DCT

2:21-cv-10057

Bausch Health Ireland Ltd v. MSN Laboratories Private Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:21-cv-10057, D.N.J., 04/22/2021
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because MSN Pharmaceuticals Inc. operates a principal place of business in the district, MSN Laboratories Private Ltd. is a foreign corporation subject to jurisdiction, and the district is a likely destination for the accused generic drug products.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Trulance® product constitutes an act of infringement of eight U.S. patents related to the drug's active ingredient, plecanatide.
  • Technical Context: The technology concerns peptides that are agonists of the guanylate cyclase-C receptor, used for treating gastrointestinal disorders such as chronic idiopathic constipation and irritable bowel syndrome.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to a Notice Letter dated March 15, 2021, in which MSN informed Plaintiffs of its ANDA filing containing a Paragraph IV certification. The patents-in-suit are listed in the FDA’s “Orange Book” for the branded drug Trulance®, which was approved by the FDA on January 19, 2017.

Case Timeline

Date Event
2002-01-17 Earliest Priority Date for ’786, ’897, ’451 Patents
2006-05-09 U.S. Patent No. 7,041,786 Issues
2010-09-21 U.S. Patent No. 7,799,897 Issues
2010-09-29 Earliest Priority Date for ’321, ’097, ’024, ’231 Patents
2013-06-05 Earliest Priority Date for ’637 Patent
2014-01-28 U.S. Patent No. 8,637,451 Issues
2017-01-19 FDA Approves NDA for Trulance®
2017-04-04 U.S. Patent No. 9,610,321 Issues
2017-04-11 U.S. Patent No. 9,616,097 Issues
2018-03-20 U.S. Patent No. 9,919,024 Issues
2018-03-27 U.S. Patent No. 9,925,231 Issues
2018-07-03 U.S. Patent No. 10,011,637 Issues
2021-03-15 Plaintiffs Receive MSN’s Notice Letter
2021-04-22 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"

The Invention Explained

  • Problem Addressed: The patent addresses conditions related to gastrointestinal (GI) inflammation and carcinogenesis, noting that a disruption in the balance between cell proliferation and apoptosis in the GI mucosa is a key factor in these diseases (Compl. Ex. A, ’786 Patent, col. 1:40-62). It suggests that reduced levels of the peptides uroguanylin and guanylin contribute to this imbalance.
  • The Patented Solution: The invention provides peptide agonists of the guanylate cyclase receptor, which enhance the intracellular production of cyclic guanosine monophosphate (cGMP). This is intended to restore the homeostatic balance between cell growth and death (apoptosis), thereby treating or preventing inflammatory conditions and the development of cancerous growths in epithelial tissues (Compl. Ex. A, ’786 Patent, col. 3:1-14; col. 4:1-5).
  • Technical Importance: This approach provides a therapeutic pathway for treating GI disorders by targeting the underlying cellular mechanisms of tissue renewal and inflammation, rather than merely addressing symptoms.

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶35). Independent claim 1 is representative.
  • Essential elements of claim 1 include:
    • A method for stimulating water transport in the gastrointestinal tract in a patient.
    • Administering to the patient a guanylate cyclase receptor agonist peptide consisting of SEQ ID NO:20.
    • Wherein the peptide is administered in an amount sufficient to induce cGMP production in a gastrointestinal epithelial cell.
    • Wherein the peptide is a (4,12; 7,15) bicycle.

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

The Invention Explained

  • Problem Addressed: Similar to the ’786 Patent, this patent addresses GI inflammation and carcinogenesis resulting from an imbalance between cell proliferation and apoptosis (Compl. Ex. B, ’897 Patent, col. 1:45-2:5). It notes the role of uroguanylin and guanylin in regulating this process.
  • The Patented Solution: The invention discloses specific peptide analogs of uroguanylin that act as agonists of the guanylate cyclase receptor to increase intracellular cGMP levels. These peptides are designed to have superior properties, such as improved stability or receptor activation, to treat conditions that respond to enhanced cGMP (Compl. Ex. B, ’897 Patent, col. 3:5-14).
  • Technical Importance: The claimed peptides represent specific molecular structures designed to improve upon naturally occurring compounds for therapeutic use in GI diseases.

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶46). Independent claim 1 is representative.
  • Essential elements of claim 1 include:
    • A peptide consisting of SEQ ID NO:8.
    • Wherein the peptide is a (4,12; 7,15) bicycle.
    • Wherein the peptide binds a guanylate cyclase receptor and induces cGMP production.

U.S. Patent No. 8,637,451 - "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis"

  • Patent Identification: "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis," issued January 28, 2014 (Compl. ¶18).
  • Technology Synopsis: This patent claims methods for stimulating water transport in the GI tract. This is achieved by administering a specific peptide agonist (SEQ ID NO:20) that activates the guanylate cyclase receptor, thereby increasing cGMP production in epithelial cells and regulating fluid and electrolyte transport (Compl. Ex. C, ’451 Patent, Abstract; col. 39:1-12).
  • Asserted Claims: At least one claim (Compl. ¶57).
  • Accused Features: MSN’s generic plecanatide oral tablets, which are intended to be generic versions of Trulance® (Compl. ¶27, ¶58).

