Vertex Pharma Inc v. Lupin Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Vertex Pharmaceuticals Incorporated (Massachusetts)
  • Defendant: Lupin Limited (India) and Lupin Pharmaceuticals, Inc. (Delaware)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; White & Case LLP
• Case Identification: 1:26-cv-00084, D. Del., 01/23/2026
• Venue Allegations: Venue is asserted based on Lupin Limited being a non-U.S. resident, permitting suit in any judicial district, and Lupin Pharmaceuticals, Inc. being a Delaware corporation.
• Core Dispute: Plaintiff alleges that Defendants' proposed generic version of the cystic fibrosis drug KALYDECO® (ivacaftor) will infringe a patent covering a specific pharmaceutical formulation of the drug.
• Technical Context: The dispute centers on pharmaceutical formulation technology, specifically solid dispersions used to improve the stability and bioavailability of poorly soluble active pharmaceutical ingredients for treating cystic fibrosis.
• Key Procedural History: This complaint is the latest in a series of infringement actions brought by Vertex against Lupin concerning the same Abbreviated New Drug Application (ANDA). Prior suits involving seven other patents were filed between 2022 and 2025 and have been consolidated. This action was triggered by a new notice letter from Lupin regarding the recently issued patent-in-suit, indicating Lupin's intent to challenge it.

Case Timeline

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

U.S. Patent No. 12,458,635 - "Pharmaceutical Composition and Administrations Thereof"

• Patent Identification: U.S. Patent No. 12,458,635, “Pharmaceutical Composition and Administrations Thereof,” issued November 4, 2025.

The Invention Explained

• Problem Addressed: The patent addresses the need for "stable bioavailable pharmaceutical compositions" of the active ingredient ivacaftor ("Compound 1"), which is used to treat cystic fibrosis (CF) ’635 Patent, col. 3:25-29 CF is a genetic disease caused by mutations in the CFTR gene, which disrupts ion and fluid transport and leads to severe respiratory and digestive problems ’635 Patent, col. 1:27-40
• The Patented Solution: The invention is a pharmaceutical formulation where the active ingredient is prepared as a "solid dispersion" ’635 Patent, col. 3:32-35 This involves dispersing amorphous (non-crystalline) ivacaftor within a polymer matrix, which can improve the drug's dissolution rate and bioavailability compared to a crystalline form ’635 Patent, col. 7:56-col. 8:1 The patent’s FIG. 1 graphically illustrates the improved dissolution profiles achieved by certain formulations.
• Technical Importance: Solid dispersion technology is a critical method for formulating modern drugs that are potent but poorly soluble in water, enabling them to be effectively absorbed by the body when taken orally.

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" without specification Compl. ¶36 Independent claim 1 is central to the patent.
• Independent Claim 1: A pharmaceutical composition comprising a "single solid dispersion" with three specific components at defined weight percentages:
  • "about 80 wt %" of amorphous or substantially amorphous Compound 1 (ivacaftor), which must be less than 15% crystalline;
  • "about 19.5 wt %" of the polymer hydroxypropylmethylcellulose acetate succinate (HPMCAS); and
  • "about 0.5 wt %" of the surfactant sodium lauryl sulfate (SLS).
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

• Lupin's proposed generic ivacaftor oral granules in 25, 50, and 75 mg dosages, as described in Abbreviated New Drug Application (ANDA) No. 217431 submitted to the FDA ("Lupin's ANDA Products") Compl. ¶16

Functionality and Market Context

• Lupin's ANDA Products are designed to be a generic equivalent to Vertex's KALYDECO® oral granules, a commercial drug used to treat CF in young children Compl. ¶¶1, 14, 16
• The complaint alleges that Lupin's ANDA relies on data demonstrating the bioequivalence of its product to Vertex's NDA Products, positioning it to compete directly with KALYDECO® upon FDA approval Compl. ¶17

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or any specific technical details regarding the composition of Lupin's ANDA Products. The infringement theory is characteristic of Hatch-Waxman litigation: by filing an ANDA seeking approval for a generic drug that is bioequivalent to the branded KALYDECO® product, and certifying that the ’635 Patent will not be infringed, Lupin has committed a statutory act of infringement under 35 U.S.C. § 271(e)(2) Compl. ¶36 The core of the allegation rests on the premise that to be bioequivalent, Lupin's product must necessarily practice the formulation claimed in the ’635 Patent, which is listed in the FDA's Orange Book for KALYDECO® Compl. ¶15

• Identified Points of Contention:
  • Factual Question: The central factual dispute will be whether Lupin’s proposed generic formulation, as described in its confidential ANDA submission, actually contains the specific components (amorphous ivacaftor, HPMCAS, and SLS) in the precise weight-percentage ratios required by the asserted claims.
  • Scope Questions: The analysis may raise questions about the scope of the claim term "about." For example, does Lupin's formulation, if it does not contain exactly 80% ivacaftor, 19.5% HPMCAS, and 0.5% SLS, still fall within the scope of a claim limitation reciting "about" those percentages?

V. Key Claim Terms for Construction

• The Term: "about" (e.g., "about 80 wt %", "about 19.5 wt %", "about 0.5 wt %")
• Context and Importance: The construction of "about" will be critical for defining the literal scope of the claims. The infringement analysis will likely turn on whether the weight percentages of the components in Lupin’s formulation are sufficiently close to the recited values to be considered "about" them. Practitioners may focus on this term as it directly controls the boundaries of infringement for these quantitative limitations.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent uses the term "about" repeatedly without providing an explicit numerical definition, which may suggest that the patentee did not intend for the values to be read with absolute precision ’635 Patent, Claim 1 Parties arguing for a broader scope may contend the term should be given its ordinary meaning, connoting a range of reasonable tolerance around the stated value.
  • Evidence for a Narrower Interpretation: The patent provides specific weight percentages to two decimal places in some examples and claims them to one decimal place, which could suggest a relatively high degree of precision was intended ’635 Patent, Claim 1; FIG. 1 A party arguing for a narrower scope may point to the detailed examples and dissolution data (e.g., FIG. 1) to argue that even small deviations from the recited percentages could materially alter the composition's performance, thereby limiting the permissible range of "about."

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement and contributory infringement Compl. ¶37 Inducement is premised on the allegation that Lupin’s proposed product labeling will instruct physicians and patients to use the generic drug in an infringing manner Compl. ¶38 Contributory infringement is based on the allegation that Lupin's product is especially adapted for an infringing use and has no substantial non-infringing use Compl. ¶40
• Willful Infringement: The complaint alleges that Defendants acted with "full knowledge of the ’635 patent," citing Lupin's December 18, 2025 Paragraph IV Notice Letter as evidence of pre-suit knowledge Compl. ¶¶22, 38

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

The resolution of this case will likely depend on the answers to two central questions:

• A core issue will be one of compositional identity: What are the actual ingredients and their precise weight percentages in Lupin's proposed generic product, as revealed through discovery from its confidential ANDA filing, and do they match the specific formulation recited in the asserted claims?
• A key legal question will be one of definitional scope: How broadly will the court construe the claim term "about"? The outcome of this construction will determine whether minor variations in Lupin's formulation, if any, are sufficient to avoid literal infringement of the patent.