DCT

0:25-cv-61939

Glaxo Group Ltd v. Transpire Bio Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 0:25-cv-61939, S.D. Fla., 09/25/2025
  • Venue Allegations: Venue is alleged to be proper as Defendant Transpire is a Florida corporation incorporated and residing within the judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s proposed generic respiratory drug and its associated dry powder inhaler infringe four patents related to specific pharmaceutical formulations and medicament dispenser technology.
  • Technical Context: The technology concerns dry powder inhalers for delivering combination drug therapies to treat respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD), a major segment of the pharmaceutical market.
  • Key Procedural History: This patent infringement action was initiated under the Hatch-Waxman Act following Defendant Transpire's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking to market a generic version of Plaintiff GSK’s BREO ELLIPTA product. The lawsuit was filed within 45 days of GSK’s receipt of Transpire’s Paragraph IV Notice Letter, triggering a potential 30-month stay on FDA approval of the ANDA. The complaint also notes that GSK submitted a request to the FDA to withdraw one of the patents-in-suit, the ’968 patent, from the Orange Book listing for BREO ELLIPTA.

Case Timeline

Date Event
2003-07-24 ’968 Patent Priority Date
2005-07-28 ’242 Patent Priority Date
2005-12-12 ’281 Patent Priority Date
2008-02-27 ’721 Patent Priority Date
2012-04-24 ’968 Patent Issue Date
2012-07-11 GSK submits New Drug Application (NDA) for BREO ELLIPTA
2013-05-10 FDA approves GSK's NDA for BREO ELLIPTA
2013-09-17 ’281 Patent Issue Date
2014-06-10 ’242 Patent Issue Date
2021-09-14 ’721 Patent Issue Date
2023-01-25 Transpire files U.S. Trademark Applications for inhaler design
2024-09-03 Alleged first use in commerce date for Transpire Inhaler Product
2024-11-12 Transpire files Amendments to Allege Use for its trademark applications
2025-05-07 GSK requests withdrawal of ’968 Patent from Orange Book
2025-08-12 Transpire sends Paragraph IV Notice Letter to GSK
2025-08-13 GSK receives Paragraph IV Notice Letter
2025-09-25 Complaint Filing Date

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

U.S. Patent No. 11,116,721 - “Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol” (Issued Sep. 14, 2021)

The Invention Explained

  • Problem Addressed: The patent addresses the need for stable and effective dry powder pharmaceutical formulations for inhaled administration, specifically for combining a particular long-acting beta-2 agonist (vilanterol, or Compound I) with a corticosteroid (fluticasone furoate, or Compound II) for treating respiratory diseases (Compl. ¶24; ’721 Patent, col. 1:11-26).
  • The Patented Solution: The invention is a pharmaceutical product comprising two separate dry powder formulations intended for co-administration. The first formulation combines the beta-2 agonist (Compound I) with lactose as a carrier and a specific, narrow range of magnesium stearate (e.g., 0.6 to 2% w/w) as a ternary agent. The second formulation contains the corticosteroid (Compound II) and lactose (’721 Patent, Abstract; col. 4:1-5). The inclusion of magnesium stearate is described as improving the physical and chemical stability of the product (’721 Patent, col. 4:21-25).
  • Technical Importance: This formulation enables the effective co-delivery of two distinct active ingredients in a once-daily dosage, which can improve patient adherence to treatment regimens for chronic conditions like asthma and COPD (Compl. ¶2, ¶43).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 12, among others (Compl. ¶89).
  • Independent Claim 1 recites:
    • A pharmaceutical product consisting essentially of:
    • (a) a dry powder formulation of Compound (I) (vilanterol or a salt) in micronized form, in a dose of 12.5, 25, or 50 mcg, in admixture with lactose and 0.6 to 2% w/w magnesium stearate; and
    • (b) a dry powder formulation of Compound (II) (fluticasone furoate) and lactose.
  • Independent Claim 12 is more specific, reciting:
    • A pharmaceutical product consisting essentially of:
    • (a) a dry powder formulation of Compound (I) as triphenyl acetate, in a 25 mcg dose, in admixture with lactose and 0.75 to 1.5% w/w magnesium stearate; and
    • (b) a dry powder formulation of Compound (II) in a dose of 100 mcg and lactose.
  • The complaint also asserts dependent claims 28-34, 49-50, 52, and 57-61, which cover methods of treatment for respiratory diseases and specific product compositions (’721 Patent, col. 27:29-col. 29:3).

