DCT

3:25-cv-00233

AstraZeneca Pharma LP v. Cipla Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-00233, D.N.J., 01/09/2025
  • Venue Allegations: Venue is alleged to be proper as Defendant Cipla USA, Inc. has its principal place of business in New Jersey, and Defendant Cipla Limited is a foreign corporation subject to personal jurisdiction. The complaint also notes that Cipla has previously consented to venue in the district in related litigation.
  • Core Dispute: Plaintiff alleges that Defendant's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of the cancer drug LYNPARZA® (olaparib) constitutes an act of infringement of a patent covering a specific pharmaceutical formulation of the drug.
  • Technical Context: The technology concerns pharmaceutical formulation science, specifically the use of a solid dispersion to improve the bioavailability and stability of olaparib, a poorly water-soluble PARP inhibitor used to treat various cancers.
  • Key Procedural History: This action is part of a larger, consolidated litigation involving multiple patents and defendants concerning generic versions of LYNPARZA®. This specific complaint was filed shortly after the patent-in-suit, U.S. Patent No. 12,178,816, issued on December 31, 2024. The complaint notes that Plaintiffs provided Defendant with notice of the patent’s impending issuance on December 16, 2024, an allegation relevant to potential claims of willfulness.

Case Timeline

Date Event
2008-10-07 '816 Patent Priority Date
2024-05-21 Cipla's Notice Letter for related patents
2024-12-11 USPTO issues Issue Notification for '816 Patent
2024-12-16 Plaintiffs notify Cipla of impending '816 Patent issuance
2024-12-17 Cipla's counsel indicates awareness of '816 Patent
2024-12-31 '816 Patent Issue Date
2025-01-09 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 12,178,816, "Immediate Release Pharmaceutical Formulation of 4-[3-(4-Cyclopropanecarbonyl-Piperazine-1-Carbonyl)-4-Fluoro-Benzyl]-2H-Phthalazin-1-One," issued December 31, 2024.

The Invention Explained

  • Problem Addressed: The patent describes the active drug, olaparib (referred to as Compound 1), as having very low aqueous solubility, which complicates the development of an effective oral tablet (’816 Patent, col. 2:35-44). A conventional immediate-release tablet formulation was found to have unexpectedly low bioavailability, while an alternative lipid-based formulation (using Gelucire™) created a high "pill burden," potentially requiring patients to take as many as 16 capsules to achieve a therapeutic dose (’816 Patent, col. 2:61-64, col. 3:20-28).
  • The Patented Solution: The invention is a pharmaceutical composition that formulates olaparib as a "solid dispersion" with a specific type of "matrix polymer" that has low moisture absorption (hygroscopicity) and a high softening temperature (’816 Patent, Abstract). This approach, particularly using the polymer copovidone, aims to stabilize the drug in an amorphous (non-crystalline) state, thereby improving its dissolution and bioavailability and allowing for a higher drug concentration in each tablet (’816 Patent, col. 3:36-38, col. 4:40-51).
  • Technical Importance: Developing a commercially viable and patient-friendly oral dosage form for poorly soluble drugs is a significant challenge in pharmaceutics, and this invention purports to solve that problem for olaparib by identifying a specific formulation strategy that avoids the pitfalls of both conventional tablets and high-volume lipid capsules (’816 Patent, col. 3:45-55).

Key Claims at a Glance

  • The complaint primarily asserts infringement of independent claim 1 ('816 Patent) (Compl. ¶¶43, 48).
  • The essential elements of independent claim 1 are:
    • An immediate-release pharmaceutical composition in the form of a tablet;
    • Comprising an extrudate, which itself comprises:
      • 100 mg to 200 mg of olaparib;
      • At least one polymer from a specified list (including copovidone and povidone); and
      • At least one glidant;
    • Comprising at least one additional excipient (outside the extrudate);
    • Wherein the weight ratio of olaparib to the polymer in the extrudate is between 1:1 and 1:9; and
    • Wherein the total concentration of olaparib in the tablet is between 10% and 35% by weight.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Cipla's ANDA Product," a generic version of LYNPARZA® (olaparib) in 100 mg and 150 mg tablet form, for which Defendant Cipla has filed ANDA No. 219410 with the FDA (Compl. ¶¶1-2, 30).

Functionality and Market Context

The complaint alleges that Cipla's product is a generic equivalent to LYNPARZA®, intended for the same therapeutic uses in treating certain cancers (Compl. ¶¶29-30). The act of infringement alleged under the Hatch-Waxman Act is the submission of the ANDA itself, which seeks FDA approval to market the generic drug prior to the expiration of the '816 Patent (Compl. ¶47). The specific formulation details of Cipla's ANDA Product are not public, but the complaint asserts that the product described in the ANDA filing contains olaparib and "certain excipients" and meets the limitations of the asserted patent claims (Compl. ¶¶41, 48).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart. The infringement theory is based on the allegation that Cipla's filing of an ANDA for a generic version of LYNPARZA® tablets is an act of infringement because the product described therein will meet all limitations of at least claim 1 of the '816 patent.

