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

motion-to-compel-production.docx DOCUMENT Litigation

10 / 35 ← → ✕

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

PLAINTIFF GENOME DX THERAPEUTICS INC.'S MOTION TO COMPEL DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. TO PRODUCE DOCUMENTS RESPONSIVE TO REQUESTS FOR PRODUCTION NOS. 22, 23, AND 31

Date Filed: January 30, 2026 Hearing: Date and time to be set by Magistrate Judge Cabrera

NOTICE OF MOTION

TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. AND ITS ATTORNEYS OF RECORD, RIDGECREST DURNEVAL LLP:

PLEASE TAKE NOTICE that Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") will and does hereby move this Court pursuant to Federal Rule of Civil Procedure 37(a)(3)(B)(iv) for an order compelling Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents withheld on claims of attorney-client privilege and work-product protection from categories covered by Plaintiff's First Set of Requests for Production Nos. 22, 23, and 31, served January 27, 2026. This motion is made on the grounds that the withheld documents were shared with non-lawyer business personnel and third-party investors, thereby waiving any applicable privilege, and that the documents are primarily business records that do not qualify for privilege protection.

This motion is based on this Notice of Motion, the accompanying Memorandum of Points and Authorities set forth below, the Declaration of Peter Vassiliev and Exhibits A through E thereto, the pleadings and papers on file in this action, and such other matters as may be presented to the Court at or before the hearing on this motion. The hearing date and time are to be set by Magistrate Judge Cabrera.

MEMORANDUM OF POINTS AND AUTHORITIES

I. INTRODUCTION

Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") respectfully moves to compel Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents that Helios has improperly withheld from production 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 and are central to GenomeDx's patent infringement claims in this action.

The thirty-four documents at issue fall within three categories requested by GenomeDx: pre-launch business plans, board presentations, and investor materials referencing GenomeDx's patents — U.S. Patent Nos. 10,438,271 (the "'271 Patent"), 11,204,893 (the "'893 Patent"), and 11,891,647 (the "'647 Patent") — or GenomeDx's commercially successful Decipher® genomic classifier test. Helios produced 1,247 documents responsive to these three requests but withheld a total of eighty-three (83) documents on privilege grounds and logged them on its privilege log served concurrently with its production. After careful review of Helios's privilege log, GenomeDx challenges thirty-four (34) of those eighty-three entries as improperly withheld.

These documents are critical to GenomeDx's infringement case. They bear directly on Helios's knowledge of GenomeDx's patent portfolio prior to launching its accused ProstaSignal™ Genomic Classifier product, Helios's competitive positioning of ProstaSignal™ against the Decipher® test, and the commercial motivation behind the launch of the accused product on October 7, 2024. Without these documents, GenomeDx will be unable to fully develop its infringement and damages theories or prepare adequately for upcoming depositions of key Helios witnesses.

The privilege assertions fail for two independent reasons. First, the documents were shared with non-lawyer business personnel and third-party investors — including Corinth Ventures Fund III, LP ("Corinth"), Helios's 58.7% majority equity holder, and Aether Life Sciences Partners ("Aether"), an 11.0% Series A investor — thereby destroying the confidentiality that is the sine qua non of attorney-client privilege. The privilege log entries themselves reveal that many of the challenged documents were distributed to individuals and entities outside any attorney-client relationship, including venture capital investment team members, due diligence analysts, and external business consultants. Second, many of the documents are predominantly business records — market analyses, financial projections, board presentations, and investor updates — that happen to include passing references to legal advice or freedom-to-operate conclusions. Such documents do not qualify as privileged communications under the standards consistently applied by courts in this District.

GenomeDx does not invoke the crime-fraud exception in this motion. This motion rests squarely on two well-established grounds: waiver through disclosure to third parties, and the business-records doctrine.

The urgency of this motion cannot be overstated. Fact discovery in this action closes on March 6, 2026 — barely five weeks away. GenomeDx has noticed depositions of Dr. Nathan Ashford (Helios's Chief Executive Officer), Dr. Elaine Kossack (Helios's Chief Scientific Officer), and Derek Mallinson (Helios's Vice President, Commercial Operations), as well as Federal Rule of Civil Procedure 30(b)(6) depositions of Helios on fourteen topics. The withheld documents are essential for preparing for these depositions and for supporting GenomeDx's infringement contentions and damages theories, including its claims for willful infringement and enhanced damages under 35 U.S.C. § 284.

II. FACTUAL BACKGROUND

A. The Parties and the Dispute

GenomeDx is a Delaware corporation headquartered at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130. GenomeDx is a recognized leader in molecular diagnostics for prostate cancer prognosis. Its flagship product, the Decipher® Prostate genomic classifier test, utilizes a proprietary 22-gene expression panel to predict prostate cancer outcomes, including metastatic risk and cancer-specific mortality, thereby enabling clinicians and patients to make informed treatment decisions following radical prostatectomy or radiation therapy. The Decipher® test has been extensively validated in peer-reviewed clinical studies and is covered by major commercial and government payers, including Medicare. In fiscal year 2024, GenomeDx's Decipher® platform generated approximately $387.6 million in revenue, reflecting the product's widespread clinical adoption and commercial importance.

GenomeDx holds three patents-in-suit that are asserted in this action: 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, respectively, methods for predicting prostate cancer clinical outcomes using multi-gene expression classifiers, machine-learning-based systems for generating genomic risk scores from tumor tissue samples, and related computational methods for integrating genomic expression data with clinical variables to produce actionable prognostic reports. The patents-in-suit collectively protect the core methodology underlying GenomeDx's Decipher® platform and represent significant investments in research and development spanning more than a decade.

Helios is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140. Helios operates a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, from which it processes and reports its genomic testing products. Helios commercially launched its ProstaSignal™ Genomic Classifier on October 7, 2024. ProstaSignal™ uses a 24-gene expression panel to analyze prostate cancer tumor specimens and generates a "ProstaScore" risk classification that purports to predict disease aggressiveness and guide treatment decisions. Nineteen of the twenty-four genes in the ProstaSignal™ panel overlap with GenomeDx's patented gene set. The degree of overlap between the ProstaSignal™ panel and GenomeDx's patented technology is striking and is at the heart of GenomeDx's infringement claims.

GenomeDx filed this action on March 28, 2025, asserting that ProstaSignal™ infringes the asserted claims of all three patents-in-suit. The Complaint seeks injunctive relief, compensatory damages, and enhanced damages for willful infringement.

Helios is represented in this action by Ridgecrest Durneval LLP. The Ridgecrest Durneval team is led by Marcus Pellegrini (Partner), with Danielle Forrest (Senior Associate) and Owen Chu (Associate) also appearing on behalf of Helios. Ridgecrest Durneval maintains offices at One Federal Street, Suite 3400, Boston, Massachusetts 02110, and at 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071.

B. Helios's Ownership and Investor Structure

Understanding Helios's ownership and investor structure is essential to this motion because many of the challenged privilege log entries involve communications with individuals affiliated with Helios's investors rather than with Helios itself.

Helios's majority equity holder is Corinth Ventures Fund III, LP, a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116. Corinth is a life sciences-focused venture capital fund with approximately $2.1 billion in assets under management. Its Managing Director is Priya Chandrasekaran. Corinth holds 58.7% of Helios's total equity. By virtue of its majority ownership position, Corinth has significant board representation and has participated actively in Helios's strategic decisions regarding the development and commercial launch of the ProstaSignal™ Genomic Classifier, including decisions regarding competitive positioning against GenomeDx and its Decipher® test.

Aether Life Sciences Partners holds 11.0% of Helios's equity, representing its Series A investment in the company. Aether is a separate investment fund that, like Corinth, is a distinct legal entity from Helios.

The remaining equity is held by Helios's founders (22.3%) and an employee stock option pool (8.0%).

Although Corinth and Aether are significant investors in Helios, they are separate legal entities with their own management, employees, investment portfolios, and fiduciary obligations to their own limited partners. Their personnel — including investment professionals, portfolio managers, due diligence analysts, and operating partners — are not employees, officers, or agents of Helios. This distinction is legally significant because disclosure of otherwise privileged communications to individuals outside the corporate client destroys the confidentiality that is the foundation of the attorney-client privilege.

C. The discovery Requests at Issue

On January 27, 2026, GenomeDx served its First Set of Requests for Production (Nos. 1 through 47) on Helios pursuant to Federal Rule of Civil Procedure 34. Three of those requests are at issue in this motion:

Request for Production No. 22: All documents constituting, reflecting, or relating to pre-launch business plans for the ProstaSignal™ Genomic Classifier, including but not limited to market analyses, competitive assessments, go-to-market strategies, and financial projections, that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of U.S. Patent Nos. 10,438,271, 11,204,893, or 11,891,647.

Request for Production No. 23: All board of directors presentations, board packages, and board meeting minutes relating to the development, regulatory pathway, or commercial launch of the ProstaSignal™ Genomic Classifier that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of the patents-in-suit.

Request for Production No. 31: All investor presentations, investment memoranda, investor updates, and communications with investors (including but not limited to Corinth Ventures Fund III, LP and Aether Life Sciences Partners) relating to the ProstaSignal™ Genomic Classifier that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of the patents-in-suit.

These requests seek documents that go to the core of this litigation: Helios's knowledge of GenomeDx's intellectual property, Helios's deliberate decision to design and launch a competing product that overlaps significantly with GenomeDx's patented technology, and the commercial strategy behind that decision.

D. Helios's Production and Privilege Assertions

In response to RFP Nos. 22, 23, and 31, Helios produced 1,247 documents totaling approximately 14,800 pages. Helios simultaneously served a privilege log identifying eighty-three (83) additional responsive documents that it withheld in their entirety on grounds of attorney-client privilege and/or work-product protection.

GenomeDx's counsel reviewed Helios's privilege log in detail and identified thirty-four (34) of the eighty-three entries as improperly withheld. The challenged documents fall into four general categories based on the descriptions contained in Helios's own privilege log:

Category A (approximately 12 documents): Board Presentations and Board Packages. These documents are described in the privilege log as board presentations, board packages, and board meeting materials that were circulated to Helios's board of directors, including board members who are representatives of Corinth Ventures Fund III, LP. According to the privilege log descriptions, these documents contain slides or sections discussing the competitive landscape, GenomeDx's patent portfolio, and Helios's market positioning strategy, alongside what Helios characterizes as summaries of legal advice. The privilege log entries for these documents identify multiple non-attorney recipients, including Corinth-designated board representatives and other Helios business personnel.

Category B (approximately 9 documents): Investor Update Emails and Memoranda. These documents are described as investor update emails and memoranda that were sent to representatives of Corinth Ventures Fund III, LP and/or Aether Life Sciences Partners. The privilege log descriptions indicate that these communications reference GenomeDx's patents or the Decipher® test and include what Helios characterizes as mixed business and legal content. Critically, the log entries identify recipients who are investment professionals at Corinth and Aether — individuals who are not employees or agents of Helios and who are not within any attorney-client relationship with Helios's counsel.

