DCT

3:25-cv-00234

AstraZeneca Pharma LP v. Zydus Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-00234, D.N.J., 01/09/2025
  • Venue Allegations: Venue is asserted based on Zydus Pharmaceuticals (USA) Inc. having a regular and established place of business in New Jersey, and Zydus Lifesciences Limited being a foreign corporation subject to personal jurisdiction in the district where it is sued.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug LYNPARZA® (olaparib) constitutes an act of infringement of a patent covering specific pharmaceutical formulations of the drug.
  • Technical Context: The technology concerns immediate-release pharmaceutical formulations for olaparib, a PARP (poly (ADP-ribose) polymerase) inhibitor, designed to improve the drug's stability and bioavailability when delivered orally.
  • Key Procedural History: This action was triggered by a November 5, 2024 notice letter from Zydus, informing Plaintiffs of its ANDA filing containing a Paragraph IV certification against several patents. The patent-in-suit, U.S. Patent No. 12,178,816, issued on December 31, 2024. Plaintiffs allege they provided Zydus with notice of the patent's impending issuance on December 16, 2024. This case is related to prior, consolidated litigation between the parties concerning other patents covering LYNPARZA®.

Case Timeline

Date Event
2008-10-07 '816 Patent Priority Date
2024-11-05 Zydus sends Notice Letter regarding ANDA filing
2024-12-16 Plaintiffs notify Zydus of upcoming '816 patent
2024-12-31 '816 Patent issues
2025-01-09 Complaint filed

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

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”

The Invention Explained

  • Problem Addressed: The patent describes the active pharmaceutical ingredient, olaparib ("Compound 1"), as a weakly acidic compound with low aqueous solubility and moderate permeability ('816 Patent, col. 2:35-51). These properties can lead to poor bioavailability when formulated in a conventional immediate-release tablet, potentially requiring patients to take a large number of capsules to achieve a therapeutic dose, which presents compliance challenges ('816 Patent, col. 3:11-28).
  • The Patented Solution: The invention claims to solve this problem by formulating the drug as a solid dispersion with a specific type of matrix polymer that has low hygroscopicity (i.e., absorbs little moisture) and a high softening temperature ('816 Patent, Abstract; col. 4:39-46). By dispersing the drug within such a polymer (copovidone is identified as particularly suitable), the formulation aims to stabilize the drug in an amorphous form, thereby increasing its dissolution rate and bioavailability and allowing for higher drug loading in a smaller number of dosage units ('816 Patent, col. 3:36-55).
  • Technical Importance: Developing stable, highly bioavailable oral formulations for poorly soluble drugs is a significant challenge in pharmaceutical development, and this approach seeks to enable effective and patient-friendly oral delivery of an important oncology drug. ('816 Patent, col. 3:42-55).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶47).
  • The essential elements of independent claim 1 are:
    • An immediate-release pharmaceutical composition in the form of a tablet comprising:
    • (a) an extrudate comprising:
      • (i) 100 mg to 200 mg of olaparib;
      • (ii) at least one polymer from a specified list that includes copovidone and povidone; and
      • (iii) at least one glidant;
    • (b) at least one excipient;
    • 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 "Zydus’s ANDA Product," identified as a generic version of LYNPARZA® (olaparib) tablets in 100 mg and 150 mg dosage strengths (Compl. ¶¶ 1, 28).

Functionality and Market Context

  • The complaint alleges that Zydus’s ANDA Product is a generic version of Plaintiffs’ LYNPARZA®, a PARP inhibitor approved for treating certain types of ovarian, breast, pancreatic, and prostate cancers (Compl. ¶¶ 27-28). The act of infringement alleged is the submission of ANDA No. 219893 to the FDA, which seeks approval to market this generic product prior to the expiration of the '816 Patent (Compl. ¶¶ 1-2).
  • The complaint does not provide specific technical details regarding the formulation, excipients, or manufacturing process of Zydus’s ANDA Product, as this information is contained within the confidential ANDA submission. The infringement allegations are based on information and belief that the product described in the ANDA will meet the limitations of the asserted claims (Compl. ¶47).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint’s infringement theory appears to be that because Zydus’s product is a generic version of LYNPARZA®, and LYNPARZA® is allegedly covered by the patent, the Zydus product must also infringe (Compl. ¶¶ 28, 42, 47). The following chart summarizes the allegations for the lead asserted claim.

