DCT

1:25-cv-00003

Bausch Health Ireland Ltd v. Mylan Pharma Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00003, N.D. W. Va., 01/13/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business in the district, is registered to do business in the district, has a place of business in Morgantown, West Virginia, and has previously submitted to the jurisdiction of the court. The complaint further alleges that the district is a likely destination for the accused generic product and that the ANDA filing constitutes a formal act purposefully directed at the district.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' Trulance® product constitutes an act of infringement of a patent directed to oral formulations of a purified peptide.
  • Technical Context: The technology relates to methods for purifying plecanatide, a peptide agonist of guanylate cyclase C, to achieve specific purity characteristics suitable for pharmaceutical drug products used to treat gastrointestinal disorders.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant’s submission of ANDA No. 215686 seeking FDA approval to market a generic version of Trulance®. The complaint notes that Defendant sent Plaintiffs three separate Paragraph IV certification notice letters regarding this ANDA, dated March 18, 2021, July 18, 2022, and March 6, 2024. These letters prompted related, consolidated litigation between the parties in the same district (Case No. 1:22-cv-00020).

Case Timeline

Date Event
2013-06-05 ’003 Patent Priority Date
2017-01-19 FDA approves NDA for Trulance®
2021-03-18 Plaintiffs receive Mylan's First Notice Letter for ANDA
2022-07-18 Plaintiffs receive Mylan's Second Notice Letter for ANDA
2024-03-06 Plaintiffs receive Mylan's Third Notice Letter for ANDA
2024-11-19 ’003 Patent Issue Date
2025-01-13 Complaint Filing Date

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

U.S. Patent No. 12,146,003 - ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME

  • Issued: November 19, 2024

The Invention Explained

  • Problem Addressed: The patent describes challenges in the synthesis of peptides for pharmaceutical use, noting that previous methods result in low overall yield and high levels of impurities, including contaminants from organic solvents and degradation products created during purification (’003 Patent, col. 3:36-44). Specifically, the specification notes that a prior precipitation-based purification process, while reducing certain impurities, created a "thermal degradant, alpha-Asp-9-plecanatide" at levels as high as 0.9% (’003 Patent, col. 8:22-33).
  • The Patented Solution: The patent discloses purification processes designed to solve the problems of residual solvents and degradation products (’003 Patent, col. 8:34-52). The described solution involves steps such as exchanging an acetonitrile/water solvent with an isopropanol/water solvent, followed by rotary evaporation and multiple lyophilization (freeze-drying) steps (’003 Patent, col. 8:36-47; Fig. 6). This process allegedly results in a purified peptide with specific characteristics, including low bulk density and critically low levels of specified impurities like acetamide and alpha-Asp-9-plecanatide (’003 Patent, col. 3:54-63, col. 8:53-65).
  • Technical Importance: Achieving high purity and stability in a peptide-based drug substance is critical for ensuring safety, efficacy, and a commercially viable shelf life for the final pharmaceutical product (’003 Patent, col. 8:27-33, col. 8:43-47).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim without specifying any particular claims (Compl. ¶26). Independent claim 1 is representative of the patented composition.
  • Independent Claim 1:
    • An oral formulation
    • comprising a purified peptide comprising a Guanylate Cyclase-C (GCC) agonist of amino acid sequence of SEQ ID NO: 1
    • wherein the purified peptide has less than 0.25% alpha-Asp-9-plecanatide relative to the weight of the purified peptide.
  • The complaint states that Defendant’s product will infringe "at least one claim," preserving the right to assert other independent and dependent claims (Compl. ¶27).

III. The Accused Instrumentality

Product Identification

  • Defendant’s generic plecanatide oral tablets, 3 mg, as described in Abbreviated New Drug Application (ANDA) No. 215686 (Compl. ¶4, ¶13).