U.S. Patent No. 8,746,242 - “Medicament Dispenser” (Issued June 10, 2014)

The Invention Explained

  • Problem Addressed: The patent describes a problem with prior art dry powder inhalers where the action of opening the mouthpiece cover is coupled to advancing the medicament strip to prepare a dose. This creates a risk of accidental dose advancement and wastage if a user opens the cover for other reasons, such as cleaning, without intending to take a dose (’242 Patent, col. 1:56-61).
  • The Patented Solution: The invention is a dispenser with a cover that moves sequentially through three positions: a first "covered" position, a second "part-uncovered" position, and a third "uncovered" position. The dispenser’s internal mechanism is designed such that moving the cover from the first to the second position does not actuate the dose dispensing mechanism. Only the subsequent movement from the second to the third position results in actuation, preparing the dose for inhalation (’242 Patent, Abstract; col. 2:50-58). This staged actuation uncouples partial opening from dose preparation.
  • Technical Importance: This design feature enhances user convenience and safety by preventing the inadvertent waste of medication, which is particularly important for patients managing chronic diseases with expensive therapies (Compl. ¶31).

Key Claims at a Glance

  • The complaint asserts independent claim 1, among others (Compl. ¶127).
  • Independent Claim 1 recites:
    • A medicament dispenser for use with at least one medicament carrier.
    • Comprising a dispensing mechanism, a mouthpiece, and a cover.
    • The cover is movably mounted for sequential movement from a first position (mouthpiece covered), to a second position (mouthpiece part-uncovered), to a third position (mouthpiece uncovered).
    • The cover couples with the dispensing mechanism such that movement from the first to the second position does not cause actuation, but further movement from the second to the third position does cause actuation.
  • The complaint also asserts dependent claims 2, 4, and 5, which add limitations including the use of a plurality of medicament carriers (e.g., two strips) and specific drug types (bronchodilator and anti-inflammatory) on those carriers (’242 Patent, col. 40:46-col. 41:7).

U.S. Patent No. 8,534,281 - “Manifold for Use in Medicament Dispenser” (Issued Sep. 17, 2013)

  • Technology Synopsis: The patent addresses the technical challenge of ensuring that dry powder medicament is effectively de-agglomerated when aerosolized during inhalation (’281 Patent, col. 1:40-52). The patented solution is a manifold with a specific internal geometry comprising a "chimney" and a "chamber," separated by a wall containing one or more "bleed holes." This structure splits the patient's inhaled airflow, using a primary portion to lift the powder from a blister pocket and a secondary "bleed airflow" to disruptively impact the powder-laden stream, thereby improving de-aggregation and the fine particle fraction available for inhalation (’281 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 as an example (Compl. ¶187).
  • Accused Features: The internal manifold of the Transpire Inhaler Product is accused of infringing. The complaint alleges this manifold contains a body, a chimney with a single inlet and plural exits, a chamber, and one or more bleed holes arranged to direct airflow and entrain medicament powder from blister packs in the claimed manner (Compl. ¶¶190-196).

U.S. Patent No. 8,161,968 - “Medicament Dispenser” (Issued April 24, 2012)

  • Technology Synopsis: This patent describes the internal mechanics of a medicament dispenser designed to handle plural elongate blister strips. The invention focuses on a dispensing mechanism coupled to a movable cover, where movement of the cover from an "at rest" position to a "primed" position does not actuate the mechanism, but subsequent movement from the "primed" position to an "actuated" position does. This ensures that the indexing of the medicament strips and release of the dose only occurs upon a full, deliberate opening action by the user (’968 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint asserts independent claims 1 and 14 as examples (Compl. ¶246, ¶279).
  • Accused Features: The entire Transpire Inhaler Product is accused, specifically its alleged internal mechanism comprising a receiving station for plural blister strips, a release mechanism, an outlet, an indexer, and a movable cover that allegedly actuates the dispensing components only after moving through a non-actuating "primed" position (Compl. ¶¶247-252).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Transpire Bio Inc.’s Proposed ANDA Product and its associated "Transpire Inhaler Product," which is marketed under the name "Rollingstar" (Compl. ¶4, ¶60).