Category C (approximately 8 documents): Internal Business-Planning Documents. These documents are described as market analyses, financial projections, and competitive assessments prepared by Helios's commercial and scientific teams, including Derek Mallinson (VP, Commercial Operations), Dr. Nathan Ashford (CEO), and Dr. Elaine Kossack (CSO). The privilege log indicates that these documents were shared with non-lawyer personnel across multiple departments within Helios and contain, at most, incidental references to legal advice or freedom-to-operate conclusions — for example, notations such as "cleared by legal" or "per counsel's advice" embedded within otherwise business-focused analyses.

Category D (approximately 5 documents): Pre-Launch Strategy Presentations Shared With External Consultants. These documents are described as pre-launch strategy presentations or related materials that were shared with external consultants or advisors who are neither attorneys nor employees of Helios. The privilege log entries identify recipients who are outside Helios's corporate structure entirely and who do not appear to have been retained by Helios's counsel for the purpose of assisting in the provision of legal advice.

The privilege log descriptions themselves are revealing. They demonstrate on their face that the challenged documents were distributed to persons outside any attorney-client relationship, including Corinth Ventures board representatives and investment team members, Aether Life Sciences investor contacts, non-attorney Helios business personnel across multiple departments, and external business consultants. These disclosures vitiate any claim of privilege.

E. Meet-and-Confer Efforts

The parties in this action entered into a Stipulated Protective Order providing for two tiers of confidentiality designation — "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — which was entered by this Court on December 18, 2025, following a meet-and-confer between counsel on December 5, 2025. The Protective Order provides robust protections for the disclosure and use of confidential business information produced in discovery and adequately addresses any concern that production of the challenged documents might expose sensitive business information.

On January 15, 2026, Peter Vassiliev of Calderwood & Harkness LLP sent a detailed meet-and-confer letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP identifying the thirty-four challenged privilege log entries by Bates range and privilege log entry number and requesting that Helios either produce the documents or, in the alternative, provide additional information to support the privilege claims, including identification of the specific legal advice sought or rendered, the identity of the attorney involved, and the basis for asserting that the communication was confidential notwithstanding disclosure to non-attorney third parties. (Vassiliev Decl. ¶ 4, Ex. A.)

On January 21, 2026, Danielle Forrest responded on behalf of Helios, maintaining all privilege assertions with respect to the thirty-four challenged documents. The response refused to produce any of the documents or to provide any additional detail beyond what was contained in the privilege log, stating only that "Helios stands by its privilege designations and its privilege log fully complies with the requirements of Federal Rule of Civil Procedure 26(b)(5)(A)." (Vassiliev Decl. ¶ 5, Ex. B.)

On January 24, 2026, counsel for the parties conducted a telephonic meet-and-confer. Participating on behalf of GenomeDx were Peter Vassiliev and Wendy Schultz of Calderwood & Harkness LLP. Participating on behalf of Helios were Danielle Forrest and Owen Chu of Ridgecrest Durneval LLP. During the call, GenomeDx's counsel explained in detail the bases for challenging the privilege assertions and offered to narrow the dispute if Helios would produce even a subset of the challenged documents or agree to in camera review. Helios refused to modify its position in any respect. (Vassiliev Decl. ¶ 6, Ex. C.)

The parties are at an impasse, and GenomeDx now brings this motion. The meet-and-confer correspondence is attached as Exhibits A through D to the Declaration of Peter Vassiliev filed herewith. GenomeDx has satisfied the requirements of Civil Local Rule 37-1(a) and Federal Rule of Civil Procedure 37(a)(1) before filing this motion.

III. LEGAL STANDARD

Under Federal Rule of Civil Procedure 37(a)(3)(B)(iv), a party may move for an order compelling production of documents when the responding party "fails to produce documents . . . as requested under Rule 34." Fed. R. Civ. P. 37(a)(3)(B)(iv). The moving party must demonstrate that the discovery sought is relevant to any party's claim or defense and proportional to the needs of the case. Fed. R. Civ. P. 26(b)(1).

The party asserting attorney-client privilege bears the burden of establishing each element of the privilege for each document or communication withheld. United States v. Graf, 610 F.3d 1148, 1156 (9th Cir. 2010); In re Grand Jury Investigation, 974 F.2d 1068, 1070 (9th Cir. 1992). This burden is not met by "blanket claims of privilege." United States v. Martin, 278 F.3d 988, 1000 (9th Cir. 2002). Rather, the privilege holder must make a "prima facie showing that the privilege protects the information" at issue by establishing each element of the privilege with respect to each specific communication. In re Grand Jury Subpoena, 357 F.3d 900, 906 (9th Cir. 2004).

Attorney-client privilege protects "confidential communications between attorneys and clients, which are made for the purpose of giving or obtaining legal advice." Upjohn Co. v. United States, 449 U.S. 383, 389 (1981). The privilege "exists to protect not only the giving of professional advice to those who can act on it but also the giving of information to the lawyer to enable him to give sound and informed advice." Id. at 390. Critically, the privilege protects only those communications that were made in confidence and that were intended to remain confidential. Voluntary disclosure of a privileged communication to a third party waives the privilege because such disclosure "is inconsistent with the confidential attorney-client relationship." Weil v. Inv./Indicators, Research & Mgmt., Inc., 647 F.2d 18, 24 (9th Cir. 1981). The privilege "does not extend to communications made in the presence of or disclosed to third parties, as such disclosure destroys the confidentiality essential to the privilege." United States v. Ackert, 169 F.3d 136, 139 (2d Cir. 1999); see also In re Pac. Pictures Corp., 679 F.3d 1121, 1126–27 (9th Cir. 2012).

The work-product doctrine, codified in 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). Work-product protection may be waived by disclosure to an adversary or to third parties whose interests are not aligned with the disclosing party. In re Chrysler Motors Corp. Overnight Evaluation Program Litig., 860 F.2d 844, 846 (8th Cir. 1988); see also Roe v. City & County of San Francisco, No. 20-cv-01868-CRB, 2021 WL 1222674, at 4 (N.D. Cal. Apr. 1, 2021). Moreover, the work-product doctrine does not protect documents created primarily for business rather than litigation purposes, even if those documents touch on subjects that later become the subject of litigation. In re Grand Jury Subpoena (Mark Torf/Torf Env't Mgmt.), 357 F.3d 900, 907–08 (9th Cir. 2004); United States v. Richey*, 632 F.3d 559, 567–68 (9th Cir. 2011).

Courts in this District apply a strict standard for maintaining privilege over mixed business-legal communications. Where a document's predominant purpose is business rather than legal, the document is not privileged, even if it contains incidental references to legal advice. See Ridgeline Industries Am., Inc. v. Calderon Corporation, No. 10-cv-03561-WHA, 2016 WL 1073318, at 2 (N.D. Cal. Mar. 18, 2016) ("[W]here a communication's primary purpose is business rather than legal, the mere inclusion of a lawyer on the distribution list does not cloak the entire communication in privilege."); Harborview Specialty Insurance Integrated Sys. Ltd. v. Nat'l Bank of Wash., 103 F.R.D. 52, 68 (D.D.C. 1984) (holding that "dual-purpose" documents are privileged only when the legal purpose is the primary purpose). The Ninth Circuit has endorsed the "primary purpose" test, under which courts examine whether the communication "would not have been made 'but for' the fact that legal advice was sought." In re Grand Jury Subpoena*, 357 F.3d at 907.

IV. ARGUMENT

A. Helios Waived Attorney-Client Privilege by Disclosing Documents to Third-Party Investors

The privilege log itself reveals that multiple challenged documents — spanning Categories A, B, and D — were shared with representatives of Corinth Ventures Fund III, LP and Aether Life Sciences Partners. This disclosure to third-party investors is fatal to Helios's privilege claims.

The foundational requirement of attorney-client privilege is confidentiality. A communication ceases to be privileged when it is voluntarily disclosed to a third party outside the attorney-client relationship. Weil, 647 F.2d at 24. This principle applies with full force to disclosures to outside investors, even those with significant equity stakes in the client entity.

Although Corinth holds 58.7% of Helios's equity and Aether holds 11.0%, they are separate legal entities — each is a Delaware limited partnership with its own management structure, employees, limited partners, and fiduciary obligations. Their personnel are not employees, officers, or agents of Helios. Disclosure of privileged communications to outside investors destroys the privilege because such investors are not within the scope of the attorney-client relationship between Helios and its counsel. See Cavallaro v. United States, 284 F.3d 236, 249 (1st Cir. 2002) (holding that communications shared with outside business advisors and investors are not privileged); In re Bieter Co., 16 F.3d 929, 938–40 (8th Cir. 1994) (disclosure to outside investors waived privilege); Bank Brussels Lambert v. Credit Lyonnais (Suisse) S.A., 160 F.R.D. 437, 442 (S.D.N.Y. 1995) (disclosure to non-client investors constitutes waiver of attorney-client privilege).

Courts in this District have specifically held that disclosure of otherwise privileged communications to venture capital firms, private equity investors, and outside board observers affiliated with investor entities waives the attorney-client privilege. See, e.g., Roe v. City & County of San Francisco, 2021 WL 1222674, at 3–4 (N.D. Cal. Apr. 1, 2021) (disclosure to third parties outside the attorney-client relationship waived privilege); In re Application of Chevron Corp.*, No. 11-mc-80171-CRB, 2013 WL 12146644 (N.D. Cal. May 30, 2013) (applying strict confidentiality requirement). The rationale is straightforward: the privilege exists to encourage candid communication between a client and its lawyer, and that purpose is not served when the client voluntarily shares those communications with outside parties, regardless of how closely aligned their business interests may be.

The privilege log entries for the challenged documents make this waiver plain. Category A documents — board presentations and board packages — were circulated to Helios board members who are identified in the log as representatives of Corinth Ventures Fund III, LP. While Helios may argue that these individuals serve as board members and thus fall within the corporate privilege, the privilege log indicates that these same materials were also shared with Corinth personnel beyond board-designated representatives, including investment team members and due diligence analysts at Corinth whose role is monitoring Corinth's investment in Helios, not governing Helios's corporate affairs. These individuals are agents of Corinth, not of Helios, and disclosure to them constitutes waiver.

Category B documents — investor update emails and memoranda — were sent to contacts at both Corinth and Aether. The privilege log entries identify specific recipients at these firms who are investment professionals, not board members or officers of Helios. Sending documents containing legal advice to these individuals is the antithesis of maintaining confidentiality.

Category D documents were shared with external consultants or advisors who are neither attorneys nor employees of Helios or its investors. Disclosure to such third parties is an even more clear-cut basis for waiver.

Helios cannot avoid the consequences of its voluntary disclosures by pointing to the business relationship between itself and its investors. The Ninth Circuit has been clear that "[t]he privilege is not designed to protect communications just because they are made between parties who happen to have a financial relationship." See United States v. Ackert, 169 F.3d at 139–40 (common financial interest insufficient to prevent waiver). A shared business interest is not the same as a common legal interest, and Helios has not asserted — nor could it credibly assert — that a common-interest privilege or joint-defense agreement applies to the communications at issue.

