DCT

2:25-cv-14606

Jazz Pharma Ireland Ltd v. Granules India Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-14606, D.N.J., 08/13/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendant's subsidiary, Granules USA, Inc., being registered and operating in the state, and on the assertion that the district is a likely destination for the accused generic drug product.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Xywav® oral solution constitutes an act of infringement of fourteen U.S. patents.
  • Technical Context: The technology concerns pharmaceutical formulations of gamma-hydroxybutyrate (GHB), a central nervous system depressant used to treat narcolepsy, and methods for its administration.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 220725 and its associated Paragraph IV Certifications, which allege that Plaintiff’s patents are invalid and/or not infringed. Plaintiff also certifies that this case is related to prior consolidated litigation against Lupin Inc. concerning the same patents, suggesting a history of enforcement for this patent portfolio.

Case Timeline

Date Event
2012-12-14 Earliest Priority Date for ’922, ’173, ’373, ’102 Patent Families
2013-03-01 Earliest Priority Date for ’306, ’302, ’426, ’400, ’446 Patent Families
2013-11-26 U.S. Patent No. 8,591,922 Issues
2014-07-08 U.S. Patent No. 8,772,306 Issues
2014-12-02 U.S. Patent No. 8,901,173 Issues
2015-06-09 U.S. Patent No. 9,050,302 Issues
2015-09-15 U.S. Patent No. 9,132,107 Issues
2016-11-08 U.S. Patent No. 9,486,426 Issues
2019-02-05 U.S. Patent No. 10,195,168 Issues
2019-02-26 U.S. Patent No. 10,213,400 Issues
2020-06-09 U.S. Patent No. 10,675,258 Issues
2020-12-15 U.S. Patent No. 10,864,181 Issues
2022-02-22 U.S. Patent No. 11,253,494 Issues
2022-08-30 U.S. Patent No. 11,426,373 Issues
2023-01-17 U.S. Patent No. 11,554,102 Issues
2024-05-21 U.S. Patent No. 11,986,446 Issues
2025-07-02 Granules Sends Paragraph IV Notice Letter
2025-08-13 Complaint Filed

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

U.S. Patent No. 8,591,922 - "Gamma-hydroxybutyrate compositions and their use for the treatment of disorders"

The Invention Explained

  • Problem Addressed: The patent describes that chronic use of sodium oxybate (Na.GHB), sold as Xyrem®, significantly increases a patient's dietary sodium intake, which is undesirable for patients with or at risk for hypertension, heart disease, or renal disease (Compl., Ex. A, ’922 Patent, col. 2:1-5).
  • The Patented Solution: The invention is a pharmaceutical composition that replaces some or all of the sodium cations in a GHB formulation with other cations—specifically potassium, magnesium, and calcium—to create mixed salts of GHB. This approach aims to reduce the total sodium load on the patient while maintaining the therapeutic effects of GHB ('922 Patent, Abstract; col. 2:22-36).
  • Technical Importance: This innovation provided a way to deliver a proven therapy for narcolepsy while mitigating a significant cardiovascular risk factor associated with the drug's high sodium content ('922 Patent, col. 2:12-21).

Key Claims at a Glance

The complaint does not identify specific asserted claims. Independent claim 1 is representative of the patent's composition claims and its elements include:

  • A pharmaceutical composition of gamma-hydroxybutyrate (GHB)
  • comprising a mixture of salts of GHB,
  • wherein the mixture comprises two or more salts selected from the group consisting of a sodium salt of gamma-hydroxybutyrate (Na.GHB), a potassium salt of gamma-hydroxybutyrate (K.GHB), a magnesium salt of gamma-hydroxybutyrate (Mg.(GHB)2), and a calcium salt of gamma-hydroxybutyrate (Ca.(GHB)2).

U.S. Patent No. 8,772,306 - "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters"

The Invention Explained

  • Problem Addressed: The patent recognizes that the therapeutic effect of GHB can be altered by concomitantly administered drugs that inhibit monocarboxylate transporters (MCTs). Specifically, it identifies that co-administration with the MCT inhibitor valproate can dangerously increase GHB's effects, while co-administration with the MCT inhibitor diclofenac can reduce its effects (Compl., Ex. B, ’306 Patent, col. 16:15-24, Abstract).
  • The Patented Solution: The patent claims methods for safely administering GHB to a patient who is also taking an MCT inhibitor. The solution involves adjusting the standard GHB dosage—reducing it when co-administered with valproate and increasing it when co-administered with diclofenac—to maintain a safe and effective therapeutic window (’306 Patent, col. 16:25-67).
  • Technical Importance: This invention provided specific, counterintuitive dosing guidance to manage significant drug-drug interactions, enhancing the safety of GHB therapy for patients with co-morbidities requiring treatment with common drugs like valproate (’306 Patent, col. 17:30-44).

