Szabo — Named inventor on all three Asserted Patents and Vice President of Engineering at Apex;
(b) Dr. Priya Chandrasekaran — Chief intellectual Property Officer at Apex;
(c) One or more Apex corporate representatives designated pursuant to Federal Rule of Civil Procedure 30(b)(6); and
(d) Apex damages fact witnesses, including personnel with knowledge of Apex's licensing activities, financial performance, and damages calculations.
Defendant's anticipated fact deponents include:
(a) Niamh Cassidy — Vice President, Regulatory Affairs and intellectual Property at Solstice;
(b) Engineering personnel responsible for the design and development of the PrecisionEdge™ products;
(c) One or more Solstice corporate representatives designated pursuant to Federal Rule of Civil Procedure 30(b)(6); and
(d) Financial personnel with knowledge of sales data, revenue figures, cost structures, and margin calculations for the Accused Products.
Rule 30(b)(6) deposition notices shall be served on or before November 1, 2024. Defendant anticipates designating approximately twelve (12) topics for the Rule 30(b)(6) deposition of Apex's corporate representative(s). Plaintiff anticipates designating a comparable number of topics for the Rule 30(b)(6) deposition of Solstice's corporate representative(s). The Parties will meet and confer in good faith regarding the scope and number of Rule 30(b)(6) topics to ensure that the noticed topics are reasonably tailored and do not impose undue burden.
D. Requests for Admission
Requests for admission shall be governed by Federal Rule of Civil Procedure 36. Either Party may serve requests for admission at any time during the fact discovery period. The Parties have not agreed to any specific limitations on requests for admission beyond those imposed by the Federal Rules, including the general obligations of good faith and reasonableness.
VI. ELECTRONICALLY STORED INFORMATION (ESI) PROTOCOL
A. General Principles
The Parties agree to cooperate in good faith regarding the identification, preservation, collection, review, and production of electronically stored information ("ESI") in this action. The proportionality principles of Federal Rule of Civil Procedure 26(b)(1) shall govern the scope of ESI discovery, taking into account the importance of the issues at stake, the amount in controversy, the Parties' relative access to relevant information, the Parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit.
Both Parties represent that they have issued litigation hold notices to relevant custodians and will maintain their preservation obligations throughout the pendency of this action. The Parties will promptly notify opposing counsel if any issues arise with respect to preservation, including any loss or destruction of ESI.
B. Custodians. Each Party shall identify up to fifteen (15) key custodians for initial ESI collection. The Parties may request additional custodians upon a showing of relevance and proportionality, subject to meet-and-confer requirements.
Plaintiff's anticipated key custodians include:
(a) Dr. Raymond Szabo (Vice President, Engineering; Named Inventor);
(b) Dr. Priya Chandrasekaran (Chief intellectual Property Officer);
(c) Martin Hale (General Counsel); and
(d) Other engineering, research and development, and licensing personnel to be identified.
Defendant's anticipated key custodians include:
(a) Niamh Cassidy (Vice President, Regulatory Affairs and intellectual Property);
(b) Design engineers responsible for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 product lines;
(c) Regulatory affairs personnel involved in FDA clearance and product submissions for the Accused Products; and
(d) Sales and finance personnel with responsibility for revenue reporting and financial analysis of the Accused Products.
The Parties reserve the right to request the identification and collection of ESI from additional custodians upon a showing that such custodians are reasonably likely to possess unique, relevant, and non-duplicative information.
C. ESI Vendor and Processing
Defendant has retained DataVault Litigation Solutions, LLC ("DataVault"), located at 2000 Market Street, Suite 600, Philadelphia, Pennsylvania 19103, as its e-discovery vendor for the collection, processing, hosting, and production of ESI in this matter. DataVault will serve as the platform for Defendant's document review and production workflows.
Plaintiff has retained its own e-discovery vendor for the collection, processing, hosting, and production of ESI. The identity of Plaintiff's e-discovery vendor will be disclosed to Defendant upon request.
Based on preliminary assessments, Defendant's anticipated data volume for processing is approximately 1.2 terabytes (TB). Plaintiff's anticipated data volume has not yet been finally determined but is expected to be of comparable magnitude.
