DCT

2:24-cv-07550

Jazz Pharma Research Uk Ltd v. Apotex Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07550, D.N.J., 07/03/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on various grounds for the different defendants, including purposeful conduct of business in the district, maintaining physical places of business, consent to jurisdiction in prior litigation, and for foreign defendants, based on 28 U.S.C. § 1391(c)(3).
  • Core Dispute: Plaintiff alleges that Defendants’ filing of Abbreviated New Drug Applications (ANDAs) to market generic versions of Epidiolex® infringes a patent related to methods of using cannabidiol to treat specific forms of epilepsy.
  • Technical Context: The technology concerns the use of highly purified cannabidiol (CBD), a non-psychoactive cannabinoid, for treating severe, treatment-resistant forms of childhood epilepsy, a market where Epidiolex® was the first FDA-approved, plant-derived cannabinoid medicine.
  • Key Procedural History: This action under the Hatch-Waxman Act was triggered by Paragraph IV certifications sent by the various defendants notifying Jazz of their intent to market generic versions of Epidiolex® prior to the expiration of the patent-in-suit. The complaint notes that many of the defendants have previously stipulated that they would not contest personal jurisdiction or venue in the District of New Jersey in prior, related litigation.

Case Timeline

Date Event
2014-06-17 ’937 Patent Priority Date
2022-11-28 Apotex sent Paragraph IV notice letter (earliest date)
2022-12-02 InvaGen and Lupin sent Paragraph IV notice letters (earliest date)
2022-12-05 Taro sent Paragraph IV notice letter (earliest date)
2022-12-06 Ascent and Biophore/Zenara sent Paragraph IV notice letters (earliest date)
2024-04-23 ’937 Patent Issue Date
2024-07-03 Complaint Filing Date

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

U.S. Patent No. 11,963,937 - Use of Cannabinoids in the Treatment of Epilepsy

  • Patent Identification: U.S. Patent No. 11,963,937, "Use of Cannabinoids in the Treatment of Epilepsy," issued April 23, 2024.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of "treatment-resistant epilepsy" (TRE), a condition where patients, particularly children, fail to achieve sustained freedom from seizures despite adequate trials of available anti-epileptic drugs (AEDs) (Compl. Ex. A, ’937 Patent, col. 1:49-2:11). Such conditions, including Dravet syndrome, can lead to frequent, prolonged seizures and significant neurological damage (Compl. Ex. A, ’937 Patent, col. 2:12-16, 2:36-44).
  • The Patented Solution: The invention is a method of treatment using cannabidiol (CBD), a non-psychoactive cannabinoid, to significantly reduce convulsive seizure frequency in patients with TRE (Compl. Ex. A, ’937 Patent, Abstract). The solution involves administering a pharmaceutical composition containing a highly purified CBD drug substance (greater than 98% w/w CBD) within a specific dosage range, often in combination with other AEDs, to treat specific epileptic syndromes like Dravet syndrome (Compl. Ex. A, ’937 Patent, col. 2:30-43).
  • Technical Importance: This approach provided a new therapeutic option for patients with severe forms of epilepsy who had not responded to existing treatments, and it represented the first FDA-approved medicine derived from the cannabis plant for this purpose (Compl. ¶15).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶144, 152, 160, 168, 176, 184).
  • The essential elements of independent claim 1 are:
    • A method of treating a type of treatment-resistant epilepsy, which is Dravet syndrome, in a patient in need thereof,
    • comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance and sesame oil,
    • wherein the CBD drug substance comprises at least 98% w/w CBD; and
    • wherein the dose of CBD administered to the patient ranges from about 5 mg/kg/day to about 25 mg/kg/day.
  • The complaint alleges infringement of "one or more of the claims" of the patent, implying the potential assertion of other claims in addition to claim 1 (Compl. ¶144).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the proposed generic cannabidiol oral solution drug products (100 mg/mL) for which the Defendants have filed ANDAs with the U.S. Food and Drug Administration (FDA) (Compl. ¶1). The complaint identifies specific ANDA numbers for each defendant group (Compl. ¶1).

