DCT

2:23-cv-23141

Jazz Pharma Research Uk Ltd v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-23141, D.N.J., 03/06/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey for the various domestic and foreign defendants based on established places of business within the district, systematic and continuous contacts with the state, consent to jurisdiction in prior litigation, and/or because the district will be a destination for the allegedly infringing products upon FDA approval.
  • Core Dispute: Plaintiff alleges that Defendants' filing of Abbreviated New Drug Applications (ANDAs) to market generic versions of Plaintiff's Epidiolex® (cannabidiol) oral solution constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical-grade cannabidiol (CBD) preparations and their use in treating severe, treatment-resistant forms of epilepsy, such as Lennox-Gastaut Syndrome and Dravet Syndrome.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendants' submission of ANDAs with Paragraph IV certifications to the FDA. These certifications assert that the patents-in-suit are invalid, unenforceable, or will not be infringed by the Defendants' proposed generic products. The complaint notes that several of the defendants have previously been parties in related litigation in the same district and did not contest personal jurisdiction or venue.

Case Timeline

Date Event
2014-06-17 Earliest Priority Date for ’330 and ’411 Patents
2018-04-27 Earliest Priority Date for ’102 Patent
2022-11-28 Apotex sent first Paragraph IV Notice Letter to Jazz
2022-12-02 InvaGen and Lupin sent first Paragraph IV Notice Letters to Jazz
2022-12-05 Taro sent first Paragraph IV Notice Letter to Jazz
2022-12-06 Ascent, MSN, Biophore, and Zenara sent first Paragraph IV Notice Letters to Jazz
2023-07-18 U.S. Patent No. 11,701,330 Issued
2023-09-26 U.S. Patent No. 11,766,411 Issued
2024-01-09 U.S. Patent No. 11,865,102 Issued
2024-03-06 Amended Complaint Filed

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

U.S. Patent No. 11,701,330 - Use of Cannabinoids in the Treatment of Epilepsy

  • Issued: July 18, 2023

The Invention Explained

  • Problem Addressed: The patent describes the significant clinical challenge of "treatment-resistant epilepsy" (TRE), where approximately 30% of epilepsy patients cannot achieve seizure freedom with available anti-epileptic drugs (AEDs) (’330 Patent, col. 1:60-65). The patent highlights the particular difficulty in treating childhood epilepsies like Dravet syndrome, for which there were no FDA-approved treatments at the time (’330 Patent, col. 2:49-53).
  • The Patented Solution: The invention is a method for treating specific types of TRE—Lennox-Gastaut syndrome or Dravet syndrome—by administering a pharmaceutical composition containing a highly purified cannabidiol (CBD) drug substance (at least 98% w/w CBD) (’330 Patent, col. 15:15-27). The method involves a specific dosing regimen, starting at approximately 5 mg/kg/day and titrating upwards in increments, which was found to be effective in reducing seizure frequency (’330 Patent, col. 15:28-36).
  • Technical Importance: The patent claims a method that provides a therapeutic option for a vulnerable patient population with severe, difficult-to-treat forms of epilepsy.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶177).
  • The essential elements of Claim 1 are:
    • A method of treating seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
    • Administering a pharmaceutical composition comprising a cannabidiol (CBD) drug substance.
    • The CBD drug substance comprises at least 98% w/w CBD.
    • The CBD is administered at a starting dose of about 5 mg/kg/day.
    • The dose is then increased by increments of about 5 mg/kg.
  • The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more claims" (Compl. ¶177).