Finally, the existence of the Stipulated Protective Order entered by this Court on December 18, 2025, further undermines any argument that production of these documents to GenomeDx would cause undue harm. The Protective Order provides for two tiers of confidentiality designation — "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — and restricts the use and dissemination of designated materials. Helios may designate any produced documents at the appropriate confidentiality level, thereby protecting its legitimate business interests while complying with its discovery obligations.

B. Documents Shared With Non-Lawyer Business Personnel Across Helios Are Not Privileged

Even setting aside the disclosures to third-party investors, the Category C documents — approximately eight internal business-planning documents — were improperly withheld because they were prepared by and circulated among non-lawyer business and scientific personnel and distributed broadly within Helios's commercial and R&D departments.

The privilege log descriptions indicate that these documents were prepared by Dr. Nathan Ashford (CEO), Dr. Elaine Kossack (CSO), and Derek Mallinson (VP, Commercial Operations) and were disseminated to non-lawyer personnel across multiple departments within Helios. These documents include market analyses, financial projections, and competitive assessments — core business records — with, at most, incidental or passing references to legal conclusions, such as notations that a particular course of action was "cleared by legal" or taken "per counsel's advice."

Broad internal dissemination of attorney-client communications beyond the individuals who originally sought or received legal advice waives the privilege. See Upjohn, 449 U.S. at 394–95 (recognizing that the privilege applies to communications between corporate employees and counsel made "at the direction of corporate superiors in order to secure legal advice" but not to the wholesale redistribution of that advice throughout the corporation); Harborview Specialty Insurance Integrated Sys., 103 F.R.D. at 68; In re Copper Mkt. Antitrust Litig., 200 F.R.D. 213, 219 (S.D.N.Y. 2001) ("[W]hen privileged communications are disseminated to persons within the corporation who have no need to know the legal advice in order to carry out their corporate duties, the privilege may be waived."). The underlying rationale is that a corporation cannot claim that a communication was intended to be confidential if it disseminates that communication broadly to employees who were not involved in seeking or receiving legal advice and who do not need the legal advice to perform their job functions.

Moreover, the mere fact that a business document references or summarizes legal advice in passing does not transform the entire document into a privileged communication. Courts have consistently distinguished between documents created for the primary purpose of seeking or conveying legal advice and documents created for business purposes that incidentally reference legal advice. See Ridgeline Industries Am., 2016 WL 1073318, at 2; In re Grand Jury Subpoena (Mark Torf)*, 357 F.3d at 907–08. A market analysis that contains the phrase "cleared by legal" in a footnote or bullet point remains a market analysis; it does not become a privileged legal memorandum by virtue of that incidental reference.

The Category C documents, as described in the privilege log, are exactly the type of business-purpose documents that courts routinely hold are not protected by the attorney-client privilege. Their preparation by business and scientific personnel, their broad dissemination across the organization, and their characterization as market analyses, financial projections, and competitive assessments all point to the same conclusion: these are business records, not privileged legal communications.

C. The Predominant Purpose of the Withheld Documents Is Business, Not Legal

The privilege log entries for the thirty-four challenged documents are replete with business-oriented descriptions. Helios's own characterizations of these documents use terms such as "business plan," "market analysis," "board presentation," "investor update," "financial projections," "go-to-market strategy," and "competitive assessment." These are hallmarks of business records, not privileged attorney-client communications.

Under the predominant-purpose test applied by the Ninth Circuit and by courts in this District, a document is privileged only if its primary purpose is to seek or convey legal advice. In re Grand Jury Subpoena (Mark Torf), 357 F.3d at 907. Where a document's primary purpose is business planning, investment communications, or commercial strategy, the inclusion of legal content does not render the entire document privileged. See id.; Ridgeline Industries Am., 2016 WL 1073318, at *2.

This principle is especially pertinent in the context of board presentations and investor materials. A thirty-slide board presentation that contains a single slide addressing intellectual property risk, for example, is not a privileged document; it is a business presentation with a de minimis legal component. The predominant purpose of such a document is to inform the board about the company's business strategy, not to convey legal advice. See Harborview Specialty Insurance Integrated Sys., 103 F.R.D. at 68 (holding that documents with "dual purposes" are privileged only when the legal purpose predominates).

GenomeDx does not ask this Court to apply the crime-fraud exception or any other extraordinary basis for overriding privilege. Rather, GenomeDx submits that these are business records that should never have been withheld in the first instance. The privilege log entries on their face demonstrate that the documents were created to serve business purposes — securing investment, planning commercial launches, developing competitive strategy, and informing boards of directors about company operations — not to obtain legal advice. Helios cannot bootstrap its business records into the protection of the attorney-client privilege simply by including a passing reference to legal counsel's views or by copying an attorney on a distribution list.

In the alternative, if the Court finds that portions of certain documents contain genuinely privileged attorney-client communications, GenomeDx respectfully requests that the Court order production of the documents with narrowly tailored redactions of any truly privileged content, rather than permitting Helios to withhold entire documents. This approach — well-established in this District — "preserves the privilege for truly confidential legal communications while ensuring that the nonprivileged business portions of the documents are disclosed." See, e.g., Ridgeline Industries Am., 2016 WL 1073318, at 3; F.T.C. v. Pemberton Corporation, No. 17-cv-00220-LHK, 2017 WL 2774406, at 6 (N.D. Cal. June 27, 2017).

D. Category D Documents Shared With External Non-Attorney Consultants Were Not Privileged

Approximately five of the challenged documents (Category D) were shared with external consultants or advisors who are neither attorneys nor employees of Helios or any entity within Helios's corporate family. The privilege log entries for these documents identify recipients who are outside Helios's corporate structure entirely.

Disclosure of attorney-client privileged materials to outside non-attorney consultants waives the privilege unless the consultant was retained by counsel to assist in providing legal advice — the so-called Kovel doctrine. See United States v. Kovel, 296 F.2d 918, 921–22 (2d Cir. 1961); In re Grand Jury Proceedings, 220 F.3d 568, 571 (7th Cir. 2000). Under this doctrine, communications with a non-attorney consultant may be protected by the privilege only when (i) the consultant is retained by counsel (not by the client directly), (ii) the consultant's role is to assist counsel in rendering legal advice, and (iii) the communications are made for the purpose of facilitating legal advice. See Kovel, 296 F.2d at 922; United States v. Ackert, 169 F.3d at 139.

Here, the privilege log does not indicate that any of the external recipients identified in the Category D entries were retained by Helios's in-house counsel, Sara Whitmore, or by Ridgecrest Durneval LLP for the purpose of assisting in the provision of legal advice. To the contrary, the log descriptions characterize the documents as "pre-launch strategy presentations" — business materials shared with business consultants for business purposes. Absent a showing that the Kovel doctrine applies, disclosure of privileged communications to outside business consultants constitutes a complete waiver of the privilege. See In re Teleglobe Commc'ns Corp., 493 F.3d 345, 364 (3d Cir. 2007) ("[D]isclosure to an outside agent of the client will waive the privilege unless the disclosure is necessary for the client to obtain informed legal advice.").

Helios bears the burden of demonstrating that each external consultant was within the scope of the privilege. It has made no such showing, either in its privilege log or in its meet-and-confer correspondence. The Category D documents should therefore be produced in their entirety.

E. Helios Has Not Met Its Burden of Establishing Privilege

As the party asserting privilege, Helios bears the burden of demonstrating that each withheld document satisfies every element of the attorney-client privilege or work-product doctrine. Graf, 610 F.3d at 1156; In re Grand Jury Investigation, 974 F.2d at 1070. This burden requires more than conclusory assertions; Helios must provide sufficient factual detail to enable the requesting party and the Court to assess the validity of the privilege claim for each document. Fed. R. Civ. P. 26(b)(5)(A); Burlington N. & Santa Fe Ry. Co. v. U.S. Dist. Court, 408 F.3d 1142, 1149 (9th Cir. 2005).

Helios's privilege log entries for the thirty-four challenged documents fall far short of this standard. Many entries state only "Attorney-Client Privileged Communication" or "Work Product" as the basis for withholding, without identifying the attorney involved in the communication, the specific legal advice sought or rendered, or the facts establishing that the communication was made in confidence and intended to remain confidential. The log entries do not explain how or why the presence of non-attorney third-party recipients — Corinth investment professionals, Aether investor contacts, and external consultants — is consistent with a claim that the communications were confidential.

Inadequate privilege log entries are themselves grounds for compelling production. See Burlington N., 408 F.3d at 1149 (privilege log must provide "sufficient information to enable the court and opposing counsel to evaluate" the privilege claim); Ruiz v. Sauerwein, No. 14-cv-02629-WHO (JSC), 2015 WL 4040197, at *3 (N.D. Cal. July 1, 2015) (ordering production where privilege log entries were "conclusory and insufficient"). Rule 26(b)(5)(A) requires that a party withholding information on privilege grounds "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." Fed. R. Civ. P. 26(b)(5)(A). Helios has failed to meet this requirement for the thirty-four challenged entries.

F. The Work-Product Doctrine Does Not Shield Business Records

To the extent Helios invokes the work-product doctrine as an independent basis for withholding any of the thirty-four documents, that assertion likewise fails. The work-product doctrine protects only documents "prepared in anticipation of litigation or for trial." Fed. R. Civ. P. 26(b)(3)(A). This requires that the document was created "because of" the prospect of litigation, not merely that it relates to a topic that later became the subject of litigation. In re Grand Jury Subpoena (Mark Torf), 357 F.3d at 907; Richey, 632 F.3d at 567–68.

Pre-launch business plans, board presentations, and investor materials are paradigmatic business records created in the ordinary course of business — not in anticipation of litigation. Companies routinely prepare market analyses, competitive assessments, financial projections, and board and investor presentations as part of their normal business operations. The fact that such documents may reference a competitor's intellectual property does not convert them into work product.

Many of the challenged documents predate the filing of this lawsuit on March 28, 2025. According to the privilege log, documents in the challenged set were created during Helios's product development and commercialization process beginning as early as 2020 — years before GenomeDx asserted any claim against Helios. Documents created in the ordinary course of product development and business planning cannot be characterized as having been prepared "in anticipation of litigation" simply because litigation later ensued.

Even if some of the challenged documents were created after GenomeDx raised intellectual property concerns with Helios, the predominant-purpose test requires that the document was created primarily for litigation purposes — not merely that it touches on a topic that later became or was then the subject of litigation. Richey, 632 F.3d at 567–68. Business plans, board presentations, and investor updates serve business purposes irrespective of whether litigation is pending or anticipated. Their creation is driven by business needs — fundraising, corporate governance, strategic planning — not by litigation strategy.

