DCT

2:18-cv-12663

Boehringer Ingelheim Pharma GmbH Co KG v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-12663, D.N.J., 08/10/2018
  • Venue Allegations: Venue is alleged to be proper because Defendants are foreign corporations, have previously been sued in the district without objecting to personal jurisdiction, and intend to market the accused product in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the SPIRIVA® HandiHaler® product infringes two U.S. patents covering the drug's formulation and its inhalation device.
  • Technical Context: The technology relates to dry powder inhalation formulations and devices for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV certification notice letter from Defendant. The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for the generic product.

Case Timeline

Date Event
2000-10-12 U.S. Patent No. 7,070,800 Priority Date
2004-01-01 FDA Approval of New Drug Application for SPIRIVA® HandiHaler®
2005-04-22 U.S. Patent No. 7,694,676 Filing Date
2006-07-04 U.S. Patent No. 7,070,800 Issued
2010-04-13 U.S. Patent No. 7,694,676 Issued
2018-06-26 Defendant Mails Paragraph IV Notice Letter
2018-08-10 Complaint Filed

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

U.S. Patent No. 7,070,800 - “Inhalable Powder Containing Tiotropium,” issued July 4, 2006

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge of creating a stable and accurately metered inhalable powder when the active pharmaceutical ingredient, tiotropium bromide, is highly potent and thus required only in very small quantities. (’800 Patent, col. 1:49-61). Ensuring that each dose contains a consistent amount of the drug and that the drug can be effectively delivered deep into the lungs is difficult due to the large amount of excipient (filler) required. (’800 Patent, col. 1:62-65).
  • The Patented Solution: The invention is a specific powder formulation that combines the active tiotropium with a physiologically acceptable excipient. Crucially, this excipient is not uniform but is a mixture of a "coarser" fraction and a "finer" fraction, each with a defined average particle size. (’800 Patent, col. 2:50-63). This specific blend of particle sizes is asserted to improve the powder's homogeneity and flow properties, leading to more reproducible and reliable dosing for the patient. (’800 Patent, col. 2:30-46).
  • Technical Importance: This formulation method provided a way to ensure reliable and consistent delivery of a low-dose, high-potency inhaled drug, a significant challenge in pharmaceutical manufacturing for respiratory diseases. (’800 Patent, col. 2:26-39).

Key Claims at a Glance

  • The complaint asserts one or more unspecified claims (Compl. ¶37). Independent claim 1 is representative and recites:
    • An inhalable powder comprising 0.04 to 0.8% of tiotropium in admixture with a physiologically acceptable excipient.
    • Wherein the excipient consists of a mixture of a coarser excipient with an average particle size of 15 to 80 µm and a finer excipient with an average particle size of 1 to 9 µm.
    • The proportion of the finer excipient constitutes 1 to 20% of the total amount of excipient.
    • Wherein the inhalable proportion of active substance is released reproducibly in low variability amounts when administered to a patient.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,694,676 - “Dry Powder Inhaler,” issued April 13, 2010

The Invention Explained

  • Problem Addressed: The patent seeks to improve the handling and ease of use of dry powder inhalers, particularly for patients who may have arthritis or other conditions restricting finger mobility, or who may be using the device at the start of an asthma attack. (’676 Patent, col. 1:4-15; col. 2:7-15).
  • The Patented Solution: The invention is an inhaler device featuring a single "double function actuating member." In a first actuation (e.g., a short press), this member unlatches the device's protective lid via a "clockwork-type mechanism." In a second actuation (e.g., a full press), the same member drives pins to pierce the drug capsule, making it ready for inhalation. (’676 Patent, col. 1:41-49). The patent also describes a "gripping aid" on the mouthpiece to make it easier to open without touching the area that goes into the patient's mouth. (’676 Patent, col. 2:59-65; Fig. 1).
  • Technical Importance: The design simplifies the multi-step process of preparing a capsule-based inhaler for use, which may improve patient safety, compliance, and the effectiveness of drug delivery. (’676 Patent, col. 2:60-62).

Key Claims at a Glance

  • The complaint asserts one or more unspecified claims (Compl. ¶45). Independent claim 1 is representative and recites:
    • An inhaler for inhaling powdered pharmaceutical compositions from capsules.
    • Comprising a lower part, a plate, a capsule holder, a mouthpiece, and a lid, all hinged by a single joint.
    • An actuating member that interacts with at least one pin to pierce the capsule.
    • A mouthpiece with a "gripping aid" for flipping it open.
    • Wherein the actuating member is a "double function actuating member" that, in a first actuation, releases the lid's closure element, and in a second actuation, pierces the capsule.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Lupin’s proposed generic "tiotropium bromide inhalation powder, 18 mcg/capsule," as described in Abbreviated New Drug Application (ANDA) No. 211287 (Compl. ¶¶1, 24).

