1013-00005 · Genome Dx Therapeutics Inc · Discovery/Motions

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

GENOME DX THERAPEUTICS INC., a Delaware corporation,

Plaintiff,

HELIOS PRECISION DIAGNOSTICS, INC., a Delaware corporation,

Defendant.

Case No. 3:25-cv-01847-JWL

Assigned to: Hon. Jessica W. Langston Referred to: Hon. David R. Cabrera, United States Magistrate Judge

MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF PLAINTIFF GENOME DX THERAPEUTICS INC.'S MOTION TO COMPEL PRODUCTION OF DOCUMENTS RESPONSIVE TO REQUEST FOR PRODUCTION NOS. 22, 23, AND 31

Date: February 20, 2026

Time: 10:00 a.m. Courtroom: F, 15th Floor Before: Hon. David R. Cabrera

TABLE OF AUTHORITIES

Cases:

Statutes and Rules:

I. INTRODUCTION

Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") respectfully submits this Memorandum of Points and Authorities in support of its motion to compel Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents that Helios has improperly withheld on claims of attorney-client privilege and work-product protection. These documents are responsive to GenomeDx's First Set of Requests for Production Nos. 22, 23, and 31, which were served on January 27, 2026. Despite extensive meet-and-confer efforts, the parties have been unable to resolve this dispute, and GenomeDx now seeks judicial intervention to obtain documents that are plainly discoverable and critically relevant to the issues in this case.

The discovery requests at the heart of this motion target three categories of business documents. Request for Production ("RFP") No. 22 seeks pre-launch business plans referencing GenomeDx's patents or the Decipher® genomic classifier test. RFP No. 23 seeks board presentations relating to the same subjects. RFP No. 31 seeks investor materials, investment memoranda, and due diligence materials provided to or shared with Helios's investors that reference GenomeDx's patents or the Decipher® test. Each of these categories seeks precisely the type of business-critical information that bears directly on Helios's pre-launch awareness of GenomeDx's patent rights, Helios's deliberate competitive strategy vis-à-vis GenomeDx, and the commercial dynamics that will inform the damages analysis in this case.

To Helios's credit, it has produced a substantial volume of responsive documents from these categories — 1,247 documents in total. However, Helios has withheld 83 documents on privilege grounds, logging each on its privilege log served concurrently with its production. GenomeDx has carefully reviewed those privilege log entries and has determined that the privilege assertions for 34 of the 83 withheld documents are deficient, unsupported, or both. GenomeDx challenges only these 34 documents in this motion.

The 34 documents at issue are quintessentially business-oriented documents: board presentations, investor decks, business plans, and due diligence materials. They were shared broadly with non-lawyer business personnel within Helios and, critically, with outside investors — including Corinth Ventures Fund III, LP, Helios's 58.7% majority equity holder, and Aether Life Sciences Partners, an 11.0% Series A investor. These are not confidential attorney-client communications prepared in the privacy of a lawyer's office; they are documents created to guide business decisions, to attract and retain investor capital, and to chart Helios's commercial strategy in the precision diagnostics market. The fact that Helios's General Counsel, Sara Whitmore, may appear as a recipient or contributor on some of these documents does not transform them into privileged communications. Lawyers at technology companies routinely participate in business planning in their capacity as business advisors and executives, and the attorney-client privilege does not cloak every document that passes through a lawyer's inbox.

Further, Helios's work-product assertions are equally unavailing. Many of the withheld documents predate the filing of this lawsuit by months or even years. They were created in connection with Helios's pre-launch business planning and investor fundraising activities — activities that occur in the ordinary course of business. The mere fact that some of these documents mention GenomeDx's patents does not render them documents prepared "in anticipation of litigation." And even if any of the 34 documents were to qualify as fact work product, GenomeDx has demonstrated substantial need for these materials, which reflect Helios's contemporaneous understanding of GenomeDx's patent portfolio and the competitive landscape — information that is uniquely within Helios's possession and that cannot be obtained from any other source.

The Stipulated Protective Order entered by this Court on December 18, 2025 provides robust safeguards for any commercially sensitive information contained in these documents. Documents may be designated at the "Confidential" or "Highly Confidential — Attorneys' Eyes Only" tier, restricting access to outside counsel and designated experts only. Helios's confidentiality concerns, to the extent they are genuine, are fully addressed by these protections. Privilege should not be wielded as a substitute for the protections already afforded by the Protective Order.

GenomeDx and its counsel at Calderwood & Harkness LLP engaged in extensive good-faith meet-and-confer efforts with Helios's counsel at Ridgecrest Durneval LLP, including a detailed deficiency letter, a written response, and a telephonic conference. These efforts, described more fully below and documented in the Declaration of Peter Vassiliev filed concurrently herewith, were unsuccessful. GenomeDx therefore respectfully requests that the Court grant this motion and order production of the 34 withheld documents.

II. FACTUAL BACKGROUND

A. The Litigation

GenomeDx filed this patent infringement action on March 28, 2025, asserting claims under 35 U.S.C. § 271 against Helios's ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test for prostate cancer that Helios launched commercially on October 7, 2024. GenomeDx asserts 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"). These patents cover methods and compositions relating to genomic classifiers used to assess prostate cancer prognosis, and they form the foundation of GenomeDx's market-leading Decipher® Prostate genomic classifier test, which employs a validated 22-gene expression panel.

GenomeDx is a Delaware corporation qualified to do business in the State of California, with its principal place of business at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130. GenomeDx is a recognized leader in molecular diagnostics, and its Decipher® Prostate test is one of the most widely used genomic classifiers in clinical urology, endorsed by multiple guidelines from the National Comprehensive Cancer Network ("NCCN") and the American Urological Association ("AUA"). GenomeDx reported fiscal year 2024 revenue of approximately $387.6 million, reflecting the significant market position and clinical adoption of its diagnostic products.

Helios is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, with a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, where Helios processes and reports the ProstaSignal™ test. Helios reported fiscal year 2024 revenue of approximately $71.2 million, a substantial portion of which is attributable to the commercial launch and rapid scaling of ProstaSignal™ beginning in October 2024.

The factual basis for GenomeDx's infringement claims is compelling. Of ProstaSignal™'s 24-gene expression panel, 19 genes overlap with GenomeDx's patented gene set claimed in the '271, '893, and '647 Patents. This substantial overlap lies at the core of GenomeDx's contention that Helios's ProstaSignal™ classifier practices the methods and compositions claimed in GenomeDx's patents.

On May 12, 2025, Helios filed its Answer and Counterclaims, denying infringement and asserting affirmative defenses of invalidity under 35 U.S.C. §§ 101, 102, and 103; non-infringement under 35 U.S.C. § 271; and unenforceability. Helios's Answer further affirmatively pleads that its scientists "independently developed" the ProstaSignal™ classifier beginning in approximately 2020, purportedly relying on publicly available gene-expression datasets from repositories such as the Gene Expression Omnibus ("GEO") and The Cancer Genome Atlas ("TCGA").

On October 21, 2025, Helios filed a Motion to Dismiss GenomeDx's claims under 35 U.S.C. § 101, arguing that the asserted patent claims are directed to unpatentable abstract ideas or natural phenomena. After full briefing and oral argument, the Honorable Jessica W. Langston denied Helios's Motion to Dismiss on January 13, 2026, finding that GenomeDx's patent claims recite patent-eligible subject matter at the pleading stage. Dkt. No. 87. The litigation is now proceeding through fact discovery.

The Scheduling Order entered on June 18, 2025 by Magistrate Judge Cabrera establishes the following key deadlines: fact discovery closes on March 6, 2026; expert reports are due May 15, 2026, with rebuttal reports due July 1, 2026; the Markman hearing is set for September 18, 2026; and trial is currently scheduled for February 2027. The rapidly approaching fact-discovery close date underscores the urgency of GenomeDx's motion.

B. The discovery Requests at Issue

On January 27, 2026, GenomeDx served its First Set of Requests for Production (Nos. 1–47) on Helios pursuant to Federal Rule of Civil Procedure 34. The requests at issue in this motion are RFP Nos. 22, 23, and 31, which seek the following categories of documents:

RFP No. 22 requests: "All pre-launch business plans, business strategy documents, and market-entry analyses that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."

RFP No. 23 requests: "All board of directors presentations, board memoranda, and board packages that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."

RFP No. 31 requests: "All investor materials, investment memoranda, due diligence reports, and due diligence materials provided to, shared with, or prepared for Helios's investors, venture capital investors, or potential investors that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."

These three categories of documents are directly and specifically relevant to GenomeDx's claims and to the issues that will be contested at trial. Documents reflecting Helios's knowledge of, assessment of, and intent regarding GenomeDx's patent rights prior to and contemporaneous with ProstaSignal™'s October 2024 commercial launch are critical to GenomeDx's claims of willful infringement, its damages theories (including the Georgia-Pacific hypothetical negotiation framework), and its challenge to Helios's "independent development" defense. They are also relevant to the broader competitive landscape that will inform the Court's claim construction and the jury's understanding of the commercial context of the alleged infringement.

C. Helios's Production and Privilege Assertions

In response to RFP Nos. 22, 23, and 31, Helios produced 1,247 documents. GenomeDx acknowledges this production and does not challenge its adequacy as to the produced documents. However, Helios simultaneously withheld 83 documents on privilege grounds, asserting attorney-client privilege and/or the work-product doctrine for each withheld document. Helios served a privilege log identifying the 83 withheld documents, as required by Federal Rule of Civil Procedure 26(b)(5)(A).

GenomeDx's counsel carefully reviewed the privilege log entries for all 83 withheld documents. Based on that review, GenomeDx identified 34 documents for which the privilege assertions are, on the face of the privilege log, deficient, unsupported, or both. GenomeDx challenges only these 34 documents in the instant motion. The 34 documents fall into three broad categories based on their privilege log descriptions:

Board Presentations (approximately 12 documents). These documents are described on the privilege log as presentations to Helios's board of directors. The log entries indicate that the presentations include slides addressing the "competitive landscape," Helios's "market positioning vis-à-vis GenomeDx's Decipher® test," and "references to GenomeDx patent portfolio." The described recipients include all members of Helios's board of directors, which, according to Helios's publicly available filings and its initial disclosures in this case, includes representatives of Corinth Ventures Fund III, LP — Helios's 58.7% majority equity holder — who hold three board seats or possess board observer rights pursuant to the terms of Helios's stockholders' agreement. While some entries list Sara Whitmore (General Counsel) as a recipient or "cc," the entries describe the substance of these documents in overwhelmingly business terms: competitive positioning, market share analysis, commercial launch planning, and reimbursement strategy.

Investor Materials (approximately 14 documents). These documents are described on the privilege log as investment memoranda, due diligence reports, and presentation decks that were shared with Helios's outside investors, specifically Corinth Ventures Fund III, LP (a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116, and managed by Priya Chandrasekaran, Managing Director) and Aether Life Sciences Partners (an 11.0% Series A investor in Helios). The privilege log entries describe these documents as discussing "ProstaSignal™'s market opportunity relative to GenomeDx's IP position," "competitive analysis," "market sizing," "reimbursement landscape," and "Intellectual property risk assessment." The described recipients include non-lawyer investor representatives from both Corinth Ventures and Aether Life Sciences Partners, as well as Helios executives including CEO Dr. Nathan Ashford, Chief Scientific Officer Dr. Elaine Kossack, and Vice President of Commercial Operations Derek Mallinson. Several entries list Sara Whitmore (General Counsel) among the recipients, but the documents were plainly created and distributed for investor relations and fundraising purposes, not for the purpose of obtaining or rendering legal advice.

Internal Business Plans (approximately 8 documents). These documents are described as strategic planning documents and market-entry analyses circulated to Helios senior management. The described recipients include CEO Dr. Nathan Ashford, CSO Dr. Elaine Kossack, VP Commercial Operations Derek Mallinson, and General Counsel Sara Whitmore. The privilege log entries describe these documents in terms such as "business plan addressing competitive landscape," "market entry strategy," "pre-launch planning," and "commercial strategy memorandum." While some entries reference "legal considerations" or "IP risk," the documents are, by their own descriptions, business planning documents created in the ordinary course of Helios's commercial operations.

