DCT

3:25-cv-02049

Janssen Sciences Ireland UNLtd Company v. Laurus LABS, LTD.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-02049, D.N.J., 03/24/2025
  • Venue Allegations: Venue is alleged based on Defendant Laurus Generics Inc.’s principal place of business in New Jersey and Defendant Laurus Labs, Ltd.’s status as a foreign entity.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the HIV drug COMPLERA® constitutes an act of infringement of three patents covering the drug's specific bilayer tablet formulation and the processes used to manufacture a key active ingredient.
  • Technical Context: The technology concerns a fixed-dose combination antiretroviral therapy for HIV-1, where formulation stability and manufacturing scalability are critical for commercial viability.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants’ Paragraph IV certification notice. The complaint alleges that Defendants refused pre-suit requests to produce the ANDA and related manufacturing information. The complaint also notes prior litigation involving two of the patents-in-suit, which may be used to support allegations of pre-suit knowledge for willfulness claims.

Case Timeline

Date Event
2005-05-31 Priority Date for ’752 and ’291 Patents
2010-11-19 Priority Date for ’102 Patent
2012-01-24 ’752 Patent Issued
2013-12-31 ’291 Patent Issued
2020-12-08 ’102 Patent Issued
2025-02-14 Plaintiffs receive Paragraph IV Notice Letter from Defendants
2025-03-24 Complaint Filed

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

U.S. Patent No. 10,857,102 - “Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate”

Issued December 8, 2020 (’102 Patent)

The Invention Explained

  • Problem Addressed: The patent describes a chemical stability problem where tenofovir disoproxil fumarate (TDF), a key active ingredient, degrades when formulated in the presence of another active ingredient, rilpivirine HCl, using a conventional co-wet granulation process (’102 Patent, col. 2:23-29; Compl. ¶44). This instability makes creating a single, combination tablet "not ideal for human clinical use" (’102 Patent, col. 2:29-30).
  • The Patented Solution: The invention is a multilayer tablet that physically separates the incompatible active ingredients. A first layer contains rilpivirine HCl, and a second layer contains TDF and a third active ingredient, emtricitabine (’102 Patent, col. 2:41-44, Fig. 1). This structure is designed to provide chemical stability while delivering plasma concentrations of the drugs equivalent to those achieved by taking three separate pills (’102 Patent, col. 2:44-50; Compl. ¶44).
  • Technical Importance: This formulation enabled the creation of a stable, single-tablet, once-daily regimen for a three-drug HIV therapy, which can improve patient convenience and dosing compliance (’102 Patent, col. 2:15-21).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶82).
  • Claim 1 recites:
    • A tablet comprising a first layer and a second layer.
    • The first layer consists of specific amounts of rilpivirine HCl and six named excipients (microcrystalline cellulose, lactose monohydrate, povidone, polysorbate 20, croscarmellose sodium, and magnesium stearate).
    • The second layer consists of specific amounts of emtricitabine, tenofovir disoproxil fumarate, and six named excipients (microcrystalline cellulose, lactose monohydrate, pregelatinized starch, croscarmellose sodium, and magnesium stearate).

U.S. Patent No. 8,101,752 - “Process for preparing 4-[(1,6-dihydro-6-oxo-2-pyrimidinyl)amino]benzonitrile”

Issued January 24, 2012 (’752 Patent)

The Invention Explained

  • Problem Addressed: Prior art methods for producing a key intermediate (PBN-II) for the synthesis of rilpivirine were not suitable for commercial-scale manufacturing (Compl. ¶3). One specific prior art process liberated methyl mercaptane, a "toxic and extremely odorous compound," which created significant purification challenges, making the process "impractical for large-scale production" (’752 Patent, col. 3:25-30).
  • The Patented Solution: The patent claims a new process for making PBN-II (formula I) that involves condensing a guanidine derivative with an alkoxymethylene malonic acid ester, followed by a dealkoxycarbonylation step (’752 Patent, Abstract; col. 6:25-34). The patent describes that this process can be conducted as a "one-pot procedure" without isolating the intermediate, using a dipolar aprotic solvent like N-methylpyrrolidone (NMP) (’752 Patent, col. 3:30-32; col. 4:50-53).
  • Technical Importance: This process provided an efficient, reproducible, and scalable method for manufacturing a critical component of the active pharmaceutical ingredient rilpivirine, enabling its commercial supply (Compl. ¶53).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶113).
  • Claim 1 recites:
    • A process for preparing the compound of formula (I) (PBN-II).
    • The process comprises condensing the guanidine of formula (III) with an alkoxymethylene malonic acid ester of formula (IV).
    • This is followed by a dealkoxycarbonylation step to obtain the final product of formula (I).

