DCT

2:23-cv-01617

Jazz Pharma Ireland Ltd v. Teva Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-01617, D.N.J., 03/21/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Teva Pharmaceuticals, Inc. maintains a regular and established physical place of business in Parsippany, New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s Xywav® drug product constitutes an act of infringement of thirteen patents related to gamma-hydroxybutyrate (GHB) compositions and methods of their administration.
  • Technical Context: The technology concerns pharmaceutical formulations of gamma-hydroxybutyrate (GHB), a treatment for narcolepsy, that are designed to reduce the high sodium intake associated with the prior art medication Xyrem®.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s Paragraph IV certification notice letters, sent on February 6 and February 13, 2023, which alleged that the patents-in-suit are invalid and/or would not be infringed by its proposed generic product. The complaint notes a related consolidated case involving the same plaintiff and patents, Jazz Pharmaceuticals Ireland Limited v. Lupin Inc., et al., No. 21-14271 (D.N.J.).

Case Timeline

Date Event
2012-12-14 Earliest Priority Date for '922, '173, '107, '168, '258, '373, '102 Patents
2013-03-01 Earliest Priority Date for '306, '302, '426, '400, '181, '494 Patents
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
2023-02-06 Defendant sends first Paragraph IV Notice Letter to Plaintiff
2023-02-13 Defendant sends second Paragraph IV Notice Letter to Plaintiff
2023-03-21 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 (Issued Nov. 26, 2013)

The Invention Explained

  • Problem Addressed: The patent describes that sodium oxybate (Na•GHB), sold as Xyrem®, is an effective treatment for narcolepsy but requires high levels of sodium intake (’168 Patent, col. 2:1-5). This high sodium load is undesirable for patients with conditions such as hypertension, heart disease, or renal disease, or those at risk of stroke ('168 Patent, col. 2:1-5).
  • The Patented Solution: The invention is a pharmaceutical composition of gamma-hydroxybutyrate (GHB) that uses a mixture of salts with different cations—specifically, sodium, potassium, magnesium, and calcium. This approach is designed to deliver a therapeutically effective dose of GHB while significantly reducing the total amount of sodium a patient consumes compared to a formulation using only sodium oxybate ('168 Patent, col. 2:16-24, col. 2:34-39; Abstract).
  • Technical Importance: This mixed-salt formulation allows patients who are sensitive to high sodium intake to undergo GHB therapy, thereby expanding the treatment's applicability and safety profile ('168 Patent, col. 2:34-39).

Key Claims at a Glance

The complaint asserts infringement of one or more claims of the ’922 Patent without specifying which claims will be asserted (Compl. ¶35). U.S. Patent No. 10,195,168, which is in the same family, contains representative independent claim 1, which includes the following essential elements:

  • A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB;
  • Wherein the mixture consists of a sodium salt, a potassium salt, a magnesium salt, and a calcium salt of GHB;
  • Wherein the salts are present in a weight/weight percentage ratio of about 8%:23%:21%:48%, respectively; and
  • Wherein the composition is a liquid formulation with a total GHB salt concentration of about 350 mg/mL to about 650 mg/mL.

The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more of the claims" (Compl. ¶35).

U.S. Patent No. 8,772,306 - Method of administration of gamma hydroxybutyrate with monocarboxylate transporters (Issued Jul. 8, 2014)

The Invention Explained

  • Problem Addressed: The patent identifies a safety issue arising from drug-drug interactions. It states that the effect of GHB in the body can be altered by other drugs that inhibit monocarboxylate transporters (MCTs), which are involved in GHB's metabolism. Specifically, co-administration with valproate increases the effect of GHB, while co-administration with diclofenac lowers it, both of which can lead to unsafe conditions for the patient (’400 Patent, col. 1:49-65; Abstract).
  • The Patented Solution: The invention claims a method for safely administering GHB by adjusting its dosage to compensate for these interactions. The method involves reducing the GHB dose when a patient is also taking valproate and increasing the dose when a patient is also taking diclofenac, thereby maintaining the intended therapeutic effect and safety profile ('400 Patent, col. 2:5-18).
  • Technical Importance: This patented method provides a protocol for managing known drug-drug interactions, which is critical for ensuring the safe and effective use of GHB in patients who may require concomitant therapy with common medications like valproate ('400 Patent, col. 2:5-18).

