DCT

1:25-cv-01331

ViiV Healthcare Co v. Aurobindo Pharma Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01331, D. Del., 10/30/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendant Aurobindo Pharma USA, Inc.'s incorporation in Delaware and because both Defendants are subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the HIV treatment TIVICAY® constitutes an act of infringement of a patent claiming a specific crystalline sodium salt form of the active ingredient, dolutegravir.
  • Technical Context: The dispute centers on pharmaceutical formulation, specifically the patentability of a particular crystalline structure (polymorph) of an active pharmaceutical ingredient, which can affect a drug's stability, solubility, and bioavailability.
  • Key Procedural History: The litigation was triggered by Defendants' submission of ANDA No. 208355 to the FDA and their subsequent notification to Plaintiffs, via a letter dated September 17, 2025, containing a Paragraph IV Certification asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed. The complaint notes that the patent has been awarded pediatric exclusivity through June 8, 2030.

Case Timeline

Date Event
2008-12-11 ’986 Patent Priority Date
2016-01-26 ’986 Patent Issue Date
2025-09-17 Defendants' ANDA Paragraph IV Notice Letter Date
2025-10-30 Complaint Filing Date

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

U.S. Patent No. 9,242,986 - "Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates"

  • Patent Identification: U.S. Patent No. 9,242,986, "Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates," issued January 26, 2016.

The Invention Explained

  • Problem Addressed: While the patent's title and background focus on methods for synthesizing HIV integrase inhibitors, the asserted claims address a different problem inherent in pharmaceutical development: controlling the solid-state physical properties of the final drug substance (Compl. ¶27; ’986 Patent, col. 9:40-42). Different crystalline forms, or polymorphs, of the same chemical compound can have significantly different properties, such as stability and solubility, which are critical for an effective and manufacturable drug product (’986 Patent, col. 12:52-58).
  • The Patented Solution: The patent claims specific crystalline forms of the sodium salt of the HIV drug known as dolutegravir, identified as "formula AA" (’986 Patent, col. 9:43-45). These forms are defined by their unique X-ray powder diffraction (XRPD) patterns and infrared absorption spectra, which act as fingerprints for the specific crystal lattice structure (’986 Patent, Claim 1; FIG. 1). The invention is not the chemical compound itself, but rather this specific, stable, and soluble solid form of its sodium salt.
  • Technical Importance: The creation of a stable and highly soluble crystalline salt form of a drug is a critical step in transforming a promising compound into a viable pharmaceutical product suitable for oral administration (’986 Patent, col. 12:52-58).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’986 Patent, and specifically references claims 1-6 as being the subject of Defendants' Paragraph IV certification (Compl. ¶31, ¶37). Independent claim 1 is central to the dispute.
  • Independent Claim 1:
    • A crystal form of a sodium salt of a compound of formula AA
    • having characteristic diffraction peaks at 6.4°±0.2°, 9.2°±0.2°, 13.8°±0.2°, 19.2°±0.2° and 21.8°±0.2° degrees two-theta in an X-ray powder diffraction pattern.
  • The complaint reserves the right to assert other claims, including dependent claims that add further defining characteristics to the crystal form (Compl. ¶31).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed generic dolutegravir sodium tablets, equivalent to a 50 mg base, which are the subject of Abbreviated New Drug Application ("ANDA") No. 208355 (Compl. ¶10).

Functionality and Market Context

  • The Proposed ANDA Product is a generic version of Plaintiffs' TIVICAY® tablets, which are approved by the FDA for the treatment of HIV-1 infection (Compl. ¶10, ¶21).
  • The complaint alleges that Defendants' ANDA relies on the safety and efficacy data of TIVICAY® and contains data intended to demonstrate the bioequivalence of the accused generic product to the branded drug (Compl. ¶28). The product's proposed instructions for use are alleged to substantially copy those of TIVICAY® (Compl. ¶29).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart or detailed, element-by-element infringement allegations. Instead, it advances a theory of infringement based on the nature of the ANDA filing and alleged statements made by the Defendants. The central infringement allegation is that the "dolutegravir sodium as covered in one or more of the claims of the '986 Patent is and/or will be present in the Proposed ANDA Product" (Compl. ¶27).