A critical and recurring deficiency across many of the 34 privilege log entries is that the documents were distributed to individuals who are not lawyers and who do not fall within the scope of the attorney-client relationship. Dr. Ashford, Dr. Kossack, and Mr. Mallinson are Helios executives participating in business decisions — they are not attorneys. The representatives of Corinth Ventures and Aether Life Sciences Partners are outside investors whose interest in Helios is financial and commercial, not legal. The fact that Sara Whitmore (General Counsel) appears as a recipient or contributor on many of these documents does not alter their fundamental character as business documents. As discussed in detail below, the privilege log entries describe the documents in terms that indicate their predominant purpose was business strategy, commercial planning, and investor relations — not the provision or seeking of legal advice.

D. Meet-and-Confer Efforts

The parties have engaged in good-faith meet-and-confer efforts regarding this discovery dispute, as required by Federal Rule of Civil Procedure 37(a)(1) and Civil Local Rule 37-1 of this District.

On December 5, 2025, counsel for the parties met and conferred telephonically to resolve a related dispute concerning the terms of a protective order governing the production of confidential business information in this case. That meet-and-confer was successful, and the resulting Stipulated Protective Order was entered by Magistrate Judge Cabrera on December 18, 2025. Dkt. No. 74. The Protective Order established two tiers of confidentiality protection: "Confidential" and "Highly Confidential — Attorneys' Eyes Only."

Following GenomeDx's review of Helios's privilege log, on January 10, 2026, Peter Vassiliev of Calderwood & Harkness LLP sent a detailed deficiency letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP, counsel for Helios. The letter identified the 34 specific documents for which GenomeDx's challenged Helios's privilege assertions, explained the legal bases for GenomeDx's position, and requested that Helios either produce the 34 documents (subject to appropriate confidentiality designations under the Protective Order) or provide supplemental privilege log entries with sufficient detail to allow GenomeDx to assess the applicability of the claimed privilege. Vassiliev Decl. Ex. A.

On January 17, 2026, Ridgecrest Durneval responded by letter, declining to produce any of the 34 documents and asserting that all 34 are protected by attorney-client privilege and/or the work-product doctrine. The response letter stated that the 34 documents "reflect legal analysis and advice provided by counsel regarding intellectual property matters" and that "disclosure was limited to individuals with a need to know for purposes of obtaining and implementing legal advice." The response did not provide any supplemental detail regarding the privilege log entries and did not address GenomeDx's specific objections regarding disclosure to outside investors or the business-oriented nature of the documents. Vassiliev Decl. Ex. B.

On January 22, 2026, the parties participated in a follow-up telephonic meet-and-confer. During that call, GenomeDx's counsel reiterated the specific bases for its objections to Helios's privilege assertions — including the disclosure of the documents to non-lawyer third-party investors, the business-oriented descriptions in the privilege log, and the insufficiency of the log entries. Helios's counsel maintained its position that all 34 documents are privileged and declined to produce any of them or to supplement the privilege log. The parties were unable to resolve the dispute.

All meet-and-confer correspondence, including the January 10, 2026 deficiency letter, the January 17, 2026 response, and a summary of the January 22, 2026 telephonic conference, is attached as exhibits to the Declaration of Peter Vassiliev filed concurrently with this Memorandum. Vassiliev Decl. Exs. A–C.

III. LEGAL STANDARD

Under Federal Rule of Civil Procedure 37(a)(3)(B), a party may move to compel production of documents when the responding party has failed to produce documents or has failed to permit inspection as requested under Rule 34. The moving party bears the initial burden of demonstrating that the discovery sought is relevant to any party's claim or defense and proportional to the needs of the case under Rule 26(b)(1). See Fed. R. Civ. P. 26(b)(1) ("Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case.").

Relevance in the discovery context is construed broadly. Information "need not be admissible in evidence to be discoverable." Fed. R. Civ. P. 26(b)(1). Discovery is appropriate where the information sought "appears reasonably calculated to lead to the discovery of admissible evidence." Hickman v. Taylor, 329 U.S. 495, 507 (1947). GenomeDx submits that there is no genuine dispute regarding the relevance of the 34 withheld documents, as their descriptions on the privilege log confirm that they address precisely the subjects — competitive analysis, patent awareness, market positioning, and commercial strategy — that lie at the heart of this patent infringement action. The dispute here is solely whether the documents are protected from disclosure by the attorney-client privilege or the work-product doctrine.

The Attorney-Client Privilege. The attorney-client privilege is the "oldest of the privileges for confidential communications known to the common law." Upjohn Co. v. United States, 449 U.S. 383, 389 (1981). In the Ninth Circuit, the privilege protects confidential communications between a client and an attorney, made for the purpose of obtaining or providing legal advice. In re Grand Jury Subpoena (Torf), 357 F.3d 900, 907 (9th Cir. 2004); United States v. Richey, 632 F.3d 559, 566 (9th Cir. 2011). The privilege exists to encourage "full and frank communication between attorneys and their clients," Upjohn, 449 U.S. at 389, and thereby to promote broader public interests in the observance of law and the administration of justice.

The burden of establishing the applicability of the attorney-client privilege rests on the party asserting it. Weil v. Inv./Indicators, Research & Mgmt., Inc., 647 F.2d 18, 25 (9th Cir. 1981). The asserting party must demonstrate each element of the privilege: (1) a communication; (2) made between the client and the attorney (or the attorney's agents); (3) in confidence; (4) for the purpose of seeking, obtaining, or providing legal assistance to the client. In re Grand Jury Subpoena (Torf), 357 F.3d at 907. Because the privilege "is in derogation of the search for truth," it is construed narrowly. Clark v. City of Los Angeles, 950 F.2d 1430, 1441 (9th Cir. 1991); Weil, 647 F.2d at 25.

Critically, the attorney-client privilege does not attach to communications that are made primarily for business purposes, even if a lawyer is involved. Where a communication serves both a legal and a business purpose, the privilege attaches only if the "primary purpose" of the communication was to obtain or provide legal advice. In re Cnty. of Erie, 473 F.3d 413, 420 (2d Cir. 2007); Nidec Corp. v. Victor Co. of Japan, 249 F.R.D. 575, 578 (N.D. Cal. 2007). The privilege also does not protect communications that have been disclosed to third parties outside the attorney-client relationship, because such disclosure destroys the confidentiality that is essential to the privilege. United States v. Ruehle, 583 F.3d 600, 612 (9th Cir. 2009).

The Work-Product Doctrine. The work-product doctrine, codified at Federal Rule of Civil Procedure 26(b)(3), protects from discovery "documents and tangible things that are prepared in anticipation of litigation or for trial by or for another party or its representative." Fed. R. Civ. P. 26(b)(3)(A). The doctrine shields the mental processes of attorneys and protects against the disclosure of an attorney's legal theories, strategies, and impressions. Hickman v. Taylor, 329 U.S. at 510–11.

To invoke the work-product doctrine, the asserting party must demonstrate that the documents were prepared "because of" the prospect of litigation. United States v. Richey, 632 F.3d at 567–68 (9th Cir. 2011) (applying the "because of" test). Documents prepared in the ordinary course of business, or for a purpose that would have existed irrespective of the prospect of litigation, are not protected. Id. at 568. Even where the work-product doctrine applies, factual (as opposed to opinion) work product may be discovered upon a showing that the discovering party has "substantial need for the materials to prepare its case and cannot, without undue hardship, obtain their substantial equivalent by other means." Fed. R. Civ. P. 26(b)(3)(A)(ii).

The Court's Broad Discretion. The district court has "broad discretion in controlling discovery." Admiral Ins. Co. v. U.S. Dist. Court for Dist. of Ariz., 881 F.2d 1486, 1494 (9th Cir. 1989). This Court's Civil Local Rules further provide for the resolution of discovery disputes through motion practice after good-faith meet-and-confer efforts. N.D. Cal. Civ. L.R. 37-1. The Court's Patent Local Rules also govern discovery in patent cases and reflect the particular importance of discovery regarding infringement, validity, and damages in cases involving complex technology. N.D. Cal. Patent L.R. 3-1 et seq.

IV. ARGUMENT

A. The 34 Documents Are Not Protected by Attorney-Client Privilege Because They Were Not Made for the Purpose of Obtaining Legal Advice

Helios's blanket assertion of attorney-client privilege over the 34 challenged documents cannot withstand scrutiny. The privilege log entries for these documents reveal, on their face, that they are business documents — board presentations, investor decks, business plans, and due diligence materials — that were created for business purposes and distributed to non-lawyer business personnel and outside investors. The mere fact that Helios's General Counsel, Sara Whitmore, appears as a recipient or contributor on some of these documents does not transform them into privileged communications. Helios has failed to carry its burden of establishing that the primary purpose of these documents was to obtain or provide legal advice.

1. The Predominant Purpose of the Documents Is Business, Not Legal. The privilege log descriptions for the 34 challenged documents uniformly characterize them in business terms. The log entries describe these documents variously as "board presentation," "investor update," "business plan," "market analysis," "competitive landscape assessment," "due diligence report," "commercial strategy memorandum," and "market entry strategy." These descriptions — drafted by Helios's own counsel — reveal the nature and purpose of the documents: they are business-planning and investor-relations materials created to inform commercial decisions, guide strategic planning, and communicate with investors. They are not attorney-client communications created for the purpose of obtaining or rendering legal advice.

Courts in the Ninth Circuit apply the "primary purpose" test to determine whether a communication involving in-house counsel is privileged. Under this test, where a document serves both a legal and a business purpose, the privilege attaches only if the primary purpose of the communication was to obtain or provide legal advice. See Nidec Corp. v. Victor Co. of Japan, 249 F.R.D. 575, 578 (N.D. Cal. 2007) (holding that documents created for business purposes are not privileged merely because they were copied to in-house counsel); Theranos, Inc. v. Draven Pharma LLC, No. 11-cv-05236-PSG, 2014 WL 1168429, at 3 (N.D. Cal. Mar. 21, 2014) (applying the primary-purpose test and ordering production of documents where the "primary purpose" was "business-related" rather than "legal"). As the Second Circuit has explained, in determining the primary purpose of a communication, the court should examine "whether the communication would have been made in substantially similar form but for the prospect of legal advice." Schaeffler v. United States*, 806 F.3d 34, 40 (2d Cir. 2015).

Here, the privilege log descriptions make clear that the 34 documents were created for purposes that are distinctly and predominantly commercial. Board presentations discussing "competitive landscape" and "market positioning vis-à-vis GenomeDx's Decipher® test" are presentations prepared to inform the board's governance and strategic oversight functions — not to seek or receive legal advice. Investor memoranda and due diligence reports discussing "ProstaSignal™'s market opportunity relative to GenomeDx's IP position" were prepared for the purpose of communicating with investors and securing capital — a quintessentially business activity. Internal business plans addressing "market entry strategy" and "commercial strategy" were created to guide the commercial decisions of Helios's management team. These are documents that Helios would have created in substantially the same form regardless of whether legal advice was being sought.

The mere inclusion of Sara Whitmore as a recipient or contributor does not alter this analysis. It is well established that in-house counsel frequently participate in business discussions in their capacity as business advisors and executives, and the attorney-client privilege does not attach to communications in which a lawyer is acting in a business rather than a legal capacity. See Nidec, 249 F.R.D. at 578 ("The fact that [the defendant's in-house] counsel reviewed or commented on [a document] does not make it privileged, particularly where the document was created for a business purpose."); Burlington N. & Santa Fe Ry. Co. v. U.S. Dist. Court for Dist. of Mont., 408 F.3d 1142, 1149 (9th Cir. 2005) ("Many in-house lawyers serve dual roles, functioning as both legal and business advisors. When such lawyers participate in business discussions in their business capacity, the communications are not privileged.").