The Parties agree that technology-assisted review ("TAR") protocols are permissible for document review in this action, subject to the following terms and conditions:
(a) The use of TAR 2.0 (continuous active learning) methodology is permissible, as is the use of other forms of technology-assisted review, provided that the producing Party can demonstrate that its methodology is reasonable and defensible;
(b) Upon reasonable notice, the requesting Party may request disclosure of the TAR methodology employed, including the composition of any seed sets, the training methodology, the number of training rounds, recall and precision estimates, and any validation metrics used to assess the completeness and accuracy of the review;
(c) The Parties will meet and confer in good faith regarding any disputes over TAR methodology, including disputes about validation sampling, richness estimates, or the adequacy of recall rates, before raising any such disputes with the Court; and
(d) Nothing in this agreement waives any Party's right to challenge the completeness or adequacy of the opposing Party's document production or review methodology.
D. Production Format
Documents shall be produced in the following formats:
(a) Image Format: Single-page TIFF images (.tif), with accompanying extracted text files (.txt) for electronically generated documents and optical character recognition ("OCR") text for image-only documents (e.g., scanned paper documents);
(b) Metadata Fields: Productions shall include, at a minimum, the following standard metadata fields: Custodian, Date Created, Date Modified, Date Sent, Author, From, To, CC, BCC, Subject, File Name, File Path, File Extension, File Size, and Hash Value (MD5 or SHA-1);
(c) Native Format Production: Native format production is required for spreadsheets (Ashbury Holdings Excel or equivalent), databases, and other files where conversion to TIFF format would materially degrade the content, utility, or functionality of the document. Native files shall be produced with their associated metadata;
(d) Bates Numbering: Plaintiff shall use the Bates prefix "APEX-" followed by a six-digit sequential number (e.g., APEX-000001). Defendant shall use the Bates prefix "SBD-" followed by a six-digit sequential number (e.g., SBD-000001). Bates numbers shall be applied consistently and sequentially throughout all productions; and
(e) Confidentiality Designations: Confidentiality designations shall be applied to produced documents and ESI in accordance with the Protective Order described in Section VII below. Confidentiality stamps or endorsements shall appear on the face of each TIFF image for documents designated as CONFIDENTIAL or HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY.
E. Privilege and Clawback
The Parties agree to seek entry of an order pursuant to Federal Rule of Evidence 502(d) to protect against inadvertent waiver of the attorney-client privilege and work-product protection. The Parties will submit a proposed Rule 502(d) order to the Court for entry concurrent with or promptly following the Court's approval of this Joint discovery Plan. The Rule 502(d) order shall provide that the inadvertent production of privileged or work-product-protected documents shall not constitute a waiver of such privilege or protection in this action or in any other federal or state proceeding.
Privilege Logs. Privilege logs shall be produced on a rolling basis as document productions are made. Final privilege logs shall be due no later than thirty (30) days after the close of fact discovery (i.e., on or before January 19, 2025). Privilege logs shall include, at a minimum, the following information for each withheld document or communication:
(a) Bates number or document control number (if applicable);
(b) Date of the document or communication;
(c) Author or sender;
(d) All recipients (including CC and BCC recipients);
(e) A general description of the subject matter of the document or communication, sufficient to allow the opposing Party to assess the privilege claim without revealing privileged content; and
(f) The specific privilege or protection asserted (e.g., attorney-client privilege, work-product doctrine, joint defense privilege).
Clawback Protocol. In the event that a Party inadvertently produces a document or communication that is protected by the attorney-client privilege, the work-product doctrine, or any other applicable privilege or protection, the following procedures shall apply:
(a) The producing Party shall promptly notify the receiving Party in writing upon discovery of the inadvertent production, identifying the document(s) at issue and the basis for the privilege or protection claim;
(b) Upon receipt of such notification, the receiving Party shall, within five (5) business days, return, sequester, or destroy all copies of the inadvertently produced document(s) and shall not use or refer to such document(s) in any filing, deposition, hearing, or other proceeding pending resolution of any dispute regarding the privilege claim;
(c) If the receiving Party disputes the privilege claim, the Parties shall meet and confer in good faith before raising the dispute with the Court; and
(d) The inadvertent production shall not constitute a waiver of any privilege or protection, in accordance with the Rule 502(d) order.
