DCT

1:25-cv-01332

AbbVie Inc v. Deva Holding As

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01332, D. Del., 10/30/2025
  • Venue Allegations: Venue is alleged to be proper in any judicial district on the basis that the defendant is a foreign corporation.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market generic versions of the antipsychotic drug VRAYLAR® (cariprazine), constitutes an act of infringement of five U.S. patents.
  • Technical Context: The patents relate to the active pharmaceutical ingredient cariprazine, specific salt forms of cariprazine, and pharmaceutical formulations designed for immediate release, used in the treatment of schizophrenia and bipolar disorder.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant's submission of ANDA No. 219532 with a Paragraph IV certification, asserting that Plaintiffs' patents are invalid, unenforceable, and/or will not be infringed by the proposed generic products. The complaint was filed within the 45-day statutory window following receipt of Defendant's notice letter, which triggers an automatic 30-month stay on the FDA’s approval of the ANDA.

Case Timeline

Date Event
2003-08-04 ’142 Patent Priority Date
2007-05-11 ’621 Patent Priority Date
2008-07-16 RE’350, RE’110, and RE’302 Patents Priority Date
2010-06-15 U.S. Patent 7,737,142 Issued
2011-05-17 U.S. Patent 7,943,621 Issued
2015-09-17 FDA approves VRAYLAR® for schizophrenia and bipolar I manic/mixed episodes
2019-04-16 U.S. Patent RE47,350 Issued
2019-05-24 FDA approves VRAYLAR® for bipolar I depression
2022-06-21 U.S. Patent RE49,110 Issued
2022-11-15 U.S. Patent RE49,302 Issued
2022-12-16 FDA approves VRAYLAR® as adjunctive therapy for major depressive disorder
2025-09-17 Defendant sends Paragraph IV Notice Letter to Plaintiffs
2025-10-30 Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 7,737,142 - "(Thio) Carbamoyl-Cyclohexane Derivatives as D3/D2 Receptor Antagonists," Issued June 15, 2010

The Invention Explained

  • Problem Addressed: The patent background describes a need for new treatments for neuropsychiatric and neurodegenerative disorders like schizophrenia and Parkinson's disease, which are associated with the dopaminergic system (’142 Patent, col. 7:27-36). It implicitly identifies a problem with existing antipsychotics: that massive antagonism of the D2 dopamine receptor can lead to undesirable side effects, such as extrapyramidal motor symptoms and cognitive disturbances (’142 Patent, col. 7:53-61).
  • The Patented Solution: The patent discloses a new class of cyclohexane derivative compounds that act as dual D3/D2 receptor antagonists but show a strong preference for the D3 receptor (’142 Patent, col. 2:33-40). This D3 preference is proposed to allow for the beneficial antipsychotic effects of D2 antagonism while mitigating the known negative side effects, and potentially adding cognitive-enhancing effects attributed to D3 antagonism (’142 Patent, col. 8:37-45). The core chemical structure is defined by Formula (I) (’142 Patent, col. 2:30-55).
  • Technical Importance: This D3-preferring dual antagonist approach represented an attempt to create a more selective modulation of dopaminergic pathways, with the goal of achieving a better therapeutic window and side-effect profile than existing D2-focused antipsychotics (’142 Patent, col. 8:37-45).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶ 36). Claim 1 is the broadest independent claim covering the chemical compound genus.
  • Claim 1 of the ’142 Patent covers:
    • A compound of formula (I)
    • Wherein R₁ and R₂ are selected from a group including hydrogen and alkyl, or together form a heterocyclic ring
    • X is an oxygen or sulphur atom
    • n is 1
    • Or geometric isomers, stereoisomers, diastereomers, or salts thereof

U.S. Patent No. 7,943,621 - "Salts of Piperazine Compounds as D3/D2 Antagonists," Issued May 17, 2011

The Invention Explained

  • Problem Addressed: The patent explains that while the base form of a drug compound (in this case, cariprazine) is active, it may not have ideal properties for manufacturing and formulation (’621 Patent, col. 1:53-60). The selection of a suitable salt is described as "not always straightforward," particularly for a compound with more than one basic center, where salt formation can be difficult to achieve with high yield and purity (’621 Patent, col. 1:60-2:2).
  • The Patented Solution: The invention provides specific, novel salt forms of cariprazine: monohydrochloride, dihydrochloride, monohydrobromide, maleate, and methanesulphonate salts (’621 Patent, Abstract). The patent asserts that these specific salts can be prepared in high yield and purity and exhibit suitable solubility, handling, and stability characteristics for use in pharmaceutical compositions (’621 Patent, col. 2:7-12). The patent provides detailed analytical data, such as X-ray powder diffraction (XRD) patterns, for a specific crystalline form of the monohydrochloride salt (Form I) (’621 Patent, Fig. 1; col. 3:1-4).
  • Technical Importance: The creation of stable, high-purity salt forms is a critical step in transforming a promising drug compound into a viable, manufacturable pharmaceutical product with consistent quality and a reliable shelf life (’621 Patent, col. 2:7-12).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims," and specifically notes that Defendant’s notice letter did not contest infringement of at least claims 1 and 8-17 (Compl. ¶¶ 47, 48). Claims 1 and 8 are independent.
  • Claim 1 of the ’621 Patent covers:
    • A crystalline form of trans cariprazine hydrochloride
    • Characterized by a specific powder X-ray diffraction pattern with peaks at "about 6.6, about 7.3, about 13.2, about 21.1, and about 22.4, each about ±0.2 degrees 2θ"
  • Claim 8 of the ’621 Patent covers:
    • Trans cariprazine dihydrochloride
    • And hydrates and solvates thereof

