Hmi Medical Innovations LLC v. Black Diamond Therap Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: HMI Medical Innovations, LLC (Michigan)
  • Defendant: Black Diamond Therapeutics, Inc. (Delaware)
  • Plaintiff's Counsel: Young Conaway Stargatt & Taylor, LLP
• Case Identification: 1:26-cv-00424, D. Del., 04/14/2026
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Black Diamond Therapeutics, Inc., is a Delaware corporation.
• Core Dispute: Plaintiff alleges that Defendant's research and development of cancer therapies infringes six patents related to cell-based drug-discovery technologies for identifying and optimizing modulators of drug-resistant mutant proteins.
• Technical Context: The technology relates to cell-based assay systems used in pharmaceutical research, specifically for discovering drugs that can overcome resistance caused by mutations in protein targets, a significant challenge in modern oncology.
• Key Procedural History: The complaint alleges that Plaintiff provided Defendant with pre-suit notice of infringement via a letter dated on or about April 22, 2021, which identified at least U.S. Patent Nos. 8,367,038 and 8,431,110. This event is significant as it may form the basis for the Plaintiff's willful infringement allegations.

Case Timeline

Date	Event
2004-05-23	Earliest Priority Date ('038', '326', '610' Patents)
2005-11-23	Earliest Priority Date ('110', '137', '619' Patents)
2013-02-05	U.S. Patent No. 8,367,038 Issued
2013-04-30	U.S. Patent No. 8,431,110 Issued
2017-02-28	U.S. Patent No. 9,579,326 Issued
2017-05-09	U.S. Patent No. 9,645,137 Issued
2017-10-24	U.S. Patent No. 9,795,610 Issued
2018-07-10	U.S. Patent No. 10,018,619 Issued
2021-04-22	Plaintiff HMI sends letter to Defendant BDT alleging infringement
2022-01-01	Lucas et al. presentation at ENA 2022 (approximate)
2023-01-01	Han et al. presentation at AACR Annual Meeting 2023 (approximate)
2026-04-14	Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,431,110 (the "'110 Patent") - "Compounds and method of identifying, synthesizing, optimizing and profiling protein modulators," Issued April 30, 2013

The Invention Explained

• Problem Addressed: The patent describes the drug discovery and development process as lengthy, costly, and inefficient Compl. ¶2 '110 Patent, col. 1:11-16 It highlights the particular challenge of acquired drug resistance, where a protein target mutates during therapy, rendering a previously effective drug useless '110 Patent, col. 2:34-45
• The Patented Solution: The invention claims a method for a "cellular response-based drug discovery and creation system" '110 Patent, col. 4:50-51 This system uses a measurable cellular characteristic, termed a "phenoresponse," to assess a compound's ability to modulate a target protein within a living cell '110 Patent, abstract This approach is designed to be more predictive of a drug's ultimate clinical efficacy than traditional cell-free assays and is particularly useful for identifying compounds active against drug-resistant mutant proteins '110 Patent, col. 3:32-45
• Technical Importance: This technology represented a shift toward more physiologically relevant, cell-based screening methods, aiming to accelerate the development of drugs for difficult targets like those that develop resistance in cancer therapy.

Key Claims at a Glance

• The complaint asserts infringement of at least one claim of the '110 patent but does not specify which claims are asserted Compl. ¶44 It reserves the right to identify specific claims as the case proceeds.

U.S. Patent No. 9,645,137 (the "'137 Patent") - "Compounds and method of identifying, synthesizing, optimizing and profiling protein modulators," Issued May 9, 2017

The Invention Explained

• Problem Addressed: The '137 Patent, which is part of the same family as the '110 Patent, addresses the same core problem: the high cost, inefficiency, and low success rate of traditional pharmaceutical discovery methods, especially when targeting proteins that have developed drug-resistance mutations '137 Patent, col. 1:11-16 '137 Patent, col. 2:30-41
• The Patented Solution: The patented solution is a cell-based assay system that simplifies the drug discovery process. It uses a "phenoresponse" in engineered cells to identify, optimize, and profile compounds that can activate or inhibit target proteins, including their drug-resistant variants '137 Patent, abstract '137 Patent, col. 4:52-56 The goal is to provide a more reliable and efficient path to creating new drugs.
• Technical Importance: The method aims to convert drug "discovery" into a more predictable process of drug "creation" by providing tools to design compounds for specific protein targets, including those that have become clinically challenging due to mutation '137 Patent, col. 2:20-25

