DCT

1:22-cv-00020

Bausch Health Ireland Ltd v. Mylan Laboratories Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00020, D.N.J., 04/28/2021
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because multiple Defendant entities operate a principal place of business, have committed acts of infringement, and maintain a regular and established place of business in the district. The complaint further asserts that Defendants have purposefully availed themselves of the court through extensive prior litigation in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for approval to market generic plecanatide oral tablets constitutes an act of infringement of eight U.S. patents listed in the FDA's Orange Book for Plaintiffs' drug, Trulance®.
  • Technical Context: The technology concerns plecanatide, a synthetic peptide analog that functions as a guanylate cyclase-C agonist to treat gastrointestinal disorders such as chronic idiopathic constipation and irritable bowel syndrome.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV certification notice letter from Defendants on March 18, 2021, which stated Defendants were seeking FDA approval for a generic version of Trulance® prior to the expiration of the patents-in-suit.

Case Timeline

Date Event
2002-01-17 Priority Date for '786, '897, '451, '321, '097, '024, '231 Patents
2006-05-09 U.S. Patent No. 7,041,786 Issued
2010-09-21 U.S. Patent No. 7,799,897 Issued
2013-06-05 Priority Date for '637 Patent
2014-01-28 U.S. Patent No. 8,637,451 Issued
2017-01-19 FDA Approves NDA for Trulance® (plecanatide)
2017-04-04 U.S. Patent No. 9,610,321 Issued
2017-04-11 U.S. Patent No. 9,616,097 Issued
2018-03-20 U.S. Patent No. 9,919,024 Issued
2018-03-27 U.S. Patent No. 9,925,231 Issued
2018-07-03 U.S. Patent No. 10,011,637 Issued
2021-03-18 Plaintiffs Receive Defendants' Paragraph IV Notice Letter
2021-04-28 Complaint Filed

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

U.S. Patent No. 7,041,786 - "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis"

Issued May 9, 2006

The Invention Explained

  • Problem Addressed: The patent describes that the normal balance between cell proliferation and apoptosis (programmed cell death) in the gastrointestinal (GI) tract is critical for tissue homeostasis. It notes that a deficiency in certain peptides (uroguanylin and guanylin) that stimulate cyclic guanosine monophosphate (cGMP) production is associated with pre-cancerous polyps and tumors, leading to inflammation and abnormal growths. (’786 Patent, col. 1:40-2:68).
  • The Patented Solution: The invention provides synthetic peptide agonists of the guanylate cyclase receptor, which are designed to mimic the function of natural uroguanylin. By administering these agonists, the patent proposes to increase intracellular cGMP levels, thereby restoring the balance of cell proliferation and apoptosis to treat or prevent GI inflammation, polyps, and cancer. (’786 Patent, col. 3:1-14; col. 4:26-31).
  • Technical Importance: This approach provided a therapeutic strategy targeting the cGMP signaling pathway to address the underlying cellular mechanisms of certain GI diseases rather than merely treating symptoms. (’786 Patent, col. 2:61-68).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" of the '786 patent without specifying which claims are asserted (Compl. ¶56). Independent claim 1 is representative:

  • A peptide consisting of the amino acid sequence of SEQ ID NO:20.

U.S. Patent No. 7,799,897 - "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis"

Issued September 21, 2010

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the '786 patent, this patent addresses the same technical problem: the disruption of cellular homeostasis in the GI tract due to reduced cGMP levels, which contributes to inflammation and carcinogenesis. (’897 Patent, col. 1:25-2:51).
  • The Patented Solution: The invention claims specific peptide analogs of uroguanylin that act as guanylate cyclase receptor agonists. These peptides are designed to enhance intracellular cGMP production, thereby treating inflammatory and cancerous conditions of the GI tract. (’897 Patent, col. 3:1-14).
  • Technical Importance: The invention provides alternative peptide structures to achieve the therapeutic goal of modulating the cGMP pathway in the GI tract. (’897 Patent, col. 2:46-51).

Key Claims at a Glance

The complaint alleges infringement of "at least one claim" of the '897 patent without specifying which claims are asserted (Compl. ¶67). Independent claim 1 is representative:

  • A peptide consisting of SEQ ID NO:8, wherein said peptide is a (4,12; 7,15) bicycle
  • and wherein said peptide binds a guanylate cyclase receptor and induces cGMP production.