Key Claims at a Glance

The complaint asserts infringement of one or more claims of the ’306 Patent without specifying which claims will be asserted (Compl. ¶44). U.S. Patent No. 10,213,400, which is in the same family, contains representative independent claim 1, which includes the following essential elements:

  • A method for reducing adverse effects caused by a combination of GHB and divalproex sodium in a patient;
  • Comprising administering a reduced daily dosage amount of GHB (between about 5% to about 35% lower) compared to the daily dosage amount administered in the absence of divalproex sodium;
  • Wherein the patient is concomitantly administered divalproex sodium;
  • Wherein the patient suffers from cataplexy or excessive daytime sleepiness in narcolepsy and is currently taking GHB; and
  • Wherein the daily dosage amount of GHB in the absence of divalproex sodium is between 4.5 g and 9 g.

The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more of the claims" (Compl. ¶44).

Multi-Patent Capsules

The complaint asserts eleven additional patents which fall into the two technological families analyzed above.

  • Patents: U.S. Patent Nos. 8,901,173; 9,132,107; 10,195,168; 10,675,258; 11,426,373; and 11,554,102 (GHB Composition Family)

    • Technology Synopsis: These patents relate to pharmaceutical compositions containing mixed salts of gamma-hydroxybutyrate (e.g., sodium, potassium, calcium, magnesium) to reduce the overall sodium load compared to pure sodium oxybate formulations. The compositions are intended for treating disorders like narcolepsy (Compl. ¶¶5, 7, 9, 11, 14, 15).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" of each patent (Compl. ¶¶53, 71, 89, 107, 134, 143).
    • Accused Features: Defendant's proposed generic product is a "calcium, magnesium, potassium, and sodium oxybates oral solution," which is alleged to be a pharmaceutical composition that falls within the scope of the claims of these patents (Compl. ¶29).

  • Patents: U.S. Patent Nos. 9,050,302; 9,486,426; 10,213,400; 10,864,181; and 11,253,494 (Method of Administration Family)

    • Technology Synopsis: These patents claim methods of safely administering GHB by adjusting its dosage when a patient is also taking a monocarboxylate transporter (MCT) inhibitor, such as valproate. The methods are designed to manage drug-drug interactions to maintain both safety and efficacy (Compl. ¶¶6, 8, 10, 12, 13).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" of each patent (Compl. ¶¶62, 80, 98, 116, 125).
    • Accused Features: Plaintiff alleges that Defendant will induce infringement because its proposed product label will instruct and encourage physicians and patients to perform the patented methods of dose administration, particularly the modification of the GHB dose when co-administered with divalproex sodium (Compl. ¶¶19, 47, 65).

III. The Accused Instrumentality

No probative visual evidence provided in complaint.

Product Identification

  • The accused instrumentality is "Teva's Proposed Product," a generic version of Jazz Pharmaceuticals' Xywav® drug product, for which Teva submitted ANDA No. 216884 to the FDA (Compl. ¶1).

Functionality and Market Context

  • The accused product is a "calcium, magnesium, potassium, and sodium oxybates oral solution" (Compl. ¶29). It is intended for the same therapeutic uses as Xywav®, namely the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy (Compl. ¶18).
  • Plaintiff alleges that Defendant seeks to commercially manufacture, use, sell, and import this generic product into the United States before the expiration of the patents-in-suit, which are listed in the FDA's Orange Book with respect to Xywav® (Compl. ¶¶17, 29).

IV. Analysis of Infringement Allegations

8,591,922 Infringement Allegations

The complaint does not provide a claim chart exhibit. The following summary is based on the narrative allegations and representative claim 1 of U.S. Patent No. 10,195,168 from the same patent family.

Claim Element (from Independent Claim 1 of '168 Patent) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB... Teva's Proposed Product is a pharmaceutical composition that is an oral solution of oxybate salts. ¶29 col. 5:39-46
...wherein the mixture consists of a sodium salt..., a potassium salt..., a magnesium salt..., and a calcium salt of gamma-hydroxybutyrate... Teva's Proposed Product is specifically identified as a "calcium, magnesium, potassium, and sodium oxybates oral solution." ¶29 col. 5:42-46
...wherein the Na•GHB, K•GHB, Mg(GHB)2, and Ca(GHB)2 salts are present in a wt/wt % ratio of about 8%:23%:21%:48%, respectively... The complaint alleges that Teva's submission of its ANDA for its proposed product constitutes infringement of one or more claims, suggesting the product's formulation meets the claimed ratios. ¶35 col. 12:48-65
...wherein the composition is formulated as a liquid formulation, and wherein the liquid formulation has a total concentration of GHB salts of about 350 mg/mL to about 650 mg/mL. Teva's Proposed Product is an oral solution, and its ANDA filing for a generic equivalent of Xywav® implies that it will have a therapeutically equivalent concentration. ¶29 col. 6:4-14
  • Identified Points of Contention:
    • Scope Questions: A central question for discovery will be whether the specific weight-per-weight percentages of the different oxybate salts in Teva's Proposed Product fall within the scope of the term "about" as used in the asserted claims. The complaint does not contain Teva's precise formulation.
    • Technical Questions: While direct infringement appears to be the primary theory, the analysis may raise questions regarding bioequivalence and whether any differences in excipients or formulation between Teva's product and Xywav® impact the claimed features.