Key Claims at a Glance

• The complaint alleges infringement of at least one claim of the '137 patent but does not specify which claims are asserted Compl. ¶52

U.S. Patent No. 10,018,619 (the "'619 Patent") - "Compounds and method of identifying, synthesizing, optimizing and profiling protein modulators," Issued July 10, 2018

• Technology Synopsis: The '619 patent addresses the inefficiency of drug discovery and the specific problem of "theramuteins"-drug-resistant protein variants that arise during treatment '619 Patent, col. 2:25-33 It discloses a cellular response-based assay system that uses a "phenoresponse" to identify and optimize compounds that modulate these difficult protein targets, thereby accelerating the development of effective drugs '619 Patent, abstract
• Asserted Claims: At least one claim Compl. ¶60
• Accused Features: Defendant's use of research tools and methods for the identification and development of therapies for oncogenic mutations, as described in its publications (Exhibits G-M) Compl. ¶¶34, 39, 60

U.S. Patent No. 9,795,610 (the "'610 Patent") - "Theramutein Modulators," Issued October 24, 2017

• Technology Synopsis: This patent focuses on "theramutein modulators," which are agents designed to inhibit or activate drug-resistant variant forms of proteins '610 Patent, abstract It describes methods for identifying such variants and the agents that modulate them, providing research tools to overcome drug resistance that arises during the course of treating diseases like cancer '610 Patent, col. 2:28-40
• Asserted Claims: At least one claim Compl. ¶68
• Accused Features: Defendant's use of research tools and methods for developing therapies against oncogenic mutations, as described in its publications (Exhibits G, I, and M) Compl. ¶¶34, 39, 68

U.S. Patent No. 9,579,326 (the "'326 Patent") - "Theramutein Modulators," Issued February 28, 2017

• Technology Synopsis: The '326 patent describes methods and novel agents for modulating "theramuteins," which are variant forms of endogenous proteins that can cause drug resistance '326 Patent, abstract The invention provides research tools, including inhibitors or activators of these variants, and methods for their identification, aimed at developing therapies for difficult-to-treat diseases '326 Patent, col. 2:28-40
• Asserted Claims: At least one claim Compl. ¶76
• Accused Features: Defendant's research tools and methods for developing therapies against oncogenic mutations, as described in its publications (Exhibits G, I, and M) Compl. ¶¶34, 39, 76

U.S. Patent No. 8,367,038 (the "'038 Patent") - "Theramutein Modulators," Issued February 5, 2013

• Technology Synopsis: This patent discloses agents that act as inhibitors or activators of "theramuteins"-variant forms of proteins that have mutated and become resistant to a therapeutic agent '038 Patent, abstract '038 Patent, col. 28:57-63 The invention provides methods and research tools for identifying and targeting these drug-resistant proteins, which pose a significant challenge in chronic disease treatment.
• Asserted Claims: At least one claim Compl. ¶84
• Accused Features: Defendant's research tools and methods for developing therapies against oncogenic mutations, as described in its publications (Exhibits G, I, and M) Compl. ¶¶34, 39, 84

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant BDT's internal drug discovery methods and research tools used in the "identification, research, and development of therapies that address families of oncogenic mutations" Compl. ¶34 Compl. ¶42 Specific development programs mentioned include those for silevertinib (BDTX-1535), BDTX-4933, and BDTX-4876 Compl. ¶36

Functionality and Market Context

The complaint alleges that BDT, a clinical-stage oncology company, uses the patented technologies to develop its pipeline of cancer therapies Compl. ¶33 Compl. ¶34 For example, BDT is developing silevertinib, an EGFR inhibitor for non-small cell lung cancer and glioblastoma, which is advancing towards FDA approval Compl. ¶35 The complaint contends that BDT's own publications and patent applications (Exhibits G-M) describe its use of the allegedly infringing methods Compl. ¶39 The core of the infringement allegation is that BDT's R&D process itself embodies the patented methods for drug discovery.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that BDT infringes the asserted patents by using the patented drug-discovery technologies as research tools to develop its own therapies Compl. ¶34 Compl. ¶42 The complaint states that infringement is evidenced by claim charts provided in Exhibits N-T Compl. ¶40 However, these exhibits were not filed with the complaint, and their contents are not described. Therefore, a detailed element-by-element analysis is not possible.