Furthermore, even if any of the challenged documents were found to constitute work product, GenomeDx can demonstrate substantial need for the documents and an inability to obtain their substantial equivalent without undue hardship, thereby entitling GenomeDx to production under Rule 26(b)(3)(A)(ii). The documents at issue reflect Helios's own internal assessments of GenomeDx's patent portfolio, Helios's competitive positioning against the Decipher® test, and Helios's awareness of potential infringement risk. This evidence is uniquely within Helios's possession and cannot be reconstructed from other sources. No amount of depositions or third-party discovery can substitute for Helios's own contemporaneous assessments of the competitive landscape and the intellectual property risks associated with launching ProstaSignal™.

V. RELEVANCE OF THE WITHHELD DOCUMENTS

The thirty-four documents are directly relevant to multiple critical issues in this case, and their production is proportional to the needs of this litigation.

Willful Infringement. Helios's pre-launch awareness of and response to GenomeDx's patent portfolio is highly relevant to GenomeDx's claim for enhanced damages under 35 U.S.C. § 284. To establish willful infringement, GenomeDx must show that Helios acted despite an objectively high likelihood that its actions constituted infringement of a valid patent, and that this risk was either known or so obvious that it should have been known to the accused infringer. Halo Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S. 93, 103 (2016). Board presentations, investor materials, and internal business analyses discussing GenomeDx's patents, the Decipher® test, and the overlap between the ProstaSignal™ gene panel and GenomeDx's patented technology go directly to Helios's knowledge and state of mind. These documents will show what Helios knew about GenomeDx's patent rights, when it knew it, and what it did in response — the precise inquiries that are relevant to willfulness.

Damages. The withheld documents are also critical to GenomeDx's damages theories. GenomeDx intends to pursue both lost-profits and reasonable-royalty damages. GenomeDx's preliminary lost-profits analysis estimates damages of approximately $18,490,320, based on approximately 6,100 Decipher® tests diverted to ProstaSignal™ since its October 2024 launch, an average reimbursement rate of $4,210 per test, and a 72% incremental profit margin. GenomeDx's reasonable-royalty analysis proposes an 18% royalty rate on $32,088,000 in ProstaSignal™ revenue from October 2024 through March 2025.

Pre-launch business plans, financial projections, and competitive assessments are directly relevant to both damages theories. Board and investor materials discussing expected ProstaSignal™ revenues, pricing (including Helios's average reimbursement rate of $3,820 per test), market share targets, and projected profitability are the type of documents routinely relied upon in Georgia-Pacific hypothetical-negotiation analyses. See Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116, 1120 (S.D.N.Y. 1970) (identifying fifteen factors for reasonable royalty determination, many of which relate to the parties' expectations, the advantages of the patented technology, and the commercial relationship between the products). Helios's own assessments of its competitive positioning against Decipher® and its financial expectations for ProstaSignal™ bear on multiple Georgia-Pacific factors, including Factor 8 (established profitability), Factor 9 (utility and advantages of the patent property), Factor 11 (extent to which the infringer has made use of the invention), and Factor 13 (the portion of profit customarily allowed in the particular business).

Infringement Contentions. Documents discussing the design of the ProstaSignal™ 24-gene panel — and specifically the overlap of nineteen genes with GenomeDx's patented gene set — are relevant to GenomeDx's infringement theories under the asserted claims of the '271, '893, and '647 Patents. Internal analyses comparing ProstaSignal™ to Decipher® and assessing how ProstaSignal™'s methodology relates to GenomeDx's patented methods will inform both literal infringement and doctrine-of-equivalents arguments.

Upcoming Depositions. Fact discovery closes on March 6, 2026 — only thirty-five days from the date of this motion. GenomeDx has noticed Rule 30(b)(6) depositions of Helios on fourteen topics, as well as individual depositions of Dr. Nathan Ashford, Dr. Elaine Kossack, Derek Mallinson, Sara Whitmore (Helios's in-house counsel), and Dr. Anton Rykov (Helios's lead bioinformatics scientist). The withheld documents are essential preparation materials for these depositions. GenomeDx cannot effectively examine these witnesses about Helios's competitive strategy, knowledge of GenomeDx's patents, and commercial decision-making without access to the very documents that memorialize those strategies and decisions. Delay in production will prejudice GenomeDx's ability to conduct meaningful discovery within the time remaining.

VI. REQUEST FOR IN CAMERA REVIEW

If the Court is unable to resolve the privilege disputes based on the privilege log entries and the arguments presented in this memorandum and supporting papers, GenomeDx respectfully requests that the Court conduct an in camera review of the thirty-four challenged documents to determine whether the privilege assertions are properly maintained. See United States v. Zolin, 491 U.S. 554, 572 (1989) (approving in camera review of allegedly privileged documents); In re Grand Jury Investigation, 974 F.2d at 1074–75 (Ninth Circuit endorsing in camera review where party makes threshold showing of waiver or inapplicability of privilege).

GenomeDx submits that the privilege log entries on their face are sufficient to demonstrate waiver and the business-records nature of the documents, making in camera review unnecessary in this instance. The log entries identify non-attorney third-party recipients, describe documents in business terms, and reveal the broad dissemination patterns that are inconsistent with the maintenance of attorney-client confidentiality. However, in the alternative, should the Court desire to examine the documents themselves before ruling, in camera review would confirm that production is warranted and provide the Court with the fullest possible record for its determination.

VII. REQUEST FOR RELIEF

Based on the foregoing, GenomeDx respectfully requests that this Court enter an order:

1. Compelling production. Ordering Helios to produce all thirty-four (34) withheld documents identified in Exhibit E to the Declaration of Peter Vassiliev within ten (10) business days of the Court's order;

2. Subject to the Protective Order. Requiring that documents be produced subject to the Stipulated Protective Order entered by this Court on December 18, 2025, with appropriate confidentiality designations as Helios deems necessary;

3. Redaction alternative. In the alternative, if the Court finds that narrowly defined portions of certain documents contain genuinely privileged attorney-client communications, ordering production of those documents with targeted redactions limited to the genuinely privileged content, so that the remainder of each document — including all business, commercial, and factual content — is produced;

4. Expenses and fees. Awarding GenomeDx its reasonable expenses, including attorneys' fees, incurred in bringing this motion, pursuant to Federal Rule of Civil Procedure 37(a)(5)(A), which provides that the court "must" award reasonable expenses incurred in making a motion to compel when the motion is granted, unless the opposing party's nondisclosure was substantially justified or other circumstances make an award of expenses unjust; and

5. Further relief. Granting such other and further relief as this Court deems just and proper.

VIII. CONCLUSION

Helios has improperly withheld thirty-four documents from production by asserting attorney-client privilege and work-product protection over materials that were shared with third-party investors — Corinth Ventures Fund III, LP and Aether Life Sciences Partners — disseminated broadly among non-lawyer business personnel across multiple departments, shared with external non-attorney consultants, and created primarily for business purposes rather than to seek or convey legal advice. The privilege log entries themselves reveal the facts that defeat Helios's privilege claims: non-attorney third-party recipients, business-oriented document descriptions, and broad distribution patterns fundamentally inconsistent with the maintenance of confidentiality.

With fact discovery closing on March 6, 2026, the need for these documents is urgent and acute. GenomeDx cannot properly prepare for the depositions of key Helios witnesses — including the CEO, CSO, and VP of Commercial Operations who authored or received many of the withheld documents — or develop its infringement and damages theories without access to Helios's own internal assessments of the competitive landscape, GenomeDx's patent portfolio, and the commercial strategy behind the ProstaSignal™ launch.

GenomeDx respectfully requests that this Court grant this motion and order production of the thirty-four withheld documents.

Dated: January 30, 2026

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom (CA Bar No. 247831) Peter Vassiliev (CA Bar No. 312604)

CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5400 Facsimile: (415) 773-5401

Email: cbloom@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Attorneys for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF COMPLIANCE WITH CIVIL LOCAL RULE 37-1

I, Peter Vassiliev, hereby certify that, before filing the foregoing motion, counsel for Plaintiff Genome Dx Therapeutics Inc. met and conferred with counsel for Defendant Helios Precision Diagnostics, Inc. in a good-faith effort to resolve the discovery dispute without court intervention, as required by Civil Local Rule 37-1(a) and Federal Rule of Civil Procedure 37(a)(1).

Specifically:

1. On January 15, 2026, I sent a detailed meet-and-confer letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP identifying the thirty-four (34) challenged privilege log entries by Bates range and privilege log entry number and requesting production or, in the alternative, additional information to support the privilege claims. (Declaration of Peter Vassiliev, Ex. A.)

2. On January 21, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded in writing, maintaining all privilege assertions and refusing to produce the thirty-four documents or provide any additional detail. (Declaration of Peter Vassiliev, Ex. B.)

3. On January 24, 2026, counsel for the parties conducted a telephonic meet-and-confer conference. Participating on behalf of GenomeDx were Peter Vassiliev and Wendy Schultz of Calderwood & Harkness LLP. Participating on behalf of Helios were Danielle Forrest and Owen Chu of Ridgecrest Durneval LLP. During the call, the parties discussed each category of challenged documents and explored potential compromises, including partial production and in camera review. Helios refused to modify its position. (Declaration of Peter Vassiliev, Ex. C.)

The parties were unable to resolve the dispute, and the filing of this motion became necessary.

By: ________

Peter Vassiliev (CA Bar No. 312604) CALDERWOOD & HARKNESS LLP Attorneys for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF SERVICE

I hereby certify that on January 30, 2026, I electronically filed the foregoing Plaintiff Genome Dx Therapeutics Inc.'s Motion to Compel Defendant Helios Precision Diagnostics, Inc. to Produce Documents Responsive to Requests for Production Nos. 22, 23, and 31, together with the accompanying Declaration of Peter Vassiliev and Exhibits A through E thereto, with the Clerk of the Court using the CM/ECF system, which will send electronic notification of such filing to all counsel of record, including:

Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 854-2000

Email: mpellegrini@ridgecrestkirkpatrick.com

Email: dforrest@ridgecrestkirkpatrick.com

Email: ochu@ridgecrestkirkpatrick.com

Attorneys for Defendant Helios Precision Diagnostics, Inc.

By: ________

Peter Vassiliev (CA Bar No. 312604) CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Attorneys for Plaintiff Genome Dx Therapeutics Inc.

GENOME DX THERAPEUTICS INC.,	Case No. 3:25-cv-01847-JWL
Plaintiff,	Hon. Jessica W. Langston
v.	Referred to: Hon. David R. Cabrera,

U.S. Magistrate Judge

HELIOS PRECISION DIAGNOSTICS, INC.,

Defendant.