Functionality and Market Context

The Proposed ANDA Product is a generic version of GSK's BREO ELLIPTA, containing the active ingredients fluticasone furoate and vilanterol trifenatate for the treatment of asthma and COPD (Compl. ¶57, ¶59). The Rollingstar is a dry powder inhaler (DPI) device designed to administer these drugs from two separate foil blister strips (Compl. ¶59, ¶62). An image provided in the complaint shows the manufacture of these blister strips (Compl. p. 21, Ex. K). The complaint alleges the inhaler has a mouthpiece that is exposed by sliding a cover, with air vents located directly beneath the mouthpiece (Compl. ¶61). An image from Transpire's website shows a user inhaling from the device with the cover open, exposing these features (Compl. p. 20, Ex. N). The products are aimed at the U.S. market for respiratory therapies and are intended to be a direct competitor to GSK's branded product (Compl. ¶4, ¶58).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,116,721 Infringement Allegations

Claim Element (from Independent Claim 12) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) a dry powder formulation consisting essentially of Compound (I), which is ... triphenyl acetate present in micronized form and in a dose of 25 mcg, calculated as the free base... The Proposed ANDA Product allegedly comprises a dry powder formulation of vilanterol trifenatate, which is Compound (I), in a micronized form and at a dose of 25 mcg. ¶91, ¶109 col. 27:12-20
...and wherein Compound (I) is in admixture with lactose and 0.75 to 1.5% w/w of magnesium stearate... The vilanterol trifenatate formulation is allegedly in admixture with lactose and between 0.75% and 1.5% magnesium stearate by weight. ¶91, ¶109 col. 27:20-23
(b) a dry powder formulation consisting essentially of Compound (II), which is ... S-fluoromethyl ester present in a dose of 100 mcg and lactose. The Proposed ANDA Product allegedly comprises a second dry powder formulation of fluticasone furoate, which is Compound (II), at a dose of 100 mcg and in admixture with lactose. ¶91, ¶109 col. 27:24-28
  • Identified Points of Contention:
    • Scope Questions: The claim term "consisting essentially of" creates a potential point of dispute. The infringement analysis may depend on whether any unlisted excipients in Transpire's formulation materially alter the basic and novel characteristics of the claimed invention, such as its stability or aerosol performance.
    • Technical Questions: The complaint's allegations regarding the precise composition of the accused product, particularly the exact weight percentage of magnesium stearate, are made on "information and belief." A central evidentiary question will be whether discovery confirms that the formulation of Transpire’s ANDA product falls within the specific ranges recited in the claim.

U.S. Patent No. 8,746,242 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A medicament dispenser for use with at least one medicament carrier carrying multiple distinct medicament portions... The Transpire Inhaler Product is a dispenser allegedly for use with at least one, and specifically two, blister strip medicament carriers. An image shows the accused "Rollingstar" device (Compl. p. 19). ¶130, ¶136 col. 40:17-20
said medicament dispenser comprising (a) a dispensing mechanism actuable for dispensing the distinct medicament portions... The inhaler contains an internal mechanism that is actuated to dispense the medicament portions from the carriers. ¶131 col. 40:24-27
(b) a mouthpiece; and The inhaler includes a mouthpiece for the user. ¶132 col. 40:28-28
(c) a cover for said mouthpiece, said cover being movably mounted to the dispenser for sequential movement from a first position... to a second position... to a third position... The inhaler has a cover that moves to expose the mouthpiece. The complaint provides images of the inhaler in what it alleges correspond to closed and open positions. ¶133 col. 40:29-36
wherein said cover is adapted to couple with said dispensing mechanism such that movement of the cover from the first position to the second position does not result in actuation... but any further movement of the cover from the second position to the third position results in actuation... The complaint alleges that the cover's movement is coupled to the dispensing mechanism in a way that allows partial opening without preparing a dose, while full opening does prepare a dose. ¶134 col. 40:37-45
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis will likely focus on whether the operation of the accused inhaler's cover maps onto the claim's requirement for three distinct sequential "positions." A key question is whether the accused device has a defined, stable, non-actuating "second position," or if actuation begins as part of a single, continuous opening motion.
    • Technical Questions: A factual dispute may arise over the internal mechanics of the accused device. The court will need to examine evidence of how, and at what specific point in its travel, the cover couples with and actuates the dose indexing and preparation mechanism. The complaint does not provide details on the internal mechanism of the accused device.