The narrative theory of infringement is that BDT's publicly documented research and development work-as detailed in BDT's own publications and patent filings (Exhibits G-M)-practices the patented methods Compl. ¶39 For example, the infringement count for the '110 patent specifically references BDT's use of technologies described in Exhibit M Compl. ¶44, and the count for the '137 patent references Exhibits H and M Compl. ¶52 The dispute will likely focus on a technical comparison between the R&D methods described in BDT's publications and the steps recited in the asserted patent claims.

• Identified Points of Contention:
  • Factual Questions: A central issue will be whether the technical steps of BDT's drug discovery process, as can be inferred from its public disclosures, actually align with the specific steps required by the asserted patent claims. The court's determination will depend on the evidence presented to show what BDT's methods entail at a granular level.
  • Scope Questions: The case may raise questions about the scope of the patented methods. For example, do BDT's specific cell-based screening assays for its EGFR or RAF inhibitors perform the same functions and produce the same cellular "phenoresponse" as required by the claims of the '110 and '137 patents?

V. Key Claim Terms for Construction

The complaint does not identify specific claims, making a definitive analysis of claim terms difficult. However, based on the patents' disclosures, the following terms are likely to be central to the dispute.

• The Term: "theramutein" (or "variant forms of endogenous proteins")

• Context and Importance: This term is at the heart of several asserted patents and defines the specific type of drug-resistant protein the patented methods are designed to target. Practitioners may focus on this term because the infringement case depends on whether the mutant proteins targeted by BDT (e.g., EGFR mutants) fall within the patents' definition of a "theramutein."

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The '038 patent defines a theramutein as a protein "which has arisen by mutation from said prototheramutein" and has become "resistant to a known therapeutic agent" '038 Patent, col. 28:57-63 This could be argued to encompass any protein that has mutated to become drug-resistant.
  • Evidence for a Narrower Interpretation: A party could argue the term should be limited by the specific examples in the specification, such as the p210Bcr-Abl-T3151 mutant discussed extensively '038 Patent, col. 29:3-9 This might support an interpretation that requires a specific type or context of drug resistance.

• The Term: "phenoresponse"

• Context and Importance: This term defines the observable cellular characteristic used as the readout in the patented assay methods. Practitioners may focus on this term because infringement will turn on whether BDT's cell-based assays utilize a "phenoresponse" as claimed.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The '110 patent defines it as a "phenotypic characteristic...which is linked to the presence and functional activity of the particular protein-of-interest...in the cell" '110 Patent, col. 29:10-14 This broad language could be argued to cover a wide range of cellular readouts.
  • Evidence for a Narrower Interpretation: The definition also requires the characteristic to be "responsive to inhibitors or activators of a given protein" '110 Patent, col. 29:30-33 A defendant might argue this requires a specific, pre-validated linkage between the cellular characteristic and the protein's activity, potentially narrowing the scope to exclude more general cellular health or toxicity assays.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that BDT actively and knowingly induced infringement Compl. ¶45 Compl. ¶53 The factual basis cited is BDT's activities as described in its own publications (Exhibits G-M), which allegedly describe the use of the infringing technology.
• Willful Infringement: The complaint alleges willful infringement for all asserted patents (Compl. Prayer for Relief, e.g., B, F, J). The basis for this allegation is pre-suit knowledge, stemming from a letter HMI allegedly sent to BDT on or about April 22, 2021, which identified at least the '038 and '110 patents as being infringed Compl. ¶41

VII. Analyst's Conclusion: Key Questions for the Case

• A central issue will be one of operational correspondence: Does the evidence contained in BDT's own scientific publications and patent filings (Exhibits G-M) demonstrate that its internal drug discovery and development processes actually perform the specific technical steps of the patented cell-based assay methods, or is there a fundamental mismatch in the scientific operations conducted?
• The case will also turn on a question of definitional scope: Can the patents' key terms, such as "theramutein" (a drug-resistant mutant protein) and "phenoresponse" (a linked cellular characteristic), be construed to cover the specific mutant kinases (e.g., EGFR mutants) and the particular assay endpoints used by BDT in its oncology drug development pipeline?
• Finally, a key question for damages will be one of willfulness: Did BDT's continued use of the accused research methods after receiving HMI's notice letter in April 2021 constitute objectively reckless conduct, which could subject BDT to enhanced damages if infringement is found?