DCT

2:17-cv-00864

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-00864, D.N.J., 02/08/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey based on Defendants' systematic and continuous business contacts with the state, including maintaining a registered agent, holding licenses, employing people, conducting business, and deriving revenue from pharmaceutical sales 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® Nasal Spray constitutes an act of infringement of a patent covering naloxone formulations and methods of use.
  • Technical Context: The technology relates to needle-free, pre-primed nasal spray devices for administering naloxone, an opioid antagonist, to rapidly reverse the effects of an opioid overdose, a significant issue in public health.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 209522 to the FDA. Defendants provided Plaintiffs with a Paragraph IV Certification notice, alleging that the patent-in-suit is invalid and/or will not be infringed by their proposed generic product.

Case Timeline

Date Event
2014-03-14 ’747 Patent Priority Date
2016-10-18 ’747 Patent Issue Date
2016-12-29 Teva sends Paragraph IV Notice Letter to Plaintiffs
2017-02-08 Complaint Filing Date

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

U.S. Patent No. 9,468,747 - "Nasal Drug Products and Methods of Their Use"

  • Patent Identification: U.S. Patent No. 9,468,747, "Nasal Drug Products and Methods of Their Use," issued October 18, 2016.

The Invention Explained

  • Problem Addressed: The patent describes the growing opioid overdose crisis and the limitations of existing naloxone delivery methods, which often require trained medical personnel for injection or involve complex, multi-step assembly for intranasal administration, rendering them unsuitable for emergency use by untrained individuals like family members or bystanders (’747 Patent, col. 2:13-18, col. 6:15-35).
  • The Patented Solution: The invention provides a durable, easy-to-use, pre-primed nasal spray device containing a storage-stable, concentrated naloxone formulation. This design enables untrained individuals to quickly deliver a therapeutically effective dose of the opioid antagonist to an overdose patient in a single actuation, obviating the need for needles or device assembly during a critical emergency (’747 Patent, Abstract; col. 6:54-62).
  • Technical Importance: The technology sought to make a life-saving opioid overdose antidote widely accessible and simple enough for laypersons to use effectively, thereby addressing a critical gap in public health response strategies (’747 Patent, col. 6:43-54).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’747 patent without specifying particular claims (Compl. ¶26). Independent claim 1 is representative of the asserted methods of use.
  • Independent Claim 1 (Method):
    • A method of treatment of opioid overdose by nasally administering a dose of naloxone hydrochloride using a single-use, pre-primed device.
    • The administration is performed by one actuation into one nostril.
    • The device has a single reservoir containing an aqueous solution of about 100 µL.
    • The solution comprises about 4 mg of naloxone hydrochloride or a hydrate thereof.
    • The solution further comprises specific amounts of an isotonicity agent, a compound that is a preservative/cationic surfactant/permeation enhancer, and a stabilizing agent.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Teva's Proposed Product," identified as a generic naloxone hydrochloride nasal spray (4 mg/spray) for which Teva seeks 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). This implies the accused product is a pre-filled, pre-primed, single-dose nasal spray device designed for the emergency treatment of opioid overdose by laypersons and first responders (Compl. ¶1, 11). As a generic, it would compete directly with NARCAN®, which the complaint identifies as the first and only FDA-approved nasal spray for this indication (Compl. ¶11).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed, element-by-element infringement allegations. The infringement theory is statutory, based on 35 U.S.C. § 271(e)(2)(A), where the act of filing an ANDA for a drug claimed in a patent is an act of infringement (Compl. ¶26). The substantive allegation is that Teva's Proposed Product is a generic copy of Plaintiffs' NARCAN® Nasal Spray, a product that Plaintiffs assert is covered by the claims of the ’747 Patent (Compl. ¶1, 11-12). The complaint alleges that upon FDA approval, Teva's commercial manufacture, use, and sale of its product will directly infringe the ’747 Patent (Compl. ¶28).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: Teva’s Paragraph IV notice letter alleges non-infringement, raising the question of whether its specific formulation falls outside the scope of the patent's claims (Compl. ¶23). Disputes may arise over the interpretation of terms such as "about 4 mg" for the active ingredient and the recited ranges for excipients like the "isotonicity agent" and "stabilizing agent."
    • Technical Questions: A central technical question will be whether the formulation of Teva's Proposed Product, as detailed in its confidential ANDA, meets the specific compositional limitations of the asserted claims.

V. Key Claim Terms for Construction

  • The Term: "pre-primed device"

  • Context and Importance: This term is central to the invention's purpose of enabling rapid use by untrained individuals. The definition will be critical to determining if Teva's device, regardless of its internal mechanism, performs the function required by the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a functional definition: "a device... which is capable of delivering a pharmaceutical composition to a patient in need thereof with the first actuation of the spray pump, i.e., without the need to prime the pump prior to dosing" (’747 Patent, col. 12:31-36). This language may support a construction that covers any device ready for immediate use, regardless of its specific mechanical design.
    • Evidence for a Narrower Interpretation: A defendant could argue that the term should be limited to the specific types of single- or bi-dose devices discussed in the specification, such as those from Aptar or Becton Dickinson, if Teva's device operates via a fundamentally different mechanism (’747 Patent, col. 17:10-24).

  • The Term: "about 4 mg naloxone hydrochloride"

  • Context and Importance: The precise numerical scope of "about" is a frequent point of contention in pharmaceutical patent litigation. As Teva's product is also a 4 mg/spray formulation, the dispute will likely focus on whether manufacturing tolerances or minor deviations place Teva's product outside the claimed range.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of "about" throughout the claims suggests the patentee did not intend to be limited to the exact value of 4.00 mg (’747 Patent, col. 53:15).
    • Evidence for a Narrower Interpretation: The specification provides extensive clinical data for 2 mg and 4 mg doses, suggesting these values were not arbitrary but were specifically chosen and tested for their pharmacokinetic effects (’747 Patent, col. 41:9-14, col. 44:27-46). This could support an argument that "about 4 mg" should be construed narrowly around the specific dose tested and found to be effective.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, asserting that upon approval, Teva will intentionally encourage direct infringement with knowledge of the patent (Compl. ¶29). This is likely based on the expected instructions for use on the generic product's label. The complaint also pleads contributory infringement, alleging 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 explicitly allege "willful" infringement. However, it does seek a finding that the case is "exceptional" and requests an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶33). The basis for this allegation appears to be Teva's knowledge of the patent, as evidenced by its Paragraph IV notice letter (Compl. ¶23).

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

  • A core issue will be one of claim construction and scope: will the term "about" and the recited ranges for the formulation's excipients in claims like Claim 1 be interpreted broadly enough to read on the specific composition of Teva's proposed generic product as disclosed in its ANDA?
  • A second key question will be one of validity: although not detailed in the complaint, Teva's assertion of invalidity in its Paragraph IV notice letter suggests a central dispute will be whether the patented formulation and its delivery via a pre-primed device would have been obvious to a person of ordinary skill in the art at the time of the invention. The patent's clinical data showing specific pharmacokinetic outcomes will likely be central to the patentee's non-obviousness arguments.