Sara Whitmore holds the title of General Counsel at Helios, and she also serves as a member of Helios's senior management team, participating in business strategy, commercial planning, and board governance. In this dual capacity, her involvement in the creation or distribution of board presentations, investor materials, and business plans does not by itself establish that these documents were created for the purpose of obtaining or providing legal advice. Helios bears the burden of demonstrating, for each document, that the communication was made primarily for a legal purpose, and the privilege log entries fail to carry that burden.

The content descriptions on the privilege log further confirm the business character of the 34 documents. Entries referencing "market positioning," "competitive analysis," "commercial launch strategy," "reimbursement strategy," "market sizing," "investor relations," and "market entry" indicate that the primary purpose of these communications was to inform business decisions, attract and maintain investor confidence, and chart Helios's commercial path in the molecular diagnostics market. While some entries include passing references to "legal considerations" or "IP risk," these references are insufficient to establish that the primary purpose of the documents was to obtain or provide legal advice. Every technology company must consider intellectual property issues as part of its business planning; the mere mention of patents or IP risk in a business document does not render it a privileged attorney-client communication. See Theranos, 2014 WL 1168429, at *4 (rejecting privilege claim where documents addressed IP issues but were "created primarily for business rather than legal purposes").

In sum, Helios cannot meet its burden of establishing that the 34 challenged documents were created primarily for the purpose of obtaining or providing legal advice. The privilege log entries themselves demonstrate that these documents are business materials, and Helios's conclusory assertion that they "reflect legal analysis and advice" is insufficient to overcome the clear business character revealed by the log descriptions.

2. Disclosure to Non-Lawyer Third Parties Waives Any Privilege That Might Otherwise Attach. Even if any of the 34 documents were otherwise entitled to protection under the attorney-client privilege — which GenomeDx does not concede — that privilege has been waived as to at least 14 of the 34 documents by Helios's voluntary disclosure of those documents to outside investors who are not within the scope of the attorney-client relationship.

The privilege log reveals that at least 14 of the challenged documents are investor materials, investment memoranda, due diligence reports, and presentation decks that were shared with Helios's outside investors, specifically Corinth Ventures Fund III, LP and Aether Life Sciences Partners. Corinth Ventures Fund III, LP is a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116, managed by Priya Chandrasekaran as Managing Director. Corinth Ventures holds a 58.7% majority equity position in Helios. Aether Life Sciences Partners holds an 11.0% Series A equity position. Neither Corinth Ventures nor Aether Life Sciences Partners is a party to this litigation.

It is black-letter law that voluntary disclosure of privileged communications to third parties outside the attorney-client relationship waives the privilege. United States v. Ruehle, 583 F.3d 600, 612 (9th Cir. 2009) ("Voluntary disclosure of the content of a privileged attorney-client communication constitutes waiver of the privilege as to all other such communications on the same subject."). The rationale is straightforward: the privilege exists to protect the confidentiality of attorney-client communications, and once the client voluntarily destroys that confidentiality by sharing the communication with third parties, the justification for the privilege evaporates. Id.

Corinth Ventures and Aether Life Sciences Partners are equity investors in Helios. Their interest in Helios is financial and commercial — they have invested capital in Helios and have a financial interest in the commercial success of ProstaSignal™ and in the value of their equity positions. They are not agents of Helios for purposes of the attorney-client privilege. They are not counsel, and they were not retained to provide legal services to Helios. Their receipt of the 14 investor-related documents was in connection with their role as investors, not for the purpose of obtaining or providing legal advice. Disclosure to these outside investors constitutes a waiver of any privilege that might otherwise have attached to those documents.

Helios may attempt to argue that its investors fall within a "common interest" or "joint defense" exception to the general rule that disclosure to third parties waives the privilege. Any such argument would be unavailing. The common-interest doctrine, which is sometimes described as a narrow extension of the attorney-client privilege or work-product protection, applies only where the parties share a common legal interest and have agreed to share privileged communications in furtherance of that common legal interest. See Coltec Indus., Inc. v. Am. Motorists Ins. Co., 197 F.R.D. 368, 373 (N.D. Ill. 2000) ("[T]he common interest doctrine requires a common legal interest, not merely a common commercial interest."). A shared business, financial, or commercial interest is not sufficient. Id.

Here, Corinth Ventures and Aether Life Sciences Partners share a business and financial interest with Helios — they are investors who seek to maximize the return on their equity positions. They do not share a legal interest in this litigation. They are not parties to this case. They are not represented by Helios's litigation counsel at Ridgecrest Durneval LLP. There is no indication in the record that Helios has entered into a joint defense agreement or common-interest agreement with either Corinth Ventures or Aether Life Sciences Partners with respect to this litigation. And the documents at issue — investor memoranda, due diligence reports, and presentation decks — were not shared for the purpose of obtaining or providing legal advice; they were shared for the purpose of informing investors about Helios's business, competitive position, and market opportunity. The common-interest doctrine cannot save Helios's privilege claim as to these documents.

Additionally, the approximately 12 board presentation documents were distributed to the full Helios board of directors, which includes representatives of Corinth Ventures Fund III, LP. As the 58.7% majority equity holder, Corinth Ventures holds three board seats or board observer rights pursuant to the terms of Helios's stockholders' agreement. Board members designated by Corinth Ventures serve in a governance and oversight capacity on behalf of their fund — they are not attorneys acting within the scope of an attorney-client relationship. Distribution of these board presentations to board members in their governance and investment capacity, rather than for the specific purpose of obtaining legal advice from those individuals, similarly vitiates any attorney-client privilege that might otherwise attach. See Nidec, 249 F.R.D. at 579 (finding privilege waived where documents were distributed to board members for governance purposes rather than for the purpose of obtaining legal advice).

3. The Privilege Log Entries Are Insufficiently Detailed. Independent of the substantive deficiencies in Helios's privilege claims, several of the 34 privilege log entries are procedurally inadequate and fail to provide sufficient information to allow GenomeDx or this Court to assess the applicability of the privilege.

Under Federal Rule of Civil Procedure 26(b)(5)(A), a party withholding information on the basis of privilege must "describe the nature of the documents, communications, or tangible things not produced or disclosed — and do so in a manner that, without revealing information itself privileged or protected, will enable other parties to assess the claim." In the Ninth Circuit and in this District, a privilege log must provide sufficient information for the opposing party and the Court to evaluate the privilege assertion, including, at a minimum: (1) the identity and capacity of the author; (2) the identity and capacity of all recipients; (3) the date of the communication; (4) a description of the subject matter of the communication; and (5) the specific privilege asserted and the basis for the assertion. See Grace v. Centerplate, Inc., No. 14-cv-05162-JST, 2016 WL 1392530, at *2 (N.D. Cal. Apr. 8, 2016) (requiring sufficient specificity in privilege log entries to permit assessment of privilege claims).

Several of the 34 entries on Helios's privilege log contain only generic and conclusory descriptions that fail to meet this standard. For example, multiple entries describe the withheld documents simply as "Communication regarding IP matters" or "Board presentation including legal analysis" without identifying: (a) the specific legal advice that was sought or provided; (b) the specific lawyer who provided the advice (as distinct from a lawyer who was merely a recipient or attendee); (c) the specific legal question or issue that the communication addressed; or (d) why the document was created primarily for a legal purpose rather than a business purpose. These bare-bones descriptions are insufficient to make out even a prima facie case for the privilege.

Where a privilege log fails to provide sufficient detail to support the privilege assertion, courts in this District have deemed the privilege waived and ordered production. See Grace, 2016 WL 1392530, at 3 (ordering production where privilege log entries were "too vague and conclusory to allow the Court to assess the claim of privilege"); see also Shacket v. Philko Aviation, Inc.*, 841 F.2d 166, 170 (7th Cir. 1988) (noting that inadequate privilege logs may result in waiver of the privilege). GenomeDx requested supplemental privilege log entries in its January 10, 2026 deficiency letter, but Helios declined to provide any additional detail. The inadequacy of the log entries independently warrants an order compelling production of the documents for which the entries are deficient.

B. The Work-Product Doctrine Does Not Protect These Documents

Helios has also asserted the work-product doctrine as a basis for withholding some or all of the 34 documents. This assertion is equally unavailing. The 34 documents were not prepared "in anticipation of litigation," and even if they were, GenomeDx has demonstrated the substantial need required to overcome any work-product protection for factual materials.

1. The Documents Were Not Prepared in Anticipation of Litigation. The work-product doctrine protects documents prepared "in anticipation of litigation or for trial by or for another party or its representative." Fed. R. Civ. P. 26(b)(3)(A). In the Ninth Circuit, the relevant inquiry is whether the document was created "because of" the prospect of litigation. United States v. Richey, 632 F.3d 559, 567–68 (9th Cir. 2011). Under this standard, a document qualifies as work product only if it "would not have been created in substantially similar form but for the prospect of that litigation." Id. at 568 (internal quotation marks omitted). Documents prepared in the ordinary course of business do not qualify, even if they may also be useful in subsequent litigation. Id.

Many of the 34 documents at issue were created well before GenomeDx filed this action on March 28, 2025. Based on the dates reflected on the privilege log, a substantial number of the documents appear to have been created during the period of Helios's pre-launch business planning — i.e., prior to the October 7, 2024 commercial launch of ProstaSignal™ — and during Helios's investor fundraising activities. At those times, no litigation had been filed and, based on the information available to GenomeDx, no litigation was reasonably anticipated. Helios was engaged in the ordinary business activities of a life sciences startup: developing its product, creating business plans, presenting to its board, and communicating with its investors. These are activities that every company in the molecular diagnostics industry undertakes as a matter of course, irrespective of whether litigation is on the horizon.

Business planning, competitive analysis, and investor communications are created in the ordinary course of business and for business purposes that exist independently of any litigation. A startup company's preparation of board presentations analyzing its competitive landscape, business plans assessing market entry strategy, and investor materials describing its market opportunity are all activities driven by commercial imperatives — the need to guide management decisions, satisfy governance obligations, and attract investment capital. These activities would occur regardless of whether litigation was anticipated. See OM Grp., Inc. v. Showa Denko K.K., 235 F.R.D. 91, 95–96 (D. Conn. 2006) (finding that documents prepared for business purposes in the ordinary course are not work product even if they discuss potential IP issues); Haines v. Liggett Grp., Inc., 975 F.2d 81, 94 (3d Cir. 1992) ("[D]ocuments prepared in the ordinary course of business are not protected as work product.").

Even if some of the 34 documents mention GenomeDx's patents or the Decipher® test, an awareness of a competitor's intellectual property portfolio does not transform a business document into litigation work product. Companies in the precision diagnostics industry routinely monitor the patent landscapes of their competitors as part of their business planning. The fact that a business plan or investor deck references a competitor's patents as part of a broader competitive analysis does not mean that the document was created "because of" anticipated litigation. To hold otherwise would transform every competitive intelligence document in every technology company into protected work product, effectively immunizing entire categories of business documents from discovery. That is not the law.

The privilege log entries provide no basis for concluding that the 34 documents were created in anticipation of litigation. The entries describe the documents in business terms, identify business personnel and investors as recipients, and do not indicate that the documents were prepared at the direction of litigation counsel, in connection with a specific litigation hold, or for any litigation-related purpose. Helios has not carried its burden of demonstrating that these documents satisfy the "because of" test required for work-product protection.

2. Even If Work-Product Protection Applied, GenomeDx Has Demonstrated Substantial Need. In the alternative, even if some of the 34 documents were to qualify as fact work product — which GenomeDx does not concede — GenomeDx has established substantial need for these documents and an inability to obtain their substantial equivalent without undue hardship, thereby overcoming any protection under Rule 26(b)(3)(A)(ii).

