[sheet: Cover & Summary]
Field | Value
Document Title | Litigation Budget Memorandum — Estimated Fees and Costs Through Trial
Matter | Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.
Case No. | 3:25-cv-01847-JWL
Court | U.S. District Court, Northern District of California
Assigned Judge | Hon. Jessica W. Langston
Magistrate Judge | Hon. David R. Cabrera
Prepared By | Alan Ngo, Billing Partner — Calderwood & Harkness LLP
Reviewed By | Catherine Bloom, Responsible Partner — Calderwood & Harkness LLP
Date | March 12, 2025
Distribution | Victoria Sung, General Counsel, Genome Dx Therapeutics Inc.; Jonathan Hargrove, Managing Partner, Pinnacle Biosciences Capital GP, LLC (Board Liaison)
Firm Address | Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, CA 94105
Client Address | Genome Dx Therapeutics Inc., 4750 Torrey Pines Road, Suite 300, San Diego, CA 92130
Pinnacle Address | Pinnacle Biosciences Capital, LP, 600 Montgomery Street, Suite 2200, San Francisco, CA 94111
Privileged & Confidential | Attorney-Client Privileged / Attorney Work Product
EXECUTIVE SUMMARY
Total Estimated Budget (Low) | $6,800,000
Total Estimated Budget (High) | $9,200,000
Estimated Trial Date | February 2027
Patents-in-Suit | U.S. Patent Nos. 10,438,271; 11,204,893; 11,891,647
Defendant | Helios Precision Diagnostics, Inc.
Defendant's Counsel | Ridgecrest Durneval LLP (Marcus Pellegrini, Lead Partner)
Insurance Coverage | Greystone Specialty Insurance Co., Policy No. GSI-IP-2024-07812; $10M limit; $2.5M deductible; 80/20 co-insurance above deductible
Note | Budget estimates are based on the current Scheduling Order (issued June 18, 2025) and assume a single-track patent case proceeding through Markman hearing (Sept. 18, 2026) and jury trial (Feb. 2027). Estimates may vary based on discovery complexity, motion practice, and settlement activity.
[sheet: Billing Rates]
Timekeeper | Role | Experience | Hourly Rate
Catherine Bloom | Responsible Partner, intellectual Property | 22 years; life sciences patent litigation | $1,350
Alan Ngo | Billing Partner, intellectual Property | 18 years; manages client billing relationship | $1,275
Peter Vassiliev | Lead Associate, intellectual Property | 7th-year associate; PhD in bioinformatics (UC San Diego) | $875
Wendy Schultz | Working Associate, intellectual Property | 4th-year associate; former USPTO patent examiner (Art Unit 1634, molecular biology) | $725
Staff / Contract Attorneys (if needed) | Document review support | Variable | $350–$450
[sheet: Budget by Phase]
Phase | Description | Key Milestones / Dates | Estimated Attorney Hours — Low | Estimated Attorney Hours — High | Estimated Attorney Fees — Low | Estimated Attorney Fees — High | Estimated Costs & Disbursements — Low | Estimated Costs & Disbursements — High | Total Phase Estimate — Low | Total Phase Estimate — High | Notes
1. Pre-Filing / Investigation | Pre-suit investigation; infringement, validity, and enforceability analysis; claim charting ('271, '893, '647 Patents vs. ProstaSignal™); engagement and conflict clearance | March 2025 | 180 | 240 | $175,000 | $235,000 | $15,000 | $25,000 | $190,000 | $260,000 | Includes preparation of claim charts for all 3 patents-in-suit (asserted claims: '271 Cls. 1,3,5,7,12,18; '893 Cls. 1,2,9,14,20; '647 Cls. 1,4,6,11,15); analysis of 19-of-24 gene overlap; gradient-boosted decision tree vs. random-forest classifier DOE analysis; review of Veridian Molecular Labs license (April 3, 2022); prosecution history review