U.S. Patent No. 8,618,291 - “Process for preparing 4-[(1,6-dihydro-6-oxo-2-pyrimidinyl)amino]benzonitrile”

Issued December 31, 2013 (’291 Patent)

  • Patent Identification: U.S. Patent No. 8,618,291, “Process for preparing 4-[(1,6-dihydro-6-oxo-2-pyrimidinyl)amino]benzonitrile,” issued December 31, 2013 (Compl. ¶36).
  • Technology Synopsis: As a continuation of the application that led to the ’752 Patent, this patent also claims processes for manufacturing PBN-II, a key building block for the HIV drug rilpivirine. The invention addresses the need for a commercially viable manufacturing process, which the complaint alleges prior art methods lacked (Compl. ¶¶ 3, 69).
  • Asserted Claims: The complaint asserts at least independent claims 1 and 17 (Compl. ¶126).
  • Accused Features: The complaint alleges on information and belief that Defendants will use the processes claimed in the ’291 Patent to manufacture the rilpivirine API that is incorporated into their proposed generic ANDA product (Compl. ¶¶ 69, 126).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants’ proposed generic version of COMPLERA® tablets, for which Defendants submitted Abbreviated New Drug Application (ANDA) No. 220232 to the FDA (Compl. ¶2).

Functionality and Market Context

  • The "Laurus ANDA Product" is described as a three-drug, fixed-dose combination tablet intended for the treatment of HIV-1 infection (Compl. ¶¶ 3, 77). It contains 27.5 mg of rilpivirine hydrochloride, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate (Compl. ¶77). The complaint characterizes the branded version, COMPLERA®, as "highly successful," positioning the accused product to compete directly with an established therapy upon potential market entry (Compl. ¶2). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’102 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A tablet comprising a first layer and a second layer, The Laurus ANDA Product is alleged to be a "bilayer tablet." ¶77 col. 24:32-33
wherein the first layer consists of 27.5 mg rilpivirine HCl, 60.0 mg microcrystalline cellulose, 189.8 mg lactose monohydrate, 3.3 mg povidone, 0.4 mg polysorbate 20, 16.1 mg croscarmellose sodium, and 3.0 mg magnesium stearate; Defendants are alleged to not dispute the active ingredient but contend that "certain excipients and their amounts vary from those claimed." Plaintiffs allege on information and belief that the product infringes literally or under the doctrine of equivalents. ¶¶77, 78 col. 24:33-37
and the second layer consists of 200.0 mg emtricitabine, 300.0 mg tenofovir disoproxil fumarate, 150.0 mg microcrystalline cellulose, 80.0 mg lactose monohydrate, 50.0 mg pregelatinized starch, 60.0 mg croscarmellose sodium, and 10.0 mg magnesium stearate. As with the first layer, Defendants are alleged to not dispute the active ingredients but to contend that the excipients and/or their amounts differ from the claim. Plaintiffs allege infringement will be shown through discovery. ¶¶77, 78 col. 24:38-41
  • Identified Points of Contention:
    • Scope and Technical Questions: The central issue for the ’102 Patent is one of chemical composition. The complaint acknowledges that Defendants' infringement position, as stated in their Paragraph IV letter, is based on differences in the formulation's excipients and their amounts (Compl. ¶77). This raises the question of whether the accused product's formulation meets every limitation of claim 1 exactly, as required for literal infringement of a claim using "consists of" language. If not, the dispute will shift to a fact-intensive analysis under the doctrine of equivalents, questioning whether the different excipients or amounts perform substantially the same function, in substantially the same way, to achieve the same result (Compl. ¶78).

’752 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A process for preparing a compound of formula (I) ... The complaint alleges on information and belief that Defendants use the patented process to manufacture PBN-II, an intermediate incorporated into the rilpivirine API for the Laurus ANDA Product. ¶¶52, 69 col. 5:40-42
wherein the compound of formula (I) is prepared by condensing the guanidine of formula (III) with an alkoxymethylene malonic acid ester of formula (IV), followed by a dealkoxycarbonylation... The complaint does not specify the exact steps of Defendants' manufacturing process but alleges infringement based on "information and belief," supported by Defendants' refusal to produce manufacturing information and by a separate Laurus patent application allegedly describing an infringing process. ¶¶67, 69, 113 col. 6:25-34
  • Identified Points of Contention:
    • Evidentiary Question: A primary point of contention for the ’752 Patent will be factual: what manufacturing process do Defendants actually use to create the rilpivirine API? The complaint's allegations are based on "information and belief" rather than direct evidence, and Plaintiffs explicitly raise Defendants' "failure to produce requested manufacturing information" to support a presumption of infringement under 35 U.S.C. § 295 (Compl. ¶113). This sets the stage for a significant discovery dispute.
    • Technical and Legal Question: For infringement to be found under 35 U.S.C. § 271(g), the imported product must be "made by" the patented process and the product must not be "materially changed by subsequent processes." The complaint alleges that the PBN-II intermediate is "not materially changed when it is incorporated into rilpivirine" (Compl. ¶57). This raises the legal and technical question of whether the subsequent chemical reactions to form the final rilpivirine API constitute a "material change" that would absolve Defendants of liability.

