DCT

2:18-cv-05752

Adapt Pharma Operations Ltd v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-05752, D.N.J., 04/09/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Teva USA’s systematic and continuous contacts with the state, including business registrations, the presence of facilities and employees, and a history of litigating in the district without contesting jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s NARCAN® (naloxone hydrochloride) Nasal Spray constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical formulations and devices for the nasal delivery of naloxone, an opioid receptor antagonist used for the emergency treatment of opioid overdose.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 211561 and its associated Paragraph IV Certification, which alleges that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by Defendant's proposed generic product. The complaint also notes a related, consolidated case involving the same parties concerning a generic version of a naloxone hydrochloride drug product.

Case Timeline

Date Event
2014-03-14 Earliest Priority Date ('’644 and '’226 Patents)
2016-11-01 U.S. Patent No. 9,480,644 Issues
2017-07-18 U.S. Patent No. 9,707,226 Issues
2018-02-26 Defendant Sends Paragraph IV Notice Letter
2018-04-09 Complaint Filed

No probative visual evidence provided in complaint.

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

U.S. Patent No. 9,480,644 - “Nasal Drug Products and Methods of Their Use”

The Invention Explained

  • Problem Addressed: The patent describes the public health crisis of opioid overdose and the limitations of existing naloxone treatments, which are typically injectable and must be administered by trained medical personnel (ʼ644 Patent, col. 2:11-14). It notes that previously attempted nasal naloxone delivery systems were often inefficient, requiring on-site assembly of a separate vial and atomizer, or used large volumes of solution that could be lost to drainage rather than absorbed ('644 Patent, col. 6:42-50; col. 15:6-14).
  • The Patented Solution: The invention is a pre-primed, single- or bi-dose nasal spray device that is ready for immediate use by an untrained individual ('644 Patent, col. 6:51-63). The device contains a small, concentrated volume (e.g., 100 µL) of a naloxone hydrochloride formulation, designed to enable rapid, needle-free administration and obviate the need for a second dose or other medical intervention until professional help can arrive ('644 Patent, Abstract; col. 6:54-63).
  • Technical Importance: The invention provides an easy-to-use, storage-stable, and needleless device that allows laypersons, such as family members or first responders, to quickly administer a life-saving opioid antagonist outside of a clinical setting ('644 Patent, col. 6:51-63).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Independent claim 1 is representative of the device claims.
  • Essential elements of Independent Claim 1:
    • A single-use, pre-primed device adapted for nasal delivery by one actuation into one nostril.
    • The device has a single reservoir containing an aqueous solution of about 100 µL.
    • The solution comprises about 2 mg of naloxone hydrochloride or a hydrate thereof.
    • The solution also comprises specific concentration ranges for an isotonicity agent, a compound that is a preservative/cationic surfactant/permeation enhancer, a stabilizing agent, and an acid to achieve a specific pH.
  • The complaint reserves the right to assert infringement of one or more claims of the patent (Compl. ¶39).

U.S. Patent No. 9,707,226 - “Nasal Drug Products and Methods of Their Use”

The Invention Explained

  • Problem Addressed: This patent addresses similar problems as the ʼ644 Patent, focusing on the need for stable, easy-to-use, needleless devices for rapid overdose reversal by untrained individuals ('226 Patent, col. 2:50-62). It specifically notes the challenge of creating a stable naloxone formulation, citing prior art that taught away from using certain preservatives like benzalkonium chloride due to degradation concerns ('226 Patent, col. 2:43-49).
  • The Patented Solution: The patent describes methods and devices for nasally delivering a pharmaceutical solution containing naloxone and specific excipients, including benzalkonium chloride, which functions as a preservative and permeation enhancer ('226 Patent, col. 13:1-5). The invention also focuses on specific spray characteristics, such as delivering a "round plume" with a low ovality ratio, to ensure efficient deposition of the drug onto the nasal mucosa for rapid absorption ('226 Patent, col. 3:1-5).
  • Technical Importance: The invention provides a specific, stable formulation that enables the effective nasal delivery of naloxone, overcoming prior art concerns about excipient compatibility and optimizing spray dynamics for improved bioavailability ('226 Patent, col. 13:40-14:15).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Independent claim 1 is representative of the method claims.
  • Essential elements of Independent Claim 1:
    • A method of treating opioid overdose.
    • The method comprises delivering a 25-200 µL spray from a pre-primed device into a patient's nostril.
    • The pharmaceutical solution comprises about 2 mg naloxone hydrochloride (or a hydrate thereof), an isotonicity agent, and between about 0.005% and 0.015% (w/v) of benzalkonium chloride.
  • The complaint reserves the right to assert infringement of one or more claims of the patent (Compl. ¶48).

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic naloxone hydrochloride nasal spray, 2 mg/spray, identified in ANDA No. 211561 ("Teva's Proposed Product") (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs’ NARCAN® Nasal Spray 2 mg product (Compl. ¶1). As a generic equivalent, it is intended for the same use: the emergency treatment of opioid overdose (Compl. ¶14). The complaint alleges that upon FDA approval, the Defendant will commercially manufacture, use, sell, and import this product in the United States (Compl. ¶33). The complaint does not provide specific details regarding the formulation or device components of the accused product, noting that Defendant has not yet provided its ANDA to Plaintiffs (Compl. ¶37).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed infringement allegations beyond the statutory allegation that the filing of the ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶39, 48). The following summary is based on the necessary implication that for Teva to obtain approval for a generic version of NARCAN® Nasal Spray, its proposed product must have characteristics that Plaintiffs allege are covered by the patents-in-suit.