VII. CONFIDENTIALITY / PROTECTIVE ORDER
A. Framework. The Parties agree to submit a stipulated Protective Order to the Court for entry pursuant to Federal Rule of Civil Procedure 26(c). The Protective Order will establish the following two-tiered confidentiality framework:
Tier 1 — CONFIDENTIAL: Information that the designating Party in good faith believes constitutes confidential business information, the disclosure of which could cause competitive or commercial harm to the designating Party. Examples of information that may be designated as CONFIDENTIAL include, but are not limited to: technical specifications and engineering data, financial data (including revenue, cost, and margin information), sales figures and projections, pricing information, customer lists and customer identities, supplier information, and licensing terms and royalty rates.
Access: CONFIDENTIAL information may be disclosed to the following categories of persons: (i) the Parties' outside counsel of record and their support staff; (ii) the Parties' in-house counsel, limited to no more than three (3) designated individuals per side; (iii) retained testifying and consulting experts and consultants, after execution of the required acknowledgment form; and (iv) court personnel, including the Court, the Clerk of Court, court reporters, and any special master or mediator appointed by the Court.
Tier 2 — HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY: Particularly sensitive information that the designating Party in good faith believes constitutes trade secrets, proprietary manufacturing processes or know-how, unpublished patent applications, highly confidential financial projections and strategic planning documents, and settlement communications in other matters. This tier is reserved for information whose disclosure to the opposing Party's in-house counsel or business personnel could cause significant competitive harm.
Access: HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY information may be disclosed only to: (i) the Parties' outside counsel of record and their support staff; (ii) retained testifying and consulting experts and consultants, after execution of the required acknowledgment form; and (iii) court personnel. In-house counsel for either Party shall not have access to materials designated as HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY unless specific application is made to the Court and access is granted by order. Any such application shall be made on notice to the designating Party.
The Parties further agree that any Party may challenge the designation of specific documents or information, and that any such challenge shall be resolved through the meet-and-confer and dispute resolution procedures set forth in Section XI of this Joint discovery Plan and the Protective Order itself.
B. Expert Access
Retained testifying and consulting experts and consultants must execute a written acknowledgment form, in a form to be attached to the Protective Order, before receiving access to any CONFIDENTIAL or HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY material. The acknowledgment form shall require each expert or consultant to agree to be bound by the terms of the Protective Order, to use designated materials solely for purposes of this litigation, and to return or destroy all designated materials upon the conclusion of the expert's engagement or the termination of this action.
Expert reports, demonstratives, presentations, and other materials that contain or reference CONFIDENTIAL or HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY information may be filed under seal in accordance with the Court's procedures for sealed filings. Any motion to file under seal shall comply with the requirements of Local Rule 5.1 and the Court's standing orders regarding sealing.
C. Use Restrictions
All material designated as CONFIDENTIAL or HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY shall be used solely for purposes of this litigation, including any appeals. Designated material may not be disclosed or used for any business, commercial, competitive, or other purpose unrelated to this litigation. Upon final resolution of this action (including any appeals), all designated material and copies thereof shall be returned to the producing Party or destroyed, at the election of the producing Party, except that outside counsel may retain one archival copy of all materials in secure storage for the sole purpose of addressing any post-judgment matters.
VIII. THIRD-PARTY DISCOVERY
Defendant anticipates issuing one or more third-party subpoenas duces tecum to entities possessing documents or information relevant to Defendant's invalidity defenses. Specifically, Defendant anticipates serving a subpoena duces tecum on Veridian Medical Technologies, Inc. seeking prior art documents, including patent applications, published articles, technical presentations, and product documentation, relevant to Defendant's invalidity defenses against the '237 Patent and the '884 Patent. Defendant anticipates that this subpoena will be served on or around September 12, 2024, with a return date consistent with the requirements of Federal Rule of Civil Procedure 45.
Plaintiff reserves the right to issue third-party subpoenas as warranted by the development of the case, including subpoenas directed to third parties with knowledge of prior art, industry standards, market conditions, or other facts relevant to Plaintiff's claims or Defendant's defenses.