Multi-Patent Capsule: U.S. Patent No. 8,637,451

  • Patent Identification: U.S. Patent No. 8,637,451, "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis," Issued January 28, 2014 (Compl. ¶39).
  • Technology Synopsis: This patent claims methods of using guanylate cyclase receptor agonists to treat GI disorders by stimulating water transport into the intestinal lumen.
  • Asserted Claims: At least one claim (Compl. ¶78).
  • Accused Features: The administration of Defendants' generic plecanatide oral tablets is alleged to infringe the claimed methods (Compl. ¶79-80).

Multi-Patent Capsule: U.S. Patent No. 9,610,321

  • Patent Identification: U.S. Patent No. 9,610,321, "Formulations of Guanylate Cyclase C Agonists and Methods of Use," Issued April 4, 2017 (Compl. ¶40).
  • Technology Synopsis: This patent claims methods of treating chronic constipation by orally administering a specific dosage of a peptide agonist.
  • Asserted Claims: At least one claim (Compl. ¶89).
  • Accused Features: The intended use of Defendants' generic plecanatide oral tablets to treat chronic constipation is alleged to infringe the claimed methods (Compl. ¶90-91).

Multi-Patent Capsule: U.S. Patent No. 9,616,097

  • Patent Identification: U.S. Patent No. 9,616,097, "Formulations of Guanylate Cyclase C Agonists and Methods of Use," Issued April 11, 2017 (Compl. ¶41).
  • Technology Synopsis: This patent claims specific oral dosage formulations containing a guanylate cyclase-C agonist peptide, a moisture carrier, and a lubricant, with defined purity levels.
  • Asserted Claims: At least one claim (Compl. ¶100).
  • Accused Features: The composition and formulation of Defendants' generic plecanatide oral tablets are alleged to infringe (Compl. ¶101-102).

Multi-Patent Capsule: U.S. Patent No. 9,919,024

  • Patent Identification: U.S. Patent No. 9,919,024, "Formulations of Guanylate Cyclase C Agonists and Methods of Use," Issued March 20, 2018 (Compl. ¶42).
  • Technology Synopsis: This patent claims low-dose oral formulations of guanylate cyclase-C agonists for treating gastrointestinal disorders.
  • Asserted Claims: At least one claim (Compl. ¶111).
  • Accused Features: The formulation of Defendants' 3 mg generic plecanatide oral tablets is alleged to infringe (Compl. ¶112-113).

Multi-Patent Capsule: U.S. Patent No. 9,925,231

  • Patent Identification: U.S. Patent No. 9,925,231, "Formulations of Guanylate Cyclase C Agonists and Methods of Use," Issued March 27, 2018 (Compl. ¶43).
  • Technology Synopsis: This patent claims specific oral dosage formulations containing a guanylate cyclase-C agonist peptide, stabilized against degradation and having defined purity characteristics.
  • Asserted Claims: At least one claim (Compl. ¶122).
  • Accused Features: The composition and formulation of Defendants' generic plecanatide oral tablets are alleged to infringe (Compl. ¶123-124).

Multi-Patent Capsule: U.S. Patent No. 10,011,637

  • Patent Identification: U.S. Patent No. 10,011,637, "Ultra-Pure Agonists of Guanylate Cyclase C, Method of Making and Using Same," Issued July 3, 2018 (Compl. ¶44).
  • Technology Synopsis: This patent claims highly purified peptides with specific physical and chemical properties, such as defined bulk density, particle size distribution, and low levels of specific impurities.
  • Asserted Claims: At least one claim (Compl. ¶133).
  • Accused Features: The purified peptide in Defendants' generic plecanatide oral tablets is alleged to meet the claimed purity and physical property limitations (Compl. ¶134-135).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is "Defendants' generic plecanatide oral tablets, 3 mg," for which Defendants submitted ANDA No. 215686 to the FDA (Compl. ¶9, 47-48).
  • Functionality and Market Context: The product is a generic version of Plaintiffs' Trulance® drug, intended for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (Compl. ¶48). The complaint alleges that the generic product is "the same, or substantially the same, as Trulance®" and contains the active pharmaceutical ingredient plecanatide (Compl. ¶54). By filing an ANDA, Defendants are representing to the FDA that their product is bioequivalent to Trulance® (Compl. ¶52).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint provides a generalized theory of infringement typical for ANDA litigation, asserting that the act of filing the ANDA for a bioequivalent generic product constitutes infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶56). It does not contain a detailed claim chart or element-by-element mapping. The following table summarizes the infringement theory for a representative claim based on the complaint's allegations.