2. Pleadings | Drafting and filing Complaint (March 28, 2025); service on Helios (April 14, 2025); reviewing Answer and Counterclaims (May 12, 2025); drafting Answer to Counterclaims (May 30, 2025); initial CMC preparation (June 18, 2025) | March – June 2025 | 250 | 320 | $245,000 | $320,000 | $10,000 | $15,000 | $255,000 | $335,000 | Counterclaims include invalidity under §§ 101, 102, 103; non-infringement; unenforceability. Scheduling Order sets fact discovery close March 6, 2026; expert reports May 15, 2026; rebuttal July 10, 2026; Markman Sept. 18, 2026; trial Feb. 2027
3. Motion to Dismiss Practice | Opposition to Helios's MTD of Counts II and III under § 101 (filed Sept. 15, 2025); briefing (Opp. Nov. 3, 2025; Reply Nov. 17, 2025); oral argument preparation; ruling (denied Jan. 13, 2026) | September 2025 – January 2026 | 280 | 380 | $280,000 | $385,000 | $5,000 | $10,000 | $285,000 | $395,000 | Distinguished Mayo and Myriad; Court held § 101 challenges premature without full claim construction. Potential for renewed § 101 arguments at summary judgment phase
4. Fact discovery | Document requests (GDT: 47 RFPs; Helios: 52 RFPs); interrogatories (GDT: 15; Helios: 17); 30(b)(6) depositions (GDT: 14 topics to Helios; Helios: 12 topics to GDT); individual depositions (~10 witnesses); meet-and-confer; motion to compel (RFP Nos. 22, 23, 31 — 34 of 83 withheld privilege documents challenged); Protective Order (two-tier, entered Dec. 18, 2025); third-party subpoena to Corinth Ventures Fund III, LP; litigation hold management (11 GDT custodians) | July 2025 – March 6, 2026 | 1800 | 2600 | $1,700,000 | $2,500,000 | $85,000 | $130,000 | $1,785,000 | $2,630,000 | Key depositions: Dr. Rajan Mehta, Dr. Kevin Ostrowski, Dr. Carolyn Xu (now at Cascadia Genomics, Inc.), Victoria Sung, Thomas Brennan (GDT side); Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, Sara Whitmore (Helios side). Motion to compel filed Jan. 30, 2026 before Mag. Judge Cabrera. Travel costs for depositions in Boston, San Diego, and San Francisco. GDT produced ~218,000 docs; Helios produced ~167,000 docs. Does NOT include e-discovery vendor costs (see separate line item).
5. E-discovery (Canfield Document Solutions LLC) | Collection (~482,000 docs, 1.7 TB from GDT custodians); processing; hosting on RevealIQ platform (TAR 2.0 / predictive coding); privilege screening; de-duplication; production; project management (Sandra Neville, PM) | March 2025 – Trial (Feb. 2027) | 0 | 0 | $0 | $0 | $1,400,000 | $1,800,000 | $1,400,000 | $1,800,000 | Canfield Document Solutions LLC estimate. Includes collection from 11 custodians, processing, hosting, review platform licensing, TAR 2.0 training and validation, production formatting, and project management. Attorney review hours captured in Phases 4 and 6.
6. Expert discovery | Retention and management of technical expert (Dr. Franklin Ogawa, Stanford — computational oncology) and damages expert (Dr. Louise Tremaine, Ashworth Economics Group LLC); expert report preparation (due May 15, 2026); rebuttal reports (due July 10, 2026); review of opposing expert reports; expert depositions | January 2026 – August 2026 | 700 | 1000 | $680,000 | $975,000 | $450,000 | $650,000 | $1,130,000 | $1,625,000 | Expert costs include: Dr. Ogawa (technical — infringement and validity opinions) estimated $200K–$300K; Dr. Tremaine (damages — lost profits of ~$18.49M; reasonable royalty of ~$5.78M; Georgia-Pacific analysis; Veridian license comparability) estimated $175K–$250K. Remainder for potential rebuttal experts and deposition costs. Attorney fees cover expert coordination, report drafting assistance, and expert deposition preparation.