’816 Patent 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... Defendant's ANDA seeks approval for generic olaparib "tablets" in 100 mg and 150 mg strengths. ¶30 col. 41:1-2
comprising: (a) an extrudate comprising: The complaint alleges that the ANDA Product would infringe claim 1, which requires the composition to be made from an extrudate, but provides no specific facts on the manufacturing process. ¶48 col. 41:3
(i) 100 mg to 200 mg of...olaparib; The accused product is offered in 100 mg and 150 mg dosage strengths, which falls within the claimed range. ¶30 col. 41:4-8
(ii) at least one polymer chosen from [a specified list]... The complaint alleges infringement of claim 1, which requires a polymer from the specified list, but does not identify the specific polymer allegedly used by Defendant. ¶48 col. 41:9-16
(iii) at least one glidant... The complaint alleges infringement of claim 1, which requires a glidant, but does not identify the specific glidant allegedly used by Defendant. ¶48 col. 41:17
and (b) at least one excipient... The complaint alleges the '816 patent claims olaparib and "certain excipients" and that the ANDA product infringes. ¶41 col. 41:18
wherein the weight ratio of [olaparib] to the at least one polymer in the extrudate is in the range of from 1:1 to 1:9... The complaint alleges infringement of claim 1, which requires this specific weight ratio, but provides no facts regarding the ratio in the accused product. ¶48 col. 41:21-24
wherein the total concentration of [olaparib] in the tablet is in the range of from 10% by weight to 35% by weight. The complaint alleges infringement of claim 1, which requires this specific concentration range, but provides no facts regarding the concentration in the accused product. ¶48 col. 41:25-28
  • Identified Points of Contention:
    • Technical Questions: As this is an ANDA case based on a sparsely-detailed complaint, the central dispute will be a direct comparison of the technical specifications in Cipla's confidential ANDA against the claim limitations. Key questions will include: Does the manufacturing process described in the ANDA produce an "extrudate"? What are the specific identities and quantities of the polymer(s), glidant(s), and excipient(s) used? Do the weight ratio and total concentration fall within the claimed ranges?
    • Scope Questions: The primary scope question will concern the term "extrudate." The court may need to determine if this term is limited to the "melt extrusion" process detailed extensively in the patent's specification or if it can be read more broadly to cover other manufacturing methods that involve forcing material through a shaping die.

V. Key Claim Terms for Construction

  • The Term: "extrudate"
  • Context and Importance: This term appears in the preamble of element (a) of claim 1 and defines a core structural feature of the claimed composition. Infringement hinges on whether Cipla's product contains this component. Practitioners may focus on this term because if Cipla's manufacturing process (e.g., direct compression, wet granulation) does not create what can be legally defined as an "extrudate," there can be no literal infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims do not explicitly limit the term to a product of "melt" extrusion. A party could argue for its plain and ordinary meaning, which would be a material that has been shaped by being forced through a die.
    • Evidence for a Narrower Interpretation: The specification repeatedly and almost exclusively discusses the invention in the context of "melt extrusion" (e.g., ’816 Patent, col. 6:57-62, col. 10:1-12). A party could argue that the patentee defined the term by implication, tying it inextricably to the specific thermal and mechanical process described in the preferred embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Cipla will actively induce infringement by providing a product label that instructs users to take the infringing tablet, and that Cipla knows the product is not suitable for substantial non-infringing use (Compl. ¶¶49-50). It also alleges contributory infringement on the same basis (Compl. ¶50).
  • Willful Infringement: The complaint alleges that Cipla acted with full knowledge of the '816 patent (Compl. ¶52). The basis for this allegation is a specific communication where Plaintiffs' counsel notified Cipla's counsel of the patent's impending issuance on December 16, 2024, approximately two weeks before it issued and three weeks before the suit was filed (Compl. ¶36).

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

  • A central issue will be one of evidentiary comparison: does the precise formulation detailed in Cipla's confidential ANDA—specifically its manufacturing process, choice of polymer, and quantitative ratios—identically match every element of the asserted claims of the '816 patent? As with most ANDA litigation, the outcome will depend on this direct factual comparison, which will be revealed during discovery.
  • The case may also turn on a question of process definition: can the claim term "extrudate" be construed to read on a product made by a process other than the melt-extrusion method heavily emphasized in the patent's specification? The resolution of this claim construction issue could be dispositive if Cipla's manufacturing method differs from the patent's preferred embodiment.
  • Finally, a key question for damages and potential fee-shifting will be willfulness: given that Plaintiffs provided Cipla with explicit pre-suit notice of the patent, did Cipla proceed with its ANDA strategy without a good-faith belief that the patent was invalid or not infringed?