DCT

1:23-cv-00774

Gilead Sciences Inc v. Apotex Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Gilead Sciences, Inc. v. Apotex Inc., 1:23-cv-00774, D. Del., 07/14/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Apotex Corp. and MSN Pharmaceuticals Inc. are incorporated in Delaware. For the foreign defendants, venue is alleged to be proper in any district where personal jurisdiction exists, which Plaintiff asserts is established through systematic contacts with the district, including previous litigation where jurisdiction was not challenged.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's HIV treatment GENVOYA® constitutes an act of infringement of a patent covering a pharmaceutical formulation technology.
  • Technical Context: The dispute centers on pharmaceutical formulation technology designed to improve the physical properties and processability of an active pharmaceutical ingredient, cobicistat, a component of the HIV combination therapy GENVOYA®.
  • Key Procedural History: The complaint alleges that this action was filed within 45 days of receiving Defendants' notice letter regarding their ANDA filing, triggering a statutory stay of FDA approval. The complaint also references prior litigation where Defendants allegedly stipulated that submitting another ANDA product containing certain components would infringe the patent-in-suit, a point Gilead raises to support its current infringement and willfulness claims.

Case Timeline

Date Event
2008-05-02 ’718 Patent Priority Date
2018-08-07 ’718 Patent Issue Date
2023-06-01 Defendants allegedly sent GENVOYA Notice Letter to Gilead
2023-06-02 Gilead allegedly received Defendants' GENVOYA Notice Letter
2023-07-14 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 10,039,718, "Use of Solid Carrier Particles to Improve the Processability of A Pharmaceutical Agent," issued August 7, 2018.

The Invention Explained

  • Problem Addressed: The patent describes its key pharmaceutical compound, cobicistat (the "compound of formula (I)"), as having poor solid-state properties that "make it difficult to handle and process on a large scale" ('718 Patent, col. 2:45-48). These undesirable properties include a low glass transition temperature, hygroscopicity (tendency to absorb moisture), and a non-crystalline, non-free-flowing nature, which complicates its formulation into tablets ('718 Patent, col. 2:45-51).
  • The Patented Solution: The invention solves this problem by combining the difficult-to-handle compound with "specific solid carrier particles," such as silica derivatives ('718 Patent, col. 2:10-13). This combination results in a composition with "unexpectedly improved physical properties," including reduced hygroscopicity, improved flowability, and excellent compressibility, making it suitable for processing into solid dosage forms like tablets ('718 Patent, col. 2:13-25; Abstract). Figure 2 of the patent graphically illustrates the reduced water uptake (lower hygroscopicity) of the patented composition compared to its individual components ('718 Patent, Fig. 2).
  • Technical Importance: This formulation technique provides a significant advance that "facilitates the commercial development of the compound of formula (I) for use in treating viral infections such as HIV" ('718 Patent, col. 2:45-48).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, including independent claim 1 (Compl. ¶68).
  • Essential elements of independent claim 1:
    • A composition comprising a plurality of hydrophilic fumed silicon dioxide particles
    • and a compound of formula (I) [cobicistat]
    • wherein the compound of formula (I) is in the pores or on the surface of the silicon dioxide particles
  • The complaint does not explicitly reserve the right to assert dependent claims but references infringement of "one or more claims" (Compl. ¶79).

III. The Accused Instrumentality

Product Identification

  • The "GENVOYA ANDA Product," which is a generic version of Gilead’s branded HIV drug, GENVOYA®, for which Defendants seek FDA approval via ANDA No. 218575 (Compl. ¶¶ 8, 59).

