DCT

1:23-cv-00256

GW Research Ltd v. Invagen Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00256, E.D.N.Y., 01/13/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of New York because Defendant InvaGen maintains a principal place of business in Hauppauge, New York, and Defendant Cipla USA maintains a physical place of business in Central Islip, New York, both within the district. The complaint further alleges that the Defendants conduct continuous business in the district and that the proposed generic product will be marketed and sold there.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Epidiolex® (cannabidiol) oral solution constitutes an act of infringement of twenty U.S. patents.
  • Technical Context: The technology concerns pharmaceutical preparations of highly purified cannabidiol (CBD) and methods for using them to treat seizures associated with severe, early-onset epilepsy syndromes.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 217522 to the U.S. Food and Drug Administration (FDA). In connection with the ANDA, Defendants sent Plaintiff a Paragraph IV Certification notice, asserting that the patents-in-suit are invalid and/or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2014-06-17 Earliest Priority Date ('288, '671, '673, '674, '860, '939, '905, '516, '498, '741, '258 Patents)
2014-10-14 Earliest Priority Date ('937, '183, '184, '185, '186, '525, '840, '095 Patents)
2018-04-24 U.S. Patent No. 9,949,937 Issues
2018-05-01 U.S. Patent Nos. 9,956,183, 9,956,184, 9,956,185, and 9,956,186 Issue
2018-10-09 U.S. Patent No. 10,092,525 Issues
2018-10-30 U.S. Patent No. 10,111,840 Issues
2018-11-27 U.S. Patent No. 10,137,095 Issues
2020-03-31 U.S. Patent No. 10,603,288 Issues
2020-07-14 U.S. Patent Nos. 10,709,671, 10,709,673, and 10,709,674 Issue
2020-12-01 U.S. Patent No. 10,849,860 Issues
2021-04-06 U.S. Patent No. 10,966,939 Issues
2021-08-24 U.S. Patent No. 11,096,905 Issues
2021-10-26 U.S. Patent No. 11,154,516 Issues
2021-12-28 Earliest Priority Date ('292 Patent)
2021-12-28 U.S. Patent No. 11,207,292 Issues
2022-04-26 U.S. Patent No. 11,311,498 Issues
2022-06-14 U.S. Patent No. 11,357,741 Issues
2022-09-20 U.S. Patent No. 11,446,258 Issues
2022-12-02 Date on or after which Defendants sent Paragraph IV Notice Letter to Plaintiff
2023-01-13 Complaint Filed

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

U.S. Patent No. 10,092,525 - "Use of Cannabinoids in the Treatment of Epilepsy"

  • Issued: October 9, 2018

The Invention Explained

  • Problem Addressed: The patent describes the challenge of treating childhood epilepsy, particularly treatment-resistant forms associated with syndromes like Lennox-Gastaut, which can cause frequent "atonic seizures" or "drop attacks," leading to falls and trauma (’525 Patent, col. 1:49-2:60). Existing anti-epileptic drugs (AEDs) are often ineffective for these seizure types (’525 Patent, col. 2:44-48).
  • The Patented Solution: The invention is a method of using cannabidiol (CBD), specifically in a highly purified form (greater than 98% CBD and less than 0.15% THC), to treat atonic seizures (’525 Patent, Abstract). The patent presents clinical trial data suggesting that this formulation of CBD is surprisingly effective, reducing atonic seizure frequency by over 50% in a significant portion of treatment-resistant patients (’525 Patent, col. 11:5-12:6, Tbl. 7).
  • Technical Importance: This approach provided a targeted therapeutic method using a specific, highly purified cannabinoid for a difficult-to-treat seizure type common in severe childhood epilepsies (’525 Patent, col. 1:11-19).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶ 113).
  • The essential elements of independent claim 1 of the ’525 Patent are:
    • A method of reducing drop seizure frequency in a patient with Dravet syndrome,
    • comprising administering to the patient in need thereof cannabidiol (CBD),
    • wherein the CBD has a purity of at least 98% (w/w) CBD and comprises not more than 0.15% (w/w) Δ9-tetrahydrocannabinol (THC),
    • and wherein the dose of the CBD is about 20 mg/kg/day.
  • The complaint does not explicitly reserve the right to assert dependent claims, but each infringement count refers to "one or more claims" of the patent (Compl. ¶ 113).

