DCT

2:23-cv-03914

Jazz Pharma Research Uk Ltd v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-03914, D.N.J., 07/21/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendants having regular and established places of business in the district, conducting continuous business in the state, and/or consenting to jurisdiction in prior litigations. For foreign defendants, venue is also alleged under 28 U.S.C. § 1391(c)(3).
  • Core Dispute: Plaintiff alleges that multiple generic pharmaceutical companies have infringed its patent by filing Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Plaintiff's Epidiolex® oral solution before the patent's expiration.
  • Technical Context: The technology involves the use of a highly purified cannabidiol (CBD) formulation for treating severe, treatment-resistant forms of childhood-onset epilepsy.
  • Key Procedural History: The asserted patent is listed in the FDA's "Orange Book" for Plaintiff's approved drug product, Epidiolex®. The lawsuit was triggered by the Defendants' separate Paragraph IV certifications notifying the Plaintiff of their ANDA filings, which challenge the patent's validity or assert non-infringement. Several defendants are noted to have previously consented to jurisdiction or waived venue challenges in the District of New Jersey in other matters.

Case Timeline

Date Event
2014-10-14 U.S. Patent No. 11,633,369 Priority Date
2022-11-21 Earliest Alleged ANDA Notice Letter Sent (by Teva)
2023-04-25 U.S. Patent No. 11,633,369 Issues
2023-07-21 Complaint Filed

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

U.S. Patent No. 11,633,369 - "Use of Cannabinoids in the Treatment of Epilepsy"

  • Patent Identification: U.S. Patent No. 11,633,369, "Use of Cannabinoids in the Treatment of Epilepsy", issued April 25, 2023.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of "treatment-resistant epilepsy" (TRE), where approximately 30% of epilepsy patients fail to achieve seizure freedom with existing anti-epileptic drugs (AEDs). This problem is particularly acute in severe childhood epilepsy syndromes, which are often difficult to treat and can lead to significant neurological damage ('369 Patent, col. 1:5-2:20).
  • The Patented Solution: The invention is a method of using cannabidiol (CBD), particularly a highly purified extract with specific, low levels of other cannabinoids like THC, to treat seizures. The patent describes that this formulation is surprisingly effective in reducing "atonic seizures" (also known as 'drop attacks'), which are associated with syndromes like Lennox-Gastaut, compared to its effect on other seizure types ('369 Patent, Abstract; col. 5:16-24, col. 13:1-15). The solution includes a specific oral formulation and a dose-titration schedule.
  • Technical Importance: The invention provided a novel therapeutic approach for patient populations with limited options, demonstrating significant efficacy in reducing a particularly dangerous type of seizure ('drop attacks') in treatment-resistant cases ('369 Patent, col. 1:30-35).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, including at least independent claim 1 ('369 Patent, col. 14:48-15:2).
  • The essential elements of independent claim 1 include:
    • A method of treating seizures in a patient having Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, or Doose Syndrome.
    • Orally administering a pharmaceutical formulation comprising a cannabidiol (CBD) drug substance at a concentration of about 100 mg/mL.
    • The drug substance must comprise CBD and at least one of three specified cannabinoids (CBDV, D⁹THC, or CBD-C4) at concentrations no greater than 1.0%, 0.15%, and 0.5% w/w, respectively.
    • The method requires administering a starting dose of about 5 mg/kg/day.
    • The starting dose is then gradually increased by about 5 mg/kg increments up to a maximum of about 25 mg/kg/day.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the general allegation of infringing "one or more claims" leaves this possibility open.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the proposed generic cannabidiol oral solution products for which each of the numerous Defendants has filed an ANDA with the FDA (Compl. ¶1). For example, Teva's proposed product is identified in connection with ANDA No. 217508 (Compl. ¶167).

Functionality and Market Context

  • The complaint alleges that Defendants' proposed products are generic versions of Plaintiff's Epidiolex®, which is a 100 mg/mL oral solution of cannabidiol (Compl. ¶¶1-2, 20). The proposed products are intended for the same use: treating seizures associated with severe epileptic conditions such as Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex (Compl. ¶20). The complaint includes a screenshot of a Google search result, which it alleges demonstrates that searches for defendant "InvaGen Pharmaceuticals" are directed to the webpage of co-defendant Cipla USA, suggesting a close corporate relationship relevant to the infringement allegations (Compl. ¶56). Epidiolex® is described as the "first and only plant-derived cannabinoid medicine approved by the FDA" (Compl. ¶2).

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), where the filing of an ANDA to market a generic drug prior to patent expiration constitutes a technical act of infringement. The infringement theory is that each Defendant's ANDA seeks approval for a product that will, when marketed, meet every limitation of the asserted claims, and that its proposed label will induce infringement by doctors and patients.