The 34 withheld documents reflect Helios's contemporaneous understanding of GenomeDx's patents, the competitive relationship between ProstaSignal™ and Decipher®, and Helios's assessment of GenomeDx's intellectual property position. This information is directly and critically relevant to multiple contested issues in this case:

Willful Infringement and Enhanced Damages. GenomeDx's claim for enhanced damages under 35 U.S.C. § 284 requires evidence of Helios's knowledge of GenomeDx's patents and Helios's deliberate decision to proceed with ProstaSignal™ in the face of that knowledge. Documents reflecting Helios's pre-launch assessment of GenomeDx's patent portfolio and the risk of infringement are among the most probative evidence of willfulness. GenomeDx cannot reconstruct Helios's internal state of mind from other sources; this information is uniquely within Helios's possession and control.

Damages Analysis and Georgia-Pacific Hypothetical Negotiation. Pre-launch business plans and investor materials that discuss expected revenue, projected market share, and the competitive relationship between ProstaSignal™ and Decipher® are directly relevant to the Georgia-Pacific hypothetical negotiation analysis. These documents bear on the value that the parties would have placed on a license at the time of first infringement and on the expected profitability of ProstaSignal™. The commercial data reflected in these documents is particularly significant in light of the substantial market impact of ProstaSignal™'s launch: during the period from October 2024 to March 2025, Helios performed approximately 8,400 ProstaSignal™ tests at an average reimbursement rate of approximately $3,820 per test, generating estimated revenue of $32,088,000, while GenomeDx's market share declined from approximately 74% to approximately 68%.

Competitive intelligence. Documents reflecting how Helios assessed the competitive landscape and positioned ProstaSignal™ relative to Decipher® are essential to understanding the commercial dynamics that will inform the damages analysis and the jury's understanding of the market context. These assessments are, by their nature, internal to Helios, and GenomeDx has no other means of obtaining them.

GenomeDx cannot obtain the substantial equivalent of these documents by other means. The 34 documents reflect Helios's own contemporaneous analysis of GenomeDx's patents and the competitive landscape — a perspective that is uniquely Helios's and that cannot be reconstructed through GenomeDx's own records, public sources, or third-party discovery. While GenomeDx intends to depose Helios executives and its 30(b)(6) designee, deposition testimony cannot substitute for the contemporaneous documents themselves, which reflect Helios's actual assessments and analyses at the time they were prepared, unfiltered by the litigation posture and self-interest that inevitably color deposition testimony. The substantial-need exception to work-product protection exists precisely for this type of situation, where the requesting party cannot obtain the factual information by any other means.

See Waugh v. Pathology Assocs., No. 14-cv-01412-BLF, 2015 WL 13158082, at *3 (N.D. Cal. Sept. 10, 2015) (finding substantial need for documents reflecting defendant's contemporaneous analysis where such analysis was uniquely within defendant's possession and control).

C. To the Extent Helios Asserts a Freedom-to-Operate Analysis Privilege, That Privilege Has Been Placed at Issue

Several of the withheld documents appear, based on their privilege log descriptions, to reflect Helios's assessment of whether its ProstaSignal™ test could operate freely in light of GenomeDx's patent portfolio — in other words, a freedom-to-operate ("FTO") or patent clearance analysis. To the extent Helios is claiming privilege over these FTO-related materials, Helios has placed the substance of any such analysis squarely at issue through its own affirmative pleadings and litigation conduct, and it cannot simultaneously use the privilege as both a sword and a shield.

In its Answer and Counterclaims, Helios asserts affirmative defenses of non-infringement and invalidity and affirmatively pleads that its scientists "independently developed" the ProstaSignal™ classifier beginning in approximately 2020, based on publicly available gene-expression datasets. These assertions necessarily implicate the question of what Helios knew about GenomeDx's patents, when it acquired that knowledge, and what steps, if any, it took to evaluate the risk of infringement before launching ProstaSignal™. If Helios intends to rely on advice of counsel or an FTO analysis as evidence of its good faith — whether as a defense to GenomeDx's willfulness allegations or as context for its claim of independent development — it has placed the substance of those analyses at issue and cannot simultaneously shield the underlying documents from discovery. See In re Seagate Tech., LLC, 497 F.3d 1360, 1372–74 (Fed. Cir. 2007) (en banc) (discussing the interplay between willfulness and advice of counsel in patent cases, and noting that assertion of an advice-of-counsel defense triggers waiver of privilege over the substance of that advice).

The record in this case strongly suggests that Helios has placed the substance of its FTO analysis at issue. In its initial disclosures exchanged on July 14, 2025, Helios identified Sara Whitmore (General Counsel) as a person likely to have discoverable information regarding "freedom-to-operate analyses" and "IP clearance decisions." Whitmore is also designated as a 30(b)(6) witness on topics including FTO and IP clearance. These designations indicate that Helios intends for the substance of its IP clearance process to be part of the evidentiary record. Helios cannot designate its General Counsel as a witness on FTO topics, assert independent development as a defense, and simultaneously withhold the very documents that reflect the substance of those FTO analyses.

Documents in which Helios assessed GenomeDx's patent portfolio in the context of launching ProstaSignal™ — whether they are labeled as business plans, board presentations, or investor materials — are directly relevant to whether Helios acted with knowledge of GenomeDx's patents and with an understanding of the risk of infringement. If Helios's position is that it conducted a thorough FTO analysis and concluded in good faith that ProstaSignal™ did not infringe GenomeDx's patents, GenomeDx is entitled to test that claim through discovery of the underlying documents. Helios should not be permitted to make affirmative representations about its good faith and independent development while simultaneously shielding from discovery the documents that would reveal the true nature and extent of its pre-launch IP assessment.

D. The Protective Order Adequately Safeguards Any Confidentiality Concerns

To the extent that Helios's resistance to producing the 34 documents is motivated by concerns about the confidentiality of commercially sensitive information — rather than by a genuine belief in the applicability of the attorney-client privilege or work-product doctrine — those concerns are fully addressed by the Stipulated Protective Order already in place in this case.

The Stipulated Protective Order, which was entered by Magistrate Judge Cabrera on December 18, 2025 after good-faith negotiations between Calderwood & Harkness LLP and Ridgecrest Durneval LLP, provides a comprehensive framework for the protection of confidential information produced in discovery. Dkt. No. 74. The Protective Order establishes two tiers of protection:

"Confidential" — restricting disclosure to outside counsel, in-house counsel (subject to certain limitations), designated experts, and other litigation participants specifically enumerated in the Order.

"Highly Confidential — Attorneys' Eyes Only" — further restricting disclosure to outside counsel and designated experts only, with no disclosure to in-house counsel or other business personnel of the receiving party.

Documents produced under the "Highly Confidential — Attorneys' Eyes Only" designation receive the highest level of protection available under the Protective Order. They may be viewed only by the parties' outside litigation counsel and by experts specifically retained for this litigation who have executed the acknowledgment form attached to the Protective Order. No in-house business personnel of GenomeDx would have access to documents designated at this tier.

These protections are precisely the mechanism that courts have developed to address the tension between the need for broad discovery and the legitimate interest of litigants in protecting their confidential business information. Helios is free to designate any or all of the 34 documents at the "Highly Confidential — Attorneys' Eyes Only" tier, thereby ensuring that the documents are accessible only to GenomeDx's outside litigation counsel and designated experts.

The Court should not permit Helios to use privilege assertions as a backdoor mechanism to avoid producing relevant business documents when the Protective Order already provides the appropriate safeguard for confidentiality concerns. Privilege and confidentiality are distinct concepts: the attorney-client privilege and the work-product doctrine protect specific categories of communications from discovery entirely, while the Protective Order addresses the separate concern that produced documents not be disclosed beyond the litigation. Where the documents at issue are not genuinely privileged — as GenomeDx has demonstrated — the appropriate remedy is production under the Protective Order, not blanket withholding.

E. Relevance of the 34 Documents to GenomeDx's Claims

GenomeDx has established above that the 34 withheld documents are not protected by the attorney-client privilege or the work-product doctrine. GenomeDx further submits that these documents are highly relevant to the specific claims and defenses at issue in this case, and that their continued withholding would cause significant prejudice to GenomeDx's ability to prosecute its claims.

Willfulness and Enhanced Damages (35 U.S.C. § 284). GenomeDx seeks enhanced damages on the ground that Helios willfully infringed GenomeDx's patents by launching ProstaSignal™ with knowledge of GenomeDx's patent rights and in deliberate disregard of the risk of infringement. Documents reflecting Helios's pre-launch awareness of GenomeDx's patents, Helios's assessment of the risk of infringement, and Helios's deliberate decision to proceed with ProstaSignal™ notwithstanding that risk are central to GenomeDx's willfulness claim. The 34 withheld documents — which, based on their privilege log descriptions, discuss GenomeDx's patents and the Decipher® test in the context of competitive analysis, market positioning, and business planning — are precisely the type of evidence that will inform the Court's and the jury's assessment of whether Helios acted with the subjective knowledge and intent required for a finding of willfulness. Continued withholding of these documents deprives GenomeDx of some of the most probative evidence on this critical issue.

Damages and Georgia-Pacific Analysis. GenomeDx intends to present a damages case grounded in the Georgia-Pacific hypothetical-negotiation framework, which requires the trier of fact to determine the reasonable royalty that the parties would have agreed upon in a hypothetical negotiation at the time of first infringement. The Georgia-Pacific factors include, among others, the nature and scope of the license, the commercial relationship between the parties, the anticipated profitability of the infringing product, and the portion of the profit that is customarily attributable to the patented technology. Pre-launch business plans, investor materials, and board presentations that discuss expected revenue, projected market share, reimbursement strategy, and the competitive relationship between ProstaSignal™ and Decipher® bear directly on several of these factors. These documents reflect Helios's own contemporaneous assessment of the commercial value of ProstaSignal™ and the competitive dynamic with GenomeDx — information that is critical to establishing the appropriate royalty rate and base.

Infringement and State of Mind. Board presentations analyzing GenomeDx's patent claims and the ProstaSignal™ design may shed light on whether Helios designed around or deliberately copied GenomeDx's patented methods, including the striking overlap of 19 of ProstaSignal™'s 24 genes with GenomeDx's patented gene set. Documents reflecting Helios's internal analysis of this overlap and its implications for infringement are directly relevant to GenomeDx's infringement case and to Helios's state of mind at the time it decided to launch ProstaSignal™ with a gene panel that so substantially overlaps with GenomeDx's patented panel.

Invalidity and Independent Development. Helios contends that its scientists independently developed the ProstaSignal™ classifier beginning in approximately 2020, relying on publicly available gene-expression datasets. Business plans and investor materials that discuss GenomeDx's patents and the Decipher® test may contradict or qualify this assertion — for example, by revealing that Helios's development efforts were not truly "independent" but were instead informed by an awareness of GenomeDx's patented gene panel and its commercial success. GenomeDx is entitled to test Helios's independent-development narrative through discovery of the underlying documents.

Timing. Finally, the urgency of this motion cannot be overstated. Fact discovery in this case closes on March 6, 2026 — less than five weeks from the date of this filing. GenomeDx needs the 34 withheld documents in order to complete its remaining fact depositions, which include depositions of Dr. Nathan Ashford (CEO), Dr. Elaine Kossack (CSO), Derek Mallinson (VP Commercial Operations), and Sara Whitmore (General Counsel), as well as Helios's Rule 30(b)(6) designee on topics including FTO analysis, competitive intelligence, patent awareness, and commercial strategy. GenomeDx also needs these documents to prepare its opening expert reports, which are due May 15, 2026. Any further delay in obtaining these documents would cause substantial and potentially irreversible prejudice to GenomeDx's case preparation.

