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Contract analysis / vassiliev-declaration-motion-to-compel.docx
vassiliev-declaration-motion-to-compel.docx
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I. INTRODUCTION AND DECLARANT IDENTIFICATION
I. INTRODUCTION AND DECLARANT IDENTIFICATION
1. I am an attorney duly admitted to practice before the United States District Court for
1. I am an attorney duly admitted to practice before the United States District Court for the Northern District of California and a member in good standing of the California State Bar (Bar No. 318742). I am a Lead Associate in the intellectual Property Litigation group at Calderwood & Harkness LLP, located at 555 Mission Street, Suite 3100, San Francisco, California 94105. I hold a Doctor of Philosophy degree in Bioi
2. I am a member of the litigation team representing Plaintiff Genome Dx Therapeutics Inc
2. I am a member of the litigation team representing Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff") in the above-captioned patent infringement action, working under the supervision of Catherine Bloom, the Responsible Partner for this engagement. In this capacity, I have been actively involved in all aspects of fact discovery in this case, including the drafting and service of Plaintiff's First Set
3. I have personal knowledge of the facts set forth in this declaration and, if called as
3. I have personal knowledge of the facts set forth in this declaration and, if called as a witness, I could and would competently testify to them.
4. I submit this declaration in support of Plaintiff GenomeDx's Motion to Compel Producti
4. I submit this declaration in support of Plaintiff GenomeDx's Motion to Compel Production of Documents Responsive to Plaintiff's First Set of Requests for Production of Documents, Nos. 22, 23, and 31 (the "Motion to Compel"). Specifically, GenomeDx seeks the production of thirty-four (34) documents that Defendant Helios has improperly withheld on the basis of attorney-client privilege and/or work-product protection
II. BACKGROUND OF THE LITIGATION
II. BACKGROUND OF THE LITIGATION
5. GenomeDx filed this patent infringement action against Helios on March 28, 2025. The C
5. GenomeDx filed this patent infringement action against Helios on March 28, 2025. The Complaint asserts claims of infringement of three United States patents: U.S. Patent No. 10,438,271 (the "'271 Patent"), U.S. Patent No. 11,204,893 (the "'893 Patent"), and U.S. Patent No. 11,891,647 (the "'647 Patent") (collectively, the "Asserted Patents"). Each of the Asserted Patents is owned by GenomeDx and covers proprietary
6. GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier (the "Accused Product"
6. GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier (the "Accused Product"), which was commercially launched on or about October 7, 2024, infringes asserted claims of all three of the Asserted Patents. The ProstaSignal™ Genomic Classifier is a laboratory-developed test that analyzes gene-expression patterns in prostate tumor tissue to generate a risk score used in clinical decision-making regarding adj
7. On May 12, 2025, Helios filed its Answer and Counterclaims. Helios's Answer asserts af
7. On May 12, 2025, Helios filed its Answer and Counterclaims. Helios's Answer asserts affirmative defenses of invalidity under 35 U.S.C. §§ 101 (patent-ineligible subject matter), 102 (anticipation), and 103 (obviousness), as well as defenses of non-infringement and unenforceability. Helios's Counterclaims seek declaratory judgments of invalidity and non-infringement with respect to each of the three Asserted Patent
8. On January 13, 2026, the Court (Hon. Jessica W. Langston, presiding) issued an Order d
8. On January 13, 2026, the Court (Hon. Jessica W. Langston, presiding) issued an Order denying Helios's Motion to Dismiss Counts II and III of GenomeDx's Complaint under 35 U.S.C. § 101, finding that GenomeDx had adequately pleaded that the claimed inventions were directed to patent-eligible subject matter. The Court's Order confirmed that the infringement claims asserted against the '893 Patent and the '647 Patent
9. The Scheduling Order in this case was issued on June 18, 2025, by Judge Langston. Amon
9. The Scheduling Order in this case was issued on June 18, 2025, by Judge Langston. Among other deadlines, the Scheduling Order establishes a fact discovery close date of March 6, 2026. Given that the instant motion concerns documents that are directly relevant to GenomeDx's claims of willful infringement, damages, and Helios's state of mind regarding GenomeDx's patent rights, the timely resolution of this discovery
III. THE RELEVANT REQUESTS FOR PRODUCTION
III. THE RELEVANT REQUESTS FOR PRODUCTION A. Request for Production No. 22
10. Request for Production No. 22 ("RFP No. 22"), as set forth in Plaintiff's First Set o
10. Request for Production No. 22 ("RFP No. 22"), as set forth in Plaintiff's First Set of Requests for Production of Documents, requests the following: All pre-launch business plans, strategic plans, and market analyses relating to the ProstaSignal™ Genomic Classifier that reference, discuss, or analyze (a) U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647; (b) GenomeDx's Decipher® test; or (c) GenomeDx's i
11. RFP No. 22 is directly relevant to multiple issues in this case, including: (a) Helio
11. RFP No. 22 is directly relevant to multiple issues in this case, including: (a) Helios's knowledge of GenomeDx's patents prior to the commercial launch of the ProstaSignal™ Genomic Classifier, which bears on GenomeDx's claim of willful infringement and the potential for enhanced damages under 35 U.S.C. § 284; (b) Helios's competitive positioning of the ProstaSignal™ product relative to GenomeDx's Decipher® test,
12. Request for Production No. 23 ("RFP No. 23") requests the following:
12. Request for Production No. 23 ("RFP No. 23") requests the following: All board of directors presentations, board minutes, and board-level reports relating to the ProstaSignal™ Genomic Classifier that reference or discuss (a) Genome Dx Therapeutics Inc.; (b) GenomeDx's Decipher® test; or (c) any freedom-to-operate analysis, patent clearance analysis, or assessment of intellectual property risk.