'369 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating seizures in a patient having Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, or Doose Syndrome... Defendants' ANDAs seek approval to market their proposed products for treating seizures associated with LGS, DS, and/or TSC, the same indications for which Epidiolex® is approved. ¶¶20, 168-170, 225 col. 14:48-51
...comprising orally administering to the patient a pharmaceutical formulation comprising a cannabidiol (CBD) drug substance, wherein the CBD is present in the pharmaceutical formulation at a concentration of about 100 mg/mL... Defendants' ANDAs seek approval for a "cannabidiol oral solution 100 mg/mL" intended to be a generic equivalent of Epidiolex®. ¶¶1, 20, 210 col. 14:52-56
...wherein the drug substance comprises CBD and at least one of (i) cannabidivarin (CBDV) at not more than 1.0% w/w..., (ii) delta-9 tetrahydrocannabinol (D⁹THC) at not more than 0.15% w/w..., or (iii) cannabidiol-C4 (CBD-C4) at not more than 0.5% w/w... The complaint alleges the proposed generic product infringes the claims, which implies the active pharmaceutical ingredient will meet the claimed impurity profile. ¶¶221, 223, 225 col. 14:57-15:2
...wherein the patient is administered a starting dose of CBD of about 5 mg/kg/day, and after administering the starting dose of CBD, the starting dose is gradually increased... up to a maximum of about 25 mg/kg/day. The complaint alleges that upon approval, Defendants will induce infringement by instructing physicians and patients, via product labeling, to administer the drug according to the claimed dosing and titration schedule. ¶¶224, 240, 248 col. 15:3-9

Identified Points of Contention

  • Scope Questions: The case may raise the question of whether the Defendants' active pharmaceutical ingredient (API) meets the specific impurity profile of the "drug substance" as defined in claim 1. Infringement will depend on whether the generic product's cannabinoid profile, including trace amounts of CBDV, THC, and CBD-C4, falls within the claimed w/w percentages.
  • Technical Questions: A key evidentiary question for the inducement allegations will be whether the proposed product labels submitted with the Defendants' ANDAs instruct a dosing and titration regimen that is the same as, or bioequivalent to, the specific multi-step dosing schedule recited in claim 1.

V. Key Claim Terms for Construction

"drug substance"

  • Context and Importance: This term is critical because claim 1 defines it not just as CBD, but as CBD with a specific profile of other cannabinoids (impurities) below certain thresholds. The entire infringement analysis for this limitation hinges on whether the defendants' API is proven to meet this multi-part definition. Practitioners may focus on this term because it appears to be a "product-by-process" style limitation, where the patentee is defining the compound by its method of purification and resultant purity, which can be a focal point of litigation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue the term should be read broadly to cover any highly purified CBD used for the claimed method, with the impurity levels being merely exemplary of a preferred embodiment, although this is difficult given their explicit inclusion in the independent claim.
    • Evidence for a Narrower Interpretation: The claim language itself provides a very specific definition ("wherein the drug substance comprises CBD and at least one of..."). The specification reinforces this by describing the purification process used to achieve this specific profile and providing a detailed specification table for the final drug substance (e.g., '369 Patent, col. 9:48-10:46, Table 5). This evidence strongly supports a narrow construction limited to CBD that also meets the specified impurity criteria.

"about 100 mg/mL"

  • Context and Importance: The precise scope of "about" will determine whether a generic product with a slightly different concentration (e.g., 99 mg/mL or 101 mg/mL) infringes. This is a classic point of contention in pharmaceutical patent cases.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "about" itself implies some degree of flexibility and is not intended to be a rigid numerical limit.
    • Evidence for a Narrower Interpretation: The specification provides examples of formulations at "25 mg/ml or 100 mg/ml" ('369 Patent, col. 12:46-49). A party could argue that these discrete examples, coupled with the precision typical in pharmaceutical formulations, suggest "about" allows for only very minor variations consistent with standard manufacturing tolerances.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement against all Defendants. The inducement theory is based on the allegation that Defendants' future product labeling will instruct medical professionals and patients to administer the generic drug in a manner that directly practices the patented method (e.g., for the claimed indications at the claimed dose and titration schedule) (Compl. ¶¶224, 232). The contributory infringement theory is based on the allegation that the proposed generic products are specifically designed for the infringing use and lack a substantial non-infringing use (Compl. ¶¶225, 233).

Willful Infringement

  • While the complaint does not contain a separate count for willful infringement, it alleges that Defendants had knowledge of the '369 patent, at the latest, upon receipt of the Paragraph IV notice letters (e.g., Compl. ¶¶168-170 for Teva). The prayer for relief for each Defendant seeks a judgment that the case is "exceptional" under 35 U.S.C. § 285 and requests attorneys' fees, which is the remedy for a finding of willfulness or other litigation misconduct (e.g., Prayer for Relief Against Teva, (J)).

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

This ANDA litigation will likely center on the validity of the '369 patent, but based on the infringement allegations in the complaint, the following questions are central:

  • A core issue will be one of chemical identity: will discovery show that the Defendants' cannabidiol "drug substance," as specified in their ANDAs, possesses the exact impurity profile (i.e., the specific maximum weight percentages of CBDV, THC, and CBD-C4) required by the limitations of claim 1?
  • A key question of induced infringement will turn on the content of the Defendants' proposed drug labels: will the final FDA-approved labeling for the generic products instruct a method of administration, including the specific starting dose and titration schedule, that falls within the scope of the patent's method claims?
  • Finally, a foundational question will be the scope of the claims: given the patent's prosecution history and detailed examples, how broadly will the court construe terms like "about 100 mg/mL" and the definition of the "drug substance," which will determine the line between infringement and non-infringement for the accused generic products?