U.S. Patent No. 9,610,321 - "Formulations of Guanylate Cyclase C Agonists and Methods of Use"

  • Patent Identification: "Formulations of Guanylate Cyclase C Agonists and Methods of Use," issued April 4, 2017 (Compl. ¶19).
  • Technology Synopsis: The patent describes methods for treating chronic constipation or irritable bowel syndrome. The method involves administering an oral dosage of a specific peptide (SEQ ID NO:1) that has a high purity level and is formulated with a low moisture carrier and a lubricant (Compl. Ex. D, ’321 Patent, Abstract; col. 253:11-20).
  • Asserted Claims: At least one claim (Compl. ¶68).
  • Accused Features: MSN’s generic plecanatide oral tablets, which are alleged to be formulations for treating chronic constipation (Compl. ¶27, ¶69).

U.S. Patent No. 9,616,097 - "Formulations of Guanylate Cyclase C Agonists and Methods of Use"

  • Patent Identification: "Formulations of Guanylate Cyclase C Agonists and Methods of Use," issued April 11, 2017 (Compl. ¶20).
  • Technology Synopsis: This patent is directed to specific oral dosage formulations of a guanylate cyclase-C agonist peptide. The claims specify a formulation comprising a unit dose of the peptide, an inert low moisture carrier, and a lubricant, where the formulation is stable and has a high chromatographic purity (Compl. Ex. E, ’097 Patent, Abstract; col. 239:12-28).
  • Asserted Claims: At least one claim (Compl. ¶79).
  • Accused Features: MSN’s generic plecanatide oral tablets, which constitute an oral dosage formulation of plecanatide (Compl. ¶27, ¶80).

U.S. Patent No. 9,919,024 - "Formulations of Guanylate Cyclase C Agonists and Methods of Use"

  • Patent Identification: "Formulations of Guanylate Cyclase C Agonists and Methods of Use," issued March 20, 2018 (Compl. ¶21).
  • Technology Synopsis: Similar to the '321 patent, this patent covers methods for treating chronic constipation or irritable bowel syndrome. The method involves administering a specific peptide (SEQ ID NO:1) in a low-dose formulation with particular purity and stability characteristics (Compl. Ex. F, ’024 Patent, Abstract; col. 227:1-29).
  • Asserted Claims: At least one claim (Compl. ¶90).
  • Accused Features: MSN’s generic plecanatide oral tablets, which are alleged to be formulations for treating chronic constipation (Compl. ¶27, ¶91).

U.S. Patent No. 9,925,231 - "Formulations of Guanylate Cyclase C Agonists and Methods of Use"

  • Patent Identification: "Formulations of Guanylate Cyclase C Agonists and Methods of Use," issued March 27, 2018 (Compl. ¶22).
  • Technology Synopsis: This patent is directed to oral dosage formulations of a guanylate cyclase-C agonist peptide with specific characteristics. The claims require the peptide to have a certain bicycle structure and be combined with an inert low moisture carrier and a lubricant, resulting in a stable formulation with high purity (Compl. Ex. G, ’231 Patent, Abstract; col. 227:45-67).
  • Asserted Claims: At least one claim (Compl. ¶100).
  • Accused Features: MSN’s generic plecanatide oral tablets, which are oral dosage forms of plecanatide (Compl. ¶27, ¶101).

U.S. Patent No. 10,011,637 - "Ultra-Pure Agonists of Guanylate Cyclase C, Method of Making and Using Same"

  • Patent Identification: "Ultra-Pure Agonists of Guanylate Cyclase C, Method of Making and Using Same," issued July 3, 2018 (Compl. ¶23).
  • Technology Synopsis: This patent claims a purified peptide with specific physical and chemical properties. These include defined limits on impurities (e.g., acetamide), a specific particle size distribution, a minimum bulk density, and high chromatographic purity. The invention also includes processes for producing this ultra-pure peptide (Compl. Ex. H, ’637 Patent, Abstract; col. 231:1-12).
  • Asserted Claims: At least one claim (Compl. ¶110).
  • Accused Features: MSN’s generic plecanatide oral tablets, which contain plecanatide as the active ingredient (Compl. ¶27, ¶111).

III. The Accused Instrumentality

Product Identification

  • The accused product is "MSN's generic plecanatide oral tablets, 3 mg" (Compl. ¶6). This product is the subject of Abbreviated New Drug Application ("ANDA") No. 215780 filed with the U.S. Food and Drug Administration (FDA) (Compl. ¶26).