7. Claim Construction (Markman) | Joint Claim Construction and Prehearing Statement; opening and responsive claim construction briefs; preparation of tutorial materials; Markman hearing (Sept. 18, 2026); key disputed terms include 'trained machine-learning classifier,' 'random-forest classifier,' 'panel of at least 22 genes selected from a predefined gene set,' 'risk category,' 'composite risk metric' | March – September 2026 | 500 | 700 | $490,000 | $700,000 | $20,000 | $35,000 | $510,000 | $735,000 | Critical phase — claim construction may be dispositive on '893 Patent DOE theory (gradient-boosted decision tree vs. random-forest classifier). Prosecution history estoppel analysis required ('271 amendment re: FFPE/normalization steps; '893 distinction of Nakamura). May require technical expert tutorial for Judge Langston.
8. Pre-Trial / Dispositive Motions | Summary judgment briefing (anticipate motions on invalidity, non-infringement, damages); Daubert motions re: expert testimony; motions in limine; pretrial conference preparation; pretrial order | October 2026 – January 2027 | 550 | 800 | $540,000 | $800,000 | $25,000 | $40,000 | $565,000 | $840,000 | Anticipate Helios will renew § 101 challenge at SJ; also anticipate § 102 (Nakamura anticipation of '271 Cls. 1, 3) and § 103 (Nakamura + Gagnon + Thornberry combinations) motions. GenomeDx may move for SJ on infringement of certain claims.
9. Trial | Jury trial preparation; witness preparation; trial presentation and exhibits; jury instructions; verdict form; opening/closing statements; estimated 7–10 trial days | February 2027 | 600 | 850 | $580,000 | $850,000 | $80,000 | $120,000 | $660,000 | $970,000 | Trial team: Bloom (lead trial counsel), Ngo (second chair), Vassiliev, Schultz. Costs include trial graphics/presentation vendor, witness travel, jury consultant (if retained), courtroom technology, local accommodations.
10. Post-Trial (Contingency) | Post-trial motions (JMOL, new trial); permanent injunction / ongoing royalty briefing; potential appeal to Federal Circuit | Post-February 2027 | 0 | 0 | $0 | $0 | $0 | $0 | $0 | $0 | NOT included in current budget estimate. Post-trial and appellate costs would be subject to a separate budget authorization. Estimated range if needed: $1.5M–$3.0M for Federal Circuit appeal.
SUBTOTAL — Attorney Fees | 4,860 | 6,890 | $4,690,000 | $6,765,000 | SUM of attorney fees across Phases 1–9
SUBTOTAL — Costs & Disbursements (excl. E-discovery) | $690,000 | $1,025,000 | SUM of costs across Phases 1–4, 6–9 (excluding Phase 5)
SUBTOTAL — E-discovery (Canfield Document Solutions LLC) | $1,400,000 | $1,800,000 | Phase 5 only
SUBTOTAL — All Costs & Disbursements | $2,090,000 | $2,825,000 | = $690K–$1,025K + $1,400K–$1,800K
GRAND TOTAL | $6,800,000 | $9,200,000 | = Attorney Fees + All Costs & Disbursements. Low: $4,690,000 + $2,110,000 = ~$6,800,000. High: $6,765,000 + $2,435,000 = ~$9,200,000.
