DCT

1:24-cv-00780

Bristol Myers Squibb Co v. Synthon BV

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00780, D. Del., 07/02/2024
  • Venue Allegations: Venue is alleged to be proper because the defendant is a foreign corporation subject to personal jurisdiction in the district. The complaint further notes that the defendant has previously availed itself of the court’s jurisdiction and has confirmed it will not contest personal jurisdiction or venue in this litigation.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug Zeposia® (ozanimod) constitutes an act of infringement of a patent directed to a specific crystalline form of ozanimod hydrochloride.
  • Technical Context: The technology relates to pharmaceutical formulations, specifically a stable crystalline polymorph of an active pharmaceutical ingredient, which is critical for ensuring consistent manufacturing, shelf-life, and bioavailability of a drug product.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s May 20, 2024 notice letter, which informed Plaintiffs of its ANDA filing. The letter included a Paragraph IV certification asserting that the patent-in-suit is invalid. The complaint alleges that the notice letter does not contest that the proposed generic product would infringe the patent if its claims are found to be valid.

Case Timeline

Date Event
2016-06-14 Earliest Priority Date for '050 Patent
2023-06-20 U.S. Patent No. 11,680,050 Issued
2024-05-20 Date of Defendant's ANDA Notice Letter
2024-05-21 Date Plaintiffs Received Notice Letter (no earlier than)
2024-06-21 Defendant's Counsel Confirmed No Contest to Jurisdiction/Venue
2024-07-02 Complaint Filing Date

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

U.S. Patent No. 11,680,050 - "Crystalline Forms of Ozanimod and Ozanimod Hydrochloride, and Processes for Preparation Thereof"

  • Patent Identification: U.S. Patent No. 11,680,050, “Crystalline Forms of Ozanimod and Ozanimod Hydrochloride, and Processes for Preparation Thereof,” issued June 20, 2023.

The Invention Explained

  • Problem Addressed: The patent's background section explains that for a chemical compound to be a viable drug, it must have stable and predictable physical properties. It notes that while the ozanimod compound was known, the prior art provided no "guidance nor inspiration for finding" specific, stable crystalline forms suitable for drug development, which is necessary to ensure consistent quality, shelf-life, and bioavailability. (’050 Patent, col. 2:45-49).
  • The Patented Solution: The invention discloses novel crystalline forms of ozanimod and its hydrochloride salt. These specific solid-state forms, such as "Form CS1 of ozanimod hydrochloride," are characterized by unique X-ray powder diffraction (XRPD) patterns. The patent asserts these forms possess advantageous properties like low hygroscopicity and good stability, making them better choices for pharmaceutical manufacturing. (’050 Patent, Abstract; col. 2:50-54).
  • Technical Importance: Identifying a stable crystalline polymorph of an active pharmaceutical ingredient is a critical step in drug development that can significantly impact a product's manufacturability and clinical performance. (’050 Patent, col. 2:20-38).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’050 Patent, focusing on independent claim 1. (Compl. ¶¶ 27-28, 31).
  • Independent Claim 1:
    • A crystalline Form CS1 of ozanimod hydrochloride,
    • wherein the X-ray powder diffraction pattern shows characteristic peaks at 2theta values of 26.1°±0.20°, 24.4°±0.20° and 20.1°±0.20° using CuKα radiation.

III. The Accused Instrumentality

Product Identification

  • The "Synthon ANDA Product," which is a proposed generic version of Plaintiffs’ Zeposia® drug product, containing 0.23 mg, 0.46 mg, and 0.92 mg of ozanimod in capsule form. (Compl. ¶2).

Functionality and Market Context

  • The complaint alleges that by filing its ANDA, Synthon has represented to the FDA that its product contains the same active ingredient, has the same dosage form and strength, and is bioequivalent to Zeposia®. (Compl. ¶22). The product is intended for the same medical indications as Zeposia®, which include the treatment of multiple sclerosis and ulcerative colitis. (Compl. ¶¶ 18, 23). The central allegation is that this generic product contains the specific crystalline form of ozanimod hydrochloride claimed in the ’050 Patent. (Compl. ¶32).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA as a technical act of infringement. The core of the infringement allegation is that the product described in Synthon's ANDA, if commercially manufactured and sold, would infringe the ’050 Patent.