V. CONCLUSION

For the foregoing reasons, Plaintiff Genome Dx Therapeutics Inc. respectfully requests that the Court enter the [Proposed] Order Granting Plaintiff's Motion to Compel, requiring Defendant Helios Precision Diagnostics, Inc. to produce the 34 withheld documents identified herein within ten (10) business

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION
GENOME DX THERAPEUTICS INC., a Delaware corporation,
Plaintiff,
v.
HELIOS PRECISION DIAGNOSTICS, INC., a Delaware corporation,
Defendant.
Case No. 3:25-cv-01847-JWL
Assigned to: Hon. Jessica W. Langston Referred to: Hon. David R. Cabrera, United States Magistrate Judge
MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF PLAINTIFF GENOME DX THERAPEUTICS INC.'S MOTION TO COMPEL PRODUCTION OF DOCUMENTS RESPONSIVE TO REQUEST FOR PRODUCTION NOS. 22, 23, AND 31
Date: February 20, 2026
Time: 10:00 a.m. Courtroom: F, 15th Floor Before: Hon. David R. Cabrera
TABLE OF CONTENTS
TABLE OF AUTHORITIES
Cases:
Statutes and Rules:
I. INTRODUCTION
Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") respectfully submits this Memorandum of Points and Authorities in support of its motion to compel Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents that Helios has improperly withheld on claims of attorney-client privilege and work-product protection. These documents are responsive to GenomeDx's First Set of Requests for Production Nos. 22, 23, and 31, which were served on January 27, 2026. Despite extensive meet-and-confer efforts, the parties have been unable to resolve this dispute, and GenomeDx now seeks judicial intervention to obtain documents that are plainly discoverable and critically relevant to the issues in this case.
The discovery requests at the heart of this motion target three categories of business documents. Request for Production ("RFP") No. 22 seeks pre-launch business plans referencing GenomeDx's patents or the Decipher® genomic classifier test. RFP No. 23 seeks board presentations relating to the same subjects. RFP No. 31 seeks investor materials, investment memoranda, and due diligence materials provided to or shared with Helios's investors that reference GenomeDx's patents or the Decipher® test. Each of these categories seeks precisely the type of business-critical information that bears directly on Helios's pre-launch awareness of GenomeDx's patent rights, Helios's deliberate competitive strategy vis-à-vis GenomeDx, and the commercial dynamics that will inform the damages analysis in this case.
To Helios's credit, it has produced a substantial volume of responsive documents from these categories — 1,247 documents in total. However, Helios has withheld 83 documents on privilege grounds, logging each on its privilege log served concurrently with its production. GenomeDx has carefully reviewed those privilege log entries and has determined that the privilege assertions for 34 of the 83 withheld documents are deficient, unsupported, or both. GenomeDx challenges only these 34 documents in this motion.
The 34 documents at issue are quintessentially business-oriented documents: board presentations, investor decks, business plans, and due diligence materials. They were shared broadly with non-lawyer business personnel within Helios and, critically, with outside investors — including Corinth Ventures Fund III, LP, Helios's 58.7% majority equity holder, and Aether Life Sciences Partners, an 11.0% Series A investor. These are not confidential attorney-client communications prepared in the privacy of a lawyer's office; they are documents created to guide business decisions, to attract and retain investor capital, and to chart Helios's commercial strategy in the precision diagnostics market. The fact that Helios's General Counsel, Sara Whitmore, may appear as a recipient or contributor on some of these documents does not transform them into privileged communications. Lawyers at technology companies routinely participate in business planning in their capacity as business advisors and executives, and the attorney-client privilege does not cloak every document that passes through a lawyer's inbox.
Further, Helios's work-product assertions are equally unavailing. Many of the withheld documents predate the filing of this lawsuit by months or even years. They were created in connection with Helios's pre-launch business planning and investor fundraising activities — activities that occur in the ordinary course of business. The mere fact that some of these documents mention GenomeDx's patents does not render them documents prepared "in anticipation of litigation." And even if any of the 34 documents were to qualify as fact work product, GenomeDx has demonstrated substantial need for these materials, which reflect Helios's contemporaneous understanding of GenomeDx's patent portfolio and the competitive landscape — information that is uniquely within Helios's possession and that cannot be obtained from any other source.
The Stipulated Protective Order entered by this Court on December 18, 2025 provides robust safeguards for any commercially sensitive information contained in these documents. Documents may be designated at the "Confidential" or "Highly Confidential — Attorneys' Eyes Only" tier, restricting access to outside counsel and designated experts only. Helios's confidentiality concerns, to the extent they are genuine, are fully addressed by these protections. Privilege should not be wielded as a substitute for the protections already afforded by the Protective Order.
GenomeDx and its counsel at Calderwood & Harkness LLP engaged in extensive good-faith meet-and-confer efforts with Helios's counsel at Ridgecrest Durneval LLP, including a detailed deficiency letter, a written response, and a telephonic conference. These efforts, described more fully below and documented in the Declaration of Peter Vassiliev filed concurrently herewith, were unsuccessful. GenomeDx therefore respectfully requests that the Court grant this motion and order production of the 34 withheld documents.
II. FACTUAL BACKGROUND
A. The Litigation
GenomeDx filed this patent infringement action on March 28, 2025, asserting claims under 35 U.S.C. § 271 against Helios's ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test for prostate cancer that Helios launched commercially on October 7, 2024. GenomeDx asserts 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"). These patents cover methods and compositions relating to genomic classifiers used to assess prostate cancer prognosis, and they form the foundation of GenomeDx's market-leading Decipher® Prostate genomic classifier test, which employs a validated 22-gene expression panel.
GenomeDx is a Delaware corporation qualified to do business in the State of California, with its principal place of business at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130. GenomeDx is a recognized leader in molecular diagnostics, and its Decipher® Prostate test is one of the most widely used genomic classifiers in clinical urology, endorsed by multiple guidelines from the National Comprehensive Cancer Network ("NCCN") and the American Urological Association ("AUA"). GenomeDx reported fiscal year 2024 revenue of approximately $387.6 million, reflecting the significant market position and clinical adoption of its diagnostic products.
Helios is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, with a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, where Helios processes and reports the ProstaSignal™ test. Helios reported fiscal year 2024 revenue of approximately $71.2 million, a substantial portion of which is attributable to the commercial launch and rapid scaling of ProstaSignal™ beginning in October 2024.
The factual basis for GenomeDx's infringement claims is compelling. Of ProstaSignal™'s 24-gene expression panel, 19 genes overlap with GenomeDx's patented gene set claimed in the '271, '893, and '647 Patents. This substantial overlap lies at the core of GenomeDx's contention that Helios's ProstaSignal™ classifier practices the methods and compositions claimed in GenomeDx's patents.
On May 12, 2025, Helios filed its Answer and Counterclaims, denying infringement and asserting affirmative defenses of invalidity under 35 U.S.C. §§ 101, 102, and 103; non-infringement under 35 U.S.C. § 271; and unenforceability. Helios's Answer further affirmatively pleads that its scientists "independently developed" the ProstaSignal™ classifier beginning in approximately 2020, purportedly relying on publicly available gene-expression datasets from repositories such as the Gene Expression Omnibus ("GEO") and The Cancer Genome Atlas ("TCGA").
On October 21, 2025, Helios filed a Motion to Dismiss GenomeDx's claims under 35 U.S.C. § 101, arguing that the asserted patent claims are directed to unpatentable abstract ideas or natural phenomena. After full briefing and oral argument, the Honorable Jessica W. Langston denied Helios's Motion to Dismiss on January 13, 2026, finding that GenomeDx's patent claims recite patent-eligible subject matter at the pleading stage. Dkt. No. 87. The litigation is now proceeding through fact discovery.
The Scheduling Order entered on June 18, 2025 by Magistrate Judge Cabrera establishes the following key deadlines: fact discovery closes on March 6, 2026; expert reports are due May 15, 2026, with rebuttal reports due July 1, 2026; the Markman hearing is set for September 18, 2026; and trial is currently scheduled for February 2027. The rapidly approaching fact-discovery close date underscores the urgency of GenomeDx's motion.
B. The discovery Requests at Issue
On January 27, 2026, GenomeDx served its First Set of Requests for Production (Nos. 1–47) on Helios pursuant to Federal Rule of Civil Procedure 34. The requests at issue in this motion are RFP Nos. 22, 23, and 31, which seek the following categories of documents:
RFP No. 22 requests: "All pre-launch business plans, business strategy documents, and market-entry analyses that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."
RFP No. 23 requests: "All board of directors presentations, board memoranda, and board packages that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."
RFP No. 31 requests: "All investor materials, investment memoranda, due diligence reports, and due diligence materials provided to, shared with, or prepared for Helios's investors, venture capital investors, or potential investors that reference, discuss, or relate to any of GenomeDx's patents (including, without limitation, U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), the Decipher® genomic classifier test, or GenomeDx's intellectual property portfolio."
These three categories of documents are directly and specifically relevant to GenomeDx's claims and to the issues that will be contested at trial. Documents reflecting Helios's knowledge of, assessment of, and intent regarding GenomeDx's patent rights prior to and contemporaneous with ProstaSignal™'s October 2024 commercial launch are critical to GenomeDx's claims of willful infringement, its damages theories (including the Georgia-Pacific hypothetical negotiation framework), and its challenge to Helios's "independent development" defense. They are also relevant to the broader competitive landscape that will inform the Court's claim construction and the jury's understanding of the commercial context of the alleged infringement.
C. Helios's Production and Privilege Assertions
In response to RFP Nos. 22, 23, and 31, Helios produced 1,247 documents. GenomeDx acknowledges this production and does not challenge its adequacy as to the produced documents. However, Helios simultaneously withheld 83 documents on privilege grounds, asserting attorney-client privilege and/or the work-product doctrine for each withheld document. Helios served a privilege log identifying the 83 withheld documents, as required by Federal Rule of Civil Procedure 26(b)(5)(A).
GenomeDx's counsel carefully reviewed the privilege log entries for all 83 withheld documents. Based on that review, GenomeDx identified 34 documents for which the privilege assertions are, on the face of the privilege log, deficient, unsupported, or both. GenomeDx challenges only these 34 documents in the instant motion. The 34 documents fall into three broad categories based on their privilege log descriptions:
Board Presentations (approximately 12 documents). These documents are described on the privilege log as presentations to Helios's board of directors. The log entries indicate that the presentations include slides addressing the "competitive landscape," Helios's "market positioning vis-à-vis GenomeDx's Decipher® test," and "references to GenomeDx patent portfolio." The described recipients include all members of Helios's board of directors, which, according to Helios's publicly available filings and its initial disclosures in this case, includes representatives of Corinth Ventures Fund III, LP — Helios's 58.7% majority equity holder — who hold three board seats or possess board observer rights pursuant to the terms of Helios's stockholders' agreement. While some entries list Sara Whitmore (General Counsel) as a recipient or "cc," the entries describe the substance of these documents in overwhelmingly business terms: competitive positioning, market share analysis, commercial launch planning, and reimbursement strategy.
Investor Materials (approximately 14 documents). These documents are described on the privilege log as investment memoranda, due diligence reports, and presentation decks that were shared with Helios's outside investors, specifically Corinth Ventures Fund III, LP (a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116, and managed by Priya Chandrasekaran, Managing Director) and Aether Life Sciences Partners (an 11.0% Series A investor in Helios). The privilege log entries describe these documents as discussing "ProstaSignal™'s market opportunity relative to GenomeDx's IP position," "competitive analysis," "market sizing," "reimbursement landscape," and "Intellectual property risk assessment." The described recipients include non-lawyer investor representatives from both Corinth Ventures and Aether Life Sciences Partners, as well as Helios executives including CEO Dr. Nathan Ashford, Chief Scientific Officer Dr. Elaine Kossack, and Vice President of Commercial Operations Derek Mallinson. Several entries list Sara Whitmore (General Counsel) among the recipients, but the documents were plainly created and distributed for investor relations and fundraising purposes, not for the purpose of obtaining or rendering legal advice.
