DCT

4:23-cv-00865

Biomea Fusion Inc v. Selleck Chemicals LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:23-cv-00865, S.D. Tex., 03/08/2023
  • Venue Allegations: Venue is asserted as proper in the Southern District of Texas because Defendant, a Texas LLC, resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s sale of a chemical compound, identified as BMF-219, directly infringes a patent that claims the specific molecular structure of that compound.
  • Technical Context: The technology resides in the field of oncology therapeutics, specifically concerning small molecule compounds designed to irreversibly inhibit protein-protein interactions known to drive certain forms of leukemia.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with pre-suit notice of infringement via a cease-and-desist letter, which may form the basis for a subsequent claim of willful infringement.

Case Timeline

Date Event
2018-12-31 '825 Patent Priority Date
2021-08-10 '825 Patent Issue Date
2023-01-24 Plaintiff sends cease-and-desist letter to Defendant
2023-03-08 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 11,084,825, "Substituted Pyridines as Irreversible Inhibitors of Menin-MLL Interaction," issued August 10, 2021.
  • The Invention Explained:
    • Problem Addressed: The patent addresses the role of the Histone-lysine N-methyltransferase 2 (KMT2A, also known as MLL1) protein family in the development of certain cancers, particularly acute forms of leukemia. The interaction between menin and MLL is a critical driver of these diseases. (’825 Patent, col. 1:15-41).
    • The Patented Solution: The invention discloses novel heterocyclic compounds designed to be irreversible inhibitors of the menin-MLL interaction. Unlike reversible inhibitors, these compounds are designed to form a strong, covalent bond with a specific cysteine residue on the menin protein, thereby providing a potentially more durable and potent method of disrupting the cancer-driving mechanism. (’825 Patent, col. 2:1-6).
    • Technical Importance: Developing irreversible inhibitors for specific protein-protein interactions represented an effort to create more potent and lasting therapies for cancers that are dependent on such pathways. (’825 Patent, col. 1:51-2:6).
  • Key Claims at a Glance:
    • The complaint asserts dependent claim 19.
    • Claim 19 depends from independent claim 1. Independent claim 1 recites:
      • A compound according to a general chemical structure known as Formula (I).
      • The claim provides a Markush group defining the various possible chemical substituents (e.g., Cy, X, Y, Z, R¹, R²) that can be part of Formula (I).
      • The claim also covers a pharmaceutically acceptable salt or stereoisomer of the compound.
    • Asserted dependent claim 19 significantly narrows the scope of claim 1, reciting a single, specific chemical compound by its exact structure. (’825 Patent, col. 301:1-15). The complaint does not explicitly reserve the right to assert other claims.

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is a chemical compound identified as "BMF-219" (Selleck Catalog No. E1210), which Defendant sells and offers for sale online. (Compl. ¶12).
  • Functionality and Market Context:
    • Defendant’s website allegedly describes the BMF-219 compound as a "novel, potent, irreversible menin inhibitor, can be used in the treatment of leukemia." (Compl. ¶13).
    • The complaint alleges that "BMF-219" is an internal identifier used by Plaintiff for its proprietary compound and is not a generally used industry name. (Compl. ¶16). It further alleges that Defendant’s website uses this identifier and provides a hyperlink to Plaintiff’s clinical trial information, suggesting the accused product is being marketed as the same substance developed by Plaintiff. (Compl. ¶¶16-17).

IV. Analysis of Infringement Allegations

The complaint’s infringement theory is straightforward: the chemical structure of the compound sold by Defendant is alleged to be identical to the chemical structure explicitly claimed in the patent. A visual provided in the complaint depicts the chemical structure for "BMF-219" as advertised on Defendant's website (Compl. ¶14), which Plaintiff alleges is identical to the structure depicted in asserted claim 19 and shown in the complaint (Compl. ¶11).

U.S. Patent No. 11,084,825 Infringement Allegations

Claim Element (from Dependent Claim 19) Alleged Infringing Functionality Complaint Citation Patent Citation
The compound according to claim 1, wherein the compound is: [image of specific chemical structure] or a pharmaceutically acceptable salt or stereoisomer thereof. The "BMF-219" compound offered for sale by Defendant, which the complaint alleges possesses the identical chemical structure to that recited in the claim. The complaint provides a screenshot from Defendant's website showing this structure. ¶11, ¶14, ¶15, ¶23 col. 301:1-15
  • Identified Points of Contention:
    • Technical Questions: The central issue is factual: does the substance sold by Selleck under the "BMF-219" name actually possess the exact chemical structure recited in claim 19? The complaint’s evidence is currently based on Defendant's own website depiction. A court would likely require empirical evidence, such as results from Nuclear Magnetic Resonance (NMR) or Mass Spectrometry analysis of the accused product, for a definitive finding of infringement.
    • Scope Questions: While the infringement allegation for claim 19 is direct, a defense could theoretically arise from the limitations of independent claim 1, upon which claim 19 depends. An argument could be made that even if the structures match, some broader definitional element of claim 1 is not met, though this is less common in cases involving specific "picture claims."

V. Key Claim Terms for Construction

In a case centered on a "picture claim" for a specific chemical entity, extensive claim construction disputes are less probable than in other technology areas. The primary dispute is typically over the identity of the accused product. However, the following term may be relevant.

  • The Term: "a pharmaceutically acceptable salt or stereoisomer thereof"
  • Context and Importance: This phrase appears in both claim 1 and claim 19 and defines the scope of protection beyond the specific neutral molecule depicted. Its interpretation is critical because if Defendant sells a salt form or a different stereoisomer of the depicted compound, that product could still be found to infringe. Practitioners may focus on this term to determine the full breadth of infringing articles.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a lengthy and non-exhaustive list of potential "pharmaceutically acceptable salts," including those formed with inorganic acids (e.g., hydrochloric) and organic acids (e.g., acetic), as well as salts formed with bases. (’825 Patent, col. 75:55-76:28). This language may support a broad reading covering many derivatives.
    • Evidence for a Narrower Interpretation: An argument could be made that the scope should be guided by the specific compounds synthesized and tested in the patent's Examples, which primarily describe the synthesis of the base compound (Compound 1) and do not detail the creation of numerous salt forms. (’825 Patent, col. 114:31-121:29).

VI. Other Allegations

  • Indirect Infringement: The complaint includes conclusory allegations of active inducement and contributory infringement under 35 U.S.C. §§ 271(b) and (c). (Compl. ¶23). It alleges that by selling the compound, Selleck induces and contributes to infringement by others, but it does not specify the particular infringing acts of those third parties (e.g., researchers using the compound for its patented purpose).
  • Willful Infringement: The complaint alleges that Defendant's infringement was knowing and willful. (Compl. ¶24). This allegation is based on Defendant's alleged continued sale of the BMF-219 compound after receiving a cease-and-desist letter on January 24, 2023, which provided actual notice of the '825 patent. (Compl. ¶¶19-20).

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

This dispute appears to center on a direct and fact-intensive infringement allegation. The key questions for the court will likely be:

  1. A core issue will be one of factual identity: can the Plaintiff prove through definitive analytical evidence that the chemical compound sold by the Defendant is, in fact, the specific molecular structure recited in claim 19 of the '825 patent?
  2. A second question will concern willful infringement: assuming infringement is found, did the Defendant’s continued sales of the BMF-219 compound after receiving the January 2023 notice letter constitute conduct that was objectively reckless, thereby justifying an award of enhanced damages under 35 U.S.C. § 284?