DCT

3:24-cv-10628

AstraZeneca Pharma LP v. Cipla Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-10628, D.N.J., 11/20/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Cipla USA, Inc. maintains its principal place of business in the district, has filed its Abbreviated New Drug Application (ANDA) from the district, and will commit acts of infringement there. Venue is asserted over Cipla Limited as a foreign corporation subject to personal jurisdiction, and both entities have previously consented to jurisdiction and venue in the district in related litigation.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an ANDA to the FDA seeking approval to market a generic version of the cancer drug LYNPARZA® (olaparib) constitutes an act of infringement of a recently issued patent covering an immediate-release pharmaceutical formulation of the drug.
  • Technical Context: The technology concerns pharmaceutical formulations designed to improve the bioavailability of olaparib, a poorly soluble poly (ADP-ribose) polymerase (PARP) inhibitor used to treat various cancers.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Cipla's submission of ANDA No. 219410. The patent-in-suit issued on November 19, 2024, just one day before the complaint was filed. The complaint notes that Plaintiffs provided Defendants' counsel with notice of the patent's upcoming issuance on November 14, 2024. The parties are also engaged in separate, pending litigation in the same district over other patents related to olaparib.

Case Timeline

Date Event
2008-10-07 ’810 Patent Priority Date
2024-05-21 Cipla sends Notice Letter regarding its ANDA filing
2024-10-30 USPTO issues Issue Notification for the ’810 patent
2024-11-14 Plaintiffs notify Cipla of the upcoming issuance of the ’810 patent
2024-11-19 U.S. Patent No. 12,144,810 issues
2024-11-20 Complaint filed

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

  • Patent Identification: U.S. Patent No. 12,144,810, "Immediate Release Pharmaceutical Formulation of 4-[3-(4-Cyclopropanecarbonyl-Piperazine-1-Carbonyl)-4-Fluoro-Benzyl]-2H-Phthalazin-1-One," issued November 19, 2024.
  • The Invention Explained:
    • Problem Addressed: The patent describes the active drug, olaparib (referred to as Compound 1), as being poorly soluble and only moderately permeable, leading to low bioavailability when delivered in a conventional immediate-release (IR) tablet (’810 Patent, col. 1:48-64). An earlier attempt to solve this using a lipid-based formulation (Gelucire™) was found to have "reduced exposure" at higher drug concentrations, making it impractical to deliver high therapeutic doses without requiring patients to take a large number of capsules (’810 Patent, col. 3:13-25).
    • The Patented Solution: The invention is a pharmaceutical composition that formulates olaparib in a "solid dispersion" with a specific type of matrix polymer characterized by "low hygroscopicity and high softening temperature" (’810 Patent, Abstract). This approach, particularly using the polymer copovidone, is described as surprisingly increasing the bioavailability of olaparib compared to the prior lipidic formulation, thereby enabling higher, therapeutically effective doses to be delivered in a more patient-compliant tablet form (’810 Patent, col. 4:11-19; col. 3:56-60).
    • Technical Importance: The claimed formulation technology offered a potential solution to a significant drug delivery challenge, enabling a more effective and practical oral dosage form for an important class of cancer therapeutics (’810 Patent, col. 3:25-36).
  • Key Claims at a Glance:
    • The complaint asserts infringement of at least independent claim 1 (Compl. ¶48).
    • The essential elements of independent claim 1 are:
      • An immediate-release pharmaceutical composition in the form of a tablet.
      • The tablet comprises a "solid dispersion."
      • The solid dispersion comprises (i) 100 mg to 200 mg of olaparib and (ii) at least one polymer from a specified list (including copovidone, povidone, etc.).
      • The weight ratio of olaparib to the polymer is between 1:1 and 1:9.
      • The total concentration of olaparib in the tablet is between 10% and 50% by weight.
      • The tablet hardness is greater than or equal to 25 N.
    • The complaint does not explicitly reserve the right to assert dependent claims, though this is common practice in later stages of litigation.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Cipla's ANDA Product," identified as a generic version of LYNPARZA® (olaparib) tablets in 100 mg and 150 mg dosages, for which Cipla seeks FDA approval via ANDA No. 219410 (Compl. ¶1-2, 30).

Functionality and Market Context

  • The complaint alleges that Cipla's ANDA Product contains olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor used for treating certain types of cancer (Compl. ¶29, 42).
  • The filing of the ANDA is alleged to be an act of infringement, as it seeks approval to manufacture and sell a generic version of Plaintiffs' branded LYNPARZA® product prior to the expiration of the ’810 patent (Compl. ¶1, 47). The complaint does not contain specific details about the formulation or excipients used in Cipla's ANDA Product, asserting more broadly that the product, if approved and marketed, would infringe the ’810 patent (Compl. ¶48).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

  • Claim Chart Summary: The complaint alleges that Cipla's ANDA product will infringe at least claim 1 of the ’810 patent (Compl. ¶48). The infringement theory is based on the premise that the product described in Cipla's ANDA is a bioequivalent, generic version of LYNPARZA® and will meet all limitations of the asserted claim.