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA
PLAINTIFF GENOME DX THERAPEUTICS INC.'S MOTION TO COMPEL DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. TO PRODUCE DOCUMENTS RESPONSIVE TO REQUESTS FOR PRODUCTION NOS. 22, 23, AND 31
Date Filed: January 30, 2026 Hearing: Date and time to be set by Magistrate Judge Cabrera
NOTICE OF MOTION
TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. AND ITS ATTORNEYS OF RECORD, RIDGECREST DURNEVAL LLP:
PLEASE TAKE NOTICE that Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") will and does hereby move this Court pursuant to Federal Rule of Civil Procedure 37(a)(3)(B)(iv) for an order compelling Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents withheld on claims of attorney-client privilege and work-product protection from categories covered by Plaintiff's First Set of Requests for Production Nos. 22, 23, and 31, served January 27, 2026. This motion is made on the grounds that the withheld documents were shared with non-lawyer business personnel and third-party investors, thereby waiving any applicable privilege, and that the documents are primarily business records that do not qualify for privilege protection.
This motion is based on this Notice of Motion, the accompanying Memorandum of Points and Authorities set forth below, the Declaration of Peter Vassiliev and Exhibits A through E thereto, the pleadings and papers on file in this action, and such other matters as may be presented to the Court at or before the hearing on this motion. The hearing date and time are to be set by Magistrate Judge Cabrera.
MEMORANDUM OF POINTS AND AUTHORITIES
I. INTRODUCTION
Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") respectfully moves to compel Defendant Helios Precision Diagnostics, Inc. ("Helios") to produce thirty-four (34) documents that Helios has improperly withheld from production 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 and are central to GenomeDx's patent infringement claims in this action.
The thirty-four documents at issue fall within three categories requested by GenomeDx: pre-launch business plans, board presentations, and investor materials referencing GenomeDx's patents — U.S. Patent Nos. 10,438,271 (the "'271 Patent"), 11,204,893 (the "'893 Patent"), and 11,891,647 (the "'647 Patent") — or GenomeDx's commercially successful Decipher® genomic classifier test. Helios produced 1,247 documents responsive to these three requests but withheld a total of eighty-three (83) documents on privilege grounds and logged them on its privilege log served concurrently with its production. After careful review of Helios's privilege log, GenomeDx challenges thirty-four (34) of those eighty-three entries as improperly withheld.
These documents are critical to GenomeDx's infringement case. They bear directly on Helios's knowledge of GenomeDx's patent portfolio prior to launching its accused ProstaSignal™ Genomic Classifier product, Helios's competitive positioning of ProstaSignal™ against the Decipher® test, and the commercial motivation behind the launch of the accused product on October 7, 2024. Without these documents, GenomeDx will be unable to fully develop its infringement and damages theories or prepare adequately for upcoming depositions of key Helios witnesses.
The privilege assertions fail for two independent reasons. First, the documents were shared with non-lawyer business personnel and third-party investors — including Corinth Ventures Fund III, LP ("Corinth"), Helios's 58.7% majority equity holder, and Aether Life Sciences Partners ("Aether"), an 11.0% Series A investor — thereby destroying the confidentiality that is the sine qua non of attorney-client privilege. The privilege log entries themselves reveal that many of the challenged documents were distributed to individuals and entities outside any attorney-client relationship, including venture capital investment team members, due diligence analysts, and external business consultants. Second, many of the documents are predominantly business records — market analyses, financial projections, board presentations, and investor updates — that happen to include passing references to legal advice or freedom-to-operate conclusions. Such documents do not qualify as privileged communications under the standards consistently applied by courts in this District.
GenomeDx does not invoke the crime-fraud exception in this motion. This motion rests squarely on two well-established grounds: waiver through disclosure to third parties, and the business-records doctrine.
The urgency of this motion cannot be overstated. Fact discovery in this action closes on March 6, 2026 — barely five weeks away. GenomeDx has noticed depositions of Dr. Nathan Ashford (Helios's Chief Executive Officer), Dr. Elaine Kossack (Helios's Chief Scientific Officer), and Derek Mallinson (Helios's Vice President, Commercial Operations), as well as Federal Rule of Civil Procedure 30(b)(6) depositions of Helios on fourteen topics. The withheld documents are essential for preparing for these depositions and for supporting GenomeDx's infringement contentions and damages theories, including its claims for willful infringement and enhanced damages under 35 U.S.C. § 284.
II. FACTUAL BACKGROUND
A. The Parties and the Dispute
GenomeDx is a Delaware corporation headquartered at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130. GenomeDx is a recognized leader in molecular diagnostics for prostate cancer prognosis. Its flagship product, the Decipher® Prostate genomic classifier test, utilizes a proprietary 22-gene expression panel to predict prostate cancer outcomes, including metastatic risk and cancer-specific mortality, thereby enabling clinicians and patients to make informed treatment decisions following radical prostatectomy or radiation therapy. The Decipher® test has been extensively validated in peer-reviewed clinical studies and is covered by major commercial and government payers, including Medicare. In fiscal year 2024, GenomeDx's Decipher® platform generated approximately $387.6 million in revenue, reflecting the product's widespread clinical adoption and commercial importance.
GenomeDx holds three patents-in-suit that are asserted in this action: 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, respectively, methods for predicting prostate cancer clinical outcomes using multi-gene expression classifiers, machine-learning-based systems for generating genomic risk scores from tumor tissue samples, and related computational methods for integrating genomic expression data with clinical variables to produce actionable prognostic reports. The patents-in-suit collectively protect the core methodology underlying GenomeDx's Decipher® platform and represent significant investments in research and development spanning more than a decade.
Helios is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140. Helios operates a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, from which it processes and reports its genomic testing products. Helios commercially launched its ProstaSignal™ Genomic Classifier on October 7, 2024. ProstaSignal™ uses a 24-gene expression panel to analyze prostate cancer tumor specimens and generates a "ProstaScore" risk classification that purports to predict disease aggressiveness and guide treatment decisions. Nineteen of the twenty-four genes in the ProstaSignal™ panel overlap with GenomeDx's patented gene set. The degree of overlap between the ProstaSignal™ panel and GenomeDx's patented technology is striking and is at the heart of GenomeDx's infringement claims.
GenomeDx filed this action on March 28, 2025, asserting that ProstaSignal™ infringes the asserted claims of all three patents-in-suit. The Complaint seeks injunctive relief, compensatory damages, and enhanced damages for willful infringement.
Helios is represented in this action by Ridgecrest Durneval LLP. The Ridgecrest Durneval team is led by Marcus Pellegrini (Partner), with Danielle Forrest (Senior Associate) and Owen Chu (Associate) also appearing on behalf of Helios. Ridgecrest Durneval maintains offices at One Federal Street, Suite 3400, Boston, Massachusetts 02110, and at 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071.
B. Helios's Ownership and Investor Structure
Understanding Helios's ownership and investor structure is essential to this motion because many of the challenged privilege log entries involve communications with individuals affiliated with Helios's investors rather than with Helios itself.
Helios's majority equity holder is Corinth Ventures Fund III, LP, a Delaware limited partnership with its principal office at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116. Corinth is a life sciences-focused venture capital fund with approximately $2.1 billion in assets under management. Its Managing Director is Priya Chandrasekaran. Corinth holds 58.7% of Helios's total equity. By virtue of its majority ownership position, Corinth has significant board representation and has participated actively in Helios's strategic decisions regarding the development and commercial launch of the ProstaSignal™ Genomic Classifier, including decisions regarding competitive positioning against GenomeDx and its Decipher® test.
Aether Life Sciences Partners holds 11.0% of Helios's equity, representing its Series A investment in the company. Aether is a separate investment fund that, like Corinth, is a distinct legal entity from Helios.
The remaining equity is held by Helios's founders (22.3%) and an employee stock option pool (8.0%).
Although Corinth and Aether are significant investors in Helios, they are separate legal entities with their own management, employees, investment portfolios, and fiduciary obligations to their own limited partners. Their personnel — including investment professionals, portfolio managers, due diligence analysts, and operating partners — are not employees, officers, or agents of Helios. This distinction is legally significant because disclosure of otherwise privileged communications to individuals outside the corporate client destroys the confidentiality that is the foundation of the attorney-client privilege.
C. The discovery Requests at Issue
On January 27, 2026, GenomeDx served its First Set of Requests for Production (Nos. 1 through 47) on Helios pursuant to Federal Rule of Civil Procedure 34. Three of those requests are at issue in this motion:
Request for Production No. 22: All documents constituting, reflecting, or relating to pre-launch business plans for the ProstaSignal™ Genomic Classifier, including but not limited to market analyses, competitive assessments, go-to-market strategies, and financial projections, that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of U.S. Patent Nos. 10,438,271, 11,204,893, or 11,891,647.
Request for Production No. 23: All board of directors presentations, board packages, and board meeting minutes relating to the development, regulatory pathway, or commercial launch of the ProstaSignal™ Genomic Classifier that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of the patents-in-suit.
Request for Production No. 31: All investor presentations, investment memoranda, investor updates, and communications with investors (including but not limited to Corinth Ventures Fund III, LP and Aether Life Sciences Partners) relating to the ProstaSignal™ Genomic Classifier that reference Genome Dx Therapeutics Inc., the Decipher® test, or any of the patents-in-suit.
These requests seek documents that go to the core of this litigation: Helios's knowledge of GenomeDx's intellectual property, Helios's deliberate decision to design and launch a competing product that overlaps significantly with GenomeDx's patented technology, and the commercial strategy behind that decision.
D. Helios's Production and Privilege Assertions
In response to RFP Nos. 22, 23, and 31, Helios produced 1,247 documents totaling approximately 14,800 pages. Helios simultaneously served a privilege log identifying eighty-three (83) additional responsive documents that it withheld in their entirety on grounds of attorney-client privilege and/or work-product protection.
GenomeDx's counsel reviewed Helios's privilege log in detail and identified thirty-four (34) of the eighty-three entries as improperly withheld. The challenged documents fall into four general categories based on the descriptions contained in Helios's own privilege log:
Category A (approximately 12 documents): Board Presentations and Board Packages. These documents are described in the privilege log as board presentations, board packages, and board meeting materials that were circulated to Helios's board of directors, including board members who are representatives of Corinth Ventures Fund III, LP. According to the privilege log descriptions, these documents contain slides or sections discussing the competitive landscape, GenomeDx's patent portfolio, and Helios's market positioning strategy, alongside what Helios characterizes as summaries of legal advice. The privilege log entries for these documents identify multiple non-attorney recipients, including Corinth-designated board representatives and other Helios business personnel.