Internal Business Plans (approximately 8 documents). These documents are described as strategic planning documents and market-entry analyses circulated to Helios senior management. The described recipients include CEO Dr. Nathan Ashford, CSO Dr. Elaine Kossack, VP Commercial Operations Derek Mallinson, and General Counsel Sara Whitmore. The privilege log entries describe these documents in terms such as "business plan addressing competitive landscape," "market entry strategy," "pre-launch planning," and "commercial strategy memorandum." While some entries reference "legal considerations" or "IP risk," the documents are, by their own descriptions, business planning documents created in the ordinary course of Helios's commercial operations.
A critical and recurring deficiency across many of the 34 privilege log entries is that the documents were distributed to individuals who are not lawyers and who do not fall within the scope of the attorney-client relationship. Dr. Ashford, Dr. Kossack, and Mr. Mallinson are Helios executives participating in business decisions — they are not attorneys. The representatives of Corinth Ventures and Aether Life Sciences Partners are outside investors whose interest in Helios is financial and commercial, not legal. The fact that Sara Whitmore (General Counsel) appears as a recipient or contributor on many of these documents does not alter their fundamental character as business documents. As discussed in detail below, the privilege log entries describe the documents in terms that indicate their predominant purpose was business strategy, commercial planning, and investor relations — not the provision or seeking of legal advice.
D. Meet-and-Confer Efforts
The parties have engaged in good-faith meet-and-confer efforts regarding this discovery dispute, as required by Federal Rule of Civil Procedure 37(a)(1) and Civil Local Rule 37-1 of this District.
On December 5, 2025, counsel for the parties met and conferred telephonically to resolve a related dispute concerning the terms of a protective order governing the production of confidential business information in this case. That meet-and-confer was successful, and the resulting Stipulated Protective Order was entered by Magistrate Judge Cabrera on December 18, 2025. Dkt. No. 74. The Protective Order established two tiers of confidentiality protection: "Confidential" and "Highly Confidential — Attorneys' Eyes Only."
Following GenomeDx's review of Helios's privilege log, on January 10, 2026, Peter Vassiliev of Calderwood & Harkness LLP sent a detailed deficiency letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP, counsel for Helios. The letter identified the 34 specific documents for which GenomeDx's challenged Helios's privilege assertions, explained the legal bases for GenomeDx's position, and requested that Helios either produce the 34 documents (subject to appropriate confidentiality designations under the Protective Order) or provide supplemental privilege log entries with sufficient detail to allow GenomeDx to assess the applicability of the claimed privilege. Vassiliev Decl. Ex. A.
On January 17, 2026, Ridgecrest Durneval responded by letter, declining to produce any of the 34 documents and asserting that all 34 are protected by attorney-client privilege and/or the work-product doctrine. The response letter stated that the 34 documents "reflect legal analysis and advice provided by counsel regarding intellectual property matters" and that "disclosure was limited to individuals with a need to know for purposes of obtaining and implementing legal advice." The response did not provide any supplemental detail regarding the privilege log entries and did not address GenomeDx's specific objections regarding disclosure to outside investors or the business-oriented nature of the documents. Vassiliev Decl. Ex. B.
On January 22, 2026, the parties participated in a follow-up telephonic meet-and-confer. During that call, GenomeDx's counsel reiterated the specific bases for its objections to Helios's privilege assertions — including the disclosure of the documents to non-lawyer third-party investors, the business-oriented descriptions in the privilege log, and the insufficiency of the log entries. Helios's counsel maintained its position that all 34 documents are privileged and declined to produce any of them or to supplement the privilege log. The parties were unable to resolve the dispute.
All meet-and-confer correspondence, including the January 10, 2026 deficiency letter, the January 17, 2026 response, and a summary of the January 22, 2026 telephonic conference, is attached as exhibits to the Declaration of Peter Vassiliev filed concurrently with this Memorandum. Vassiliev Decl. Exs. A–C.
III. LEGAL STANDARD
Under Federal Rule of Civil Procedure 37(a)(3)(B), a party may move to compel production of documents when the responding party has failed to produce documents or has failed to permit inspection as requested under Rule 34. The moving party bears the initial burden of demonstrating that the discovery sought is relevant to any party's claim or defense and proportional to the needs of the case under Rule 26(b)(1). See Fed. R. Civ. P. 26(b)(1) ("Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case.").
Relevance in the discovery context is construed broadly. Information "need not be admissible in evidence to be discoverable." Fed. R. Civ. P. 26(b)(1). Discovery is appropriate where the information sought "appears reasonably calculated to lead to the discovery of admissible evidence." Hickman v. Taylor, 329 U.S. 495, 507 (1947). GenomeDx submits that there is no genuine dispute regarding the relevance of the 34 withheld documents, as their descriptions on the privilege log confirm that they address precisely the subjects — competitive analysis, patent awareness, market positioning, and commercial strategy — that lie at the heart of this patent infringement action. The dispute here is solely whether the documents are protected from disclosure by the attorney-client privilege or the work-product doctrine.
The Attorney-Client Privilege. The attorney-client privilege is the "oldest of the privileges for confidential communications known to the common law." Upjohn Co. v. United States, 449 U.S. 383, 389 (1981). In the Ninth Circuit, the privilege protects confidential communications between a client and an attorney, made for the purpose of obtaining or providing legal advice. In re Grand Jury Subpoena (Torf), 357 F.3d 900, 907 (9th Cir. 2004); United States v. Richey, 632 F.3d 559, 566 (9th Cir. 2011). The privilege exists to encourage "full and frank communication between attorneys and their clients," Upjohn, 449 U.S. at 389, and thereby to promote broader public interests in the observance of law and the administration of justice.
The burden of establishing the applicability of the attorney-client privilege rests on the party asserting it. Weil v. Inv./Indicators, Research & Mgmt., Inc., 647 F.2d 18, 25 (9th Cir. 1981). The asserting party must demonstrate each element of the privilege: (1) a communication; (2) made between the client and the attorney (or the attorney's agents); (3) in confidence; (4) for the purpose of seeking, obtaining, or providing legal assistance to the client. In re Grand Jury Subpoena (Torf), 357 F.3d at 907. Because the privilege "is in derogation of the search for truth," it is construed narrowly. Clark v. City of Los Angeles, 950 F.2d 1430, 1441 (9th Cir. 1991); Weil, 647 F.2d at 25.
Critically, the attorney-client privilege does not attach to communications that are made primarily for business purposes, even if a lawyer is involved. Where a communication serves both a legal and a business purpose, the privilege attaches only if the "primary purpose" of the communication was to obtain or provide legal advice. In re Cnty. of Erie, 473 F.3d 413, 420 (2d Cir. 2007); Nidec Corp. v. Victor Co. of Japan, 249 F.R.D. 575, 578 (N.D. Cal. 2007). The privilege also does not protect communications that have been disclosed to third parties outside the attorney-client relationship, because such disclosure destroys the confidentiality that is essential to the privilege. United States v. Ruehle, 583 F.3d 600, 612 (9th Cir. 2009).
The Work-Product Doctrine. The work-product doctrine, codified at Federal Rule of Civil Procedure 26(b)(3), protects from discovery "documents and tangible things that are prepared in anticipation of litigation or for trial by or for another party or its representative." Fed. R. Civ. P. 26(b)(3)(A). The doctrine shields the mental processes of attorneys and protects against the disclosure of an attorney's legal theories, strategies, and impressions. Hickman v. Taylor, 329 U.S. at 510–11.
To invoke the work-product doctrine, the asserting party must demonstrate that the documents were prepared "because of" the prospect of litigation. United States v. Richey, 632 F.3d at 567–68 (9th Cir. 2011) (applying the "because of" test). Documents prepared in the ordinary course of business, or for a purpose that would have existed irrespective of the prospect of litigation, are not protected. Id. at 568. Even where the work-product doctrine applies, factual (as opposed to opinion) work product may be discovered upon a showing that the discovering party has "substantial need for the materials to prepare its case and cannot, without undue hardship, obtain their substantial equivalent by other means." Fed. R. Civ. P. 26(b)(3)(A)(ii).
The Court's Broad Discretion. The district court has "broad discretion in controlling discovery." Admiral Ins. Co. v. U.S. Dist. Court for Dist. of Ariz., 881 F.2d 1486, 1494 (9th Cir. 1989). This Court's Civil Local Rules further provide for the resolution of discovery disputes through motion practice after good-faith meet-and-confer efforts. N.D. Cal. Civ. L.R. 37-1. The Court's Patent Local Rules also govern discovery in patent cases and reflect the particular importance of discovery regarding infringement, validity, and damages in cases involving complex technology. N.D. Cal. Patent L.R. 3-1 et seq.
IV. ARGUMENT
A. The 34 Documents Are Not Protected by Attorney-Client Privilege Because They Were Not Made for the Purpose of Obtaining Legal Advice
Helios's blanket assertion of attorney-client privilege over the 34 challenged documents cannot withstand scrutiny. The privilege log entries for these documents reveal, on their face, that they are business documents — board presentations, investor decks, business plans, and due diligence materials — that were created for business purposes and distributed to non-lawyer business personnel and outside investors. The mere fact that Helios's General Counsel, Sara Whitmore, appears as a recipient or contributor on some of these documents does not transform them into privileged communications. Helios has failed to carry its burden of establishing that the primary purpose of these documents was to obtain or provide legal advice.
1. The Predominant Purpose of the Documents Is Business, Not Legal.  The privilege log descriptions for the 34 challenged documents uniformly characterize them in business terms. The log entries describe these documents variously as "board presentation," "investor update," "business plan," "market analysis," "competitive landscape assessment," "due diligence report," "commercial strategy memorandum," and "market entry strategy." These descriptions — drafted by Helios's own counsel — reveal the nature and purpose of the documents: they are business-planning and investor-relations materials created to inform commercial decisions, guide strategic planning, and communicate with investors. They are not attorney-client communications created for the purpose of obtaining or rendering legal advice.
Courts in the Ninth Circuit apply the "primary purpose" test to determine whether a communication involving in-house counsel is privileged. Under this test, where a document serves both a legal and a business purpose, the privilege attaches only if the primary purpose of the communication was to obtain or provide legal advice. See Nidec Corp. v. Victor Co. of Japan, 249 F.R.D. 575, 578 (N.D. Cal. 2007) (holding that documents created for business purposes are not privileged merely because they were copied to in-house counsel); Theranos, Inc. v. Draven Pharma LLC, No. 11-cv-05236-PSG, 2014 WL 1168429, at 3 (N.D. Cal. Mar. 21, 2014) (applying the primary-purpose test and ordering production of documents where the "primary purpose" was "business-related" rather than "legal"). As the Second Circuit has explained, in determining the primary purpose of a communication, the court should examine "whether the communication would have been made in substantially similar form but for the prospect of legal advice." Schaeffler v. United States*, 806 F.3d 34, 40 (2d Cir. 2015).
Here, the privilege log descriptions make clear that the 34 documents were created for purposes that are distinctly and predominantly commercial. Board presentations discussing "competitive landscape" and "market positioning vis-à-vis GenomeDx's Decipher® test" are presentations prepared to inform the board's governance and strategic oversight functions — not to seek or receive legal advice. Investor memoranda and due diligence reports discussing "ProstaSignal™'s market opportunity relative to GenomeDx's IP position" were prepared for the purpose of communicating with investors and securing capital — a quintessentially business activity. Internal business plans addressing "market entry strategy" and "commercial strategy" were created to guide the commercial decisions of Helios's management team. These are documents that Helios would have created in substantially the same form regardless of whether legal advice was being sought.
The mere inclusion of Sara Whitmore as a recipient or contributor does not alter this analysis. It is well established that in-house counsel frequently participate in business discussions in their capacity as business advisors and executives, and the attorney-client privilege does not attach to communications in which a lawyer is acting in a business rather than a legal capacity. See Nidec, 249 F.R.D. at 578 ("The fact that [the defendant's in-house] counsel reviewed or commented on [a document] does not make it privileged, particularly where the document was created for a business purpose."); Burlington N. & Santa Fe Ry. Co. v. U.S. Dist. Court for Dist. of Mont., 408 F.3d 1142, 1149 (9th Cir. 2005) ("Many in-house lawyers serve dual roles, functioning as both legal and business advisors. When such lawyers participate in business discussions in their business capacity, the communications are not privileged.").
Sara Whitmore holds the title of General Counsel at Helios, and she also serves as a member of Helios's senior management team, participating in business strategy, commercial planning, and board governance. In this dual capacity, her involvement in the creation or distribution of board presentations, investor materials, and business plans does not by itself establish that these documents were created for the purpose of obtaining or providing legal advice. Helios bears the burden of demonstrating, for each document, that the communication was made primarily for a legal purpose, and the privilege log entries fail to carry that burden.