'050 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A crystalline Form CS1 of ozanimod hydrochloride... The Synthon ANDA Product allegedly contains "a crystalline Form CS1 of ozanimod hydrochloride." The complaint cites Synthon's Notice Letter, which states the product "contains the hydrochloride salt of ozanimod as the active ingredient." ¶32 col. 7:12-16
...wherein the X-ray powder diffraction pattern shows characteristic peaks at 2theta values of 26.1°±0.20°, 24.4°±0.20° and 20.1°±0.20° using CuKα radiation. The complaint alleges on information and belief that the Synthon ANDA Product exhibits an X-ray powder diffraction pattern with these characteristic peaks. ¶32 col. 7:17-20
  • Identified Points of Contention:
    • Factual Question: The primary factual question for infringement will be whether the product described and produced pursuant to Synthon's ANDA actually has the specific XRPD pattern recited in Claim 1. The complaint alleges that Synthon's Notice Letter does not contest infringement if the claims are valid, but this will ultimately be a matter of evidentiary proof derived from discovery and testing of the ANDA product. (Compl. ¶24).
    • Scope Questions: The core dispute presented in the complaint is over validity, not infringement. (Compl. ¶24). However, should infringement be contested, a question may arise regarding the meaning of the claim limitations. For example, what is the full scope of "crystalline Form CS1"? Does it require matching only the three peaks recited in Claim 1, or does it require a more substantial match to the full characterization data for Form CS1 disclosed in the patent's specification and figures?

V. Key Claim Terms for Construction

  • The Term: "crystalline Form CS1 of ozanimod hydrochloride"

  • Context and Importance: This term defines the specific polymorph that is the subject of the patent. The entire infringement analysis hinges on whether the accused product is properly characterized as this specific form. Practitioners may focus on this term because the patent provides multiple forms of characterization data (XRPD, DSC, TGA), and the parties may dispute which data are definitional versus merely descriptive.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that the plain language of Claim 1 defines the form solely by the three recited XRPD peaks. Under this view, any material exhibiting these three peaks would be "Form CS1," regardless of other physical properties. (’050 Patent, Claim 1).
    • Evidence for a Narrower Interpretation: The specification provides a detailed characterization of Form CS1, including a full XRPD pattern with many additional peaks (FIG. 20 and Table 9), a specific DSC curve (FIG. 18), and a TGA curve (FIG. 19). A party could argue that these details define the full scope of "Form CS1," requiring an accused product to match the polymorph's properties more holistically. (’050 Patent, col. 8:12-30, Figs. 18-20).

  • The Term: "characteristic peaks"

  • Context and Importance: The definition of this term dictates how an XRPD pattern is compared to the claim. It is central to determining whether an experimental pattern from an accused product meets the claim limitations.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim explicitly lists three peaks as "characteristic," suggesting these three are sufficient to identify the claimed form. (’050 Patent, Claim 1).
    • Evidence for a Narrower Interpretation: The patent discloses numerous other peaks for Form CS1. For example, Claim 2 and Claim 3 each recite three different peaks as being characteristic. (’050 Patent, Claims 2-3). A party could argue that the term "characteristic peaks" implies a collection of the most significant peaks that distinguish the form, potentially including more than just the three recited in any single claim.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement. The factual basis is that upon receiving FDA approval, Synthon will market its product with a proposed label that encourages infringing use by patients and medical practitioners. (Compl. ¶¶ 34, 36). Alleged knowledge of the patent stems from the patent's listing in the FDA's Orange Book and Synthon's reference to the patent in its Notice Letter. (Compl. ¶35).
  • Willful Infringement: Willfulness is alleged based on Synthon's pre-suit knowledge of the ’050 Patent via the Orange Book listing and its own ANDA notice letter. The complaint also alleges willful blindness to the inevitable infringement by end-users. (Compl. ¶¶ 35-36).

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

  • A central issue will be validity: as this is a Hatch-Waxman case triggered by a Paragraph IV certification, the primary legal battle will likely be over Synthon’s defenses that the claims of the '050 Patent are invalid under 35 U.S.C. §§ 102 (anticipation) or 103 (obviousness), as asserted in its notice letter.
  • A key evidentiary question will be one of factual infringement: although the complaint alleges infringement is not contested, the case will ultimately require an empirical determination of whether the crystalline form in Synthon’s actual ANDA product exhibits the XRPD peaks and other properties of the claimed "Form CS1."
  • The case may also turn on a question of definitional scope: will "crystalline Form CS1" be defined narrowly by the full set of analytical data provided in the patent’s specification, or will it be defined more broadly by the three specific XRPD peaks recited in the asserted independent claim?