Functionality and Market Context

  • The proposed generic products are intended to be bioequivalent versions of Plaintiff's Epidiolex® oral solution (Compl. ¶1). They are intended for the same therapeutic use: the treatment of seizures associated with Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex (Compl. ¶2, 15). The act of infringement alleged is the filing of the ANDAs themselves, which seek approval to market these generic products for uses that are allegedly covered by the ’937 Patent before its expiration (Compl. ¶144). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,963,937 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a type of treatment-resistant epilepsy, which is Dravet syndrome, in a patient in need thereof... The proposed generic products are intended for use in treating seizures associated with Dravet Syndrome, as indicated by their status as generic versions of Epidiolex®. The product labels are expected to instruct this use. ¶15, 147 col. 16:61-64
...comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance and sesame oil... Defendants have filed ANDAs for a cannabidiol oral solution product, which is alleged to be a composition containing CBD drug substance and sesame oil, mirroring the Epidiolex® formulation. ¶1, 140 col. 16:64-66
...wherein the CBD drug substance comprises at least 98% w/w CBD... The infringement allegation is predicated on the proposed generic products being equivalents of Epidiolex®, which is based on a highly purified CBD extract as described in the patent. ¶1, 15 col. 2:46-51
...and wherein the dose of CBD administered to the patient ranges from about 5 mg/kg/day to about 25 mg/kg/day. The proposed product labels are expected to instruct physicians and patients to administer doses that fall within the claimed range to achieve therapeutic effect for the indicated conditions. ¶15 col. 16:67-69
  • Identified Points of Contention:
    • Technical Questions: A primary evidentiary question will concern the specific formulation of the Defendants' proposed products. What evidence does the complaint provide, or will discovery show, that the Defendants' cannabidiol drug substance meets the "at least 98% w/w CBD" purity limitation required by the claim?
    • Scope Questions: The infringement theory relies on induced infringement via the product label. This raises the question of whether the instructions for use in the Defendants' proposed labels will direct medical professionals and patients to perform all steps of the claimed method, particularly for the specific patient population ("Dravet syndrome") and within the specific dosage range ("about 5 mg/kg/day to about 25 mg/kg/day").

V. Key Claim Terms for Construction

  • The Term: "comprising a cannabidiol (CBD) drug substance and sesame oil"

  • Context and Importance: This term defines the physical composition administered in the claimed method. Practitioners may focus on this term because its construction will determine whether alternative formulations (e.g., using different oils, excipients, or a synthetically derived CBD rather than an extract) fall within the claim's scope.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of the open-ended transitional phrase "comprising" suggests that the presence of other components in the composition would not necessarily preclude infringement.
    • Evidence for a Narrower Interpretation: The specification provides a detailed description of producing the CBD drug substance via a multi-step extraction and purification process from Cannabis sativa L. plants (Compl. Ex. A, ’937 Patent, col. 8:26-65). A party could argue that "CBD drug substance" should be interpreted as being limited to a substance with the specific impurity profile resulting from this disclosed process.

  • The Term: "about 5 mg/kg/day"

  • Context and Importance: This term defines the lower boundary of the claimed dosage range. Its construction is critical because if a defendant's proposed label instructs a starting dose that is determined to be outside the scope of "about 5," it could support a theory of non-infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term "about" is generally understood in patent law to afford some degree of numerical flexibility. A party may argue it covers doses reasonably close to 5, including standard starting doses that might be slightly different but medically equivalent.
    • Evidence for a Narrower Interpretation: The specification consistently describes the administered dose as starting at or being greater than 5 mg/kg/day (Compl. Ex. A, ’937 Patent, col. 5:1-2; col. 9:39-41). This could be cited to argue that "about 5" should not be construed to include values meaningfully below 5.0.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will induce infringement of the ’937 Patent (Compl. ¶147, 155, 163, 171, 179, 187). The basis for this allegation is that Defendants will market and sell their generic products with instructions and labels that direct physicians and patients to use the products in accordance with the patented method of treatment. The complaint also alleges contributory infringement, stating the proposed products lack a substantial non-infringing use (Compl. ¶148).

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

  • A primary issue, though not detailed in the complaint, will be one of patent validity: can the claimed method of treating Dravet syndrome with a specific dosage of highly purified CBD withstand an obviousness challenge, which will likely argue that such a treatment was a predictable development based on prior knowledge of CBD's general anti-epileptic effects?
  • A key question for infringement will be one of inducement: will the evidence, particularly the contents of the Defendants' proposed product labels, establish that Defendants will actively encourage and instruct medical professionals to perform every step of the patented method, thereby inducing direct infringement by others?
  • A central issue of claim construction will likely be the definitional scope of "CBD drug substance." The case may turn on whether this term is limited to the plant-derived, highly purified extract detailed in the specification, or if it can be read more broadly to cover, for example, synthetically produced CBD with a different impurity profile.