The content descriptions on the privilege log further confirm the business character of the 34 documents. Entries referencing "market positioning," "competitive analysis," "commercial launch strategy," "reimbursement strategy," "market sizing," "investor relations," and "market entry" indicate that the primary purpose of these communications was to inform business decisions, attract and maintain investor confidence, and chart Helios's commercial path in the molecular diagnostics market. While some entries include passing references to "legal considerations" or "IP risk," these references are insufficient to establish that the primary purpose of the documents was to obtain or provide legal advice. Every technology company must consider intellectual property issues as part of its business planning; the mere mention of patents or IP risk in a business document does not render it a privileged attorney-client communication. See Theranos, 2014 WL 1168429, at *4 (rejecting privilege claim where documents addressed IP issues but were "created primarily for business rather than legal purposes").
In sum, Helios cannot meet its burden of establishing that the 34 challenged documents were created primarily for the purpose of obtaining or providing legal advice. The privilege log entries themselves demonstrate that these documents are business materials, and Helios's conclusory assertion that they "reflect legal analysis and advice" is insufficient to overcome the clear business character revealed by the log descriptions.
2. Disclosure to Non-Lawyer Third Parties Waives Any Privilege That Might Otherwise Attach.  Even if any of the 34 documents were otherwise entitled to protection under the attorney-client privilege — which GenomeDx does not concede — that privilege has been waived as to at least 14 of the 34 documents by Helios's voluntary disclosure of those documents to outside investors who are not within the scope of the attorney-client relationship.
The privilege log reveals that at least 14 of the challenged documents are investor materials, investment memoranda, due diligence reports, and presentation decks that were shared with Helios's outside investors, specifically Corinth Ventures Fund III, LP and Aether Life Sciences Partners. Corinth Ventures Fund III, LP is a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116, managed by Priya Chandrasekaran as Managing Director. Corinth Ventures holds a 58.7% majority equity position in Helios. Aether Life Sciences Partners holds an 11.0% Series A equity position. Neither Corinth Ventures nor Aether Life Sciences Partners is a party to this litigation.
It is black-letter law that voluntary disclosure of privileged communications to third parties outside the attorney-client relationship waives the privilege. United States v. Ruehle, 583 F.3d 600, 612 (9th Cir. 2009) ("Voluntary disclosure of the content of a privileged attorney-client communication constitutes waiver of the privilege as to all other such communications on the same subject."). The rationale is straightforward: the privilege exists to protect the confidentiality of attorney-client communications, and once the client voluntarily destroys that confidentiality by sharing the communication with third parties, the justification for the privilege evaporates. Id.
Corinth Ventures and Aether Life Sciences Partners are equity investors in Helios. Their interest in Helios is financial and commercial — they have invested capital in Helios and have a financial interest in the commercial success of ProstaSignal™ and in the value of their equity positions. They are not agents of Helios for purposes of the attorney-client privilege. They are not counsel, and they were not retained to provide legal services to Helios. Their receipt of the 14 investor-related documents was in connection with their role as investors, not for the purpose of obtaining or providing legal advice. Disclosure to these outside investors constitutes a waiver of any privilege that might otherwise have attached to those documents.
Helios may attempt to argue that its investors fall within a "common interest" or "joint defense" exception to the general rule that disclosure to third parties waives the privilege. Any such argument would be unavailing. The common-interest doctrine, which is sometimes described as a narrow extension of the attorney-client privilege or work-product protection, applies only where the parties share a common legal interest and have agreed to share privileged communications in furtherance of that common legal interest. See Coltec Indus., Inc. v. Am. Motorists Ins. Co., 197 F.R.D. 368, 373 (N.D. Ill. 2000) ("[T]he common interest doctrine requires a common legal interest, not merely a common commercial interest."). A shared business, financial, or commercial interest is not sufficient. Id.
Here, Corinth Ventures and Aether Life Sciences Partners share a business and financial interest with Helios — they are investors who seek to maximize the return on their equity positions. They do not share a legal interest in this litigation. They are not parties to this case. They are not represented by Helios's litigation counsel at Ridgecrest Durneval LLP. There is no indication in the record that Helios has entered into a joint defense agreement or common-interest agreement with either Corinth Ventures or Aether Life Sciences Partners with respect to this litigation. And the documents at issue — investor memoranda, due diligence reports, and presentation decks — were not shared for the purpose of obtaining or providing legal advice; they were shared for the purpose of informing investors about Helios's business, competitive position, and market opportunity. The common-interest doctrine cannot save Helios's privilege claim as to these documents.
Additionally, the approximately 12 board presentation documents were distributed to the full Helios board of directors, which includes representatives of Corinth Ventures Fund III, LP. As the 58.7% majority equity holder, Corinth Ventures holds three board seats or board observer rights pursuant to the terms of Helios's stockholders' agreement. Board members designated by Corinth Ventures serve in a governance and oversight capacity on behalf of their fund — they are not attorneys acting within the scope of an attorney-client relationship. Distribution of these board presentations to board members in their governance and investment capacity, rather than for the specific purpose of obtaining legal advice from those individuals, similarly vitiates any attorney-client privilege that might otherwise attach. See Nidec, 249 F.R.D. at 579 (finding privilege waived where documents were distributed to board members for governance purposes rather than for the purpose of obtaining legal advice).
3. The Privilege Log Entries Are Insufficiently Detailed.  Independent of the substantive deficiencies in Helios's privilege claims, several of the 34 privilege log entries are procedurally inadequate and fail to provide sufficient information to allow GenomeDx or this Court to assess the applicability of the privilege.
Under Federal Rule of Civil Procedure 26(b)(5)(A), a party withholding information on the basis of privilege must "describe the nature of the documents, communications, or tangible things not produced or disclosed — and do so in a manner that, without revealing information itself privileged or protected, will enable other parties to assess the claim." In the Ninth Circuit and in this District, a privilege log must provide sufficient information for the opposing party and the Court to evaluate the privilege assertion, including, at a minimum: (1) the identity and capacity of the author; (2) the identity and capacity of all recipients; (3) the date of the communication; (4) a description of the subject matter of the communication; and (5) the specific privilege asserted and the basis for the assertion. See Grace v. Centerplate, Inc., No. 14-cv-05162-JST, 2016 WL 1392530, at *2 (N.D. Cal. Apr. 8, 2016) (requiring sufficient specificity in privilege log entries to permit assessment of privilege claims).
Several of the 34 entries on Helios's privilege log contain only generic and conclusory descriptions that fail to meet this standard. For example, multiple entries describe the withheld documents simply as "Communication regarding IP matters" or "Board presentation including legal analysis" without identifying: (a) the specific legal advice that was sought or provided; (b) the specific lawyer who provided the advice (as distinct from a lawyer who was merely a recipient or attendee); (c) the specific legal question or issue that the communication addressed; or (d) why the document was created primarily for a legal purpose rather than a business purpose. These bare-bones descriptions are insufficient to make out even a prima facie case for the privilege.
Where a privilege log fails to provide sufficient detail to support the privilege assertion, courts in this District have deemed the privilege waived and ordered production. See Grace, 2016 WL 1392530, at 3 (ordering production where privilege log entries were "too vague and conclusory to allow the Court to assess the claim of privilege"); see also Shacket v. Philko Aviation, Inc.*, 841 F.2d 166, 170 (7th Cir. 1988) (noting that inadequate privilege logs may result in waiver of the privilege). GenomeDx requested supplemental privilege log entries in its January 10, 2026 deficiency letter, but Helios declined to provide any additional detail. The inadequacy of the log entries independently warrants an order compelling production of the documents for which the entries are deficient.
B. The Work-Product Doctrine Does Not Protect These Documents
Helios has also asserted the work-product doctrine as a basis for withholding some or all of the 34 documents. This assertion is equally unavailing. The 34 documents were not prepared "in anticipation of litigation," and even if they were, GenomeDx has demonstrated the substantial need required to overcome any work-product protection for factual materials.
1. The Documents Were Not Prepared in Anticipation of Litigation.  The work-product doctrine protects documents prepared "in anticipation of litigation or for trial by or for another party or its representative." Fed. R. Civ. P. 26(b)(3)(A). In the Ninth Circuit, the relevant inquiry is whether the document was created "because of" the prospect of litigation. United States v. Richey, 632 F.3d 559, 567–68 (9th Cir. 2011). Under this standard, a document qualifies as work product only if it "would not have been created in substantially similar form but for the prospect of that litigation." Id. at 568 (internal quotation marks omitted). Documents prepared in the ordinary course of business do not qualify, even if they may also be useful in subsequent litigation. Id.
Many of the 34 documents at issue were created well before GenomeDx filed this action on March 28, 2025. Based on the dates reflected on the privilege log, a substantial number of the documents appear to have been created during the period of Helios's pre-launch business planning — i.e., prior to the October 7, 2024 commercial launch of ProstaSignal™ — and during Helios's investor fundraising activities. At those times, no litigation had been filed and, based on the information available to GenomeDx, no litigation was reasonably anticipated. Helios was engaged in the ordinary business activities of a life sciences startup: developing its product, creating business plans, presenting to its board, and communicating with its investors. These are activities that every company in the molecular diagnostics industry undertakes as a matter of course, irrespective of whether litigation is on the horizon.
Business planning, competitive analysis, and investor communications are created in the ordinary course of business and for business purposes that exist independently of any litigation. A startup company's preparation of board presentations analyzing its competitive landscape, business plans assessing market entry strategy, and investor materials describing its market opportunity are all activities driven by commercial imperatives — the need to guide management decisions, satisfy governance obligations, and attract investment capital. These activities would occur regardless of whether litigation was anticipated. See OM Grp., Inc. v. Showa Denko K.K., 235 F.R.D. 91, 95–96 (D. Conn. 2006) (finding that documents prepared for business purposes in the ordinary course are not work product even if they discuss potential IP issues); Haines v. Liggett Grp., Inc., 975 F.2d 81, 94 (3d Cir. 1992) ("[D]ocuments prepared in the ordinary course of business are not protected as work product.").
Even if some of the 34 documents mention GenomeDx's patents or the Decipher® test, an awareness of a competitor's intellectual property portfolio does not transform a business document into litigation work product. Companies in the precision diagnostics industry routinely monitor the patent landscapes of their competitors as part of their business planning. The fact that a business plan or investor deck references a competitor's patents as part of a broader competitive analysis does not mean that the document was created "because of" anticipated litigation. To hold otherwise would transform every competitive intelligence document in every technology company into protected work product, effectively immunizing entire categories of business documents from discovery. That is not the law.
The privilege log entries provide no basis for concluding that the 34 documents were created in anticipation of litigation. The entries describe the documents in business terms, identify business personnel and investors as recipients, and do not indicate that the documents were prepared at the direction of litigation counsel, in connection with a specific litigation hold, or for any litigation-related purpose. Helios has not carried its burden of demonstrating that these documents satisfy the "because of" test required for work-product protection.
2. Even If Work-Product Protection Applied, GenomeDx Has Demonstrated Substantial Need.  In the alternative, even if some of the 34 documents were to qualify as fact work product — which GenomeDx does not concede — GenomeDx has established substantial need for these documents and an inability to obtain their substantial equivalent without undue hardship, thereby overcoming any protection under Rule 26(b)(3)(A)(ii).
