DCT

2:17-cv-02877

Adapt Pharma Operations Ltd v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-02864, D.N.J., 04/26/2017
  • Venue Allegations: Venue is alleged to be proper based on Defendant Teva USA having systematic and continuous contacts with New Jersey, including being registered to do business, maintaining a registered agent, holding state licenses, employing personnel, conducting business, and having customers within the district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ NARCAN® (naloxone hydrochloride) Nasal Spray constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical formulations and delivery devices for the intranasal administration of naloxone, an opioid antagonist used for the emergency treatment of opioid overdose.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants’ submission of ANDA No. 209522 with a Paragraph IV certification, which alleges that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by the proposed generic product. This certification serves as the statutory act of infringement giving rise to the suit.

Case Timeline

Date Event
2014-03-14 ’177 Patent Priority Date
2017-02-07 ’177 Patent Issue Date
2017-03-17 Earliest date Teva sent Paragraph IV Notice Letter to Plaintiffs
2017-04-26 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 9,561,177, "Nasal Drug Products and Methods of Their Use," issued February 7, 2017 (’177 Patent).

The Invention Explained

  • Problem Addressed: The patent background describes a need for a durable, easy-to-use, needle-free device that enables untrained individuals to quickly administer a therapeutically effective dose of naloxone to a person experiencing an opioid overdose (’177 Patent, col. 2:50-57). Previous intranasal naloxone attempts suffered from very low bioavailability (around 4%) and formulations that were unstable with certain common preservatives (’177 Patent, col. 2:35-49).
  • The Patented Solution: The invention is a pre-primed, single-use nasal spray device containing a concentrated naloxone solution with specific excipients designed to ensure stability and rapid absorption (’177 Patent, Abstract). The formulation is designed to be delivered in a small volume (e.g., 100 µL) with specific spray characteristics, such as controlled droplet size and plume shape, to maximize bioavailability and provide a therapeutic effect comparable to or better than an intramuscular injection (’177 Patent, col. 14:41-54; FIG. 1).
  • Technical Importance: This approach makes a life-saving opioid overdose reversal agent accessible to laypersons like family members or first responders, potentially allowing for immediate intervention before professional medical help arrives (’177 Patent, col. 2:8-16).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of "one or more claims" (Compl. ¶26). Claim 1 is a representative independent method claim.
  • Essential Elements of Independent Claim 1:
    • A method of treating opioid overdose,
    • comprising delivering a 25-200 µL spray of a pharmaceutical solution,
    • from a pre-primed device into a nostril of a patient, wherein the solution comprises:
    • about 4 mg naloxone hydrochloride or a hydrate thereof,
    • between about 0.005% and about 0.015% (w/v) of benzalkonium chloride, and
    • an isotonicity agent.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • "Teva's Proposed Product" is a generic naloxone hydrochloride nasal spray (4 mg/spray) for which Teva is seeking FDA approval via ANDA No. 209522 (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that Teva's Proposed Product is a generic version of Adapt's NARCAN® Nasal Spray (Compl. ¶1). As such, its intended function is the emergency treatment of known or suspected opioid overdose (Compl. ¶11). The complaint does not provide specific technical details about the formulation or device of Teva's Proposed Product, as this information is contained within the confidential ANDA that Plaintiffs had not yet received access to (Compl. ¶24).
  • The filing of the ANDA signifies Teva's intent to commercially manufacture, use, and sell the product in the United States upon FDA approval, positioning it as a direct generic competitor to Plaintiffs' branded product (Compl. ¶20-21).

IV. Analysis of Infringement Allegations

The complaint, filed under the provisions of the Hatch-Waxman Act, does not contain a detailed claim chart. The statutory act of infringement is the filing of the ANDA itself, which seeks approval for a drug claimed in a patent before the patent's expiration (Compl. ¶26). The following chart summarizes the infringement theory that would apply if Teva's proposed product and its method of use are as described in its ANDA seeking to be a generic equivalent of NARCAN® Nasal Spray.

No probative visual evidence provided in complaint.