U.S. Patent No. RE47,350 - "Pharmaceutical Formulations Containing Dopamine Receptor Ligands," Issued April 16, 2019

  • Technology Synopsis: This patent addresses the hydrolytic instability of cariprazine hydrochloride (RE’350 Patent, col. 3:55-63). It discloses stable, immediate-release pharmaceutical formulations that solve this problem by either controlling the solid-state microenvironmental pH with a buffering agent (e.g., sodium carbonate) or by using specific excipients with low water activity (e.g., lactose monohydrate) (RE’350 Patent, col. 4:26-42, 5:6-14).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶ 58).
  • Accused Features: Defendant's proposed generic cariprazine capsules are alleged to be infringing formulations (Compl. ¶ 58).

U.S. Patent No. RE49,110 - "Pharmaceutical Formulations Containing Dopamine Receptor Ligands," Issued June 21, 2022

  • Technology Synopsis: This patent, from the same family as the RE’350 patent, also relates to stable, immediate-release formulations of dopamine receptor ligands like cariprazine (RE’110 Patent, Abstract). The invention focuses on specific combinations of excipients that yield formulations with advantageous stability profiles, rapid dissolution, and bioavailability (RE’110 Patent, col. 2:11-21).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶ 68).
  • Accused Features: Defendant's proposed generic cariprazine capsules are alleged to be infringing formulations (Compl. ¶ 68).

U.S. Patent No. RE49,302 - "Pharmaceutical Formulations Containing Dopamine Receptor Ligands," Issued November 15, 2022

  • Technology Synopsis: This patent is also from the same family as the RE’350 and RE’110 patents and addresses the same technical problem of creating stable, immediate-release formulations for cariprazine (RE’302 Patent, Abstract). It claims specific formulation compositions designed to prevent hydrolytic degradation while ensuring proper drug release (RE’302 Patent, col. 2:11-21).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶ 78).
  • Accused Features: Defendant's proposed generic cariprazine capsules are alleged to be infringing formulations (Compl. ¶ 78).

III. The Accused Instrumentality

Product Identification

  • Defendant Deva's proposed generic cariprazine capsules in 1.5 mg, 3 mg, 4.5 mg, and 6 mg strengths, as described in ANDA No. 219532 (the "Deva ANDA Products") (Compl. ¶¶ 1, 6).

Functionality and Market Context

  • The Deva ANDA Products are identified as purported generic versions of Plaintiffs' VRAYLAR® product (Compl. ¶ 26). As such, they are alleged to contain cariprazine as the active pharmaceutical ingredient. The complaint alleges that upon approval, these products would be marketed for the same indications as VRAYLAR®, which include treatment of schizophrenia, bipolar disorder, and major depressive disorder (Compl. ¶¶ 18, 40). The filing suggests an intent to compete directly with and displace sales of the brand-name drug VRAYLAR® (Compl. ¶ 14).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart exhibit. The infringement theory is based on the statutory act of infringement under 35 U.S.C. § 271(e)(2)(A)—the submission of an ANDA seeking approval to market a drug claimed in a patent before the patent's expiration (Compl. ¶ 38). The tables below summarize the plausible infringement theory for the lead patents, based on the allegation that the Deva ANDA Products contain cariprazine.

U.S. Patent 7,737,142 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of formula (I) The Deva ANDA product contains cariprazine, which is alleged to be a compound of formula (I). ¶¶ 6, 36 col. 13:5-9
R₁ and R₂ represent independently a substituent selected from hydrogen, alkyl... The cariprazine API contains a dimethyl-urea moiety, where R₁ and R₂ are methyl groups, a form of alkyl. ¶¶ 6, 36 col. 2:57-61
X represents an oxygen or sulphur atom The cariprazine API is a urea derivative, wherein X is an oxygen atom. ¶¶ 6, 36 col. 2:52-53
n is 1 The cariprazine API contains a piperazine ring, a structure where n=1. ¶¶ 6, 36 col. 2:54-55
and/or geometric isomers...and/or salts The ANDA product is alleged to contain cariprazine, which is a trans isomer and may be formulated as a salt. ¶¶ 6, 36 col. 3:16-17
  • Identified Points of Contention:
    • Scope Questions: For the ’142 Patent, the primary question may be one of scope regarding the specific isomer and salt form used by Defendant. While Claim 1 is broad, a dispute could arise if Defendant argues its specific product falls outside a properly construed claim, although this appears less likely for the base compound patent in an ANDA case.
    • Technical Questions: The complaint alleges that Defendant's notice letter failed to contest infringement of certain claims of the ’142 and ’621 patents (Compl. ¶¶ 37, 48). This raises the question of whether infringement of the base compound and its specific salt form will be a central point of dispute, or if the case will focus more on validity and infringement of the formulation patents.