V. Key Claim Terms for Construction

  • The Term: "consists of" (from ’102 Patent, claim 1)

    • Context and Importance: This term appears in claim 1 of the ’102 Patent to introduce the list of ingredients for both the first and second layers. Practitioners may focus on this term because it is a "closed" transition phrase, meaning it presumptively excludes any elements not recited in the claim. The infringement dispute, as framed by the complaint, hinges on whether Defendants' formulation contains different or additional excipients than those listed, making the construction of this term dispositive for literal infringement (Compl. ¶77).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue that the term does not exclude trace impurities or processing aids that do not materially affect the properties of the composition.
      • Evidence for a Narrower Interpretation: The patentee will likely argue that "consists of" has its plain and ordinary meaning, excluding all other components. The detailed description, which focuses on solving a specific stability problem with a unique multilayer formulation, and the high specificity of the component weights listed in the claim (e.g., "189.8 mg lactose monohydrate"), suggest that the exact recipe is a critical aspect of the invention and supports a narrow, exclusionary reading (’102 Patent, col. 2:23-50; col. 24:33-41).

  • The Term: "not materially changed" (relevant to 35 U.S.C. § 271(g) for ’752 and ’291 Patents)

    • Context and Importance: While not a claim term, this statutory phrase is central to the infringement analysis for the process patents. The complaint alleges that the PBN-II intermediate, made by the patented process, is incorporated into the final rilpivirine drug product and is "not materially changed" (Compl. ¶57). Practitioners may focus on this issue because liability for importing a product made by a patented process requires that the product itself is not materially altered by subsequent steps before importation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (favoring non-infringement): Defendants may argue that the chemical reaction converting PBN-II into the final rilpivirine molecule is, by definition, a "material change" because it creates a new chemical entity with different properties.
      • Evidence for a Narrower Interpretation (favoring infringement): Plaintiffs allege that PBN-II remains "structurally and functionally unchanged from PBN-II" when "joined to the remainder of the rilpivirine molecule" (Compl. ¶¶ 55-56). This suggests an argument that the core, patented structure is preserved in the final product and that the subsequent modification is not "material" in the context of the invention's purpose.

VI. Other Allegations

  • Indirect Infringement: For the ’102 Patent, the complaint pleads induced and contributory infringement, alleging Defendants will encourage infringement through the marketing, sale, and labeling of the ANDA product, and that the product is not suitable for substantial non-infringing use (Compl. ¶¶ 96-102). For the ’752 and ’291 process patents, the complaint alleges infringement under 35 U.S.C. § 271(g) and also includes allegations of inducement, based on Defendants acting in concert to have the API manufactured abroad using the patented process for importation into the U.S. (Compl. ¶¶ 113, 126).
  • Willful Infringement: The complaint alleges that Defendants had actual knowledge of all three patents-in-suit prior to submitting the ANDA (Compl. ¶¶ 83, 114, 127). To support this, it specifically points to prior litigation involving the ’752 and ’291 patents (Janssen v. Mylan) as evidence of Defendants' knowledge of those patents' existence and validity (Compl. ¶71). The complaint further alleges that Defendants' infringement of the process patents "would be willful" (Compl. ¶¶ 115, 128).

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

  • A central issue will be one of chemical composition versus claim scope: Does the precise formulation of the Laurus ANDA product, particularly its excipients, fall within the narrow "consists of" language of the ’102 patent's claims? If not, the case will depend on a fact-intensive doctrine of equivalents analysis, focused on the functional role of any different or additional ingredients.
  • A second core issue will be an evidentiary battle over manufacturing methods: Given the pre-suit refusal to provide manufacturing data, a key question is what process Defendants actually use to synthesize the rilpivirine API. The resolution may turn on compelled discovery and the potential application of the statutory presumption of infringement for products made by patented processes.
  • A final question will be one of statutory interpretation: For the process patent claims, does the chemical conversion of the PBN-II intermediate into the final rilpivirine drug product constitute a "material change" under 35 U.S.C. § 271(g), which would sever the link between the patented process and the imported product?