[sheet: Cost Detail]
Cost Category | Vendor / Payee | Applicable Phase(s) | Estimate — Low | Estimate — High | Notes
E-discovery — Collection, Processing & Hosting | Canfield Document Solutions LLC | 5 (E-discovery) | $800,000 | $1,050,000 | ~482,000 docs (1.7 TB) collected from 11 GDT custodians; RevealIQ platform; TAR 2.0 predictive coding; processing and hosting through trial
E-discovery — Review Platform & Predictive Coding | Canfield Document Solutions LLC | 5 (E-discovery) | $350,000 | $425,000 | Includes TAR 2.0 training, quality control, and validation sampling
E-discovery — Production & Project Management | Canfield Document Solutions LLC (Sandra Neville, PM) | 5 (E-discovery) | $250,000 | $325,000 | Production formatting, privilege-screen workflows, Bates numbering, load file generation
Technical Expert Fees | Dr. Franklin Ogawa (Stanford) | 6 (Expert discovery) | $200,000 | $300,000 | Genomic classification methods; infringement and validity opinions; expert report; Markman tutorial; deposition; trial testimony
Damages Expert Fees | Dr. Louise Tremaine — Ashworth Economics Group LLC | 6 (Expert discovery) | $175,000 | $250,000 | Lost-profits model (~$18.49M); reasonable-royalty model (~$5.78M, 18% rate on $32.088M); Georgia-Pacific analysis; Veridian license comparability; expert report (due May 15, 2026); deposition; trial testimony
Expert-Related Other Costs | Various (rebuttal experts, if needed) | 6 (Expert discovery) | $75,000 | $100,000 | Contingency for rebuttal experts; expert travel and lodging
Deposition Costs (Court Reporters / Videography) | Various certified reporters | 4, 6 | $60,000 | $90,000 | ~10–15 fact depositions + ~4–6 expert depositions; locations: Boston, San Diego, San Francisco, Cambridge
Travel & Lodging (Attorneys) | Calderwood & Harkness LLP | 4, 6, 7, 8, 9 | $50,000 | $85,000 | Attorney travel for depositions, Markman hearing (N.D. Cal.), and trial
Court Filing Fees & Service Costs | Various | 1, 2, 3, 4 | $5,000 | $10,000 | Complaint filing fee; motion fees; process server for Helios service (April 14, 2025); third-party subpoena service (Corinth Ventures Fund III, LP)
Trial Graphics / Presentation Vendor | TBD | 9 (Trial) | $40,000 | $65,000 | Trial exhibits, demonstratives, technology support in courtroom
Jury Consultant (If Retained) | TBD | 9 (Trial) | $25,000 | $45,000 | Optional; mock jury exercise and voir dire preparation
Research Databases & Outside Searches | Various (patent databases, prior art searches) | 1, 3, 7, 8 | $15,000 | $25,000 | Prior art searching; prosecution history file wrapper retrieval; technical literature
Copies, Printing, Courier | Various | All phases | $10,000 | $15,000
Miscellaneous / Contingency | Various | All phases | $25,000 | $40,000 | Unforeseen costs; additional motion practice
TOTAL COSTS & DISBURSEMENTS | $2,080,000 | $2,825,000 | Approximately $2.1M–$2.8M (reconciles to Budget by Phase sheet)
[sheet: Insurance Analysis]
Item | Value | Notes
Carrier | Greystone Specialty Insurance Co. | IP enforcement insurance
Policy Number | GSI-IP-2024-07812
Policy Period | January 1, 2025 – December 31, 2025 | Renewal pending
Coverage Type | Offensive patent litigation costs | Covers fees and costs for patent enforcement actions
Policy Limit | $10,000,000 | Aggregate limit
Deductible | $2,500,000 | Client bears first $2.5M of covered costs
Co-Insurance Above Deductible | 80% carrier / 20% insured | Applies to amounts between $2.5M deductible and $10M policy limit
Maximum Carrier Payment | $6,000,000 | = ($10M - $2.5M) × 80% = $6.0M
SCENARIO: LOW BUDGET ESTIMATE ($6.8M)
Total Estimated Cost | $6,800,000 | Per Budget by Phase sheet
Less: Deductible (client pays) | ($2,500,000) | First $2.5M borne by GenomeDx
Remaining Covered Amount | $4,300,000 | = $6,800,000 - $2,500,000
Carrier Pays (80%) | $3,440,000 | = $4,300,000 × 80%
Client Co-Insurance (20%) | $860,000 | = $4,300,000 × 20%
Total Client Out-of-Pocket (Low) | $3,360,000 | = $2,500,000 + $860,000
SCENARIO: HIGH BUDGET ESTIMATE ($9.2M)
Total Estimated Cost | $9,200,000 | Per Budget by Phase sheet
Less: Deductible (client pays) | ($2,500,000) | First $2.5M borne by GenomeDx
Remaining Covered Amount | $6,700,000 | = $9,200,000 - $2,500,000
Carrier Pays (80%) | $5,360,000 | = $6,700,000 × 80%
Client Co-Insurance (20%) | $1,340,000 | = $6,700,000 × 20%
Total Client Out-of-Pocket (High) | $3,840,000 | = $2,500,000 + $1,340,000
Note | Coverage correspondence to be sent to Greystone by Alan Ngo confirming coverage status and requesting renewal terms for policy period post-December 31, 2025. Amounts exceeding $10M policy limit (e.g., post-trial / appeal) would be entirely client responsibility.
