Teva Branded Pharmaceutical Products R&D Inc v. Lupin Alantis Holdings SA

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Teva Branded Pharmaceutical Products R&D, Inc., et al. ("Teva") (Various)
  • Defendant: Lupin Atlantis Holdings SA, et al. ("Lupin") (Various)
  • Plaintiff’s Counsel: Shaw Keller LLP
• Case Identification: 1:17-cv-00307, D. Del., 03/21/2017
• Venue Allegations: Plaintiff alleges venue is proper based on Defendant Lupin Pharmaceuticals, Inc.'s incorporation in Delaware and the systematic and continuous business contacts of all defendants within the district.
• Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's PROAIR® HFA (albuterol sulfate) inhalation aerosol infringes three patents related to pharmaceutical formulations and inhaler dose counter technology.
• Technical Context: The dispute involves both the chemical formulation of a metered-dose inhaler using modern propellants and the mechanical design of the device's dose counter, a critical safety feature.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 209954 with a Paragraph IV certification. This certification asserts that Plaintiff's patents are invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff filed this suit within the 45-day statutory window after receiving Defendant's notice letter, triggering a potential 30-month stay of FDA approval for the generic product.

Case Timeline

Date	Event
1991-12-18	Earliest Priority Date for '152 Patent
2006-09-12	U.S. Patent No. 7,105,152 Issued
2007-04-02	Earliest Priority Date for '712 Patent
2010-05-18	Earliest Priority Date for '289 Patent
2012-03-13	U.S. Patent No. 8,132,712 Issued
2016-10-11	U.S. Patent No. 9,463,289 Issued
2017-02-07	Plaintiff Received Defendant's ANDA Notice Letter
2017-03-21	Complaint Filed

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

U.S. Patent No. 7,105,152: Suspension Aerosol Formulations

• Patent Identification: U.S. Patent No. 7,105,152, "Suspension Aerosol Formulations," issued September 12, 2006 (Compl. ¶60).
• The Invention Explained:
  • Problem Addressed: The patent's background describes the global effort to phase out chlorofluorocarbons (CFCs), the once-standard propellants in pharmaceutical aerosols, due to their role in destroying the ozone layer (’152 Patent, col. 1:31-34). This created a need for new formulations based on more environmentally acceptable propellants.
  • The Patented Solution: The invention provides aerosol formulations using hydrofluorocarbons (HFCs), specifically HFC 134a or HFC 227, as propellants. The solution creates a stable suspension of a drug in the HFC propellant that is "substantially and readily redispersible" and exhibits "substantially no growth in particle size or change in crystal morphology" over time, ensuring consistent and effective dosing ('152 Patent, col. 2:40-45). Some embodiments achieve this with only the drug and propellant, while others utilize specific co-solvents like ethanol (’152 Patent, Abstract).
  • Technical Importance: The invention provided a viable pathway for reformulating essential inhalation medicines, allowing the pharmaceutical industry to transition away from ozone-depleting CFCs while maintaining product efficacy and safety.
• Key Claims at a Glance:
  • The complaint asserts infringement of one or more claims without specification (Compl. ¶86). Independent claim 1 is representative of the formulation technology.
  • The essential elements of independent claim 1 are:
    • A pharmaceutical suspension aerosol formulation
    • consisting essentially of: (i) particulate drug;
    • (ii) 1,1,1,2-tetrafluoroethane (HFC-134a) as propellant; and
    • (iii) ethanol in an amount of 5 to about 15 percent by weight,
    • wherein the formulation is further characterized in that it contains no surfactant.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" (Compl. ¶86).