U.S. Patent No. 10,111,840 - "Use of Cannabinoids in the Treatment of Epilepsy"

  • Issued: October 30, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’525 Patent: the difficulty of treating severe, treatment-resistant childhood epilepsies, particularly the atonic seizures that characterize conditions such as Lennox-Gastaut syndrome and Dravet syndrome (’840 Patent, col. 1:50-2:61).
  • The Patented Solution: The invention provides a method of treating atonic seizures by administering a highly purified cannabidiol (CBD) extract. The patent’s detailed description and clinical data tables suggest that this specific formulation of CBD provides a significant reduction in atonic seizures compared to the reduction in total seizures, indicating a selective efficacy for this seizure type (’840 Patent, Abstract; col. 13:5-11, Tbl. 8).
  • Technical Importance: The invention provided a method-of-use claim for a specific cannabinoid formulation that demonstrated efficacy against atonic seizures where many standard AEDs had failed or were contraindicated (’840 Patent, col. 3:30-34).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶ 121).
  • The essential elements of independent claim 1 of the ’840 Patent are:
    • A method of treating atonic seizures in a patient suffering from Dravet syndrome or Lennox-Gastaut syndrome,
    • comprising administering cannabidiol (CBD) to the subject in need thereof,
    • wherein the purity of the CBD is at least 98% (w/w) and comprises not more than 0.15% (w/w) Δ9-tetrahydrocannabinol,
    • and wherein the dose of the CBD is about 20 mg/kg/day.
  • The complaint refers to infringement of "one or more claims" of the patent (Compl. ¶ 121).

Multi-Patent Capsule: Additional Patents-in-Suit

  • The complaint asserts 18 additional patents. The first of these is U.S. Patent No. 9,949,937. The last is U.S. Patent No. 11,446,258. Each is the subject of a separate count of infringement (Compl. ¶¶ 72-231). The technology of these patents, based on their titles and the context of the complaint, appears to be substantially similar to that of the ’525 and ’840 patents, generally directed to methods of using cannabidiol to treat epilepsy and to specific pharmaceutical compositions. The infringement allegation for each is based on the Defendants’ filing of ANDA No. 217522 (Compl. ¶ 1). A screenshot in the complaint shows an internet search for "InvaGen Pharmaceuticals" directs users to the website for Cipla USA, which the complaint uses to support its allegation that the defendants are acting in concert (Compl. ¶ 22, p. 6).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "InvaGen's Proposed Product," a generic version of GW's Epidiolex® (cannabidiol) oral solution drug product, for which Defendants have filed ANDA No. 217522 with the FDA (Compl. ¶ 1, 12, 65).

Functionality and Market Context

  • The proposed product is a generic equivalent to Epidiolex®, which is a 100 mg/mL oral solution of cannabidiol approved for treating seizures associated with Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex in patients one year of age and older (Compl. ¶¶ 2, 63). The complaint alleges that upon receiving FDA approval, Defendants will manufacture, market, and sell this generic product in the United States prior to the expiration of the patents-in-suit, for the same therapeutic uses as Epidiolex® (Compl. ¶¶ 12, 64, 70).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element claim chart or technical breakdown of the alleged infringement. The central theory of infringement under 35 U.S.C. § 271(e)(2)(A) is that the act of filing ANDA No. 217522 for a generic drug product constitutes an act of infringement of the patents covering the approved uses of the reference listed drug, Epidiolex®. The complaint alleges that if Defendants’ ANDA is approved, the commercial manufacture, use, or sale of the proposed product for its proposed indications will infringe one or more claims of each patent-in-suit (Compl. ¶¶ 73, 75). For the asserted method claims, such as claim 1 of the ’525 and ’840 patents, this infringement would occur when physicians prescribe and patients administer the generic product according to its FDA-approved label for the treatment of the specified seizure types.