Functionality and Market Context

  • The complaint alleges that Lupin’s ANDA seeks approval to market a generic version of Plaintiff's SPIRIVA® HandiHaler® product (Compl. ¶1). The ANDA product is intended for the same long-term, once-daily maintenance treatment of bronchospasm associated with COPD (Compl. ¶18). The complaint does not provide specific technical details regarding the formulation or the mechanics of the inhaler device for Lupin's ANDA Product, as these details are contained in the confidential ANDA submission to the FDA. The user instructions for the brand-name SPIRIVA® HandiHaler® device, provided as an exhibit, show a multi-part device into which a user places a capsule. (Compl., Ex. A, p. 31, Fig. A). A small amount of powder is contained within each capsule for inhalation. (Compl., Ex. A, p. 32, Fig. C).

IV. Analysis of Infringement Allegations

The complaint, filed pursuant to 35 U.S.C. § 271(e)(2), alleges infringement based on the act of submitting the ANDA. It does not provide claim charts or a detailed theory of how the Lupin ANDA Product meets the specific limitations of the asserted patents. Therefore, a claim chart summary cannot be constructed from the complaint.

  • Identified Points of Contention:
    • '800 Patent (Formulation): The central dispute will be one of compositional identity. The key question is whether the confidential specifications in Lupin's ANDA describe a powder formulation that falls within the scope of the '800 Patent claims. This will likely involve detailed analysis of whether Lupin's excipient is a mixture of "coarser" and "finer" components with the specific "average particle size" ranges required by the claims. The method of measuring particle size may also become a point of contention.
    • '676 Patent (Device): The infringement analysis will turn on mechanical operation. The primary question is whether the inhaler device described in Lupin's ANDA incorporates the specific mechanisms claimed in the '676 Patent. This will focus on whether Lupin’s device uses a single "double function actuating member" to both release the lid and pierce the capsule, or if it employs a different, non-infringing mechanism to accomplish these actions. The structure and placement of the "gripping aid" on the mouthpiece will also be a key point of comparison.

V. Key Claim Terms for Construction

  • Term: "average particle size" ('800 Patent, Claim 1)

    • Context and Importance: The claim requires the coarser and finer excipient fractions to have distinct and specific ranges of "average particle size." The definition of this term, and the methodology used to measure it, will be dispositive for the infringement analysis of the '800 Patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue that "average particle size" is a well-understood term of art in the field and is not limited to a single measurement technique, unless expressly disclaimed.
      • Evidence for a Narrower Interpretation: The specification provides a highly specific definition: "the mean particle size denotes the value in μm at which 50% of the particles from the volume distribution have a particle size which is smaller than or equal to the value specified. Laser diffraction/dry dispersion is used as the method of measurement..." (’800 Patent, col. 10:1-5). Further, detailed examples specify the exact equipment and settings used for measurement (’800 Patent, col. 7:1-26). This explicit definition in the specification may be used to argue for a narrow construction limited to this specific methodology.

  • Term: "double function actuating member" ('676 Patent, Claim 1)

    • Context and Importance: This term is central to the novelty of the claimed inhaler device. Whether Lupin's device infringes the '676 Patent will depend heavily on whether its actuator can be characterized as performing the two distinct functions recited in the claim: releasing the lid and piercing the capsule.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language is functional, describing what the member does rather than what it is. A plaintiff may argue that any single, user-actuated component that causes both the lid release and capsule piercing, regardless of its specific mechanical implementation, meets the definition.
      • Evidence for a Narrower Interpretation: The specification describes a specific embodiment where the member has an inclined "recess (8)" that cams the "closure element (14)" open upon actuation (’676 Patent, col. 3:46-53; Fig. 1). A defendant may argue that the term should be limited to this disclosed push-button mechanism with a camming surface or a structure that is mechanically equivalent.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Lupin will contribute to and actively induce infringement by healthcare professionals and patients (Compl. ¶¶ 52, 60). The alleged basis for inducement is that the product labeling sought by Lupin will instruct users on how to use the ANDA Product in a manner that directly infringes the asserted patents (Compl. ¶¶ 52, 60).
  • Willful Infringement: The complaint alleges that Lupin had "actual and constructive notice" of the patents-in-suit prior to filing its ANDA and had "no reasonable basis" for its non-infringement certification (Compl. ¶¶ 38, 46). Based on this conduct, Plaintiffs allege the case is "exceptional" under 35 U.S.C. § 285, which forms the basis for a request for attorneys' fees (Compl. ¶¶ 39, 47).

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

The resolution of this case will likely depend on the confidential details of Lupin's ANDA. Based on the complaint and patents, the core disputes can be framed as two central questions for the court:

  • A key question of compositional identity: Does the powder formulation described in Lupin's confidential ANDA meet the specific, multi-element definition of the claimed formulation in the '800 patent—particularly the use of a two-part excipient with distinct "average particle size" ranges—or does it achieve bioequivalence through a different, non-infringing composition?
  • A central issue will be one of mechanical functionality: Does the inhaler device proposed in the ANDA employ a single "double function actuating member" that performs both the lid-release and capsule-piercing functions as claimed in the '676 patent, or does it utilize a mechanically distinct design to achieve these outcomes?