U.S. Patent No. 8,132,712: Metered-Dose Inhaler

• Patent Identification: U.S. Patent No. 8,132,712, "Metered-Dose Inhaler," issued March 13, 2012 (Compl. ¶65).
• The Invention Explained:
  • Problem Addressed: The patent identifies a critical safety issue with metered-dose inhalers: users have difficulty determining when the medication is nearly exhausted, and existing dose counters can be unreliable due to "inevitable variations in the tolerances of the components," which can lead to miscounting (’712 Patent, col. 2:11-19; col. 4:37-42).
  • The Patented Solution: The patent discloses an improved, more robust dose counter mechanism. The core innovation is a "pawl"—the component that engages a ratchet wheel to prevent it from moving backward—that is designed with "at least two ratchet teeth which are radially spaced." (’712 Patent, Abstract). This dual-tooth design provides redundancy; if a short canister stroke prevents a full count cycle with one tooth, the second tooth offers an alternate engagement point, significantly reducing the likelihood of a missed count and improving reliability despite manufacturing variations (’712 Patent, col. 4:56-col. 5:10; Fig. 5).
  • Technical Importance: This technology enhances patient safety by providing a more fault-tolerant mechanical counter, thereby increasing the reliability of the dose-remaining information provided to the user.
• Key Claims at a Glance:
  • The complaint asserts infringement of one or more claims without specification (Compl. ¶98). Independent claim 1 is representative of the dose counter mechanism.
  • The essential elements of independent claim 1 are:
    • A dose counter for a metered-dose inhaler,
    • comprising an actuator, a rotary gear, a driver, and a display,
    • a pawl to prevent reverse rotation of the rotary gear,
    • wherein the pawl comprises at least two ratchet teeth,
    • the at least two ratchet teeth are radially spaced such that one of the teeth engages the wheel's ratchet teeth after each step-wise motion.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" (Compl. ¶98).

U.S. Patent No. 9,463,289: Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof

• Patent Identification: U.S. Patent No. 9,463,289, "Dose Counters for Inhalers, Inhalers and Methods of Assembly Thereof," issued October 11, 2016 (Compl. ¶69).
• Technology Synopsis: This patent discloses further improvements to dose counters and inhaler assemblies, focusing on ensuring counter accuracy in manually operated devices where user actuation force and stroke length are inconsistent. The invention describes specific mechanical configurations of the actuator and counter to ensure a count occurs at or just after the point of dose firing, as well as features within the inhaler body, such as internal support rails, to prevent canister "rocking" that could lead to miscounting (’289 Patent, Abstract; col. 2:9-26; col. 6:46-58).
• Asserted Claims: The complaint asserts infringement of "one or more claims," including at least one independent claim (Compl. ¶110).
• Accused Features: The infringement allegation targets the complete inhaler device proposed in Lupin's ANDA, specifically its dose counter mechanism and internal body structure (Compl. ¶¶109-111).

III. The Accused Instrumentality

• Product Identification: The accused instrumentality is Defendant's "Albuterol ANDA Product," a generic version of Plaintiff's PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, for which Defendant sought FDA approval via ANDA No. 209954 (Compl. ¶¶76, 77).
• Functionality and Market Context: The product is a pressurized metered-dose inhaler containing albuterol sulfate as the active ingredient, intended for the treatment or prevention of bronchospasm (Compl. ¶¶73, 76). As a generic equivalent, it is designed to be therapeutically interchangeable with Teva's branded PROAIR® HFA product. The complaint alleges that Lupin's filing of the ANDA constitutes a legally defined act of infringement and that the future commercial sale of the product would cause Teva to lose sales and suffer injury (Compl. ¶¶55, 86).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail regarding the accused product's specific design to construct a formal claim chart. The infringement theory is statutory, based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a generic drug as an act of infringement of patents covering the branded drug (Compl. ¶¶86, 98, 110). The complaint alleges that Lupin’s Albuterol ANDA Product, if approved and marketed, would infringe one or more claims of each of the patents-in-suit.

• Identified Points of Contention:
  • Scope Questions ('152 Patent): The infringement analysis for the formulation patent will likely hinge on the claim term "consisting essentially of." A primary question for the court will be whether any unrecited ingredients in Lupin's formulation materially alter the basic and novel characteristics of the claimed HFC-based suspension, thereby placing the product outside the claim's scope.
  • Technical Questions ('712 and '289 Patents): For the device patents, the analysis will focus on the specific mechanical structure of Lupin's dose counter. Key questions will include: Does the component in Lupin's device that prevents reverse rotation meet the structural and functional requirements of the claimed "pawl with at least two radially spaced... teeth" ('712 patent)? And does the overall actuator and inhaler body assembly in Lupin's device incorporate the specific fire/count timing and anti-rocking structures claimed in the '289 patent?