13. RFP No. 23 is directly relevant to Helios's corporate state of mind, its awareness of
13. RFP No. 23 is directly relevant to Helios's corporate state of mind, its awareness of GenomeDx's patent rights at the board level, and the degree to which Helios's board of directors considered and evaluated the risk of patent infringement before approving the commercial launch of the ProstaSignal™ Genomic Classifier. Such evidence is highly probative of willfulness, as board-level knowledge and decision-making r
14. Request for Production No. 31 ("RFP No. 31") requests the following:
Medium
⚑ Liability cap to check against exposure
14. Request for Production No. 31 ("RFP No. 31") requests the following: All investor presentations, investor memoranda, and communications with investors — including but not limited to Corinth Ventures Fund III, LP and Aether Life Sciences Partners — concerning the ProstaSignal™ Genomic Classifier that reference or discuss (a) GenomeDx's patents (U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647); (b) Genom
15. RFP No. 31 is relevant to Helios's own assessment of patent risk, including how Helio
15. RFP No. 31 is relevant to Helios's own assessment of patent risk, including how Helios characterized that risk to sophisticated investors who were asked to fund the development and commercialization of the ProstaSignal™ product. These materials are also relevant to GenomeDx's damages theories, as investor presentations and memoranda frequently contain detailed market projections, revenue forecasts, pricing assump
IV. HELIOS'S RESPONSES AND PRODUCTION
IV. HELIOS'S RESPONSES AND PRODUCTION A. Initial Responses
16. GenomeDx served its First Set of Requests for Production of Documents (Nos. 1–47) on
16. GenomeDx served its First Set of Requests for Production of Documents (Nos. 1–47) on Helios on January 27, 2025. Helios served its written responses and objections to the Requests for Production on a rolling basis, beginning with certain categories of responsive documents and continuing through late fall 2025.
17. In response to RFP Nos. 22, 23, and 31, Helios produced a total of 1,247 documents, c
17. In response to RFP Nos. 22, 23, and 31, Helios produced a total of 1,247 documents, consisting primarily of internal marketing materials, publicly available investor presentations, high-level business summaries, and communications among Helios employees that do not reference GenomeDx's patents or intellectual property in any meaningful detail. While GenomeDx appreciates the documents that have been produced, the
18. Helios's privilege log identifies eighty-three (83) documents withheld across all cat
18. Helios's privilege log identifies eighty-three (83) documents withheld across all categories of Requests for Production, asserting attorney-client privilege, work-product protection, or both as the basis for withholding each document.
19. After careful review and analysis of the privilege log entries, GenomeDx challenges t
19. After careful review and analysis of the privilege log entries, GenomeDx challenges thirty-four (34) of the eighty-three (83) withheld documents as improperly withheld. GenomeDx does not challenge the remaining forty-nine (49) entries on the privilege log, which appear to involve documents whose dominant purpose is the seeking or rendering of legal advice and which were not shared with third parties outside the s
20. The thirty-four (34) challenged documents span the following categories, as described
Medium
⚑ Confidentiality undertaking
20. The thirty-four (34) challenged documents span the following categories, as described in Helios's privilege log: (a) Twelve (12) documents described as board presentations or board-level memoranda prepared for or presented to Helios's board of directors, with subject lines such as "Q2 2024 Board Presentation — ProstaSignal™ Update," "Board Memo: Competitive Landscape and Market Entry Strategy," and "ProstaSignal™
21. A true and correct copy of the relevant portions of Helios's privilege log identifyin
21. A true and correct copy of the relevant portions of Helios's privilege log identifying the thirty-four (34) challenged documents, including each document's privilege log entry number, date, author(s), recipient(s), document description, and the privilege basis asserted, is attached hereto as Exhibit D and incorporated herein by reference.
