DCT

1:24-cv-00577

Apotex Inc v. Boehringer Ingelheim Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00577, D. Del., 05/20/2024
  • Venue Allegations: Venue is based on Defendant Boehringer Ingelheim Pharmaceuticals Inc.'s incorporation in Delaware and business contacts within the state, as well as the Defendants' history of filing patent infringement suits in the district.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its generic nintedanib esylate capsules, intended for treating pulmonary fibrosis, do not infringe two of Defendant's patents covering specific pharmaceutical formulations.
  • Technical Context: The technology concerns lipid-based suspension formulations designed to ensure the stability and proper bioavailability of the active drug ingredient nintedanib when delivered in a capsule.
  • Key Procedural History: This case arises under the Hatch-Waxman Act. Plaintiff Apotex filed an Abbreviated New Drug Application (ANDA) with a "Paragraph IV" certification, asserting its product does not infringe Defendant's patents. After being notified, Defendant Boehringer declined to file an infringement suit within the statutory 45-day window. Apotex has now initiated this declaratory judgment action to obtain legal certainty for its product and potentially trigger a "failure to market" forfeiture of the 180-day market exclusivity held by an earlier generic applicant. The complaint also notes a prior, separate declaratory judgment action by another generic manufacturer, Cipla Ltd., which resulted in a consent judgment of non-infringement for Cipla's product.

Case Timeline

Date Event
2008-06-06 Earliest Priority Date for ’756 and ’323 Patents
2018-03-06 U.S. Patent No. 9,907,756 Issues
2018-10-15 First generic ANDA filers submit applications for nintedanib capsules
2018-10-23 U.S. Patent No. 10,105,323 Issues
2022-03-04 Cipla Ltd. files declaratory judgment action on ’756 and ’323 patents
2022-07-18 Consent Decree and Final Judgment entered in Cipla action
2024-03-15 Deadline by which Apotex notified Boehringer of its Paragraph IV certification
2024-05-20 Apotex files Complaint for Declaratory Judgment

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

U.S. Patent No. 9,907,756 - “Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative,” issued March 6, 2018 (’756 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the need for an oral dosage form of the active ingredient nintedanib that provides adequate bioavailability, meaning the drug is effectively absorbed and made available at its site of action in the body (’756 Patent, col. 6:40-52).
  • The Patented Solution: The invention is a soft gelatin capsule containing a liquid, viscous suspension of the active ingredient. The solution described in the specification is to suspend the drug in a specific combination of excipients: medium chain triglycerides (a lipid carrier), hard fat (a thickener), and lecithin (a glidant/solubilizing agent), which together create a stable formulation with the desired release properties (’756 Patent, col. 5:55-65).
  • Technical Importance: This specific formulation provides a vehicle for oral delivery of nintedanib that is designed to be chemically stable and facilitate proper drug absorption after ingestion (’756 Patent, col. 5:60-65).

Key Claims at a Glance

  • The complaint asserts non-infringement of claims 1-8, with claims 1 and 6 being independent (Compl. ¶¶ 100, 108).
  • Independent Claim 1: A formulation of the active substance comprising a lipid suspension containing:
    • The active substance (nintedanib monoethanesulphonate)
    • 1 to 90 wt. % of medium chain triglycerides
    • 1 to 30 wt. % of hard fat
    • 0.1 to 10 wt. % of lecithin
  • Independent Claim 6: A lipid suspension consisting essentially of:
    • The active substance
    • Medium chain triglycerides, hard fat, and lecithin in specified amounts (1 to 90 wt. %, 1 to 30 wt. %, and 0.1 to 10 wt. %, respectively)

U.S. Patent No. 10,105,323 - “Pharmaceutical dosage form for immediate release of an indolinone derivative,” issued October 23, 2018 (’323 Patent)

The Invention Explained

  • Problem Addressed: Similar to the ’756 Patent, this patent aims to create a dosage form for nintedanib that ensures adequate bioavailability. It further seeks to define this by achieving a specific "immediate release profile" (’323 Patent, col. 2:50-55).
  • The Patented Solution: The invention is a viscous lipid suspension formulation that not only contains specific components in defined ranges but also satisfies a functional requirement: a defined dissolution rate under specific laboratory conditions. The formulation comprises the active substance, medium chain triglycerides, hard fat, and lecithin in weight percentages that differ from the ’756 Patent (’323 Patent, col. 1:59-2:4).
  • Technical Importance: By claiming both the chemical composition and a functional dissolution profile, the invention provides a more precise definition of a formulation intended to achieve reliable in vivo performance (’323 Patent, col. 2:50-55).