Key Claims at a Glance

The complaint does not identify specific asserted claims. Independent claim 1 is representative of the patent's method claims and its elements include:

  • A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking gamma-hydroxybutyrate (GHB) or a salt thereof
  • comprising: reducing the daily dosage amount of GHB or salt thereof administered to the patient by at least 20%
  • during concomitant administration of divalproex sodium,
  • compared to the daily dosage amount of between 4.5 and 9 g of GHB or salt thereof currently used in the absence of concomitant administration of divalproex sodium.

U.S. Patent No. 8,901,173 - "Gamma-hydroxybutyrate compositions and their use for the treatment of disorders"

  • Technology Synopsis: This patent, related to the ’922 Patent, addresses the problem of high sodium intake from Na.GHB formulations ('173 Patent, col. 2:1-5). It provides pharmaceutical compositions containing mixed salts of GHB, including calcium, magnesium, and potassium, to reduce the overall sodium content for patients ('173 Patent, Abstract).
  • Asserted Claims: The complaint does not specify asserted claims but alleges infringement of one or more claims (Compl. ¶ 55).
  • Accused Features: The accused feature is Defendant's proposed generic oral solution containing calcium, magnesium, potassium, and sodium oxybates (Compl. ¶ 32).

U.S. Patent No. 9,050,302 - "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters"

  • Technology Synopsis: This patent, related to the ’306 Patent, discloses methods for safely administering GHB to patients who are also taking monocarboxylate transporter (MCT) inhibitors ('302 Patent, Abstract). The invention involves adjusting the GHB dosage to account for drug-drug interactions, specifically by reducing the dose when co-administered with valproate to avoid additive effects ('302 Patent, col. 16:15-24, 25-41).
  • Asserted Claims: The complaint does not specify asserted claims but alleges infringement of one or more claims (Compl. ¶ 64).
  • Accused Features: Infringement is based on the anticipated use of Defendant's proposed generic product according to a label that will allegedly instruct on dosing, including in patients taking concomitant medications like valproate (Compl. ¶¶ 19-21).

U.S. Patent No. 9,486,426 - "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters"

  • Technology Synopsis: Similar to the ’306 and ’302 Patents, this patent covers methods for safely administering GHB by adjusting its dosage in the presence of an MCT inhibitor ('426 Patent, Abstract). The method addresses the risk of altered therapeutic effects from drug-drug interactions with compounds like valproate or diclofenac by modifying the GHB dose to compensate (’426 Patent, col. 16:15-24).
  • Asserted Claims: The complaint does not specify asserted claims but alleges infringement of one or more claims (Compl. ¶ 82).
  • Accused Features: Defendant's proposed generic GHB product, which will allegedly be prescribed and used according to a label that encourages administration in a manner that practices the claimed methods (Compl. ¶¶ 19-21).

The complaint asserts eleven additional patents: U.S. Patent Nos. 9,132,107; 10,195,168; 10,213,400; 10,675,258; 10,864,181; 11,253,494; 11,426,373; 11,554,102; 11,986,446; 8,901,173; and 9,050,302. The allegations for these patents are substantively similar to those for the patents analyzed above, targeting either the formulation of Defendant's proposed product as a mixed-salt GHB solution or the methods of its administration based on anticipated label instructions (Compl., Counts III-XIV).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Granules' Proposed Product," which is a generic "calcium, magnesium, potassium, and sodium oxybates oral solution" described in ANDA No. 220725 submitted to the FDA (Compl. ¶ 32).

Functionality and Market Context

  • The complaint alleges that Granules' Proposed Product is a generic version of Jazz Pharmaceuticals' Xywav® drug product (Compl. ¶ 1). As such, it is an oral solution intended to be therapeutically equivalent to Xywav® for treating conditions such as cataplexy or excessive daytime sleepiness in patients with narcolepsy (Compl. ¶ 19). The filing of the ANDA signifies Defendant's intent to market this product as a lower-cost alternative to the branded drug upon receiving FDA approval (Compl. ¶¶ 33, 35).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim chart summary. The infringement allegations are based on the act of filing the ANDA under 35 U.S.C. § 271(e)(2)(A), rather than on an analysis of a commercial product (Compl. ¶ 37).

  • Infringement Theory for Composition Patents (e.g., ’922 Patent): The complaint alleges that by filing an ANDA for a product described as a "calcium, magnesium, potassium, and sodium oxybates oral solution," Granules seeks approval for a product that will necessarily contain the "mixture of salts of GHB" recited in the asserted composition claims (Compl. ¶¶ 17, 32, 37). This sets up a theory of literal infringement, where the composition of the product defined in the ANDA is alleged to fall within the scope of the patent claims.