U.S. Patent 7,943,621 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
Crystalline trans 4-{2-[4-(2,3-dichlorophenyl)-piperazine-1-yl]-ethyl}-N,N-dimethylcarbamoyl-cyclohexylamine hydrochloride The complaint alleges infringement but does not specify the salt form or crystallinity of the API in the Deva ANDA Product. The theory would be that the product contains this specific crystalline hydrochloride salt of cariprazine. ¶ 47 col. 3:1-4
having a powder X-ray diffraction pattern that comprises peaks at about 6.6, about 7.3, about 13.2, about 21.1, and about 22.4, each about ±0.2 degrees 2θ The complaint does not provide sufficient detail for analysis of this element, as no analytical data for the accused product is included. ¶ 47 col. 15:10-15
  • Identified Points of Contention:
    • Evidentiary Questions: A central factual question will be: what is the precise solid-state form of the cariprazine API in Deva's ANDA product? Does it exhibit the XRD peaks required by Claim 1 of the ’621 Patent, or does it correspond to the dihydrochloride of Claim 8, or another form entirely? ANDA litigation frequently turns on such "design-around" attempts related to polymorphs and salts.
    • Scope Questions: The construction of the term "about" preceding each XRD peak value in Claim 1 of the ’621 Patent may be a key issue. The dispute will center on the permissible range of experimental variance for XRD measurements and whether Defendant's product falls within that range.

V. Key Claim Terms for Construction

For the ’142 Patent:

  • The Term: "a compound of formula (I)... and/or... salts thereof"
  • Context and Importance: This term defines the entire scope of the chemical genus claimed. Its construction is foundational to determining whether cariprazine, as contained in the Deva ANDA product, infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides broad definitions for the variable substituents (R₁, R₂, X, n), suggesting the inventors contemplated a wide range of compounds (’142 Patent, col. 2:2-9, col. 2:57-col. 3:15). The explicit inclusion of "salts thereof" supports coverage of various salt forms.
    • Evidence for a Narrower Interpretation: A party could argue that the "most prominent compounds" are those where n=1 (piperazine ring) and X is oxygen (urea), and that the true scope of the invention should be centered on these preferred embodiments (’142 Patent, col. 3:45-61).

For the ’621 Patent:

  • The Term: "about" (in the context of "peaks at about 6.6... degrees 2θ")
  • Context and Importance: This term's construction is critical for determining literal infringement of the polymorph claim (Claim 1). The inherent imprecision of XRD analysis means the definition of "about" could be dispositive if the accused product's XRD peaks are close to, but not identical to, the claimed values. Practitioners may focus on this term because polymorph patent litigation often hinges on the degree of similarity between the patent's reference data and the accused product's data.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself provides context by including "each about ±0.2 degrees 2θ," which a party may argue explicitly defines the scope of "about" for the purposes of this claim (’621 Patent, col. 15:14-15).
    • Evidence for a Narrower Interpretation: A party could point to the specification’s statement that peak assignments for XRD patterns "can vary by plus or minus about 0.2 degrees 2θ" as setting a firm outer boundary, rather than an exemplary one (’621 Patent, col. 5:29-31). They might also argue that the precision of the data presented in Table 1 suggests the inventors did not intend "about" to cover significant deviation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Deva will induce infringement by knowingly marketing its products with a label and instructions directing healthcare professionals and patients to use the generic drug in an infringing manner (i.e., for its approved indications) (Compl. ¶¶ 40, 61, 71, 81).
  • Willful Infringement: The complaint alleges that Deva had actual and constructive notice of the asserted patents prior to filing its ANDA (Compl. ¶¶ 41, 52). It further alleges that Deva's Paragraph IV certification, asserting the patents are invalid or not infringed, was made "without adequate justification," rendering the case "exceptional" under 35 U.S.C. § 285 and entitling Plaintiffs to attorneys' fees (Compl. ¶¶ 42, 53).

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

  1. A central evidentiary question will be one of solid-state characterization: What is the precise salt form and crystalline structure of the cariprazine active ingredient in Defendant’s ANDA product? Will discovery show that it is the specific Form I monohydrochloride claimed in the ’621 patent, the dihydrochloride, or an alternative form intended to design around the patent?
  2. A second key issue will be one of formulation infringement: Does Defendant's generic capsule formulation meet the limitations of the asserted claims in the three reissue patents (RE’350, RE’110, RE’302)? The analysis will likely focus on the specific excipients used and whether they perform the claimed function of preventing hydrolytic degradation.
  3. An overarching legal question will be one of validity: Assuming Plaintiffs can establish infringement, can Defendant prove by clear and convincing evidence that any of the asserted claims across the five patents are invalid (e.g., for obviousness or lack of enablement), as asserted in its Paragraph IV certification?