DCT

1:25-cv-01170

GlaxoSmithKline LLC v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01170, D. Del., 09/18/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a foreign corporation and may be sued in any judicial district. The complaint also notes that Defendant has previously filed claims and counterclaims in this district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the cancer drug Zejula® (niraparib) constitutes an act of infringement of three U.S. patents covering the niraparib compound and specific crystalline compositions thereof.
  • Technical Context: The technology relates to poly (ADP-ribose) polymerase (PARP) inhibitors, a class of targeted therapies used for the maintenance treatment of adult patients with certain types of cancer, particularly advanced ovarian cancer.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a notice letter dated August 7, 2025, in which Defendant stated it had filed ANDA No. 220688 with a Paragraph IV certification, alleging the patents-in-suit are invalid or will not be infringed. The patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for Zejula®. The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for Defendant’s ANDA.

Case Timeline

Date Event
2007-04-02 ’623 Patent Priority Date
2011-12-06 ’623 Patent Issue Date
2017-03-27 ’459 and ’877 Patents Priority Date
2021-08-17 ’459 Patent Issue Date
2023-04-26 FDA Approval of New Drug Application for Zejula®
2023-06-13 ’877 Patent Issue Date
2025-08-07 Date of Defendant’s ANDA Notice Letter
2025-09-18 Complaint Filing Date

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

U.S. Patent No. 8,071,623 - “Amide Substituted Indazoles as Poly(ADP-Ribose)Polymerase(PARP) Inhibitors”

The Invention Explained

  • Problem Addressed: The patent background describes the role of the PARP enzyme in DNA repair and its overactivation in pathological conditions, which can lead to cell death in contexts like ischemia but can also be exploited for cancer therapy (U.S. Patent No. 8,071,623, col. 2:1-24). The patent seeks to provide potent PARP inhibitors for use in treating conditions such as cancer, particularly as sensitizers for traditional DNA-damaging therapies (ʼ623 Patent, col. 2:42-67).
  • The Patented Solution: The invention provides a class of amide-substituted indazole compounds that inhibit PARP activity (ʼ623 Patent, col. 3:4-10). The core chemical structure is an indazole ring system substituted with specific chemical groups, including a phenyl-piperidine moiety, designed to achieve high inhibitory potency against the PARP-1 and/or PARP-2 enzymes (ʼ623 Patent, Abstract; col. 4:1-30).
  • Technical Importance: The development of potent, orally available PARP inhibitors represented a significant advance in targeted cancer therapy, offering a mechanism to specifically kill tumor cells that have pre-existing defects in DNA repair pathways, such as those with BRCA1 or BRCA2 mutations (ʼ623 Patent, col. 2:25-34).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶29).
  • Claim 1 recites:
    • A compound of formula II, which is 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide, or a pharmaceutically acceptable salt or tautomer thereof.
  • The complaint also asserts dependent claims 2-3 and 5-9 (Compl. ¶29).

U.S. Patent No. 11,091,459 - “Niraparib Compositions”

The Invention Explained

  • Problem Addressed: The development of a solid oral dosage form for a drug requires an active ingredient with stable physical and chemical properties. The patent notes that a previously developed hydrochloride salt of niraparib was "highly hygroscopic," a property that can complicate manufacturing, storage, and product consistency (U.S. Patent No. 11,091,459, col. 11:58-62).
  • The Patented Solution: The patent discloses specific crystalline forms, or polymorphs, of niraparib tosylate. The invention centers on "crystalline Form I," a monohydrate, which is described as a "non-hygroscopic solid form having suitable solubility properties, as well as favorable physical and chemical stability" for pharmaceutical development (’459 Patent, col. 11:62-67). The specification provides detailed characterization of this form using techniques like X-ray powder diffraction (XRPD), as illustrated in FIG. 1 (’459 Patent, col. 6:50-53).
  • Technical Importance: Identifying a stable, non-hygroscopic crystalline form of a drug substance is a critical step in pharmaceutical development, as it allows for consistent manufacturing, predictable bioavailability, and improved shelf life for the final drug product.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶36).
  • Claim 1 recites:
    • A composition comprising crystalline Form I of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide tosylate monohydrate.
    • The composition is "substantially free of Form II ... and Form III."
    • Crystalline Form I is characterized by an XRPD pattern with specific diffraction angles at 2θ values of 9.5±0.2, 24.9±0.2, and 26.0±0.2 degrees, and at least two additional peaks from a specified list.
    • "Substantially free" is defined as comprising less than about 6% (w/w) combined total weight of Form II and Form III.
  • The complaint also asserts claims 20-24 and 26 (Compl. ¶36).

U.S. Patent No. 11,673,877 - “Niraparib Compositions”

Technology Synopsis

This patent is from the same family as the ’459 Patent and is also directed to compositions containing the stable, non-hygroscopic "crystalline Form I" of niraparib tosylate monohydrate (U.S. Patent No. 11,673,877, col. 11:58-67). The patent claims both compositions of this crystalline form and methods of using it to treat cancers such as ovarian, fallopian tube, or primary peritoneal cancer (’877 Patent, claims 1, 11).

Asserted Claims

Independent claims 1 and 11 (Compl. ¶43).

Accused Features

The complaint alleges that Defendant’s ANDA submission for a generic niraparib product constitutes infringement of composition claim 1, and that the future sale and marketing of that product for the approved indications will infringe method of treatment claim 11 (Compl. ¶¶43, 45).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the “Sun ANDA Product,” which is a proposed generic version of Zejula® (niraparib) tablets in 100 mg, 200 mg, and 300 mg dosage strengths, as described in ANDA No. 220688 submitted by Defendant to the FDA (Compl. ¶2).