All third-party discovery shall be subject to the confidentiality and use restrictions set forth in the Protective Order described in Section VII of this Joint discovery Plan. The Parties will include a copy of the Protective Order with any third-party subpoena and will inform third-party recipients of the procedures for designating documents as confidential. Any third-party witness or entity that designates produced documents as confidential may do so in accordance with the terms of the Protective Order, and such designations shall be subject to challenge by the Parties under the same procedures applicable to designations by the Parties themselves.
IX. PATENT-SPECIFIC DISCOVERY ISSUES
A. Infringement Contentions
Plaintiff shall serve detailed infringement contentions identifying, on a claim-by-claim and element-by-element basis, how each Accused Product (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series) is alleged to meet each limitation of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent. Plaintiff's infringement contentions shall be accompanied by claim charts mapping each claim element to the corresponding structure, feature, or function of the Accused Products, with references to available technical documentation, product samples, and other evidence.
Plaintiff's infringement contentions shall be served concurrently with Plaintiff's initial written discovery responses, or in any event no later than August 5, 2024.
B. Invalidity Contentions
Defendant shall serve detailed invalidity contentions identifying, for each asserted claim of each Asserted Patent, the prior art references relied upon and the specific basis for anticipation under 35 U.S.C. § 102 and/or obviousness under 35 U.S.C. § 103. Defendant's invalidity contentions shall include claim charts mapping each prior art reference to the elements of each asserted claim, and shall identify any combinations of references relied upon for obviousness, together with the motivation to combine such references.
Defendant's invalidity contentions shall be served concurrently with Defendant's initial written discovery responses, or in any event no later than August 19, 2024.
Defendant notes that its patent prosecution counsel, Kendrick & Lau LLP (601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004; Lead Partner: Dr. Jonathan Kendrick), has assisted with prior art searches and prosecution history reviews in connection with this matter. Relevant non-privileged materials generated in connection with those efforts may be produced in discovery, subject to Defendant's privilege review and any applicable privilege protections.
C. Prosecution History Materials
Plaintiff shall produce the complete prosecution files for U.S. Patent Nos. 9,814,237, 10,271,884, and 10,932,105, as well as the complete prosecution files for all related continuation, divisional, and reissue applications within the Apex Trocar Patent Family (encompassing fourteen (14) issued United States patents and six (6) pending continuation applications). File histories shall include, without limitation, all correspondence with the United States Patent and Trademark Office, all office actions, applicant responses, claim amendments, declarations and affidavits, Information Disclosure Statements ("IDSs") and the references cited therein, interview summaries, notices of allowance, and any petitions or requests for continued examination.
To the extent that any prosecution file materials for pending applications are subject to confidentiality restrictions under 35 U.S.C. § 122, the Parties will address the treatment of such materials under the Protective Order.
D. Licensing discovery
Both Parties shall produce all existing license agreements, covenants not to sue, settlement agreements containing license grants, and related correspondence relating to any patents in the Apex Trocar Patent Family. Licensing discovery is relevant to multiple issues in this action, including:
(a) Damages analysis under the Georgia-Pacific factors, including the determination of a reasonable royalty rate based on comparable licenses;
(b) Any defenses related to patent exhaustion or implied license; and
(c) The commercial success of the patented inventions as a secondary consideration of non-obviousness.
The Parties acknowledge that license agreements may contain highly sensitive commercial terms. Such agreements may be designated as CONFIDENTIAL or HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY under the Protective Order, as appropriate.
X. EXPERT DISCOVERY PROCEDURES
A. Expert Identification and Reports
Each Party shall identify its testifying experts no later than January 6, 2025, which is seven (7) days before the opening of expert discovery on January 13, 2025. Expert identifications shall include the name, qualifications, and subject matter of each expert's anticipated testimony.
Opening expert reports shall be served in accordance with the staggered schedule set forth in Section IV.C of this Joint discovery Plan:
• Opening expert reports on invalidity and non-infringement: January 27, 2025;
• Opening expert reports on infringement: February 10, 2025; and
• Opening expert reports on damages (both sides): February 14, 2025.