U.S. Patent No. 11,766,411 - Use of Cannabinoids in the Treatment of Epilepsy

  • Issued: September 26, 2023

The Invention Explained

  • Problem Addressed: Similar to the ’330 patent, this patent addresses the need for effective treatments for TRE, with a specific focus on Dravet syndrome, a severe form of childhood epilepsy characterized by frequent, treatment-resistant seizures (’411 Patent, col. 2:31-40).
  • The Patented Solution: The invention is a method of treating Dravet syndrome using a pharmaceutical composition containing a CBD drug substance with a specifically defined purity profile (’411 Patent, Abstract). Beyond requiring that the CBD itself be at least 98% pure, the claims define the composition by setting specific upper limits for other co-occurring cannabinoids, such as cannabidiolic acid (CBDA), cannabidivarin (CBDV), and Δ⁹-tetrahydrocannabinol (Δ⁹THC), thereby claiming a particular formulation of highly purified CBD (’411 Patent, col. 15:11-20).
  • Technical Importance: The invention moves beyond simply using CBD to defining a specific, highly purified composition with controlled levels of other cannabinoids, suggesting this specific profile is key to its therapeutic effect in treating Dravet syndrome.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶201).
  • The essential elements of Claim 1 are:
    • A method of treating seizures associated with Dravet syndrome.
    • Administering a pharmaceutical composition comprising a CBD drug substance.
    • The CBD drug substance comprises at least 98% w/w CBD.
    • The remainder of the drug substance comprises specific maximum levels of other cannabinoids, including not more than 0.15% w/w CBDA and not more than 0.15% w/w Δ⁹THC.
    • The dose of CBD administered ranges from about 5 mg/kg/day to about 25 mg/kg/day.
  • The complaint alleges infringement of "one or more claims" (Compl. ¶201).

U.S. Patent No. 11,865,102 - Cannabidiol Preparations and Its Uses

  • Issued: January 9, 2024

Technology Synopsis

This patent addresses the surprising discovery that botanically-derived CBD preparations containing specific, trace amounts of other cannabinoids, including a mixture of trans-THC and cis-THC, are therapeutically more effective than purely synthetic CBD preparations that lack these components (’102 Patent, col. 1:8-14, col. 2:2-14). The invention claims a specific pharmaceutical composition defined by the high purity of CBD (≥90% w/w) and the presence of a mixture of THC isomers (’102 Patent, col. 47:50-58).

Asserted Claims

At least independent claim 1 (Compl. ¶185).

Accused Features

Defendants' proposed generic cannabidiol oral solutions are alleged to meet the specific compositional limitations of the claims, including the required ratios of THC isomers (Compl. ¶¶185, 187).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic cannabidiol oral solution drug products for which each Defendant has filed an ANDA with the FDA (Compl. ¶1). Specific ANDA numbers are identified for each Defendant group, such as ANDA No. 217699 for Apotex and ANDA No. 217522 for InvaGen/Cipla/API Pharma (Compl. ¶¶1, 142).

Functionality and Market Context

The proposed generic products are intended to be bioequivalent versions of Plaintiff's Epidiolex®, a 100 mg/mL oral solution approved for treating seizures associated with Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex (Compl. ¶¶2, 19). Plaintiff asserts that Epidiolex® is the first and only plant-derived cannabinoid medicine approved by the FDA (Compl. ¶2). The complaint includes a screenshot from a Google search to allege that Defendant InvaGen conducts business through its subsidiary Cipla USA, which is its public-facing entity in the U.S. (Compl. p. 9). This visual is used to support arguments for personal jurisdiction by demonstrating the integrated business operations aimed at marketing pharmaceutical products in the district (Compl. ¶36). The filing of numerous ANDAs suggests a significant commercial interest in entering the market for this therapy upon expiration of regulatory exclusivities and patents.

IV. Analysis of Infringement Allegations

The complaint, typical for initial pleadings in Hatch-Waxman litigation, does not provide a detailed, element-by-element infringement analysis or claim chart. Instead, it asserts infringement based on the act of filing an ANDA under 35 U.S.C. § 271(e)(2)(A), which seeks approval to market a generic drug for uses claimed in the patents-in-suit before their expiration (Compl. ¶¶177, 185, 201).