'644 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation... Teva’s Proposed Product is alleged to be delivered via a single-use, pre-primed nasal spray device for administration in a single actuation. ¶¶1, 39 col. 12:31-36
having a single reservoir comprising a pharmaceutical composition which is an aqueous solution of about 100 µL Teva's Proposed Product is alleged to be contained in a reservoir and to deliver a small volume of aqueous solution consistent with the reference product. ¶¶1, 39 col. 17:47-52
comprising: about 2 mg naloxone hydrochloride or a hydrate thereof... Teva's Proposed Product is identified as a naloxone hydrochloride nasal spray, 2 mg/spray. ¶1 col. 13:24-31
between about 0.2 mg and about 1.2 mg of an isotonicity agent... [and other excipients] As a generic equivalent, Teva's Proposed Product is alleged to contain a formulation with excipients that perform the functions required by the claim. ¶39 col. 52:63-53:4

'226 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating opioid overdose, the method comprising: delivering a 25-200 µL spray of a pharmaceutical solution from a pre-primed device into a nostril of a patient... The proposed labeling for Teva's Proposed Product will allegedly instruct users to administer the product via a pre-primed nasal spray to treat opioid overdose. ¶¶1, 14, 48 col. 8:51-54
wherein the pharmaceutical solution comprises about 2 mg naloxone hydrochloride or a hydrate thereof, an isotonicity agent, and between about 0.005% and about 0.015% (w/v) of benzalkonium chloride. Teva's Proposed Product is alleged to contain a 2 mg naloxone hydrochloride formulation with excipients, including benzalkonium chloride, that fall within the claimed concentrations. ¶¶1, 48 col. 13:1-20
  • Identified Points of Contention:
    • Factual Questions: The core of the dispute will be factual: Does the formulation and device described in Teva's confidential ANDA actually fall within the scope of the asserted claims? The complaint notes Teva has not yet provided this information (Compl. ¶37).
    • Scope Questions: A likely point of contention will be the construction of the term "about" as it applies to the claimed dosage of naloxone and the concentrations of various excipients. Whether Teva's formulation falls inside or outside the construed range of "about 2 mg" could be dispositive.
    • Technical Questions (Invalidity): Teva's Paragraph IV certification asserts that the patents are invalid (Compl. ¶36). A key technical question will be whether formulating naloxone for nasal delivery with the claimed excipients (e.g., benzalkonium chloride as a permeation enhancer, disodium edetate as a stabilizer) was an obvious-to-try modification for a skilled formulator, given the prior art on nasal drug delivery.

V. Key Claim Terms for Construction

  • The Term: "pre-primed" ('644 Patent, Claim 1; '226 Patent, Claim 1)

  • Context and Importance: This term is central to the invention's purpose of being usable by an untrained individual in an emergency, as it eliminates the need for preparatory steps. Defendant may argue that its device requires a user action that constitutes "priming," thereby designing around the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patents provide a specific definition: a device "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, such as by actuating the pump one or more times until a spray appears" (’644 Patent, col. 12:31-36). This explicit definition provides strong intrinsic support for Plaintiff's likely interpretation.
    • Evidence for a Narrower Interpretation: Defendant might point to the specification’s criticism of prior art systems requiring assembly as context, arguing "pre-primed" should be narrowly construed to only distinguish over such multi-part, user-assembled systems (’644 Patent, col. 15:6-14).

  • The Term: "a compound which is at least one of a preservative, a cationic surfactant, and a permeation enhancer" ('644 Patent, Claim 1)

  • Context and Importance: The infringement analysis for this limitation depends on both the identity and function of the excipients in Teva's formulation. Practitioners may focus on this term because Teva could argue that its chosen excipient, while perhaps having a preservative effect, does not function as a "permeation enhancer" at the concentration used.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of "at least one of" suggests the limitation is met if the compound performs any of the three listed functions. The specification explicitly identifies benzalkonium chloride as a compound that can serve all three roles (’644 Patent, col. 17:60-65; col. 25:25-29).
    • Evidence for a Narrower Interpretation: The ʼ226 Patent notes that some prior art taught away from using benzalkonium chloride with naloxone, suggesting its function is not straightforward and may be concentration-dependent (’226 Patent, col. 2:43-49). Defendant could argue that this context requires the term to be construed narrowly to cover only formulations where the compound is present at a concentration proven to be effective for the claimed function.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement. The inducement theory is based on the allegation that Defendant, with knowledge of the patents, will encourage direct infringement by providing user instructions and marketing materials that direct end-users to administer the product in an infringing manner (Compl. ¶¶42, 51). The contributory infringement theory alleges that Defendant's product is designed for a use that infringes the patents-in-suit and lacks a substantial non-infringing use (Compl. ¶¶43, 52).
  • Willful Infringement: The complaint does not contain an explicit allegation of willfulness. However, it requests a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which is the procedural equivalent (Compl. ¶¶46, 55). This allegation is predicated on Defendant's alleged knowledge of the patents-in-suit, evidenced by its Paragraph IV certification, and its decision to seek FDA approval for its generic product before the patents expire (Compl. ¶36).

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

  • A core issue will be one of infringement analysis based on confidential data: does the specific device design and chemical formulation detailed in Teva's confidential ANDA submission literally meet every limitation of the asserted claims, or has Teva successfully "designed around" one or more elements? The outcome will depend heavily on discovery of the ANDA's contents.
  • A key legal question will be one of claim scope: how broadly will the court construe terms such as "about" in the context of specific chemical concentrations, and functional language such as "permeation enhancer"? The resolution of these claim construction disputes will likely determine the outcome of the infringement analysis.
  • A central validity question will be one of obviousness: could a person of ordinary skill in the art, seeking to develop a nasal spray for naloxone, have arrived at the claimed formulation and device characteristics with a reasonable expectation of success by combining or modifying prior art teachings on nasal drug delivery and pharmaceutical excipients?