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

'152 Patent

• The Term: "consisting essentially of" (Claim 1)
• Context and Importance: This transitional phrase is narrower than "comprising" and broader than "consisting of." Its construction is critical because it determines whether Lupin's formulation infringes if it contains any ingredients not explicitly listed in the claim. Practitioners may focus on this term because the presence of even minor, unlisted excipients in the accused product could form the basis of a non-infringement defense.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue the "basic and novel characteristics" are limited to forming a stable suspension in an HFC propellant, allowing for other unlisted additives that serve different functions (e.g., as a valve lubricant or taste-masking agent) without materially affecting suspension stability. The specification's discussion of optional surfactants in other contexts could be used to argue that the invention is not strictly limited to the recited components ('152 Patent, col. 5:36-44).
  • Evidence for a Narrower Interpretation: The patent repeatedly emphasizes formulations that achieve stability without conventional additives. The explicit limitation "contains no surfactant" in claim 1 suggests that the absence of additional functional components is a key feature. The abstract and summary of the invention describe simple compositions, supporting an interpretation that adding other functionally significant ingredients would materially alter the invention ('152 Patent, Abstract; col. 2:36-45).

'712 Patent

• The Term: "pawl" (Claim 1)
• Context and Importance: The definition of this mechanical element is central to the infringement analysis for the '712 patent. The dispute will turn on whether the component in Lupin's device that prevents reverse gear rotation has the specific structure required by the claims, most notably the "at least two radially spaced" teeth.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party may argue for the term's plain and ordinary meaning in the mechanical arts: a pivoting element that engages a ratchet wheel. This interpretation would focus on the function of preventing reverse rotation, potentially encompassing a wide range of functionally similar but structurally different mechanisms.
  • Evidence for a Narrower Interpretation: The specification provides detailed illustrations of the pawl, such as element 60 in Figure 5, showing a specific embodiment with two distinct teeth (64, 66). A party could argue that the term "pawl" should be construed as being limited to structures consistent with this disclosed embodiment, particularly since the patent presents this structure as the solution to the problems of prior art single-tooth pawls ('712 Patent, col. 4:21-36).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that upon approval and commercialization, Lupin will induce infringement by encouraging and instructing end-users (e.g., via product labeling and instructions) to use the generic inhaler in an infringing manner. It also alleges contributory infringement (Compl. ¶¶92, 104, 116).
• Willful Infringement: The complaint claims that Lupin's infringement is and has been "knowingly and willfully" infringing (Compl. ¶¶88, 100, 112). This allegation is based on Lupin's pre-suit knowledge of the patents, demonstrated by its filing of a Paragraph IV certification that explicitly identified the patents-in-suit and by sending a formal notice letter to Teva (Compl. ¶¶79, 84).

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

• A primary issue will be one of claim construction and chemistry: Can the term "consisting essentially of" in the '152 patent be interpreted to read on Lupin's proposed formulation, or do any unlisted excipients in the generic product materially alter its properties in a way that places it outside the claim scope?
• A second core issue will be a factual and mechanical comparison: Does the dose counter in Lupin's proposed inhaler incorporate the specific multi-tooth "pawl" structure of the '712 patent and the precise actuation-timing and anti-rocking features of the '289 patent, or are there sufficient structural and operational differences to support a finding of non-infringement?
• Finally, the case will involve a significant question of patent validity: As is standard in Hatch-Waxman litigation, the court must adjudicate Defendant's counterclaim, asserted in its Paragraph IV certification, that the claims of the patents-in-suit are invalid for failing to meet one or more statutory requirements for patentability (Compl. ¶78).