’177 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating opioid overdose... Teva's proposed product is indicated for the emergency treatment of opioid overdose. ¶1, ¶11 col. 61:36-37
...comprising delivering a 25-200 µL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient... Teva's proposed product is a nasal spray alleged to be a generic version of the NARCAN® product, which is a pre-primed device delivering a 100 µL spray. ¶1, ¶11 col. 61:38-41
...wherein the pharmaceutical solution comprises: about 4 mg naloxone hydrochloride or a hydrate thereof... Teva's proposed product is a naloxone hydrochloride nasal spray, 4 mg/spray. ¶1 col. 62:3-5
...between about 0.005% and about 0.015% (w/v) of benzalkonium chloride... The complaint does not provide sufficient detail for analysis of this element. The allegation is based on the statutory presumption that the proposed generic is a copy of the branded product. ¶1, ¶22 col. 62:6-8
...and an isotonicity agent. The complaint does not provide sufficient detail for analysis of this element. The allegation is based on the statutory presumption that the proposed generic is a copy of the branded product. ¶1, ¶22 col. 62:9
  • Identified Points of Contention:
    • Scope Questions: A central question will be whether the specific formulation of Teva's Proposed Product, as detailed in its ANDA, falls within the scope of the claims. For example, does the concentration of benzalkonium chloride in Teva's product meet the range required by Claim 1?
    • Technical Questions: In an ANDA case, the primary dispute is typically not over literal infringement but rather claim validity. The key technical question for the court will be whether the combination of elements in the asserted claims (e.g., the specific concentration of naloxone, the use and concentration of benzalkonium chloride, and the pre-primed nasal spray device) was obvious to a person of ordinary skill in the art at the time of the invention.

V. Key Claim Terms for Construction

  • The Term: "about 4 mg naloxone hydrochloride"

  • Context and Importance: The precise quantity of the active ingredient is a central feature of the claimed formulation. Practitioners may focus on this term because Teva's product is also a "4 mg/spray" formulation (Compl. ¶1). The dispute will likely center on whether the term "about" provides any flexibility beyond standard manufacturing tolerances and whether the prior art discloses or suggests this specific dosage for effective intranasal delivery.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of the word "about" itself suggests the patentee did not intend to be limited to exactly 4.0 mg, allowing for some variation. The specification repeatedly describes embodiments with 2 mg, 4 mg, and 8 mg, indicating a range of effective doses (’177 Patent, col. 10:37-43).
    • Evidence for a Narrower Interpretation: The claims specifically recite "about 4 mg," distinguishing this from other disclosed amounts. The patent presents extensive clinical data comparing 2 mg and 4 mg doses, suggesting that the 4 mg dose has distinct and important pharmacokinetic properties that the patentee sought to capture (’177 Patent, col. 41:1-43:65). A defendant might argue that "about" should be construed narrowly in light of this specific data.

  • The Term: "benzalkonium chloride" (in the context of the concentration range of "between about 0.005% and about 0.015% (w/v)")

  • Context and Importance: This term is critical because the patent describes benzalkonium chloride not just as a preservative but also as a potential "permeation/penetration enhancer" that improves bioavailability, a key problem the invention aimed to solve (’177 Patent, col. 14:11-17, 15:35-49). The specific, narrow concentration range claimed suggests this amount is critical to achieving the desired effect without causing toxicity.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses benzalkonium chloride more broadly as a "preservative, permeation/penetration enhancer and/or a cationic surfactant" and discloses a wider concentration range of "about 0.005% to about 1%" in some embodiments (’177 Patent, col. 14:28-31, 14:62-64).
    • Evidence for a Narrower Interpretation: Claim 1 recites a much narrower range (0.005%-0.015%) than the broader range disclosed elsewhere in the specification. This suggests a deliberate choice to claim a specific, optimized concentration. The background also discusses the unsuitability of benzalkonium chloride in prior art formulations, suggesting that the claimed amount is key to overcoming past failures (’177 Patent, col. 2:42-49).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Teva will induce infringement by marketing and selling its product with instructions that encourage end-users to perform the patented method of administration (Compl. ¶29). Contributory infringement is also alleged on the basis that Teva's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶30).
  • Willful Infringement: The complaint does not include a separate count for willfulness. However, it alleges that Teva has knowledge of the ’177 patent, at least as of the date it provided its Paragraph IV certification notice, which could form the basis for a later argument of post-suit willfulness (Compl. ¶23, ¶29). The complaint also requests a finding that the case is "exceptional" under 35 U.S.C. § 285, which is the standard for awarding attorneys' fees (Compl. ¶33).

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

  • A core issue will be one of validity: Did the prior art, including earlier attempts at intranasal naloxone, render the claimed combination of a 4 mg dose, a specific low concentration of benzalkonium chloride, and a pre-primed nasal delivery device obvious to a person of ordinary skill in pharmaceutical formulation?
  • A second key issue will be one of claim construction: How will the court define the scope of "about 4 mg"? The interpretation of this term will be critical, as it directly relates to the dosage of the accused generic product and could determine the relevance of prior art disclosing different doses.
  • A final question will be evidentiary: As discovery proceeds, will the specific formulation and device characteristics detailed in Teva's confidential ANDA reveal any non-infringing alternatives or design choices that place it outside the literal scope of the asserted claims, or will its nature as a proposed generic equivalent foreclose such arguments?