The 34 withheld documents reflect Helios's contemporaneous understanding of GenomeDx's patents, the competitive relationship between ProstaSignal™ and Decipher®, and Helios's assessment of GenomeDx's intellectual property position. This information is directly and critically relevant to multiple contested issues in this case:
Willful Infringement and Enhanced Damages. GenomeDx's claim for enhanced damages under 35 U.S.C. § 284 requires evidence of Helios's knowledge of GenomeDx's patents and Helios's deliberate decision to proceed with ProstaSignal™ in the face of that knowledge. Documents reflecting Helios's pre-launch assessment of GenomeDx's patent portfolio and the risk of infringement are among the most probative evidence of willfulness. GenomeDx cannot reconstruct Helios's internal state of mind from other sources; this information is uniquely within Helios's possession and control.
Damages Analysis and Georgia-Pacific Hypothetical Negotiation. Pre-launch business plans and investor materials that discuss expected revenue, projected market share, and the competitive relationship between ProstaSignal™ and Decipher® are directly relevant to the Georgia-Pacific hypothetical negotiation analysis. These documents bear on the value that the parties would have placed on a license at the time of first infringement and on the expected profitability of ProstaSignal™. The commercial data reflected in these documents is particularly significant in light of the substantial market impact of ProstaSignal™'s launch: during the period from October 2024 to March 2025, Helios performed approximately 8,400 ProstaSignal™ tests at an average reimbursement rate of approximately $3,820 per test, generating estimated revenue of $32,088,000, while GenomeDx's market share declined from approximately 74% to approximately 68%.
Competitive intelligence. Documents reflecting how Helios assessed the competitive landscape and positioned ProstaSignal™ relative to Decipher® are essential to understanding the commercial dynamics that will inform the damages analysis and the jury's understanding of the market context. These assessments are, by their nature, internal to Helios, and GenomeDx has no other means of obtaining them.
GenomeDx cannot obtain the substantial equivalent of these documents by other means. The 34 documents reflect Helios's own contemporaneous analysis of GenomeDx's patents and the competitive landscape — a perspective that is uniquely Helios's and that cannot be reconstructed through GenomeDx's own records, public sources, or third-party discovery. While GenomeDx intends to depose Helios executives and its 30(b)(6) designee, deposition testimony cannot substitute for the contemporaneous documents themselves, which reflect Helios's actual assessments and analyses at the time they were prepared, unfiltered by the litigation posture and self-interest that inevitably color deposition testimony. The substantial-need exception to work-product protection exists precisely for this type of situation, where the requesting party cannot obtain the factual information by any other means.
See Waugh v. Pathology Assocs., No. 14-cv-01412-BLF, 2015 WL 13158082, at *3 (N.D. Cal. Sept. 10, 2015) (finding substantial need for documents reflecting defendant's contemporaneous analysis where such analysis was uniquely within defendant's possession and control).
C. To the Extent Helios Asserts a Freedom-to-Operate Analysis Privilege, That Privilege Has Been Placed at Issue
Several of the withheld documents appear, based on their privilege log descriptions, to reflect Helios's assessment of whether its ProstaSignal™ test could operate freely in light of GenomeDx's patent portfolio — in other words, a freedom-to-operate ("FTO") or patent clearance analysis. To the extent Helios is claiming privilege over these FTO-related materials, Helios has placed the substance of any such analysis squarely at issue through its own affirmative pleadings and litigation conduct, and it cannot simultaneously use the privilege as both a sword and a shield.
In its Answer and Counterclaims, Helios asserts affirmative defenses of non-infringement and invalidity and affirmatively pleads that its scientists "independently developed" the ProstaSignal™ classifier beginning in approximately 2020, based on publicly available gene-expression datasets. These assertions necessarily implicate the question of what Helios knew about GenomeDx's patents, when it acquired that knowledge, and what steps, if any, it took to evaluate the risk of infringement before launching ProstaSignal™. If Helios intends to rely on advice of counsel or an FTO analysis as evidence of its good faith — whether as a defense to GenomeDx's willfulness allegations or as context for its claim of independent development — it has placed the substance of those analyses at issue and cannot simultaneously shield the underlying documents from discovery. See In re Seagate Tech., LLC, 497 F.3d 1360, 1372–74 (Fed. Cir. 2007) (en banc) (discussing the interplay between willfulness and advice of counsel in patent cases, and noting that assertion of an advice-of-counsel defense triggers waiver of privilege over the substance of that advice).
The record in this case strongly suggests that Helios has placed the substance of its FTO analysis at issue. In its initial disclosures exchanged on July 14, 2025, Helios identified Sara Whitmore (General Counsel) as a person likely to have discoverable information regarding "freedom-to-operate analyses" and "IP clearance decisions." Whitmore is also designated as a 30(b)(6) witness on topics including FTO and IP clearance. These designations indicate that Helios intends for the substance of its IP clearance process to be part of the evidentiary record. Helios cannot designate its General Counsel as a witness on FTO topics, assert independent development as a defense, and simultaneously withhold the very documents that reflect the substance of those FTO analyses.
Documents in which Helios assessed GenomeDx's patent portfolio in the context of launching ProstaSignal™ — whether they are labeled as business plans, board presentations, or investor materials — are directly relevant to whether Helios acted with knowledge of GenomeDx's patents and with an understanding of the risk of infringement. If Helios's position is that it conducted a thorough FTO analysis and concluded in good faith that ProstaSignal™ did not infringe GenomeDx's patents, GenomeDx is entitled to test that claim through discovery of the underlying documents. Helios should not be permitted to make affirmative representations about its good faith and independent development while simultaneously shielding from discovery the documents that would reveal the true nature and extent of its pre-launch IP assessment.
D. The Protective Order Adequately Safeguards Any Confidentiality Concerns
To the extent that Helios's resistance to producing the 34 documents is motivated by concerns about the confidentiality of commercially sensitive information — rather than by a genuine belief in the applicability of the attorney-client privilege or work-product doctrine — those concerns are fully addressed by the Stipulated Protective Order already in place in this case.
The Stipulated Protective Order, which was entered by Magistrate Judge Cabrera on December 18, 2025 after good-faith negotiations between Calderwood & Harkness LLP and Ridgecrest Durneval LLP, provides a comprehensive framework for the protection of confidential information produced in discovery. Dkt. No. 74. The Protective Order establishes two tiers of protection:
"Confidential" — restricting disclosure to outside counsel, in-house counsel (subject to certain limitations), designated experts, and other litigation participants specifically enumerated in the Order.
"Highly Confidential — Attorneys' Eyes Only" — further restricting disclosure to outside counsel and designated experts only, with no disclosure to in-house counsel or other business personnel of the receiving party.
Documents produced under the "Highly Confidential — Attorneys' Eyes Only" designation receive the highest level of protection available under the Protective Order. They may be viewed only by the parties' outside litigation counsel and by experts specifically retained for this litigation who have executed the acknowledgment form attached to the Protective Order. No in-house business personnel of GenomeDx would have access to documents designated at this tier.
These protections are precisely the mechanism that courts have developed to address the tension between the need for broad discovery and the legitimate interest of litigants in protecting their confidential business information. Helios is free to designate any or all of the 34 documents at the "Highly Confidential — Attorneys' Eyes Only" tier, thereby ensuring that the documents are accessible only to GenomeDx's outside litigation counsel and designated experts.
The Court should not permit Helios to use privilege assertions as a backdoor mechanism to avoid producing relevant business documents when the Protective Order already provides the appropriate safeguard for confidentiality concerns. Privilege and confidentiality are distinct concepts: the attorney-client privilege and the work-product doctrine protect specific categories of communications from discovery entirely, while the Protective Order addresses the separate concern that produced documents not be disclosed beyond the litigation. Where the documents at issue are not genuinely privileged — as GenomeDx has demonstrated — the appropriate remedy is production under the Protective Order, not blanket withholding.
E. Relevance of the 34 Documents to GenomeDx's Claims
GenomeDx has established above that the 34 withheld documents are not protected by the attorney-client privilege or the work-product doctrine. GenomeDx further submits that these documents are highly relevant to the specific claims and defenses at issue in this case, and that their continued withholding would cause significant prejudice to GenomeDx's ability to prosecute its claims.
Willfulness and Enhanced Damages (35 U.S.C. § 284). GenomeDx seeks enhanced damages on the ground that Helios willfully infringed GenomeDx's patents by launching ProstaSignal™ with knowledge of GenomeDx's patent rights and in deliberate disregard of the risk of infringement. Documents reflecting Helios's pre-launch awareness of GenomeDx's patents, Helios's assessment of the risk of infringement, and Helios's deliberate decision to proceed with ProstaSignal™ notwithstanding that risk are central to GenomeDx's willfulness claim. The 34 withheld documents — which, based on their privilege log descriptions, discuss GenomeDx's patents and the Decipher® test in the context of competitive analysis, market positioning, and business planning — are precisely the type of evidence that will inform the Court's and the jury's assessment of whether Helios acted with the subjective knowledge and intent required for a finding of willfulness. Continued withholding of these documents deprives GenomeDx of some of the most probative evidence on this critical issue.
Damages and Georgia-Pacific Analysis. GenomeDx intends to present a damages case grounded in the Georgia-Pacific hypothetical-negotiation framework, which requires the trier of fact to determine the reasonable royalty that the parties would have agreed upon in a hypothetical negotiation at the time of first infringement. The Georgia-Pacific factors include, among others, the nature and scope of the license, the commercial relationship between the parties, the anticipated profitability of the infringing product, and the portion of the profit that is customarily attributable to the patented technology. Pre-launch business plans, investor materials, and board presentations that discuss expected revenue, projected market share, reimbursement strategy, and the competitive relationship between ProstaSignal™ and Decipher® bear directly on several of these factors. These documents reflect Helios's own contemporaneous assessment of the commercial value of ProstaSignal™ and the competitive dynamic with GenomeDx — information that is critical to establishing the appropriate royalty rate and base.
Infringement and State of Mind. Board presentations analyzing GenomeDx's patent claims and the ProstaSignal™ design may shed light on whether Helios designed around or deliberately copied GenomeDx's patented methods, including the striking overlap of 19 of ProstaSignal™'s 24 genes with GenomeDx's patented gene set. Documents reflecting Helios's internal analysis of this overlap and its implications for infringement are directly relevant to GenomeDx's infringement case and to Helios's state of mind at the time it decided to launch ProstaSignal™ with a gene panel that so substantially overlaps with GenomeDx's patented panel.
Invalidity and Independent Development. Helios contends that its scientists independently developed the ProstaSignal™ classifier beginning in approximately 2020, relying on publicly available gene-expression datasets. Business plans and investor materials that discuss GenomeDx's patents and the Decipher® test may contradict or qualify this assertion — for example, by revealing that Helios's development efforts were not truly "independent" but were instead informed by an awareness of GenomeDx's patented gene panel and its commercial success. GenomeDx is entitled to test Helios's independent-development narrative through discovery of the underlying documents.
Timing. Finally, the urgency of this motion cannot be overstated. Fact discovery in this case closes on March 6, 2026 — less than five weeks from the date of this filing. GenomeDx needs the 34 withheld documents in order to complete its remaining fact depositions, which include depositions of Dr. Nathan Ashford (CEO), Dr. Elaine Kossack (CSO), Derek Mallinson (VP Commercial Operations), and Sara Whitmore (General Counsel), as well as Helios's Rule 30(b)(6) designee on topics including FTO analysis, competitive intelligence, patent awareness, and commercial strategy. GenomeDx also needs these documents to prepare its opening expert reports, which are due May 15, 2026. Any further delay in obtaining these documents would cause substantial and potentially irreversible prejudice to GenomeDx's case preparation.
V. CONCLUSION
For the foregoing reasons, Plaintiff Genome Dx Therapeutics Inc. respectfully requests that the Court enter the [Proposed] Order Granting Plaintiff's Motion to Compel, requiring Defendant Helios Precision Diagnostics, Inc. to produce the 34 withheld documents identified herein within ten (10) business

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

TABLE OF CONTENTS

TABLE OF AUTHORITIES

I. INTRODUCTION

II. FACTUAL BACKGROUND

III. LEGAL STANDARD

IV. ARGUMENT

V. CONCLUSION

Record

Parties

Dates

Amounts