DCT

2:24-cv-11179

Bausch Health Ireland Ltd v. MSN Laboratories Private Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-11179, D.N.J., 12/16/2024
  • Venue Allegations: Venue is alleged to be proper against MSN Pharmaceuticals Inc. because it operates a principal place of business in the district. For MSN Laboratories Private Ltd., a foreign corporation, venue is alleged based on personal jurisdiction and the district being a likely destination for sales of the accused generic product.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic plecanatide oral tablets constitutes an act of infringement of a patent covering oral formulations of the purified peptide.
  • Technical Context: The technology relates to pharmaceutical formulations of plecanatide, a peptide agonist of guanylate cyclase C used to treat gastrointestinal disorders such as chronic idiopathic constipation.
  • Key Procedural History: The complaint notes that this action follows a series of three Paragraph IV certification notice letters from Defendants related to the same ANDA, dated March 15, 2021, May 2, 2023, and May 7, 2024. The complaint also references prior, consolidated patent litigation between the same parties in the same district, indicating an established litigation history concerning the subject matter.

Case Timeline

Date Event
2013-06-05 ’003 Patent Priority Date
2017-01-19 FDA approves NDA for Trulance®
2021-03-15 Plaintiffs receive First Notice Letter for ANDA No. 215780
2023-05-02 Plaintiffs receive Second Notice Letter for ANDA No. 215780
2024-05-07 Plaintiffs receive Third Notice Letter for ANDA No. 215780
2024-11-19 U.S. Patent No. 12,146,003 Issues
2024-12-16 Complaint Filed

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"

  • Patent Identification: 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’s background section describes challenges in the synthesis of peptides for pharmaceutical use, specifically noting problems of low overall yield and high levels of impurities, including contaminants from organic solvents or degradation products created during purification (’003 Patent, col. 2:38-44).
  • The Patented Solution: The invention provides processes for purifying a peptide that involve a solvent exchange step prior to a freeze-drying (lyophilization) step (’003 Patent, Abstract). This process, which can involve exchanging an acetonitrile/water solvent with an isopropanol/water solvent, is described as solving problems of residual solvents and product degradation, resulting in a highly purified peptide product with specific characteristics such as low bulk density and defined low levels of certain impurities (’003 Patent, col. 3:56-64; col. 8:31-48).
  • Technical Importance: The patented purification process provides a solution to "unexpected problems encountered during the purification processes of peptide GCC agonists for pharmaceutical application," thereby enabling the creation of a purer and more stable drug substance suitable for commercial development (’003 Patent, col. 7:65 - col. 8:30).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim without specifying which claim(s) will be asserted (Compl. ¶36). Independent claims 1 and 7 are directed to oral formulations.
  • The essential elements of independent claim 1 are:
    • 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 does not explicitly reserve the right to assert dependent claims, but such a reservation is standard practice.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "MSN's generic plecanatide oral tablets, 3 mg," for which MSN Laboratories Private Ltd. has filed Abbreviated New Drug Application (ANDA) No. 215780 with the FDA (Compl. ¶6, ¶19).

Functionality and Market Context

  • The accused product is intended to be a generic version of Plaintiffs’ branded drug, Trulance® (Compl. ¶20). The complaint alleges that MSN’s ANDA seeks approval for tablets that are "the same, or substantially the same, as Trulance®" (Compl. ¶30).
  • The basis for the infringement action is the submission of the ANDA itself, which under 35 U.S.C. § 271(e)(2) is a statutory act of infringement for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of a patented drug before the patent's expiration (Compl. ¶36). The complaint states that MSN's notice letters confirm the ANDA contains the required bioavailability and bioequivalence data for its generic plecanatide oral tablets (Compl. ¶23, ¶26, ¶29).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed infringement contentions. The infringement theory is predicated on the ANDA regulatory framework, which requires a generic drug to be the same as, or bioequivalent to, the reference listed drug.

’003 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An oral formulation comprising a purified peptide comprising a Guanylate Cyclase-C (GCC) agonist of amino acid sequence of SEQ ID NO: 1 MSN's ANDA product is an oral tablet formulation containing plecanatide, which the complaint alleges is the same active ingredient as in Trulance® and corresponds to SEQ ID NO: 1. ¶6, ¶20 col. 3:56-59
wherein the purified peptide has less than 0.25% alpha-Asp-9-plecanatide relative to the weight of the purified peptide. The complaint alleges that regulatory requirements, coupled with information from prior notice letters, demonstrate that MSN's product will infringe. This implies an assertion that to be bioequivalent to Trulance®, MSN's product must meet this purity limitation. ¶30, ¶34 col. 3:62-64

Identified Points of Contention

  • Evidentiary Questions: A primary question is what evidence exists within the ANDA submission itself to demonstrate that MSN's proposed product will meet the negative limitation of "less than 0.25% alpha-Asp-9-plecanatide." The complaint's infringement theory appears to rest on the inference that bioequivalence necessitates meeting this purity profile, an assertion that will require factual support through discovery (Compl. ¶34).
  • Scope Questions: The dispute may turn on whether MSN's product, potentially manufactured by a different process, necessarily falls within the scope of the claims. This raises the question of whether MSN could achieve bioequivalence for FDA purposes while engineering a product with an impurity profile that avoids this specific claim limitation.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a definitive analysis of claim construction disputes. However, based on the patent's focus, certain terms may become central to the case.

  • The Term: "purified peptide"
  • Context and Importance: The patent is titled "Ultra-Pure Agonists..." and dedicates significant discussion to a novel purification process and the resulting product's characteristics. The definition of "purified peptide" is therefore fundamental. Practitioners may focus on this term because the claims define the peptide by its purity profile (e.g., the level of alpha-Asp-9-plecanatide). The construction of this term will be critical to determining whether MSN's product, if made by a different process, infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the "purified peptide" by its resulting characteristics, such as having a bulk density "of not greater than 0.1 g/mL" and containing "less than 0.3% alpha-Asp-9-plecanatide" (’003 Patent, col. 3:59-64). A party could argue that any peptide meeting these objective purity and physical property criteria is a "purified peptide" under the patent, regardless of the manufacturing process.
    • Evidence for a Narrower Interpretation: The patent repeatedly emphasizes its novel purification process, which solves "unexpected problems" of prior art methods (’003 Patent, col. 7:65 - col. 8:30). A party could argue that "purified peptide" is implicitly limited to a product possessing the specific purity profile that results from the disclosed process involving, for example, a solvent exchange from acetonitrile to isopropanol before lyophilization, suggesting a potential process-based limitation on the product claim (’003 Patent, col. 8:31-48).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if and when MSN commercially manufactures, uses, sells, or imports its generic product, it will directly, contributorily, and/or inducibly infringe at least one claim of the ’003 patent (Compl. ¶38, ¶44). These allegations are prospective and supplement the core statutory infringement claim based on the ANDA submission under § 271(e)(2).

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 MSN’s confidential ANDA submission reveal about the level of alpha-Asp-9-plecanatide in its proposed generic product? The viability of Plaintiffs' infringement case will depend heavily on whether discovery confirms that MSN's product meets this specific negative claim limitation.
  • A key legal question will be the enforceability of the purity limitation: Can Plaintiffs establish that the claimed purity profile—specifically, "less than 0.25% alpha-Asp-9-plecanatide"—is a necessary characteristic of any generic plecanatide product that is bioequivalent to Trulance®, or can MSN demonstrate that it can achieve regulatory approval with a product that is formulated to avoid this precise claim element?