Identified Points of Contention

  • Scope Questions: A central question will be whether the specific formulation detailed in the Defendants' ANDA falls within the scope of the claims' purity and composition limitations (e.g., "at least 98% (w/w) CBD" and "not more than 0.15% (w/w) Δ9-tetrahydrocannabinol"). Further, the interpretation of the term "about" in the dosage limitation ("about 20 mg/kg/day") will be a key point of dispute regarding the literal scope of the claims.
  • Technical Questions: A key factual question for the infringement analysis will be whether the proposed label for the generic product will instruct or encourage administration for the specific purpose of "reducing drop seizure frequency" or "treating atonic seizures" as required by the asserted claims. The content of the ANDA filing, particularly the proposed product label, will be the primary evidence for this determination.

V. Key Claim Terms for Construction

  • The Term: "about 20 mg/kg/day" (from claim 1 of the ’525 and ’840 Patents)

  • Context and Importance: The definition of "about" will determine the enforceable range of the claimed dosage. Infringement will depend on whether the dosage information on the proposed generic label falls within the construed range. Practitioners may focus on this term because even a small difference in the proposed labeled dosage could potentially avoid literal infringement if the term is construed narrowly.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes a clinical study where the daily dose was "gradually increased by 2 to 5 mg/kg increments until intolerance occurred or a maximum dose of 25 mg/kg/day was achieved" (’525 Patent, col. 12:26-30). This disclosure of a titration process up to 25 mg/kg/day may support a construction of "about 20" that encompasses a range of therapeutically effective doses.
    • Evidence for a Narrower Interpretation: The claim explicitly recites the specific value "20 mg/kg/day." A party could argue that this represents a deliberate choice by the patentee to claim a specific optimal dose, distinguishing it from other potential doses mentioned in the specification, which might support a narrower construction centered tightly on 20.

  • The Term: "drop seizure" (from claim 1 of the ’525 Patent)

  • Context and Importance: This term defines the specific type of seizure being treated. The infringement analysis for this claim will depend on whether the proposed indication on the generic product's label includes the treatment of what would be medically understood as "drop seizures."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification appears to use "atonic seizure" and "drop attack" as interchangeable with "drop seizure," stating: "Atonic seizures involve the loss of muscle tone, causing the person to fall to the ground. These are sometimes called 'drop attacks'..." (’525 Patent, col. 2:55-57). This suggests the term is meant to cover the functional outcome of falling due to seizure-induced loss of muscle tone.
    • Evidence for a Narrower Interpretation: A party might argue that "drop seizure" has a specific clinical meaning distinct from a general atonic seizure, and that the patentee's choice of this term over the more common "atonic seizure" in claim 1 was a deliberate limitation of claim scope.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that upon FDA approval, Defendants will induce infringement of the patents-in-suit (Compl. ¶ 76, 84, etc.). The alleged basis for inducement is that Defendants will "intentionally encourage acts of direct infringement," which would presumably be through the product's labeling, marketing, and instructions for use, which will direct physicians and patients to use the generic product in a manner that practices the claimed methods (Compl. ¶ 76).

Willful Infringement

  • The complaint does not use the word "willful," but it seeks a judgment that the case is "exceptional" under 35 U.S.C. § 285, a remedy associated with willful infringement (Prayer ¶ J). The basis for this allegation is Defendants' pre-suit knowledge of the patents, which is evidenced by their sending of a Paragraph IV Certification letter to GW prior to the filing of the complaint (Compl. ¶ 66).

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

  • A core issue will be one of factual correspondence: Does the chemical composition of the proposed generic product, as described in ANDA No. 217522, meet the specific purity limitations recited in the asserted claims, particularly the requirements for CBD concentration and the upper limits for THC?
  • A second central question will be one of induced infringement: Will the final, FDA-approved label for Defendants' generic product instruct or encourage physicians and patients to administer the drug for the specific purpose of treating the seizure types (e.g., "atonic seizures," "drop seizures") in the patient populations (e.g., "Lennox-Gastaut syndrome," "Dravet syndrome") recited in the asserted method claims?
  • A third key issue, raised by Defendants' Paragraph IV certification, will be validity: Can Defendants demonstrate, by clear and convincing evidence, that the claimed methods of using highly purified CBD at specific dosages were obvious over prior art that may have disclosed the general use of cannabis or less-purified CBD for treating epilepsy?