'10,011,637 Patent Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement of the '786 or '897 patents in a claim chart format. The infringement theory for the '637 patent, which involves specific quantifiable characteristics of the active ingredient, highlights the factual nature of the dispute.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A purified peptide comprising the GCC agonist amino acid sequence of SEQ ID NO: 1 The accused product is a generic version of Trulance® and contains the active ingredient plecanatide, which corresponds to SEQ ID NO: 1. ¶9, ¶54 col. 231:1-4
wherein the purified peptide has the following characteristics: a) a bulk density of not greater than 0.1 g/mL; The complaint does not provide specific facts mapping to these limitations but alleges that the generic product, if approved, will infringe. Infringement is premised on the generic product being the same as Trulance®, which is covered by the patent. ¶134 col. 231:5-6
b) contains less than 50 ppm acetamide; The complaint does not provide specific facts mapping to these limitations but alleges that the generic product, if approved, will infringe. Infringement is premised on the generic product being the same as Trulance®, which is covered by the patent. ¶134 col. 231:7-8
c) less than 0.25% of alpha-Asp-9-plecanatide The complaint does not provide specific facts mapping to these limitations but alleges that the generic product, if approved, will infringe. Infringement is premised on the generic product being the same as Trulance®, which is covered by the patent. ¶134 col. 231:9-10

Identified Points of Contention

  • Scope Questions: Do the physical and chemical properties of the plecanatide in Defendants' ANDA product, as manufactured, fall within the specific quantitative limits for purity, impurity levels, bulk density, and particle size distribution recited in the claims of the '637 patent?
  • Technical Questions: What evidence will be presented to demonstrate that Defendants' proposed generic product—including its active ingredient, excipients, and stability profile—meets the limitations of the various asserted formulation claims (e.g., '097 and '231 patents)? The complaint relies on the assertion that the generic is "the same, or substantially the same" as the branded product, but proof of infringement will require an element-by-element factual analysis.

V. Key Claim Terms for Construction

  • The Term: "purified peptide"
  • Context and Importance: This term appears in independent claim 1 of the '637 patent. The claim proceeds to define the "purified peptide" by reciting a series of specific physical and chemical characteristics (e.g., bulk density, acetamide content, particle size). The central infringement question for this patent will be whether Defendants' product meets these specific, quantifiable limitations. Practitioners may focus on this term because its construction will determine whether infringement can be decided by comparing the ANDA product against a list of objective criteria.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The '637 patent specification repeatedly discusses achieving high purity via processes like RP-HPLC, and in some contexts describes the resulting peptide as having "a chromatographic purity of no less than 95%, or no less than 96%, or no less than 97%" ('637 Patent, col. 4:56-59). Plaintiffs may argue this suggests the term refers more generally to a high degree of chromatographic purity.
    • Evidence for a Narrower Interpretation: The claim language itself appears to define the term by its subsequent limitations ("A purified peptide ... having the following characteristics: a)... b)... c)..."). Defendants may argue that the term has no meaning independent of the specific quantitative thresholds recited in the claim body, effectively making those characteristics definitional requirements of the "purified peptide." The abstract also links the invention to a peptide having the specific characteristics "described herein" ('637 Patent, Abstract).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will contributorily infringe and induce infringement of the patents-in-suit (Compl. ¶58, ¶69). The basis for this allegation is that Defendants, upon receiving FDA approval, will market their generic product with a label instructing physicians and patients to administer it for the same indications as Trulance®, thereby inducing them to perform the patented methods of treatment.
  • Willful Infringement: The complaint does not use the word "willful." However, the prayer for relief requests that the court declare this to be an "exceptional case" under 35 U.S.C. § 285 and § 271(e)(4) and award attorney's fees (Compl. p. 42, ¶12). The factual basis for this request is not detailed in the complaint.

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

  • A core issue will be one of evidentiary proof: While the act of filing the ANDA creates jurisdiction under the Hatch-Waxman Act, proving infringement will require Plaintiffs to demonstrate, on an element-by-element basis, that the specific product described in Defendants' confidential ANDA meets all limitations of the asserted claims. This will be particularly critical for patents like the '637 patent, which claim the active ingredient based on specific, quantifiable purity and physical property metrics.
  • A second key question will be one of claim scope differentiation: Plaintiffs have asserted a portfolio of eight patents with different claim types, including claims to the peptide itself, methods of treatment, and specific oral formulations. The case will likely involve distinct infringement analyses for each patent, raising the question of whether Defendants' product and its proposed label manage to avoid the scope of some claim sets while infringing others.