V. Key Claim Terms for Construction

  • Term from the ’721 Patent: "consisting essentially of"

    • Context and Importance: This transitional phrase is critical because it defines the scope of the claimed formulation. Its construction will determine whether the presence of any additional, unlisted ingredients in Transpire's product—such as flow agents or alternative stabilizers—would allow it to avoid infringement. Practitioners may focus on this term because the dispute could hinge on whether such an unlisted ingredient "materially affects the basic and novel properties" of the claimed formulation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patentee used the more restrictive term "consisting of" in other claims (e.g., claim 49), which may suggest that "consisting essentially of" was intentionally chosen to permit some unlisted ingredients that do not alter the invention's fundamental character.
      • Evidence for a Narrower Interpretation: The specification emphasizes the importance of the specific combination of lactose and magnesium stearate for achieving stability (’721 Patent, col. 4:1-5). A party could argue that any additional substance that affects stability or aerosol performance, even slightly, would be a material alteration.

  • Term from the ’242 Patent: "a second position, in which said mouthpiece is part-uncovered"

    • Context and Importance: The existence of this discrete, intermediate, non-actuating state is a key limitation distinguishing the invention from prior art where any opening action might prepare a dose. Infringement hinges on whether the accused device's operation includes a state that meets this definition before the dispensing mechanism is actuated.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language does not require the "second position" to be a stable, locked state. A party could argue that any point along the cover's path of travel between fully closed and the point of actuation, where the mouthpiece is partially visible, would satisfy this limitation.
      • Evidence for a Narrower Interpretation: The patent's figures and description portray a sequence of distinct states (e.g., '242 patent, Fig. 2a, 2b, 2c). A party could argue this implies that the "second position" must be a mechanically distinct, stable position a user can pause in, not merely a transient point in a continuous motion from closed to fully open and actuated.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for the method claims of the ’721 patent, stating that Transpire’s proposed product label will instruct and encourage physicians and patients to administer the product in an infringing manner (e.g., once daily for COPD) (Compl. ¶¶92-95). For the device patents, inducement is alleged based on Transpire’s marketing of the Rollingstar inhaler for co-development and commercialization partnerships, which would allegedly cause partners to use the device to directly infringe (Compl. ¶141, ¶201).
  • Willful Infringement: Willfulness is alleged for all four patents-in-suit. For the ’721, ’242, and ’281 patents, the complaint bases the allegation on Transpire’s alleged knowledge of the patents as evidenced by its Paragraph IV Notice Letter (Compl. ¶102, ¶150, ¶211). For the ’968 patent, willfulness is alleged based on knowledge from the patent’s prior listing in the FDA’s Orange Book (Compl. ¶309).

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

  • A core issue will be one of compositional identity: Will discovery evidence show that Transpire's generic formulation contains the exact components—specifically the vilanterol salt, the 25 mcg dose, and the narrow 0.75% to 1.5% w/w range of magnesium stearate—recited in the asserted claims of the ’721 patent, or will deviations in composition or concentration create a non-infringement defense?
  • A key question will be one of mechanical operation: Does the accused "Rollingstar" inhaler’s cover mechanism function in the specific multi-stage sequence required by the device patents, particularly the existence of a distinct, non-actuating "second position" where the mouthpiece is part-uncovered, or does its mechanism actuate in a fundamentally different manner that falls outside the literal scope of the claims?
  • A central procedural question will be the relevance of the ’968 patent: Given GSK’s request to delist the ’968 patent from the Orange Book, the court will have to address what, if any, subject matter jurisdiction it has over infringement allegations related to that patent in the context of an ANDA filing, and how that delisting impacts claims for relief tied to the Hatch-Waxman framework.