V. MEET-AND-CONFER EFFORTS
V. MEET-AND-CONFER EFFORTS A. Initial Correspondence — December 12, 2025
22. After reviewing the privilege log entries that accompanied Helios's early rolling pro
22. After reviewing the privilege log entries that accompanied Helios's early rolling productions, I sent a detailed letter dated December 12, 2025 to Marcus Pellegrini, Lead Partner at Ridgecrest Durneval LLP, One Federal Street, Suite 3400, Boston, Massachusetts 02110, counsel of record for Defendant Helios. In that letter, I identified GenomeDx's specific concerns regarding thirty-four (34) privilege log entries a
23. In the December 12, 2025 letter, I explained that many of the withheld documents appe
23. In the December 12, 2025 letter, I explained that many of the withheld documents appeared, based on their privilege log descriptions, to be primarily business documents — including board presentations, investor materials, and strategic plans — whose dominant purpose was commercial decision-making, not the seeking or rendering of legal advice. I noted that the inclusion of Sara Whitmore (General Counsel) as a copy
24. A true and correct copy of my December 12, 2025 letter to Marcus Pellegrini is attach
24. A true and correct copy of my December 12, 2025 letter to Marcus Pellegrini is attached hereto as Exhibit A and incorporated herein by reference. B. Telephone Conference — December 19, 2025
25. On December 19, 2025, I participated in a telephonic meet-and-confer conference with
25. On December 19, 2025, I participated in a telephonic meet-and-confer conference with Catherine Bloom, Responsible Partner at Calderwood & Harkness LLP. Representing Helios on the call were Marcus Pellegrini, Lead Partner, and Danielle Forrest, Senior Associate, both of Ridgecrest Durneval LLP.
26. During the approximately forty-five-minute telephone conference, Mr. Pellegrini and M
26. During the approximately forty-five-minute telephone conference, Mr. Pellegrini and Ms. Forrest took the position that all thirty-four (34) of the challenged documents were protected by attorney-client privilege because Sara Whitmore, Helios's General Counsel, was either copied on, contributed to, or otherwise participated in the creation or dissemination of each document. Mr. Pellegrini stated that Ms. Whitmore'
27. Ms. Bloom and I responded to defense counsel's position with several arguments. First
27. Ms. Bloom and I responded to defense counsel's position with several arguments. First, we explained that the mere inclusion of in-house counsel on a communication or document does not establish attorney-client privilege, particularly where the dominant purpose of the communication was business rather than legal in nature. We cited applicable Ninth Circuit authority for the proposition that the privilege protects
28. Mr. Pellegrini responded that Helios's position was that the common-interest doctrine
28. Mr. Pellegrini responded that Helios's position was that the common-interest doctrine protected communications shared with its investors because Corinth Ventures and Aether had a shared legal interest in Helios's patent risk management. Ms. Bloom and I disagreed, noting that an investor's financial interest in the success of a portfolio company is a business interest, not a common legal interest, and that the com
29. After extensive discussion, the parties were unable to reach agreement on any of the
29. After extensive discussion, the parties were unable to reach agreement on any of the thirty-four (34) challenged documents. Mr. Pellegrini stated that Helios would maintain its privilege assertions in full. I contemporaneously memorialized the substance of the December 19, 2025 call in my internal notes. C. Follow-Up Letter — January 8, 2026
30. On January 8, 2026, I sent a follow-up letter to Marcus Pellegrini and Danielle Forre
30. On January 8, 2026, I sent a follow-up letter to Marcus Pellegrini and Danielle Forrest at Ridgecrest Durneval LLP. In that letter, I reiterated GenomeDx's position that the thirty-four (34) challenged documents had been improperly withheld, and I identified each document by its privilege log entry number, date, and description. I requested that Helios produce the documents by January 20, 2026, to allow sufficien
31. The January 8, 2026 letter also noted that the Stipulated Protective Order entered on
Medium
⚑ Confidentiality undertaking
31. The January 8, 2026 letter also noted that the Stipulated Protective Order entered on December 18, 2025 by Judge Langston (Dkt. No. 74) — which establishes two tiers of protection, "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — provides adequate safeguards for any sensitive business information contained in the challenged documents. I emphasized that Helios could designate the produced document
32. A true and correct copy of my January 8, 2026 letter to Marcus Pellegrini and Daniell
32. A true and correct copy of my January 8, 2026 letter to Marcus Pellegrini and Danielle Forrest is attached hereto as Exhibit B and incorporated herein by reference. D. Helios's Response — January 15, 2026
33. On January 15, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded on behalf
33. On January 15, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded on behalf of Helios by letter addressed to me. Ms. Forrest's letter refused to produce any of the thirty-four (34) challenged documents.