Functionality and Market Context

  • The accused product is intended to be a generic version of Trulance®, an FDA-approved drug for treating chronic idiopathic constipation and irritable bowel syndrome with constipation (Compl. ¶27). As a generic, it is required to contain the same active ingredient, plecanatide, and exhibit bioequivalence to the branded product (Compl. ¶30). The filing of the ANDA signals Defendants' intent to engage in the commercial manufacture, use, and sale of the generic tablets in the United States upon receiving FDA approval (Compl. ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed infringement analysis or claim chart. Instead, it alleges infringement under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking approval to market a generic drug before the expiration of patents covering the branded drug as a statutory act of infringement (Compl. ¶35, ¶46, ¶57, ¶68, ¶79, ¶90, ¶100, ¶110). The complaint makes conclusory allegations that MSN’s generic plecanatide oral tablets will infringe at least one claim of each asserted patent if approved and marketed (Compl. ¶36, ¶47, ¶58, ¶69, ¶80, ¶91, ¶101, ¶111). No specific claim elements are mapped to features of the accused product.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Statutory Infringement: The primary basis for the lawsuit is the statutory act of infringement created by the ANDA filing. The core dispute will center on the merits of MSN’s Paragraph IV certification, in which MSN presumably asserted that the patents-in-suit are invalid, unenforceable, or will not be infringed by its generic product.
    • Technical Questions: A key factual question for the court will be whether the specific plecanatide peptide and final formulation in MSN’s ANDA product meet the limitations of the asserted claims. This will involve comparing the chemical structure, purity levels, particle size, and formulation components of MSN's product against the corresponding claim elements of the ’786, ’897, and ’637 patents (composition claims) and the ’451, ’321, ’097, ’024, and ’231 patents (method and formulation claims).

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms as being in dispute. However, based on the technology and the nature of ANDA litigation, the following terms may become central to the case.

  • The Term: "peptide agonist of a guanylate cyclase receptor" (from '786 Patent, claim 1)

  • Context and Importance: This term defines the scope of the active ingredient covered by the method claims. Its construction is critical to determining whether MSN's plecanatide product, even if not identical to a specific disclosed sequence, would still fall within the scope of certain claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides numerous examples of agonists, including uroguanylin, guanylin, and E. coli ST peptide, and defines the term functionally as compounds that "bind to a guanylate cyclase receptor and stimulate cGMP production" (Compl. Ex. A, ’786 Patent, col. 7:8-14).
    • Evidence for a Narrower Interpretation: Defendants may argue the term should be limited by the specific structures and sequences disclosed as preferred embodiments, such as SEQ ID NO:20, to exclude other potential agonists (Compl. Ex. A, ’786 Patent, col. 5:4-15).

  • The Term: "a purified peptide ... having a chromatographic purity of no less than 97%" (from '637 Patent, claim 1)

  • Context and Importance: This term, and similar purity limitations in other asserted patents, sets a quantitative threshold for infringement. The case may turn on the precise measurement of purity in MSN's product and the methodology used to determine it.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Plaintiffs may argue that any standard, accepted method for measuring chromatographic purity (such as HPLC) that shows a result of 97% or greater meets this limitation.
    • Evidence for a Narrower Interpretation: The patent specification describes specific analytical methods, such as UPLC (Compl. Ex. H, ’637 Patent, col. 7:3). A defendant might argue that the claim should be construed to require purity as measured only by the specific methods disclosed in the patent, potentially yielding a different result than other methods.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, MSN will contributorily infringe and/or induce infringement of the patents-in-suit (Compl. ¶37, ¶48). The basis for this allegation is the future commercial manufacture, marketing, and sale of the generic product with labeling that will instruct physicians and patients to use it for the patented indications.
  • Willful Infringement: The complaint does not explicitly allege "willful infringement." However, it requests that the court declare this to be an "exceptional case" under 35 U.S.C. § 285 and award attorney’s fees (Compl., Prayer for Relief ¶12). The basis for this is MSN's knowledge of the patents, which is evidenced by their listing in the FDA's Orange Book and MSN's submission of a Paragraph IV certification as part of its ANDA filing (Compl. ¶24, ¶28).

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

  • A central question will be one of claim scope and validity: Will MSN be able to prove, by clear and convincing evidence, that the asserted claims of the eight patents are invalid over the prior art? Conversely, can Plaintiffs demonstrate that MSN’s proposed generic product falls within the scope of valid and enforceable claims?
  • A key evidentiary question will be one of technical and factual infringement: Does MSN’s plecanatide product, as specified in its confidential ANDA, possess the exact peptide sequences, purity levels, particle sizes, and formulation components required by the various composition, method, and formulation claims across the asserted patents?
  • The outcome of the case will likely depend on claim construction: How the court defines critical but potentially ambiguous terms, such as the specific parameters for purity, particle size, and stability in the formulation patents (e.g., '097 and '637), will be decisive in determining whether MSN's product infringes.