Category B (approximately 9 documents): Investor Update Emails and Memoranda. These documents are described as investor update emails and memoranda that were sent to representatives of Corinth Ventures Fund III, LP and/or Aether Life Sciences Partners. The privilege log descriptions indicate that these communications reference GenomeDx's patents or the Decipher® test and include what Helios characterizes as mixed business and legal content. Critically, the log entries identify recipients who are investment professionals at Corinth and Aether — individuals who are not employees or agents of Helios and who are not within any attorney-client relationship with Helios's counsel.
Category C (approximately 8 documents): Internal Business-Planning Documents. These documents are described as market analyses, financial projections, and competitive assessments prepared by Helios's commercial and scientific teams, including Derek Mallinson (VP, Commercial Operations), Dr. Nathan Ashford (CEO), and Dr. Elaine Kossack (CSO). The privilege log indicates that these documents were shared with non-lawyer personnel across multiple departments within Helios and contain, at most, incidental references to legal advice or freedom-to-operate conclusions — for example, notations such as "cleared by legal" or "per counsel's advice" embedded within otherwise business-focused analyses.
Category D (approximately 5 documents): Pre-Launch Strategy Presentations Shared With External Consultants. These documents are described as pre-launch strategy presentations or related materials that were shared with external consultants or advisors who are neither attorneys nor employees of Helios. The privilege log entries identify recipients who are outside Helios's corporate structure entirely and who do not appear to have been retained by Helios's counsel for the purpose of assisting in the provision of legal advice.
The privilege log descriptions themselves are revealing. They demonstrate on their face that the challenged documents were distributed to persons outside any attorney-client relationship, including Corinth Ventures board representatives and investment team members, Aether Life Sciences investor contacts, non-attorney Helios business personnel across multiple departments, and external business consultants. These disclosures vitiate any claim of privilege.
E. Meet-and-Confer Efforts
The parties in this action entered into a Stipulated Protective Order providing for two tiers of confidentiality designation — "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — which was entered by this Court on December 18, 2025, following a meet-and-confer between counsel on December 5, 2025. The Protective Order provides robust protections for the disclosure and use of confidential business information produced in discovery and adequately addresses any concern that production of the challenged documents might expose sensitive business information.
On January 15, 2026, Peter Vassiliev of Calderwood & Harkness LLP sent a detailed meet-and-confer letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP identifying the thirty-four challenged privilege log entries by Bates range and privilege log entry number and requesting that Helios either produce the documents or, in the alternative, provide additional information to support the privilege claims, including identification of the specific legal advice sought or rendered, the identity of the attorney involved, and the basis for asserting that the communication was confidential notwithstanding disclosure to non-attorney third parties. (Vassiliev Decl. ¶ 4, Ex. A.)
On January 21, 2026, Danielle Forrest responded on behalf of Helios, maintaining all privilege assertions with respect to the thirty-four challenged documents. The response refused to produce any of the documents or to provide any additional detail beyond what was contained in the privilege log, stating only that "Helios stands by its privilege designations and its privilege log fully complies with the requirements of Federal Rule of Civil Procedure 26(b)(5)(A)." (Vassiliev Decl. ¶ 5, Ex. B.)
On January 24, 2026, counsel for the parties conducted a telephonic meet-and-confer. Participating on behalf of GenomeDx were Peter Vassiliev and Wendy Schultz of Calderwood & Harkness LLP. Participating on behalf of Helios were Danielle Forrest and Owen Chu of Ridgecrest Durneval LLP. During the call, GenomeDx's counsel explained in detail the bases for challenging the privilege assertions and offered to narrow the dispute if Helios would produce even a subset of the challenged documents or agree to in camera review. Helios refused to modify its position in any respect. (Vassiliev Decl. ¶ 6, Ex. C.)
The parties are at an impasse, and GenomeDx now brings this motion. The meet-and-confer correspondence is attached as Exhibits A through D to the Declaration of Peter Vassiliev filed herewith. GenomeDx has satisfied the requirements of Civil Local Rule 37-1(a) and Federal Rule of Civil Procedure 37(a)(1) before filing this motion.
III. LEGAL STANDARD
Under Federal Rule of Civil Procedure 37(a)(3)(B)(iv), a party may move for an order compelling production of documents when the responding party "fails to produce documents . . . as requested under Rule 34." Fed. R. Civ. P. 37(a)(3)(B)(iv). The moving party must demonstrate that the discovery sought is relevant to any party's claim or defense and proportional to the needs of the case. Fed. R. Civ. P. 26(b)(1).
The party asserting attorney-client privilege bears the burden of establishing each element of the privilege for each document or communication withheld. United States v. Graf, 610 F.3d 1148, 1156 (9th Cir. 2010); In re Grand Jury Investigation, 974 F.2d 1068, 1070 (9th Cir. 1992). This burden is not met by "blanket claims of privilege." United States v. Martin, 278 F.3d 988, 1000 (9th Cir. 2002). Rather, the privilege holder must make a "prima facie showing that the privilege protects the information" at issue by establishing each element of the privilege with respect to each specific communication. In re Grand Jury Subpoena, 357 F.3d 900, 906 (9th Cir. 2004).
Attorney-client privilege protects "confidential communications between attorneys and clients, which are made for the purpose of giving or obtaining legal advice." Upjohn Co. v. United States, 449 U.S. 383, 389 (1981). The privilege "exists to protect not only the giving of professional advice to those who can act on it but also the giving of information to the lawyer to enable him to give sound and informed advice." Id. at 390. Critically, the privilege protects only those communications that were made in confidence and that were intended to remain confidential. Voluntary disclosure of a privileged communication to a third party waives the privilege because such disclosure "is inconsistent with the confidential attorney-client relationship." Weil v. Inv./Indicators, Research & Mgmt., Inc., 647 F.2d 18, 24 (9th Cir. 1981). The privilege "does not extend to communications made in the presence of or disclosed to third parties, as such disclosure destroys the confidentiality essential to the privilege." United States v. Ackert, 169 F.3d 136, 139 (2d Cir. 1999); see also In re Pac. Pictures Corp., 679 F.3d 1121, 1126–27 (9th Cir. 2012).
The work-product doctrine, codified in 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). Work-product protection may be waived by disclosure to an adversary or to third parties whose interests are not aligned with the disclosing party. In re Chrysler Motors Corp. Overnight Evaluation Program Litig., 860 F.2d 844, 846 (8th Cir. 1988); see also Roe v. City & County of San Francisco, No. 20-cv-01868-CRB, 2021 WL 1222674, at 4 (N.D. Cal. Apr. 1, 2021). Moreover, the work-product doctrine does not protect documents created primarily for business rather than litigation purposes, even if those documents touch on subjects that later become the subject of litigation. In re Grand Jury Subpoena (Mark Torf/Torf Env't Mgmt.), 357 F.3d 900, 907–08 (9th Cir. 2004); United States v. Richey*, 632 F.3d 559, 567–68 (9th Cir. 2011).
Courts in this District apply a strict standard for maintaining privilege over mixed business-legal communications. Where a document's predominant purpose is business rather than legal, the document is not privileged, even if it contains incidental references to legal advice. See Ridgeline Industries Am., Inc. v. Calderon Corporation, No. 10-cv-03561-WHA, 2016 WL 1073318, at 2 (N.D. Cal. Mar. 18, 2016) ("[W]here a communication's primary purpose is business rather than legal, the mere inclusion of a lawyer on the distribution list does not cloak the entire communication in privilege."); Harborview Specialty Insurance Integrated Sys. Ltd. v. Nat'l Bank of Wash., 103 F.R.D. 52, 68 (D.D.C. 1984) (holding that "dual-purpose" documents are privileged only when the legal purpose is the primary purpose). The Ninth Circuit has endorsed the "primary purpose" test, under which courts examine whether the communication "would not have been made 'but for' the fact that legal advice was sought." In re Grand Jury Subpoena*, 357 F.3d at 907.
IV. ARGUMENT
A. Helios Waived Attorney-Client Privilege by Disclosing Documents to Third-Party Investors
The privilege log itself reveals that multiple challenged documents — spanning Categories A, B, and D — were shared with representatives of Corinth Ventures Fund III, LP and Aether Life Sciences Partners. This disclosure to third-party investors is fatal to Helios's privilege claims.
The foundational requirement of attorney-client privilege is confidentiality. A communication ceases to be privileged when it is voluntarily disclosed to a third party outside the attorney-client relationship. Weil, 647 F.2d at 24. This principle applies with full force to disclosures to outside investors, even those with significant equity stakes in the client entity.
Although Corinth holds 58.7% of Helios's equity and Aether holds 11.0%, they are separate legal entities — each is a Delaware limited partnership with its own management structure, employees, limited partners, and fiduciary obligations. Their personnel are not employees, officers, or agents of Helios. Disclosure of privileged communications to outside investors destroys the privilege because such investors are not within the scope of the attorney-client relationship between Helios and its counsel. See Cavallaro v. United States, 284 F.3d 236, 249 (1st Cir. 2002) (holding that communications shared with outside business advisors and investors are not privileged); In re Bieter Co., 16 F.3d 929, 938–40 (8th Cir. 1994) (disclosure to outside investors waived privilege); Bank Brussels Lambert v. Credit Lyonnais (Suisse) S.A., 160 F.R.D. 437, 442 (S.D.N.Y. 1995) (disclosure to non-client investors constitutes waiver of attorney-client privilege).
Courts in this District have specifically held that disclosure of otherwise privileged communications to venture capital firms, private equity investors, and outside board observers affiliated with investor entities waives the attorney-client privilege. See, e.g., Roe v. City & County of San Francisco, 2021 WL 1222674, at 3–4 (N.D. Cal. Apr. 1, 2021) (disclosure to third parties outside the attorney-client relationship waived privilege); In re Application of Chevron Corp.*, No. 11-mc-80171-CRB, 2013 WL 12146644 (N.D. Cal. May 30, 2013) (applying strict confidentiality requirement). The rationale is straightforward: the privilege exists to encourage candid communication between a client and its lawyer, and that purpose is not served when the client voluntarily shares those communications with outside parties, regardless of how closely aligned their business interests may be.
The privilege log entries for the challenged documents make this waiver plain. Category A documents — board presentations and board packages — were circulated to Helios board members who are identified in the log as representatives of Corinth Ventures Fund III, LP. While Helios may argue that these individuals serve as board members and thus fall within the corporate privilege, the privilege log indicates that these same materials were also shared with Corinth personnel beyond board-designated representatives, including investment team members and due diligence analysts at Corinth whose role is monitoring Corinth's investment in Helios, not governing Helios's corporate affairs. These individuals are agents of Corinth, not of Helios, and disclosure to them constitutes waiver.
Category B documents — investor update emails and memoranda — were sent to contacts at both Corinth and Aether. The privilege log entries identify specific recipients at these firms who are investment professionals, not board members or officers of Helios. Sending documents containing legal advice to these individuals is the antithesis of maintaining confidentiality.
Category D documents were shared with external consultants or advisors who are neither attorneys nor employees of Helios or its investors. Disclosure to such third parties is an even more clear-cut basis for waiver.
Helios cannot avoid the consequences of its voluntary disclosures by pointing to the business relationship between itself and its investors. The Ninth Circuit has been clear that "[t]he privilege is not designed to protect communications just because they are made between parties who happen to have a financial relationship." See United States v. Ackert, 169 F.3d at 139–40 (common financial interest insufficient to prevent waiver). A shared business interest is not the same as a common legal interest, and Helios has not asserted — nor could it credibly assert — that a common-interest privilege or joint-defense agreement applies to the communications at issue.