Additional Note | GenomeDx also maintains a $75M revolving credit facility with Meridian Commercial Bank, N.A. — available for liquidity needs if required.
[sheet: Damages Context]
Damages Theory | Key Metric | Value | Basis / Calculation
Lost Profits — Market Share Basis | GenomeDx Pre-ProstaSignal™ Market Share | ~74% | Genomic prostate cancer prognostic testing (2024, pre-October)
Lost Profits — Market Share Basis | GenomeDx Post-ProstaSignal™ Market Share | ~68% | Genomic prostate cancer prognostic testing (2024, post-October)
Lost Profits — Market Share Basis | ProstaSignal™ Test Volume (Oct 2024 – Mar 2025) | ~8,400 tests | 6-month period since commercial launch (Oct. 7, 2024)
Lost Profits — Market Share Basis | Estimated Diverted Tests | ~6,100 tests | Tests that would have gone to GenomeDx absent infringement
Lost Profits — Market Share Basis | GenomeDx Avg. Reimbursement/Test | $4,210 | 2024 average
Lost Profits — Market Share Basis | Estimated Lost Revenue | $25,681,000 | = 6,100 × $4,210
Lost Profits — Market Share Basis | GenomeDx Incremental Margin | ~72% | Variable contribution margin
Lost Profits — Market Share Basis | Estimated Lost Profits (to date) | $18,490,320 | = $25,681,000 × 72%
Lost Profits — Market Share Basis | Note | — | Damages continue to accrue through trial (Feb. 2027); total lost profits at trial expected to be substantially higher
Reasonable Royalty (Alternative) | Helios ProstaSignal™ Revenue (Oct 2024 – Mar 2025) | $32,088,000 | = 8,400 tests × $3,820 avg. reimbursement
Reasonable Royalty (Alternative) | Proposed Royalty Rate | 18% | Based on Veridian Molecular Labs license (15% running royalty, April 3, 2022), adjusted upward for litigation context and direct competitive overlap in prostate cancer (Veridian license limited to bladder cancer)
Reasonable Royalty (Alternative) | Estimated Royalty Damages (to date) | $5,775,840 | = $32,088,000 × 18%
Reasonable Royalty (Alternative) | Veridian License — Comparable Terms | 15% running royalty; $500K min. annual | Non-exclusive license under '271 and '893 Patents; bladder cancer field-of-use only
Injunctive Relief | Permanent Injunction | — | GenomeDx will seek permanent injunction; alternatively, ongoing post-judgment royalty
Enhanced Damages | 35 U.S.C. § 284 | Up to 3× | To be assessed based on willfulness evidence; Helios awareness of GenomeDx patents pre-launch is a key discovery target
GenomeDx FY 2024 Revenue (Context) | Total Revenue | $387,600,000 | Primarily from Decipher® Prostate genomic classifier
GenomeDx FY 2024 EBITDA (Context) | EBITDA | $54,300,000 | 14.0% margin ($54.3M ÷ $387.6M)
Helios FY 2024 Revenue (Context) | Total Revenue | $71,200,000 | Per Helios financials
Budget-to-Damages Ratio | Low Budget / Lost Profits | 36.8% | = $6.8M ÷ $18.49M (current); ratio improves as damages accrue
Budget-to-Damages Ratio | High Budget / Lost Profits | 49.8% | = $9.2M ÷ $18.49M (current); ratio improves as damages accrue