34. Ms. Forrest's letter asserted three grounds for Helios's continued withholding of the
34. Ms. Forrest's letter asserted three grounds for Helios's continued withholding of the documents: (1) First, Ms. Forrest stated that each of the thirty-four documents reflects or incorporates legal advice from General Counsel Sara Whitmore regarding freedom-to-operate and patent clearance, and that accordingly each document is protected in its entirety by the attorney-client privilege; (2) Second, Ms. Forrest argu
35. A true and correct copy of Danielle Forrest's January 15, 2026 response letter is att
35. A true and correct copy of Danielle Forrest's January 15, 2026 response letter is attached hereto as Exhibit C and incorporated herein by reference. E. Exhaustion of Meet-and-Confer
36. Despite GenomeDx's good-faith efforts to resolve this discovery dispute without Court
36. Despite GenomeDx's good-faith efforts to resolve this discovery dispute without Court intervention, the parties remain at an impasse regarding all thirty-four (34) challenged documents. Over the course of approximately seven weeks — from December 12, 2025 through January 15, 2026 — the parties exchanged three written communications (December 12, 2025; January 8, 2026; and January 15, 2026) and participated in one
37. Consistent with Civil Local Rule 37-1 of the Northern District of California and the
37. Consistent with Civil Local Rule 37-1 of the Northern District of California and the Northern District of California's Guidelines for discovery, GenomeDx has exhausted its meet-and-confer obligations before filing the instant Motion to Compel.
VI. ANALYSIS OF THE CHALLENGED DOCUMENTS
VI. ANALYSIS OF THE CHALLENGED DOCUMENTS A. The 34 Challenged Documents Are Primarily Business Documents
38. Based on my review of the privilege log descriptions provided by Helios, the thirty-f
38. Based on my review of the privilege log descriptions provided by Helios, the thirty-four (34) challenged documents are board presentations, investor materials, business plans, and strategy memoranda whose dominant purpose is commercial decision-making — not the seeking or rendering of legal advice. The privilege log descriptions themselves reveal the business character of these documents. For example, the log ent
39. While some of these documents may contain incidental references to legal topics or ma
39. While some of these documents may contain incidental references to legal topics or may have been shared with or reviewed by Sara Whitmore in her capacity as General Counsel, the inclusion of in-house counsel on a communication or the presence of incidental legal references does not transform a business document into a privileged legal communication. Under Ninth Circuit law, the attorney-client privilege protects
40. In the context of in-house counsel, this distinction is particularly important. In-ho
40. In the context of in-house counsel, this distinction is particularly important. In-house counsel frequently perform dual roles within corporations, serving both as legal advisors and as business participants in corporate strategy, product development, and operational decision-making. When in-house counsel acts in a business capacity — for example, by contributing to market strategy presentations, participating in
41. At least nine (9) of the thirty-four (34) challenged documents were shared with Corin
41. At least nine (9) of the thirty-four (34) challenged documents were shared with Corinth Ventures Fund III, LP ("Corinth Ventures") and/or Aether Life Sciences Partners ("Aether"). Corinth Ventures is Helios's majority investor, holding 58.7% of Helios's equity, and is managed by Priya Chandrasekaran, with offices at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116. Aether is a Series A investor holdin
42. It is well established that voluntary disclosure of otherwise privileged communicatio
42. It is well established that voluntary disclosure of otherwise privileged communications to third parties who are outside the attorney-client relationship constitutes a waiver of attorney-client privilege. Helios's disclosure of these nine (9) documents to Corinth Ventures and Aether destroyed any privilege that might have attached to those communications. Neither Corinth Ventures nor Aether is Helios's attorney,
43. Helios's assertion that the common-interest doctrine protects these communications is
43. Helios's assertion that the common-interest doctrine protects these communications is without merit. The common-interest doctrine (sometimes referred to as the "joint defense" or "community of interest" doctrine) is a narrow exception to the general rule that disclosure to third parties waives privilege. To invoke the common-interest doctrine, the party asserting privilege must demonstrate that the parties share