The central infringement theory for the method claims of the ’330 and ’411 Patents is that the Defendants' proposed product labels will instruct physicians and patients to administer the generic drug for the patented indications (e.g., Dravet syndrome) and at the claimed dosages, which would constitute direct infringement by the end-users. This conduct by the Defendants is alleged to constitute induced infringement (Compl. ¶¶180, 204). For the composition claims of the ’102 Patent, the theory is that the product described in the ANDA itself has the chemical makeup recited in the claims (Compl. ¶185).

  • Identified Points of Contention:
    • Scope Questions: A potential issue is whether the Defendants' proposed product labeling will be identical to the Epidiolex® label or if it will "carve out" certain patented indications or dosing regimens. The viability of such a carve-out, and whether it would be sufficient to avoid infringement, raises a question for the court.
    • Technical Questions: A primary factual question will be whether the generic products, as formulated and described in the confidential ANDA submissions, actually meet the specific compositional and purity limitations of the asserted claims. For instance, what evidence will demonstrate that the Defendants' products contain a "CBD drug substance" that meets the ≥98% purity threshold of the ’330 and ’411 Patents and the specific THC isomer ratios required by the ’102 Patent?

V. Key Claim Terms for Construction

  • The Term: "CBD drug substance comprising at least 98% w/w CBD" (’330 Patent, cl. 1; ’411 Patent, cl. 1)
    • Context and Importance: This term is foundational to the asserted claims, defining the purity of the active pharmaceutical ingredient. The dispute will likely center on whether this limitation applies to the raw CBD material before formulation or to the active ingredient as it exists within the final drug product, and how the percentage is calculated.
    • Evidence for a Broader Interpretation: A defendant may argue that this term refers only to the purity of the API as a starting material, and that the final formulated product (containing excipients) does not need to meet this limitation.
    • Evidence for a Narrower Interpretation: The patentee may point to the specification, which details a multi-step process for creating a "highly purified" extract used in the final drug product, to argue that this purity level is a defining characteristic of the inventive composition being administered (’330 Patent, col. 6:46-62).
  • The Term: "a mixture of trans-THC and cis-THC" (’102 Patent, cl. 1)
    • Context and Importance: This term is critical to the ’102 Patent, which distinguishes the invention from synthetic CBD (which would lack THC) and potentially other botanical extracts. Practitioners may focus on this term because infringement will require proof that the accused generic products contain this specific mixture of isomers.
    • Evidence for a Broader Interpretation: A defendant might argue that any detectable amount of both isomers meets this limitation, potentially rendering the claim obvious over prior art extracts.
    • Evidence for a Narrower Interpretation: The patentee will likely argue that the term, read in light of the specification, refers to the specific, controlled ratios (e.g., 0.8:1 trans-to-cis) produced by its proprietary process, which it alleges provides a synergistic therapeutic effect (’102 Patent, col. 34:1-12; col. 47:56-58).

VI. Other Allegations

  • Indirect Infringement: The complaint explicitly pleads both induced and contributory infringement. Inducement is based on allegations that Defendants' future product labeling will actively instruct and encourage medical professionals and patients to administer the generic products in a manner that directly infringes the patented methods (Compl. ¶¶180, 204, 212). Contributory infringement is based on the allegation that the proposed generic products are specifically designed for an infringing use and lack a substantial non-infringing use (Compl. ¶¶181, 205, 213).

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

  • A core issue will be one of compositional identity: will discovery reveal that the Defendants’ generic formulations, as detailed in their confidential ANDA filings, contain the specific purity profiles (e.g., ≥98% CBD) and trace cannabinoid compositions (e.g., the mixture of trans-THC and cis-THC) required by the asserted claims?
  • A key legal question will be one of infringement by labeling: for the asserted method claims, will the Defendants’ proposed product labels inevitably instruct users to perform the patented methods of treating specific epilepsy syndromes at the claimed dosages, thereby giving rise to liability for induced infringement?
  • A central validity question, though not detailed in the complaint, will likely be one of obviousness: can the Defendants demonstrate with clear and convincing evidence that a person of ordinary skill in the art would have been motivated to treat the specific claimed epilepsy syndromes with the claimed highly purified CBD compositions and dosing regimens with a reasonable expectation of success?