Functionality and Market Context

  • The accused product is intended to be a generic version of Trulance®, which is an approved drug for treating certain gastrointestinal disorders (Compl. ¶14, ¶20). The complaint alleges that the ANDA submission contains data demonstrating that the accused generic tablets are the same as or substantially the same as Trulance® and are bioequivalent (Compl. ¶21-22).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-by-claim analysis or the construction of a claim chart. The infringement theory is statutory, based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA as an artificial act of infringement if the product described in the ANDA would infringe a valid patent upon its commercial manufacture, use, or sale (Compl. ¶26).

The narrative theory of infringement is that Mylan, by submitting its ANDA, seeks FDA approval to market a 3 mg plecanatide oral tablet that is a generic version of Trulance® (Compl. ¶14). Plaintiffs allege that this proposed generic product, if approved and marketed, will meet all the limitations of at least one claim of the ’003 Patent (Compl. ¶27). This action seeks to obtain a court order preventing the FDA from approving the ANDA until after the expiration of the ’003 Patent (Prayer ¶2-3).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Technical Questions: A central question will be whether the product specified in Mylan's confidential ANDA will, in fact, possess the purity characteristics required by the asserted claims. For Claim 1, this raises the evidentiary question of whether Mylan's manufacturing process will consistently produce a purified peptide with "less than 0.25% alpha-Asp-9-plecanatide." The complaint asserts this only "upon information and belief" (Compl. ¶27).
    • Scope Questions: It is possible that the parties will dispute the proper analytical method for measuring the percentage of "alpha-Asp-9-plecanatide." While the patent specification provides a UPLC method and relative retention time that may inform this analysis (’003 Patent, col. 8:27-33), disputes over testing protocols are common in pharmaceutical patent litigation.

V. Key Claim Terms for Construction

  • The Term: "alpha-Asp-9-plecanatide"
  • Context and Importance: This term defines the critical impurity limitation in independent claim 1. The infringement analysis will turn on whether the accused product meets this negative limitation (i.e., has less than the specified amount). The precise chemical identity and method of quantification for this substance will therefore be a central issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification identifies "alpha-Asp-9-plecanatide" as a "thermal degradant" and provides a technical identifier for it: a substance having a "Relative Retention Time (RRT) of ~1.33 from ultra-performance liquid chromatography (UPLC) analysis" (’003 Patent, col. 8:27-33). A party could argue that the term should be construed simply as the chemical entity that meets this technical description, regardless of its method of formation.
    • Evidence for a Narrower Interpretation: The specification discusses the formation of this impurity in the context of a specific prior art "precipitation process" that involved "low temperature heating (45° C.)" (’003 Patent, col. 8:22-33). A party could argue that the definition of the term should be informed by this context, though limiting a composition claim by the process used to create an impurity is a potential point of contention.

VI. Other Allegations

  • Indirect Infringement: The complaint includes a conclusory allegation of contributory and induced infringement "upon information and belief" (Compl. ¶28). The factual basis alleged for Defendant's knowledge of the patent and intent to infringe is the series of Paragraph IV notice letters sent to Plaintiffs, which explicitly reference the patent-in-suit in the context of Defendant’s ANDA filing (Compl. ¶15-17).
  • Willful Infringement: The complaint does not contain a separate count for willful infringement. However, the prayer for relief requests that the court "Declare this to be an exceptional case under 35 U.S.C. §§ 285" (Prayer ¶5). The basis for this request appears to be Defendant's alleged knowledge of the ’003 patent, as evidenced by the multiple notice letters sent between March 2021 and March 2024, and its decision to nonetheless proceed with seeking FDA approval for its generic product (Compl. ¶15-17).

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

  • A core issue will be one of evidentiary proof: What do the specifications and stability data within Mylan's confidential ANDA filing reveal about the level of the "alpha-Asp-9-plecanatide" impurity in its proposed generic product? The outcome of the case will depend heavily on a technical comparison of the ANDA data against the "less than 0.25%" threshold required by the patent's claims.
  • A key secondary issue may be one of analytical methodology: Should the parties disagree on how to measure the "alpha-Asp-9-plecanatide" impurity, the court may need to resolve disputes over the precise parameters of the required UPLC testing, potentially leading to a "battle of the experts" on analytical chemistry.