Functionality and Market Context

  • The complaint alleges that the accused GENVOYA ANDA Product is a generic copy of Gilead's four-drug combination tablet for treating HIV-1 infection (Compl. ¶¶ 2, 55).
  • The key technical feature relevant to the infringement allegation is that the Defendants' proposed generic product, like the branded GENVOYA®, allegedly "will contain COBI on SiO₂" (cobicistat on silicon dioxide) (Compl. ¶15, ¶82). Cobicistat (COBI) is one of the four active ingredients in GENVOYA® and corresponds to the "compound of formula (I)" in the '718 patent ('718 Patent, col. 2:26-28).
  • The complaint asserts that GENVOYA® is a "highly successful product," and by filing an ANDA, Defendants have represented to the FDA that their product has the same active ingredients, dosage form, and is bioequivalent to GENVOYA® (Compl. ¶¶ 2, 64).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The complaint alleges that the submission of ANDA No. 218575 is an act of infringement under 35 U.S.C. § 271(e)(2) and that the future manufacture and sale of the product would infringe under other subsections (Compl. ¶¶ 67, 79). The core of the infringement theory for claim 1 is summarized below.
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising a plurality of hydrophilic fumed silicon dioxide particles The GENVOYA ANDA Product is alleged to be a composition that will include silicon dioxide (SiO₂) as a component. ¶15; ¶82 col. 3:57-59
and a compound of formula (I) The GENVOYA ANDA Product is alleged to contain cobicistat (COBI), which is the compound of formula (I). ¶15; ¶82 col. 2:26-28
wherein the compound of formula (I) is in the pores or on the surface of the silicon dioxide particles The GENVOYA ANDA Product is alleged to contain "COBI on SiO₂," which Plaintiff contends meets this limitation. ¶15; ¶76 col. 3:1-3
  • Identified Points of Contention:
    • Scope Questions: The complaint asserts that Defendants' notice letter "does not contest infringement of the claims of the '718 patent" (Compl. ¶62, ¶69). Assuming this is accurate, the primary dispute may shift to patent validity rather than infringement. However, for infringement, a question could be raised whether the specific type of silicon dioxide used in the Defendants' product meets the "hydrophilic fumed" limitation as construed by the court.
    • Technical Questions: The complaint's allegations regarding the composition of the ANDA product are made "on information and belief" (Compl. ¶15). A key evidentiary question for the court will be what proof demonstrates that the physical structure of Defendants' product satisfies the "in the pores or on the surface" limitation, as opposed to simply being a dry mixture of the two components.

V. Key Claim Terms for Construction

  • The Term: "hydrophilic fumed silicon dioxide particles"
  • Context and Importance: This term defines the specific type of carrier particle required by the claim. The properties of these particles are described in the patent as being key to solving the technical problem of poor processability. The construction of this term will be critical to determining the scope of the claim and whether the silicon dioxide used in the Defendants' ANDA product falls within it.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses "solid carriers" more generally, listing examples such as "kaolin, bentonite, hectorite, colloidal magnesium-aluminum silicate, silicon dioxide, magnesium trisilicate," and others, which could suggest the specific "hydrophilic fumed" type is exemplary, not strictly limiting ('718 Patent, col. 3:56-61).
    • Evidence for a Narrower Interpretation: The patent repeatedly identifies a specific commercial product, AEROPERL® 300 (fumed silica), as "particularly useful" ('718 Patent, col. 5:15-18). The specification also provides specific physical parameters for suitable silica derivatives, such as a "mean particle diameter of 10 to 120 micron and a BET surface area of 40 to 400 m²/g" ('718 Patent, col. 5:4-7). A defendant may argue these specific examples and parameters limit the scope of the term to particles with similar characteristics.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendants will actively induce infringement under § 271(b) with knowledge and specific intent, citing Defendants' notice letter and prior stipulations as evidence of their knowledge (Compl. ¶88). It further alleges contributory infringement under § 271(c), asserting that the "COBI on SiO₂" component is "especially made or adapted for use in infringing the '718 patent" and is "not suitable for substantial non-infringing use" (Compl. ¶91).
  • Willful Infringement: The complaint does not use the word "willful" but lays the factual groundwork for such a claim. It alleges Defendants have "actual knowledge of the '718 patent" and became aware of it "no later than the filing of the GENVOYA ANDA" (Compl. ¶¶ 85-86). It also points to prior stipulations to infringement in other cases as evidence of knowledge (Compl. ¶81, ¶88).

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

  • A central issue will be one of patent validity and enforceability. Given the complaint's repeated assertions that Defendants are not contesting infringement and have previously stipulated to it in other matters, the defense will likely focus on arguing that the claims of the '718 patent are invalid over the prior art—an issue on which the complaint is silent but which is foundational in ANDA litigation.
  • A key question of claim scope will be how the court construes the term "hydrophilic fumed silicon dioxide particles." The outcome of this construction could determine whether the specific excipient used in the Defendants' ANDA product falls within the bounds of the asserted claims, should infringement become a contested issue.
  • An evidentiary question remains regarding the physical composition of the accused product. While the complaint alleges the product contains "COBI on SiO₂," the court will require definitive evidence, beyond allegations made on information and belief, that the generic product's formulation meets the claim limitation requiring the active ingredient to be "in the pores or on the surface" of the silicon dioxide particles.