  • U.S. Patent No. 12,178,816 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: Zydus’s ANDA Product is alleged to be an immediate-release olaparib tablet. ¶¶ 1, 28, 40 col. 2:55-56
(a) an extrudate comprising: On information and belief, the Zydus ANDA Product is, or is made from, an extrudate containing the active ingredient, a polymer, and a glidant. ¶47 col. 5:62-63
(i) 100 mg to 200 mg of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluorobenzyl]-2H-phthalazin-1-one (Compound 1); Zydus’s ANDA is for 100 mg and 150 mg olaparib tablets, which falls within the claimed dosage range. ¶28 col. 1:52-64
(ii) at least one polymer chosen from copovidone, povidone, hypromellose phthalate, hypromellose acetate succinate, 2-hydroxypropyl-β-cyclodextrin, hypromellose, polymethacrylates, hydroxypropyl cellulose, and cellulose acetate phthalate; and On information and belief, the Zydus ANDA Product contains at least one of the recited polymers. ¶¶ 40, 47 col. 5:14-19
(iii) at least one glidant; and On information and belief, the extrudate in the Zydus ANDA Product contains at least one glidant. ¶47 col. 8:14-15
(b) at least one excipient; On information and belief, the final Zydus ANDA Product tablet contains at least one excipient. ¶¶ 40, 47 col. 8:12-15
wherein the weight ratio of Compound 1 to the at least one polymer in the extrudate is in the range of from 1:1 to 1:9; and On information and belief, the formulation in the Zydus ANDA Product meets the claimed weight ratio. ¶47 col. 7:4-7
wherein the total concentration of Compound 1 in the tablet is in the range of from 10% by weight to 35% by weight. On information and belief, the formulation in the Zydus ANDA Product meets the claimed total drug concentration. ¶47 col. 8:22-26
  • Identified Points of Contention:
    • Factual Question: The central factual dispute will be the precise composition and manufacturing process of the Zydus ANDA Product. What evidence will discovery reveal about whether the product is an "extrudate," contains the claimed polymer and glidant, and meets the specified ratio and concentration limitations?
    • Scope Questions: A likely point of contention is the meaning of "extrudate." Does this term limit the claim to products made by a specific melt extrusion process, or could it be interpreted more broadly to cover a product's structure regardless of its manufacturing method? If Zydus uses a different solid dispersion technique (e.g., spray drying), this question will be critical to the infringement analysis.

V. Key Claim Terms for Construction

  • The Term: "extrudate"
  • Context and Importance: This term, recited in independent claim 1, appears to be a product-by-process limitation. Its construction is critical because if it is interpreted as requiring a specific manufacturing process (melt extrusion), Zydus may have a non-infringement defense if its product is made using an alternative method, even if the final composition is chemically similar or bioequivalent. Practitioners may focus on this term because the patent discloses other manufacturing methods for solid dispersions, such as spray drying, that are not explicitly recited in this claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader (Structural) Interpretation: The patent does not provide an explicit definition of "extrudate." A party could argue that the term should be given its plain meaning, referring to the structure of the resulting solid mass (i.e., material that has been forced through a die), and that the properties of the final product, not the method of its creation, are what matters for patentability.
    • Evidence for a Narrower (Process-Based) Interpretation: The specification describes the process as involving "extruding the melt to produce a solid product" and discusses using a "melt extrusion apparatus" ('816 Patent, col. 5:62-63; col. 9:55-60). A party could argue these passages define "extrudate" as a product necessarily resulting from a melt extrusion process, thereby excluding products made by other disclosed methods like spray drying ('816 Patent, col. 9:31-33).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating on information and belief that Zydus plans to market its ANDA product with proposed labeling that will instruct physicians and patients to use it in an infringing manner. It further alleges the product and its labeling are not suitable for substantial non-infringing use (Compl. ¶¶ 48-49).
  • Willful Infringement: Willfulness is alleged based on Zydus having "full knowledge of the '816 patent" prior to the lawsuit (Compl. ¶51). The complaint asserts this knowledge was established, at the latest, on December 16, 2024, when Plaintiffs' counsel notified Zydus's counsel of the patent's imminent issuance (Compl. ¶44).

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

  • A central legal issue will be one of claim scope: is the term "extrudate" in Claim 1 a strict process limitation requiring melt extrusion, or can it be interpreted structurally? The answer will determine whether Zydus can design around the claim by using an alternative manufacturing process for its solid dispersion, such as spray drying, which is disclosed in the patent's specification but not claimed.
  • The primary evidentiary question will be factual correspondence: once Zydus's confidential ANDA is produced in discovery, does its proposed generic product actually contain all elements of the asserted claim, including the specific polymer, the presence of a glidant within the extrudate, and the claimed weight and concentration ratios?
  • A key question for validity, which Zydus has raised in its Paragraph IV certification, will be non-obviousness: given the background art on using solid dispersions to improve the bioavailability of poorly soluble drugs, was the specific combination of an olaparib "extrudate" with the claimed polymers, ratios, and concentrations an obvious step to one of ordinary skill in the art?