Finally, the existence of the Stipulated Protective Order entered by this Court on December 18, 2025, further undermines any argument that production of these documents to GenomeDx would cause undue harm. The Protective Order provides for two tiers of confidentiality designation — "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — and restricts the use and dissemination of designated materials. Helios may designate any produced documents at the appropriate confidentiality level, thereby protecting its legitimate business interests while complying with its discovery obligations.
B. Documents Shared With Non-Lawyer Business Personnel Across Helios Are Not Privileged
Even setting aside the disclosures to third-party investors, the Category C documents — approximately eight internal business-planning documents — were improperly withheld because they were prepared by and circulated among non-lawyer business and scientific personnel and distributed broadly within Helios's commercial and R&D departments.
The privilege log descriptions indicate that these documents were prepared by Dr. Nathan Ashford (CEO), Dr. Elaine Kossack (CSO), and Derek Mallinson (VP, Commercial Operations) and were disseminated to non-lawyer personnel across multiple departments within Helios. These documents include market analyses, financial projections, and competitive assessments — core business records — with, at most, incidental or passing references to legal conclusions, such as notations that a particular course of action was "cleared by legal" or taken "per counsel's advice."
Broad internal dissemination of attorney-client communications beyond the individuals who originally sought or received legal advice waives the privilege. See Upjohn, 449 U.S. at 394–95 (recognizing that the privilege applies to communications between corporate employees and counsel made "at the direction of corporate superiors in order to secure legal advice" but not to the wholesale redistribution of that advice throughout the corporation); Harborview Specialty Insurance Integrated Sys., 103 F.R.D. at 68; In re Copper Mkt. Antitrust Litig., 200 F.R.D. 213, 219 (S.D.N.Y. 2001) ("[W]hen privileged communications are disseminated to persons within the corporation who have no need to know the legal advice in order to carry out their corporate duties, the privilege may be waived."). The underlying rationale is that a corporation cannot claim that a communication was intended to be confidential if it disseminates that communication broadly to employees who were not involved in seeking or receiving legal advice and who do not need the legal advice to perform their job functions.
Moreover, the mere fact that a business document references or summarizes legal advice in passing does not transform the entire document into a privileged communication. Courts have consistently distinguished between documents created for the primary purpose of seeking or conveying legal advice and documents created for business purposes that incidentally reference legal advice. See Ridgeline Industries Am., 2016 WL 1073318, at 2; In re Grand Jury Subpoena (Mark Torf)*, 357 F.3d at 907–08. A market analysis that contains the phrase "cleared by legal" in a footnote or bullet point remains a market analysis; it does not become a privileged legal memorandum by virtue of that incidental reference.
The Category C documents, as described in the privilege log, are exactly the type of business-purpose documents that courts routinely hold are not protected by the attorney-client privilege. Their preparation by business and scientific personnel, their broad dissemination across the organization, and their characterization as market analyses, financial projections, and competitive assessments all point to the same conclusion: these are business records, not privileged legal communications.
C. The Predominant Purpose of the Withheld Documents Is Business, Not Legal
The privilege log entries for the thirty-four challenged documents are replete with business-oriented descriptions. Helios's own characterizations of these documents use terms such as "business plan," "market analysis," "board presentation," "investor update," "financial projections," "go-to-market strategy," and "competitive assessment." These are hallmarks of business records, not privileged attorney-client communications.
Under the predominant-purpose test applied by the Ninth Circuit and by courts in this District, a document is privileged only if its primary purpose is to seek or convey legal advice. In re Grand Jury Subpoena (Mark Torf), 357 F.3d at 907. Where a document's primary purpose is business planning, investment communications, or commercial strategy, the inclusion of legal content does not render the entire document privileged. See id.; Ridgeline Industries Am., 2016 WL 1073318, at *2.
This principle is especially pertinent in the context of board presentations and investor materials. A thirty-slide board presentation that contains a single slide addressing intellectual property risk, for example, is not a privileged document; it is a business presentation with a de minimis legal component. The predominant purpose of such a document is to inform the board about the company's business strategy, not to convey legal advice. See Harborview Specialty Insurance Integrated Sys., 103 F.R.D. at 68 (holding that documents with "dual purposes" are privileged only when the legal purpose predominates).
GenomeDx does not ask this Court to apply the crime-fraud exception or any other extraordinary basis for overriding privilege. Rather, GenomeDx submits that these are business records that should never have been withheld in the first instance. The privilege log entries on their face demonstrate that the documents were created to serve business purposes — securing investment, planning commercial launches, developing competitive strategy, and informing boards of directors about company operations — not to obtain legal advice. Helios cannot bootstrap its business records into the protection of the attorney-client privilege simply by including a passing reference to legal counsel's views or by copying an attorney on a distribution list.
In the alternative, if the Court finds that portions of certain documents contain genuinely privileged attorney-client communications, GenomeDx respectfully requests that the Court order production of the documents with narrowly tailored redactions of any truly privileged content, rather than permitting Helios to withhold entire documents. This approach — well-established in this District — "preserves the privilege for truly confidential legal communications while ensuring that the nonprivileged business portions of the documents are disclosed." See, e.g., Ridgeline Industries Am., 2016 WL 1073318, at 3; F.T.C. v. Pemberton Corporation, No. 17-cv-00220-LHK, 2017 WL 2774406, at 6 (N.D. Cal. June 27, 2017).
D. Category D Documents Shared With External Non-Attorney Consultants Were Not Privileged
Approximately five of the challenged documents (Category D) were shared with external consultants or advisors who are neither attorneys nor employees of Helios or any entity within Helios's corporate family. The privilege log entries for these documents identify recipients who are outside Helios's corporate structure entirely.
Disclosure of attorney-client privileged materials to outside non-attorney consultants waives the privilege unless the consultant was retained by counsel to assist in providing legal advice — the so-called Kovel doctrine. See United States v. Kovel, 296 F.2d 918, 921–22 (2d Cir. 1961); In re Grand Jury Proceedings, 220 F.3d 568, 571 (7th Cir. 2000). Under this doctrine, communications with a non-attorney consultant may be protected by the privilege only when (i) the consultant is retained by counsel (not by the client directly), (ii) the consultant's role is to assist counsel in rendering legal advice, and (iii) the communications are made for the purpose of facilitating legal advice. See Kovel, 296 F.2d at 922; United States v. Ackert, 169 F.3d at 139.
Here, the privilege log does not indicate that any of the external recipients identified in the Category D entries were retained by Helios's in-house counsel, Sara Whitmore, or by Ridgecrest Durneval LLP for the purpose of assisting in the provision of legal advice. To the contrary, the log descriptions characterize the documents as "pre-launch strategy presentations" — business materials shared with business consultants for business purposes. Absent a showing that the Kovel doctrine applies, disclosure of privileged communications to outside business consultants constitutes a complete waiver of the privilege. See In re Teleglobe Commc'ns Corp., 493 F.3d 345, 364 (3d Cir. 2007) ("[D]isclosure to an outside agent of the client will waive the privilege unless the disclosure is necessary for the client to obtain informed legal advice.").
Helios bears the burden of demonstrating that each external consultant was within the scope of the privilege. It has made no such showing, either in its privilege log or in its meet-and-confer correspondence. The Category D documents should therefore be produced in their entirety.
E. Helios Has Not Met Its Burden of Establishing Privilege
As the party asserting privilege, Helios bears the burden of demonstrating that each withheld document satisfies every element of the attorney-client privilege or work-product doctrine. Graf, 610 F.3d at 1156; In re Grand Jury Investigation, 974 F.2d at 1070. This burden requires more than conclusory assertions; Helios must provide sufficient factual detail to enable the requesting party and the Court to assess the validity of the privilege claim for each document. Fed. R. Civ. P. 26(b)(5)(A); Burlington N. & Santa Fe Ry. Co. v. U.S. Dist. Court, 408 F.3d 1142, 1149 (9th Cir. 2005).
Helios's privilege log entries for the thirty-four challenged documents fall far short of this standard. Many entries state only "Attorney-Client Privileged Communication" or "Work Product" as the basis for withholding, without identifying the attorney involved in the communication, the specific legal advice sought or rendered, or the facts establishing that the communication was made in confidence and intended to remain confidential. The log entries do not explain how or why the presence of non-attorney third-party recipients — Corinth investment professionals, Aether investor contacts, and external consultants — is consistent with a claim that the communications were confidential.
Inadequate privilege log entries are themselves grounds for compelling production. See Burlington N., 408 F.3d at 1149 (privilege log must provide "sufficient information to enable the court and opposing counsel to evaluate" the privilege claim); Ruiz v. Sauerwein, No. 14-cv-02629-WHO (JSC), 2015 WL 4040197, at *3 (N.D. Cal. July 1, 2015) (ordering production where privilege log entries were "conclusory and insufficient"). Rule 26(b)(5)(A) requires that a party withholding information on privilege grounds "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." Fed. R. Civ. P. 26(b)(5)(A). Helios has failed to meet this requirement for the thirty-four challenged entries.
F. The Work-Product Doctrine Does Not Shield Business Records
To the extent Helios invokes the work-product doctrine as an independent basis for withholding any of the thirty-four documents, that assertion likewise fails. The work-product doctrine protects only documents "prepared in anticipation of litigation or for trial." Fed. R. Civ. P. 26(b)(3)(A). This requires that the document was created "because of" the prospect of litigation, not merely that it relates to a topic that later became the subject of litigation. In re Grand Jury Subpoena (Mark Torf), 357 F.3d at 907; Richey, 632 F.3d at 567–68.
Pre-launch business plans, board presentations, and investor materials are paradigmatic business records created in the ordinary course of business — not in anticipation of litigation. Companies routinely prepare market analyses, competitive assessments, financial projections, and board and investor presentations as part of their normal business operations. The fact that such documents may reference a competitor's intellectual property does not convert them into work product.
Many of the challenged documents predate the filing of this lawsuit on March 28, 2025. According to the privilege log, documents in the challenged set were created during Helios's product development and commercialization process beginning as early as 2020 — years before GenomeDx asserted any claim against Helios. Documents created in the ordinary course of product development and business planning cannot be characterized as having been prepared "in anticipation of litigation" simply because litigation later ensued.
Even if some of the challenged documents were created after GenomeDx raised intellectual property concerns with Helios, the predominant-purpose test requires that the document was created primarily for litigation purposes — not merely that it touches on a topic that later became or was then the subject of litigation. Richey, 632 F.3d at 567–68. Business plans, board presentations, and investor updates serve business purposes irrespective of whether litigation is pending or anticipated. Their creation is driven by business needs — fundraising, corporate governance, strategic planning — not by litigation strategy.