  • Infringement Theory for Method Patents (e.g., ’306 Patent): The complaint alleges that Granules will induce and contribute to infringement of the method patents (Compl. ¶¶ 49-50). This theory is based on the expected use of the generic product. It is alleged that the product's labeling will instruct and encourage physicians and patients to administer the drug in a manner that practices the claimed methods, such as by adjusting the dose when taken concomitantly with other specified drugs like divalproex sodium (valproate) (Compl. ¶ 20). The direct infringers would be the healthcare providers and patients following these alleged instructions.

  • Identified Points of Contention:

    • Scope Questions: A central question for the composition patents will be whether the specific formulation in Granules' ANDA—including the identity and relative amounts of the different oxybate salts and any excipients—falls within the literal scope of the asserted claims. For the method patents, a key question will be whether the language in Granules' proposed label actively encourages, recommends, or promotes the specific, claimed steps of dose adjustment, thereby meeting the legal standard for inducement of infringement.
    • Technical Questions: The dispute will likely focus on the confidential details of the ANDA filing. Key technical questions will include: What are the precise weight percentages or molar equivalents of the sodium, potassium, calcium, and magnesium cations in Granules' proposed formulation? What specific instructions, warnings, or contraindications related to co-administration with MCT inhibitors like valproate are included in the proposed product labeling?

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms. However, based on the nature of the asserted patents, certain terms may become central to the dispute.

  • The Term: "a mixture of salts" (from claim 1 of the ’922 Patent)

  • Context and Importance: The definition of this term is fundamental to the scope of the composition patents. Practitioners may focus on whether this term implies only the presence of the listed salt components or if it also carries implicit requirements regarding, for example, the homogeneity, stability, or manufacturing process of the final formulation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims recite a composition comprising a mixture "selected from the group consisting of" various salts, language which typically supports a broader reading that includes any combination of the listed members ('922 Patent, col. 36:3-9).
    • Evidence for a Narrower Interpretation: The specification repeatedly describes the mixtures in terms of specific weight-per-weight percentage ratios and discusses the importance of achieving a formulation that is "chemically stable and resistant to microbial growth" and "free of preservatives" ('922 Patent, col. 4:1-5). A defendant may argue these properties are defining characteristics of the claimed "mixture."

  • The Term: "concomitant administration" (from claim 1 of the ’306 Patent)

  • Context and Importance: This term is critical for determining when the claimed method steps of dose adjustment are practiced. The dispute will likely center on the required temporal proximity between the administration of GHB and an MCT inhibitor like valproate for the administration to be considered "concomitant."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term itself is not explicitly defined with a narrow time window, which could support an interpretation covering administrations separated by several hours or even days, as long as both drugs are therapeutically active in the patient's system.
    • Evidence for a Narrower Interpretation: The patent specification describes clinical studies and provides examples that may imply a more immediate or overlapping dosing schedule. Further, the description of the invention explains that the methods are for a patient "currently taking or has been prescribed" the interacting drug, and later clarifies that administration can be "within three days, one or two weeks (before or after)" ('306 Patent, col. 16:29-31, col. 17:62-64), which could be argued to define the scope of the term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all fourteen patents-in-suit (e.g., Compl. ¶¶ 40-41, 49-50). The basis for inducement is the allegation that Granules, with knowledge of the patents, will intentionally encourage direct infringement by physicians and patients through the product's labeling, instructions, and marketing (Compl. ¶ 40). Contributory infringement is alleged on the basis that Granules' product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶ 41).
  • Willful Infringement: The complaint does not use the word "willful" but alleges that each count presents an "exceptional case" and requests attorneys' fees pursuant to 35 U.S.C. § 285 (e.g., Compl. ¶ 44). This serves as a pleading for enhanced damages and fees. The basis for knowledge is Defendant's submission of a Paragraph IV Certification, which demonstrates awareness of the patents prior to the lawsuit's filing (Compl. ¶ 34).

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

  • A core issue will be one of bioequivalence versus claim scope: Will the specific chemical formulation described in Granules' confidential ANDA—a formulation designed to be bioequivalent to Xywav®—fall within the literal boundaries of the composition claims asserted by Jazz, particularly with respect to the claimed ratios and combinations of cations?
  • A key evidentiary question will be one of inducement by labeling: Does the specific language in Granules’ proposed product insert, which must be substantially similar to the Xywav® label to gain approval, contain affirmative instructions that would lead a fact-finder to conclude that Granules actively encouraged physicians and patients to perform the patented methods of dose adjustment?
  • The case will also depend heavily on validity challenges: As signaled by its Paragraph IV certification, Granules will likely argue that the asserted claims are invalid as obvious or anticipated in light of prior art related to GHB formulations and general pharmacological principles of managing drug-drug interactions. The outcome of the related Lupin litigation may be influential on this question.