U.S. Patent No. 12,144,810 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An immediate-release pharmaceutical composition in the form of a tablet comprising: The complaint alleges Cipla's ANDA Product is a generic olaparib tablet intended for immediate release. ¶1, 30 col. 3:56-60
a solid dispersion comprising: The complaint's infringement allegation implies that Cipla's ANDA Product is or contains a solid dispersion. ¶41, 48 col. 4:40-41
(i) 100 mg to 200 mg of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluorobenzyl]-2H-phthalazin-1-one (Compound 1); Cipla's ANDA is for 100 mg and 150 mg olaparib tablets, which falls within the claimed dosage range. ¶2, 30 col. 39:62-67
and (ii) at least one polymer chosen from copovidone, povidone, hypromellose phthalate... The infringement allegation implies that Cipla's ANDA Product contains one of the polymers recited in the claim. ¶41, 48 col. 40:1-5
wherein the weight ratio of Compound 1 to the at least one polymer in the solid dispersion is in the range of from 1:1 to 1:9; The infringement allegation implies that the formulation in Cipla's ANDA Product meets this weight ratio limitation. ¶48 col. 40:6-7
wherein the total concentration of Compound 1 in the tablet is in the range of from 10% by weight to 50% by weight; and The infringement allegation implies that the formulation in Cipla's ANDA Product meets this concentration limitation. ¶48 col. 40:8-9
wherein the hardness of the tablet is greater than or equal to 25 N. The infringement allegation implies that the tablets described in Cipla's ANDA meet this hardness specification. ¶48 col. 40:9-10
  • Identified Points of Contention:
    • Scope Questions: As the complaint does not detail the composition of Cipla's ANDA product, a central question will be factual: does the accused formulation actually constitute a "solid dispersion" with a claimed polymer, and do its drug load, component ratios, and tablet hardness fall within the specific ranges required by claim 1?
    • Technical Questions: A key technical dispute may arise over the nature of Cipla's formulation. The infringement analysis will depend on whether the accused product achieves bioequivalence through a stable, amorphous solid dispersion as described in the patent, or through an alternative, potentially non-infringing, formulation technology.

V. Key Claim Terms for Construction

  • The Term: "solid dispersion"
  • Context and Importance: This term is the technological core of the asserted claim. The outcome of the infringement analysis will hinge on whether Cipla’s formulation is properly characterized as a "solid dispersion." Practitioners may focus on this term because its construction will define the boundary between the patented technology and other formulation types, such as simple physical mixtures.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent provides a general definition of "solid dispersion" as "systems in which an active agent is dispersed in an excipient carrier" (’810 Patent, col. 9:5-7). A plaintiff could argue this broad language encompasses a wide variety of drug-polymer compositions.
    • Evidence for a Narrower Interpretation: The specification explicitly states that the definition "does not encompass physical mixtures from dry or wet mixing or dry blending operations" (’810 Patent, col. 9:20-22). Furthermore, the patent repeatedly emphasizes the goal of creating a stable amorphous form of the drug to improve bioavailability. A defendant may argue that to be a "solid dispersion" under the patent, the composition must be a non-physical mixture, likely one where the drug is rendered amorphous within the polymer matrix.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Cipla will induce infringement because its proposed product labeling will instruct physicians and patients to use the generic tablets in an infringing manner (Compl. ¶49). The complaint also alleges contributory infringement, asserting that Cipla knows its product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶50).
  • Willful Infringement: Willfulness is alleged based on Cipla having "full knowledge of the '810 patent" at the time of its infringing activities (Compl. ¶52). The factual basis for this knowledge is Plaintiffs' pre-suit notification to Cipla's counsel on November 14, 2024, five days before the patent issued and six days before the suit was filed (Compl. ¶45).

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

  • A central factual question will be one of compositional identity: does Cipla’s ANDA product, once its formulation details are revealed in discovery, meet every quantitative and qualitative limitation of claim 1, including the use of a "solid dispersion," a claimed polymer, and the specified ranges for drug load, weight ratio, and tablet hardness?
  • The case will likely turn on a critical issue of claim construction: how will the court define "solid dispersion"? Will the term be given a broad meaning, or will it be narrowly construed to require a stable, amorphous, molecular-level dispersion that is distinct from a simple physical mixture, as the patent's specification appears to emphasize?
  • A key evidentiary question for damages and remedies will be willfulness: given that Plaintiffs notified Cipla of the patent's imminent issuance just days before filing suit, can Plaintiffs establish that Cipla’s continued pursuit of its ANDA constitutes the sort of egregious conduct required for an enhancement of damages?