8,772,306 Infringement Allegations

The complaint does not provide a claim chart exhibit. The following summary is based on the narrative allegations and representative claim 1 of U.S. Patent No. 10,213,400 from the same patent family.

Claim Element (from Independent Claim 1 of '400 Patent) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing adverse effects caused by a combination of gamma-hydroxybutyrate (GHB)...and divalproex sodium... Teva's proposed label will allegedly instruct users on how to administer its product, including in combination with other drugs, for the treatment of narcolepsy. ¶¶19, 47 col. 1:49-65
...administering a reduced daily dosage amount of GHB...compared to a daily dosage amount...administered in the absence of concomitant administration of divalproex sodium... Plaintiff alleges that the label for its own product, Xywav®, instructs physicians to modify the dose when divalproex sodium is concomitantly administered. It is alleged that Teva's label will contain the same or similar instructions, thereby encouraging the claimed method. ¶¶19, 47 col. 2:5-15
...wherein the patient is a patient suffering from cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy and currently taking GHB or salt thereof... The accused product is indicated for treating, among other things, cataplexy or excessive daytime sleepiness in patients with narcolepsy. ¶18 col. 2:5-12
  • Identified Points of Contention:
    • Scope Questions: The dispute may turn on whether the instructions in Teva's proposed label meet the legal standard for inducing infringement. A key question for the court will be whether the label's language actively "encourages" or "instructs" the performance of the patented method, rather than merely informing of a potential interaction.
    • Technical Questions: What evidence does the complaint provide that Teva's proposed label will, in fact, contain the specific dosage adjustment instructions required by the claims? The infringement theory rests on the content of a label that has not yet been finalized or approved by the FDA.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a full analysis of claim construction. However, based on the technology and the nature of the dispute, certain terms may become central.

  • The Term: "about" (from claims of the ’922 patent family)
  • Context and Importance: This term modifies the specific weight-per-weight percentage ratios of the different salts in the claimed composition. The scope of "about" will be critical to determining literal infringement, as it defines the permissible range of deviation for Teva's formulation from the recited percentages.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses numerous embodiments with varying salt percentages, which may suggest that the inventors did not intend to be limited to the exact ratios recited in a specific claim (’168 Patent, col. 11:57-col. 12:47).
    • Evidence for a Narrower Interpretation: The patent provides specific examples with precise calculations for arriving at the claimed ratios, which could support an argument that "about" should be construed narrowly to encompass only minor variations that do not materially change the composition's fundamental characteristics ('168 Patent, Table 3).

VI. Other Allegations

  • Indirect Infringement: Plaintiff alleges both induced and contributory infringement for all thirteen patents-in-suit. The inducement theory for the method patents (e.g., ’306 Patent) is based on the allegation that Teva's product labeling will instruct or encourage physicians and patients to perform the claimed dosage-adjustment steps (Compl. ¶47). The contributory infringement theory alleges that Teva's product is especially adapted for an infringing use and has no substantial non-infringing use (Compl. ¶48).
  • Willful Infringement: The complaint does not use the word "willful." However, it alleges that Defendant had knowledge of the patents-in-suit at least as of the dates of its Paragraph IV notice letters (Compl. ¶¶32-33). Furthermore, the complaint asserts that the case is "exceptional" and seeks an award of attorneys' fees under 35 U.S.C. § 285, a remedy often associated with findings of willful infringement or litigation misconduct (Compl. ¶¶42, 51).

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

  • A central issue will be one of compositional identity: does the precise formulation of Teva's proposed generic product, specifically the weight-per-weight ratios of its four constituent oxybate salts, fall within the literal scope of the asserted composition claims, including the interpretation of the term "about"?
  • A key question will be one of inducement via labeling: will the final, FDA-approved label for Teva's product contain language that is found to actively encourage and instruct the performance of the patented methods of dose adjustment, thereby satisfying the specific intent requirement for induced infringement under 35 U.S.C. § 271(b)?