Furthermore, even if any of the challenged documents were found to constitute work product, GenomeDx can demonstrate substantial need for the documents and an inability to obtain their substantial equivalent without undue hardship, thereby entitling GenomeDx to production under Rule 26(b)(3)(A)(ii). The documents at issue reflect Helios's own internal assessments of GenomeDx's patent portfolio, Helios's competitive positioning against the Decipher® test, and Helios's awareness of potential infringement risk. This evidence is uniquely within Helios's possession and cannot be reconstructed from other sources. No amount of depositions or third-party discovery can substitute for Helios's own contemporaneous assessments of the competitive landscape and the intellectual property risks associated with launching ProstaSignal™.
V. RELEVANCE OF THE WITHHELD DOCUMENTS
The thirty-four documents are directly relevant to multiple critical issues in this case, and their production is proportional to the needs of this litigation.
Willful Infringement. Helios's pre-launch awareness of and response to GenomeDx's patent portfolio is highly relevant to GenomeDx's claim for enhanced damages under 35 U.S.C. § 284. To establish willful infringement, GenomeDx must show that Helios acted despite an objectively high likelihood that its actions constituted infringement of a valid patent, and that this risk was either known or so obvious that it should have been known to the accused infringer. Halo Elecs., Inc. v. Pulse Elecs., Inc., 579 U.S. 93, 103 (2016). Board presentations, investor materials, and internal business analyses discussing GenomeDx's patents, the Decipher® test, and the overlap between the ProstaSignal™ gene panel and GenomeDx's patented technology go directly to Helios's knowledge and state of mind. These documents will show what Helios knew about GenomeDx's patent rights, when it knew it, and what it did in response — the precise inquiries that are relevant to willfulness.
Damages. The withheld documents are also critical to GenomeDx's damages theories. GenomeDx intends to pursue both lost-profits and reasonable-royalty damages. GenomeDx's preliminary lost-profits analysis estimates damages of approximately $18,490,320, based on approximately 6,100 Decipher® tests diverted to ProstaSignal™ since its October 2024 launch, an average reimbursement rate of $4,210 per test, and a 72% incremental profit margin. GenomeDx's reasonable-royalty analysis proposes an 18% royalty rate on $32,088,000 in ProstaSignal™ revenue from October 2024 through March 2025.
Pre-launch business plans, financial projections, and competitive assessments are directly relevant to both damages theories. Board and investor materials discussing expected ProstaSignal™ revenues, pricing (including Helios's average reimbursement rate of $3,820 per test), market share targets, and projected profitability are the type of documents routinely relied upon in Georgia-Pacific hypothetical-negotiation analyses. See Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116, 1120 (S.D.N.Y. 1970) (identifying fifteen factors for reasonable royalty determination, many of which relate to the parties' expectations, the advantages of the patented technology, and the commercial relationship between the products). Helios's own assessments of its competitive positioning against Decipher® and its financial expectations for ProstaSignal™ bear on multiple Georgia-Pacific factors, including Factor 8 (established profitability), Factor 9 (utility and advantages of the patent property), Factor 11 (extent to which the infringer has made use of the invention), and Factor 13 (the portion of profit customarily allowed in the particular business).
Infringement Contentions. Documents discussing the design of the ProstaSignal™ 24-gene panel — and specifically the overlap of nineteen genes with GenomeDx's patented gene set — are relevant to GenomeDx's infringement theories under the asserted claims of the '271, '893, and '647 Patents. Internal analyses comparing ProstaSignal™ to Decipher® and assessing how ProstaSignal™'s methodology relates to GenomeDx's patented methods will inform both literal infringement and doctrine-of-equivalents arguments.
Upcoming Depositions. Fact discovery closes on March 6, 2026 — only thirty-five days from the date of this motion. GenomeDx has noticed Rule 30(b)(6) depositions of Helios on fourteen topics, as well as individual depositions of Dr. Nathan Ashford, Dr. Elaine Kossack, Derek Mallinson, Sara Whitmore (Helios's in-house counsel), and Dr. Anton Rykov (Helios's lead bioinformatics scientist). The withheld documents are essential preparation materials for these depositions. GenomeDx cannot effectively examine these witnesses about Helios's competitive strategy, knowledge of GenomeDx's patents, and commercial decision-making without access to the very documents that memorialize those strategies and decisions. Delay in production will prejudice GenomeDx's ability to conduct meaningful discovery within the time remaining.
VI. REQUEST FOR IN CAMERA REVIEW
If the Court is unable to resolve the privilege disputes based on the privilege log entries and the arguments presented in this memorandum and supporting papers, GenomeDx respectfully requests that the Court conduct an in camera review of the thirty-four challenged documents to determine whether the privilege assertions are properly maintained. See United States v. Zolin, 491 U.S. 554, 572 (1989) (approving in camera review of allegedly privileged documents); In re Grand Jury Investigation, 974 F.2d at 1074–75 (Ninth Circuit endorsing in camera review where party makes threshold showing of waiver or inapplicability of privilege).
GenomeDx submits that the privilege log entries on their face are sufficient to demonstrate waiver and the business-records nature of the documents, making in camera review unnecessary in this instance. The log entries identify non-attorney third-party recipients, describe documents in business terms, and reveal the broad dissemination patterns that are inconsistent with the maintenance of attorney-client confidentiality. However, in the alternative, should the Court desire to examine the documents themselves before ruling, in camera review would confirm that production is warranted and provide the Court with the fullest possible record for its determination.
VII. REQUEST FOR RELIEF
Based on the foregoing, GenomeDx respectfully requests that this Court enter an order:
1. Compelling production. Ordering Helios to produce all thirty-four (34) withheld documents identified in Exhibit E to the Declaration of Peter Vassiliev within ten (10) business days of the Court's order;
2. Subject to the Protective Order. Requiring that documents be produced subject to the Stipulated Protective Order entered by this Court on December 18, 2025, with appropriate confidentiality designations as Helios deems necessary;
3. Redaction alternative. In the alternative, if the Court finds that narrowly defined portions of certain documents contain genuinely privileged attorney-client communications, ordering production of those documents with targeted redactions limited to the genuinely privileged content, so that the remainder of each document — including all business, commercial, and factual content — is produced;
4. Expenses and fees. Awarding GenomeDx its reasonable expenses, including attorneys' fees, incurred in bringing this motion, pursuant to Federal Rule of Civil Procedure 37(a)(5)(A), which provides that the court "must" award reasonable expenses incurred in making a motion to compel when the motion is granted, unless the opposing party's nondisclosure was substantially justified or other circumstances make an award of expenses unjust; and
5. Further relief. Granting such other and further relief as this Court deems just and proper.
VIII. CONCLUSION
Helios has improperly withheld thirty-four documents from production by asserting attorney-client privilege and work-product protection over materials that were shared with third-party investors — Corinth Ventures Fund III, LP and Aether Life Sciences Partners — disseminated broadly among non-lawyer business personnel across multiple departments, shared with external non-attorney consultants, and created primarily for business purposes rather than to seek or convey legal advice. The privilege log entries themselves reveal the facts that defeat Helios's privilege claims: non-attorney third-party recipients, business-oriented document descriptions, and broad distribution patterns fundamentally inconsistent with the maintenance of confidentiality.
With fact discovery closing on March 6, 2026, the need for these documents is urgent and acute. GenomeDx cannot properly prepare for the depositions of key Helios witnesses — including the CEO, CSO, and VP of Commercial Operations who authored or received many of the withheld documents — or develop its infringement and damages theories without access to Helios's own internal assessments of the competitive landscape, GenomeDx's patent portfolio, and the commercial strategy behind the ProstaSignal™ launch.
GenomeDx respectfully requests that this Court grant this motion and order production of the thirty-four withheld documents.
Dated: January 30, 2026
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom (CA Bar No. 247831) Peter Vassiliev (CA Bar No. 312604)
CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5400 Facsimile: (415) 773-5401
Email: cbloom@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Attorneys for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF COMPLIANCE WITH CIVIL LOCAL RULE 37-1
I, Peter Vassiliev, hereby certify that, before filing the foregoing motion, counsel for Plaintiff Genome Dx Therapeutics Inc. met and conferred with counsel for Defendant Helios Precision Diagnostics, Inc. in a good-faith effort to resolve the discovery dispute without court intervention, as required by Civil Local Rule 37-1(a) and Federal Rule of Civil Procedure 37(a)(1).
Specifically:
1. On January 15, 2026, I sent a detailed meet-and-confer letter to Marcus Pellegrini and Danielle Forrest of Ridgecrest Durneval LLP identifying the thirty-four (34) challenged privilege log entries by Bates range and privilege log entry number and requesting production or, in the alternative, additional information to support the privilege claims. (Declaration of Peter Vassiliev, Ex. A.)
2. On January 21, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded in writing, maintaining all privilege assertions and refusing to produce the thirty-four documents or provide any additional detail. (Declaration of Peter Vassiliev, Ex. B.)
3. On January 24, 2026, counsel for the parties conducted a telephonic meet-and-confer conference. Participating on behalf of GenomeDx were Peter Vassiliev and Wendy Schultz of Calderwood & Harkness LLP. Participating on behalf of Helios were Danielle Forrest and Owen Chu of Ridgecrest Durneval LLP. During the call, the parties discussed each category of challenged documents and explored potential compromises, including partial production and in camera review. Helios refused to modify its position. (Declaration of Peter Vassiliev, Ex. C.)
The parties were unable to resolve the dispute, and the filing of this motion became necessary.
By: ________
Peter Vassiliev (CA Bar No. 312604) CALDERWOOD & HARKNESS LLP Attorneys for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF SERVICE
I hereby certify that on January 30, 2026, I electronically filed the foregoing Plaintiff Genome Dx Therapeutics Inc.'s Motion to Compel Defendant Helios Precision Diagnostics, Inc. to Produce Documents Responsive to Requests for Production Nos. 22, 23, and 31, together with the accompanying Declaration of Peter Vassiliev and Exhibits A through E thereto, with the Clerk of the Court using the CM/ECF system, which will send electronic notification of such filing to all counsel of record, including:
Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 854-2000
Email: mpellegrini@ridgecrestkirkpatrick.com
Email: dforrest@ridgecrestkirkpatrick.com
Email: ochu@ridgecrestkirkpatrick.com
Attorneys for Defendant Helios Precision Diagnostics, Inc.
By: ________
Peter Vassiliev (CA Bar No. 312604) CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Attorneys for Plaintiff Genome Dx Therapeutics Inc.
GENOME DX THERAPEUTICS INC., | Case No. 3:25-cv-01847-JWL
Plaintiff, | Hon. Jessica W. Langston
v. | Referred to: Hon. David R. Cabrera,
U.S. Magistrate Judge
HELIOS PRECISION DIAGNOSTICS, INC.,
Defendant.

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

NOTICE OF MOTION

MEMORANDUM OF POINTS AND AUTHORITIES

I. INTRODUCTION

II. FACTUAL BACKGROUND

III. LEGAL STANDARD

IV. ARGUMENT

V. RELEVANCE OF THE WITHHELD DOCUMENTS

VI. REQUEST FOR IN CAMERA REVIEW

VII. REQUEST FOR RELIEF

VIII. CONCLUSION

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF COMPLIANCE WITH CIVIL LOCAL RULE 37-1

CERTIFICATE OF SERVICE

HELIOS PRECISION DIAGNOSTICS, INC.,

Record

Parties

Dates

Amounts