Functionality and Market Context

  • The complaint alleges that by submitting its ANDA, Defendant has represented to the FDA that its proposed generic product has the same active ingredient (niraparib), dosage form, and strength as Plaintiffs’ commercial product, Zejula®, and is bioequivalent to it (Compl. ¶24). Zejula® is a PARP inhibitor approved for maintenance treatment of adult patients with certain types of advanced or recurrent ovarian, fallopian tube, or primary peritoneal cancer (Compl. ¶16).
  • The complaint characterizes Zejula® as a significant milestone in personalized cancer treatment that contributes significantly to the improvement of patient care (Compl. ¶17). Defendant’s product, if approved, would compete directly with Zejula® in this market.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement theory is based on the statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), which arises from the submission of an ANDA seeking approval to market a generic drug prior to the expiration of patents covering the branded product. The complaint alleges that Defendant’s product will contain the same active ingredient in the same form as Plaintiffs’ product, Zejula®, which is alleged to be a commercial embodiment of the patents-in-suit (Compl. ¶¶19, 24).

’623 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of formula II... or pharmaceutically acceptable salts or tautomers thereof. The Sun ANDA Product contains the active ingredient niraparib, which is the compound 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide, or a pharmaceutically acceptable salt thereof. ¶24 col. 45:1-67

Identified Points of Contention

  • Scope Questions: Since claim 1 is a straightforward compound claim and the Sun ANDA product is alleged to contain the same active ingredient as Zejula®, direct infringement is primarily a question of fact. The central dispute on this patent may shift to validity, as suggested by Defendant's Paragraph IV certification (Compl. ¶25).
  • Technical Questions: Does the active pharmaceutical ingredient in the Sun ANDA Product meet the structural and stereochemical requirements of formula II as claimed?

’459 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising crystalline Form I of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide tosylate monohydrate... The Sun ANDA Product is alleged to be a generic version of Zejula®, which embodies the patents-in-suit and therefore contains niraparib tosylate monohydrate as the claimed crystalline Form I. ¶¶19, 24 col. 11:1-14
...substantially free of Form II... and Form III... wherein substantially free... means the composition comprises less than about 6% (w/w) combined total weight for Form II and Form III... The Sun ANDA Product, as a bioequivalent generic, will allegedly meet the claimed purity standard by containing less than about 6% of the alternative crystalline Forms II and III. ¶¶19, 24 col. 42:25-29
...wherein the crystalline Form I is characterized by an X-ray powder diffraction (XRPD) comprising diffraction angles at 2θ values of 9.5±0.2, 24.9±0.2, and 26.0±0.2 degrees... The crystalline form of niraparib in the Sun ANDA Product will allegedly exhibit an XRPD pattern that includes the characteristic peaks required by the claim for Form I. ¶¶19, 24 col. 2:5-11; FIG. 1

Identified Points of Contention

  • Scope Questions: The definition of "substantially as shown in FIG. 1" and the precision required to match the specified 2θ peaks (e.g., within the ±0.2 degree tolerance) may become a central issue. How many of the preferred peaks must be present for a finding of infringement?
  • Technical Questions: What is the actual polymorphic form and purity of the niraparib tosylate monohydrate in the Sun ANDA Product? What do its XRPD and other analytical data show regarding the presence of Form I and the absence of Forms II and III?

V. Key Claim Terms for Construction

  • Term: "substantially free of Form II and Form III" (from ’459 Patent, claim 1)
  • Context and Importance: This term is critical because it defines the required purity of the claimed crystalline Form I. The infringement analysis will depend on whether Defendant's product meets this negative limitation. Practitioners may focus on this term because polymorphic purity is a common point of dispute in pharmaceutical patent cases.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a definition that "substantially free... means less than about 20% (w/w) combined total weight" (’459 Patent, col. 2:61-64). A party could argue this broader definition from the specification should inform the claim construction.
    • Evidence for a Narrower Interpretation: Claim 1 itself contains a more explicit definition: "wherein substantially free of Form II and Form III means the composition comprises less than about 6% (w/w) combined total weight for Form II and Form III" (’459 Patent, col. 42:25-29). A party will likely argue that this explicit definition within the claim itself governs and limits the scope of the term, superseding the broader definition in the specification.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. The inducement allegation is based on the assertion that Defendant, with knowledge of the patents, will encourage infringement by distributors, healthcare providers, and patients through its marketing and labeling of the generic product for the patented uses (Compl. ¶¶32, 39, 46). The contributory infringement allegation is based on the assertion that the niraparib active ingredient is a material part of the inventions and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶33, 40, 47).
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that Defendant had knowledge of the patents-in-suit no later than the date it submitted its ANDA, based on the required Paragraph IV certification (Compl. ¶25). This allegation of pre-suit knowledge could potentially form the basis for a later claim of willfulness or a request for enhanced damages.

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

  1. A central evidentiary question will be one of polymorphic identity: Does the specific crystalline form of niraparib tosylate monohydrate used in Defendant’s ANDA product, as established through analytical testing like XRPD, in fact correspond to the claimed "crystalline Form I," or does it represent a different, non-infringing polymorph?
  2. The case may also turn on a question of definitional scope and purity: Assuming Defendant’s product contains Form I, does it meet the claim limitation of being "substantially free of Form II and Form III" by having "less than about 6% (w/w)" of these other forms, and how will experimental variability in measuring these low percentages be addressed?
  3. For the foundational ’623 compound patent, where infringement may be more straightforward, a key issue will likely be validity: What arguments and prior art will Defendant raise to support its allegation of invalidity, and can the patent withstand challenges based on obviousness or lack of enablement/written description?