Key Claims at a Glance

  • The complaint asserts non-infringement of claims 1-10, with claim 1 being independent (Compl. ¶¶ 118, 127).
  • Independent Claim 1: A pharmaceutical dosage form which is a viscous lipid suspension formulation comprising:
    • 10 to 50 wt. % of the active substance
    • 10 to 70 wt. % of medium chain triglycerides
    • 10 to 30 wt. % of hard fat
    • 0.25 to 2.5 wt. % of lecithin
    • Which delivers an immediate release profile where not less than 70% of the active substance is dissolved in 60 minutes under specified in vitro conditions.

III. The Accused Instrumentality

Product Identification

Apotex's generic nintedanib esylate 100 mg and 150 mg capsules, as described in its Abbreviated New Drug Application (ANDA) No. 219227 ("Apotex's ANDA Products") (Compl. ¶42).

Functionality and Market Context

The products are generic equivalents to Boehringer's Ofev® capsules, intended for treating certain lung diseases (Compl. ¶¶ 42, 85). The complaint's central allegation for non-infringement is compositional. While the specific formulation of Apotex's product is redacted, the complaint alleges that it does not contain "hard fat" as required by the asserted claims of the patents-in-suit (Compl. ¶¶ 106, 125). Apotex is a "subsequent filer" under the Hatch-Waxman Act, and its ability to market its product is currently blocked by the 180-day market exclusivity period potentially held by a "first applicant" (Compl. ¶¶ 69, 94).

IV. Analysis of Infringement Allegations

The complaint seeks a declaratory judgment of non-infringement. The core of Apotex's argument is that its product is missing a key ingredient required by all asserted claims.

’756 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged (Non-)Infringing Functionality Complaint Citation Patent Citation
a lipid suspension of the active substance in ... 1 to 30 wt. % of hard fat The complaint alleges that Apotex's ANDA Products do not contain the claimed "1 to 30 wt.% of hard fat" and therefore do not literally infringe claims 1-8 of the ’756 patent. ¶106, ¶108 col. 8:13-14

’323 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged (Non-)Infringing Functionality Complaint Citation Patent Citation
a viscous lipid suspension formulation comprising ... 10 to 30 wt. % of hard fat The complaint alleges that Apotex's ANDA Products do not contain the claimed "10 to 30 wt.% of hard fat" and therefore do not literally infringe claims 1-10 of the ’323 patent. ¶125, ¶127 col. 22:64

Identified Points of Contention

  • Scope Questions: The dispute raises a central question of claim interpretation: what is the scope of the term "hard fat" as used in the patents? The complaint alleges its product lacks this ingredient, suggesting the case will depend on whether any component in Apotex's formulation can be defined as "hard fat," either literally or under the doctrine of equivalents.
  • Technical Questions: A key question relates to the doctrine of equivalents and prosecution history estoppel. The complaint alleges that Boehringer specifically added the "hard fat" limitation to the claims during prosecution to overcome prior art rejections (Compl. ¶¶ 113, 134). The complaint includes a reproduction of Figure 3 from the patent's specification, a graph showing the effect of the melting range of hard fat on the drug's dissolution rate, to underscore the patentee's focus on this specific excipient (Compl. ¶104). This raises the question of whether Boehringer surrendered the right to claim that formulations with different thickeners are equivalent.

V. Key Claim Terms for Construction

  • The Term: "hard fat"
  • Context and Importance: This term appears in every asserted independent claim and is the foundation of Apotex's non-infringement position. The outcome of the literal infringement analysis, and potentially the equivalents analysis, will depend on how this term is construed. Practitioners may focus on this term because Apotex's complaint is built entirely on the alleged absence of this specific ingredient from its formulation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification refers to hard fat as "the most preferred thickener," which may suggest that other, non-preferred thickeners could fall within the scope of the invention (’756 Patent, col. 7:38-39; ’323 Patent, col. 12:41-42).
    • Evidence for a Narrower Interpretation: The specification provides specific examples of commercially available products that are considered "hard fat" (e.g., Gelucire®, Witepsol®, Softisan®) and defines a "most suitable" melting range (30° C. to 44° C.) (’756 Patent, col. 7:42-45). Further, the complaint alleges that the patentee added the "hard fat" limitation during prosecution to distinguish the invention from prior art, an action that typically supports a narrower construction (Compl. ¶¶ 113-115, 134-135).

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

This declaratory judgment action appears poised to turn on two central issues for the court's determination:

  1. A core issue will be one of definitional scope: How should the term "hard fat" be construed? Will its meaning be limited to the specific commercial examples and melting point ranges disclosed in the specification, as Apotex's non-infringement theory requires, or can it be interpreted more broadly to cover other excipients that perform a similar thickening function?

  2. A critical legal question will be the applicability of prosecution history estoppel: Based on the evidence presented in the complaint, did the patentee, by adding the "hard fat" limitation to overcome prior art, clearly and unmistakably surrender any claim to formulations that achieve the same result using different thickeners? This will be central to resolving any dispute under the doctrine of equivalents.