44. An investor's interest in the financial success of its portfolio company is a quintes
44. An investor's interest in the financial success of its portfolio company is a quintessential business interest, not a common legal interest. Corinth Ventures and Aether are not co-defendants in this litigation, are not parties to any related legal proceeding, and are not engaged in a joint legal defense strategy with Helios. Their interest in Helios's patent risk management is derivative of and subordinate to the
45. Twelve (12) of the thirty-four (34) challenged documents are described in the privile
45. Twelve (12) of the thirty-four (34) challenged documents are described in the privilege log as board presentations or board-level memoranda. To the extent that any of these documents contain mixed business and legal content, the business portions of those documents are not protected by attorney-client privilege. The privilege does not provide blanket protection for an entire document merely because some portion o
46. The composition of Helios's board of directors further undermines Helios's privilege
46. The composition of Helios's board of directors further undermines Helios's privilege assertions with respect to these twelve (12) board presentations. Based on publicly available information and Helios's own filings in this case, Helios's board includes representatives of Corinth Ventures, including at least one board seat occupied by a Corinth Ventures designee. The sharing of allegedly privileged documents with
47. Five (5) of the thirty-four (34) challenged documents are described as email communic
47. Five (5) of the thirty-four (34) challenged documents are described as email communications between Helios executives — specifically Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), and Derek Mallinson (Vice President of Commercial Operations) — and Sara Whitmore (General Counsel), where those emails were also sent to or shared with non-legal business personnel within H
VII. RELEVANCE OF THE 34 CHALLENGED DOCUMENTS
VII. RELEVANCE OF THE 34 CHALLENGED DOCUMENTS
48. The thirty-four (34) withheld documents are directly relevant to GenomeDx's claims an
48. The thirty-four (34) withheld documents are directly relevant to GenomeDx's claims and damages theories in this action. Specifically: (a) Willful Infringement. Board presentations and investor materials discussing GenomeDx's patents, the Decipher® test, or freedom-to-operate analyses are probative of Helios's pre-launch knowledge of GenomeDx's patent rights and the deliberateness of Helios's decision to launch th
49. The importance of these documents to GenomeDx's case cannot be overstated. Willful in
49. The importance of these documents to GenomeDx's case cannot be overstated. Willful infringement, damages, and the accused infringer's state of mind are among the central issues in this patent infringement action, and the thirty-four (34) challenged documents — by Helios's own privilege log descriptions — are squarely directed to those issues. Helios should not be permitted to use overbroad and unsupported privile
VIII. THE PROTECTIVE ORDER PROVIDES ADEQUATE SAFEGUARDS
VIII. THE PROTECTIVE ORDER PROVIDES ADEQUATE SAFEGUARDS
50. On December 18, 2025, the Court entered the parties' Stipulated Protective Order (Dkt
Medium
⚑ Confidentiality undertaking
50. On December 18, 2025, the Court entered the parties' Stipulated Protective Order (Dkt. No. 74), which establishes two tiers of confidentiality protection: "Confidential" and "Highly Confidential — Attorneys' Eyes Only." The Stipulated Protective Order was the product of good-faith negotiations between Calderwood & Harkness LLP and Ridgecrest Durneval LLP, following a meet-and-confer conference held on December 5,
51. The Stipulated Protective Order provides robust safeguards against the public disclos
Medium
⚑ Confidentiality undertaking
51. The Stipulated Protective Order provides robust safeguards against the public disclosure or misuse of sensitive business information. Documents designated as "Confidential" may be viewed by a defined group of individuals, including outside counsel, in-house counsel, experts, and certain litigation support personnel. Documents designated as "Highly Confidential — Attorneys' Eyes Only" are subject to even more rest
52. Helios may designate any or all of the thirty-four (34) challenged documents at eithe
Medium
⚑ Confidentiality undertaking
52. Helios may designate any or all of the thirty-four (34) challenged documents at either tier of the Stipulated Protective Order, thereby ensuring that any sensitive business information contained in those documents is adequately protected from public disclosure, competitive harm, or any other misuse. The existence of the Stipulated Protective Order undermines any argument by Helios that production of the challenge