Critically, the complaint alleges that in the Paragraph IV Notice Letter, "Defendants do not dispute that the Proposed ANDA Product will infringe Claims 1-6 of the '986 Patent unless Claims 1-6 of the '986 Patent are found invalid" (Compl. ¶37). This suggests that Plaintiffs' case for infringement will rely heavily on this alleged concession, effectively shifting the primary focus of the litigation to the question of the patent's validity. The filing of the ANDA itself is asserted as the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶32).

Identified Points of Contention

  • Validity vs. Infringement: The complaint's framing suggests the central dispute will be over the validity of claims 1-6, rather than a technical debate over infringement (Compl. ¶37). The key question for the court will likely be whether the claimed crystalline form is novel and non-obvious over the prior art.
  • Technical Equivalence: Should the validity of the patent be upheld, a potential point of contention could be whether Defendants' generic product, as manufactured, actually possesses the precise crystalline structure defined by the XRPD peaks in the asserted claims. Such disputes often involve expert testimony on analytical chemistry and measurement tolerances.

V. Key Claim Terms for Construction

The Term

  • "characteristic diffraction peaks at 6.4°±0.2°, 9.2°±0.2°, 13.8°±0.2°, 19.2°±0.2° and 21.8°±0.2°"

Context and Importance

  • This term is the primary technical limitation defining the patented invention. The infringement analysis will depend entirely on whether the accused product's XRPD pattern meets this definition. Practitioners may focus on this term because the scope of "characteristic" and the experimental variability inherent in XRPD measurements (reflected in the "±0.2°" tolerance) are common areas of dispute in pharmaceutical patent cases.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The use of the word "having" could be argued to mean that the presence of at least these five peaks is required, but that the presence of additional peaks does not avoid infringement. The specification's reference to the complete XRPD pattern in FIG. 1 could be used to argue that the claim is meant to cover any crystalline form exhibiting the overall pattern shown, with the listed peaks being merely exemplary of that pattern (’986 Patent, col. 10:30-31).
  • Evidence for a Narrower Interpretation: The patent claims multiple distinct crystalline forms, including a monohydrate form with a different set of characteristic peaks (e.g., Claim 7, citing peaks at 8.0°, 9.3°, etc.). This explicit claiming of a different polymorph using different peaks suggests that the specific sets of peaks recited in each independent claim are intended to be strictly limiting, serving to distinguish one patented form from another (’986 Patent, Claim 7). An argument for a narrower interpretation would posit that the five peaks listed in Claim 1 are the necessary and sufficient identifiers of that specific invention.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges induced infringement under 35 U.S.C. § 271(b) (Compl. ¶35). The factual basis is the allegation that Defendants' product, upon approval, will be sold with instructions for use that copy the TIVICAY® label, thereby directing and encouraging physicians and patients to use the generic drug in an infringing manner (i.e., for treating HIV) (Compl. ¶29, ¶33).

Willful Infringement

  • The complaint does not use the word "willful" but alleges facts that support a claim for enhanced damages and attorneys' fees. It alleges that Defendants had knowledge of the ’986 Patent when they filed their ANDA (Compl. ¶38) and "lacked a good faith basis" for their Paragraph IV certification that the patent was invalid or not infringed (Compl. ¶40). This conduct is alleged to make the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶40; Prayer for Relief ¶f).

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

  • A core issue will be one of patent validity: Based on the complaint's allegation that Defendants have conceded infringement contingent on validity, the central question for the court will be whether the specific crystalline form of dolutegravir sodium, as defined by the five XRPD peaks in Claim 1, is valid over the prior art.
  • A key evidentiary question will be one of technical proof: Assuming the patent is held valid, does the crystalline form in Defendants' Proposed ANDA Product, as characterized by analytical testing, definitively exhibit the "characteristic diffraction peaks" required by Claim 1, or is there a measurable difference in the solid-state structure that places it outside the claim's scope?