DCT

2:25-cv-01147

Celgene Corp v. Cipla Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-01147, D.N.J., 02/10/2025
  • Venue Allegations: Venue is alleged to be proper because the defendant, Cipla, is a corporation organized under the laws of India and may be sued in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Pomalyst® drug product infringes three patents related to specific formulations of the active ingredient pomalidomide.
  • Technical Context: The technology concerns pharmaceutical formulations designed to provide stable and effective oral dosage forms for pomalidomide, an immunomodulatory drug used in cancer therapy.
  • Key Procedural History: The lawsuit was triggered by Defendant's submission of ANDA No. 219718 with a Paragraph IV certification, alleging that the patents-in-suit are invalid or will not be infringed. The complaint also notes an extensive history of prior litigation initiated by the Plaintiff against other generic drug manufacturers concerning the same Pomalyst® drug product.

Case Timeline

Date Event
2009-05-19 Priority Date for ’427, ’467, and ’939 Patents
2014-09-09 U.S. Patent No. 8,828,427 Issued
2018-06-12 U.S. Patent No. 9,993,467 Issued
2020-02-11 U.S. Patent No. 10,555,939 Issued
2024-12-30 Cipla Directed Notice of Paragraph IV Certification to Celgene
2025-02-10 Complaint Filed

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

U.S. Patent No. 8,828,427 - “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione”

  • Patent Identification: U.S. Patent No. 8,828,427, "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione," issued September 9, 2014.
  • The Invention Explained:
    • Problem Addressed: The patent's background section describes the general technical challenge that active drug substances must be combined with other agents (excipients) to create a dosage form with advantageous properties such as bioavailability, stability, and ease of administration, noting a specific need for such dosage forms for pomalidomide (’427 Patent, col. 1:20-44, col. 1:50-53).
    • The Patented Solution: The invention provides specific pharmaceutical compositions for oral administration of pomalidomide, particularly in capsule form. The solution lies in combining pomalidomide with a specific set of excipients—pregelatinized starch, sodium stearyl fumarate, and spray dried mannitol—at precise, claimed weights to create a stable and effective formulation (’427 Patent, Abstract; col. 32:1-10).
    • Technical Importance: The invention provided stable and manufacturable oral dosage forms for pomalidomide, an important immunomodulatory compound for treating various diseases, including cancer (’427 Patent, col. 1:36-40, col. 1:45-53).
  • Key Claims at a Glance:
    • The complaint asserts infringement of "one or more" of the patent's claims (Compl. ¶24). Independent claim 1 is representative of the invention's core formulation.
    • Essential elements of Independent Claim 1:
      • An oral dosage form in the form of a capsule which weighs 62.5 mg and comprises:
      • pomalidomide at an amount that provides 0.5 mg of 100% pure pomalidomide;
      • pregelatinized starch at an amount of 35 mg;
      • sodium stearyl fumarate at an amount of 0.16 mg; and
      • spray dried mannitol at an amount that brings the total weight of the composition to 62.5 mg.
    • The complaint does not specify dependent claims but reserves the right to assert additional claims.

U.S. Patent No. 9,993,467 - “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione”

  • Patent Identification: U.S. Patent No. 9,993,467, "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione," issued June 12, 2018.
  • The Invention Explained:
    • Problem Addressed: Similar to the ’427 patent, the background addresses the need for pomalidomide dosage forms with "advantageous physical and pharmaceutical properties" suitable for administration to patients (’467 Patent, col. 1:51-54).
    • The Patented Solution: This patent also discloses oral dosage formulations of pomalidomide. However, its claims define the composition using weight percentages of the total composition and a specific ratio of the primary excipients, rather than absolute weights. The claimed solution is a composition containing pomalidomide within a specific weight percent range, combined with a binder or filler mixture of starch and mannitol where the mannitol-to-starch ratio is between approximately 1:1 and 1:1.5 (’467 Patent, Abstract; col. 32:35-46).
    • Technical Importance: This patent provides an alternative, potentially broader definition of a stable oral pomalidomide formulation, providing continued protection for the drug product (’467 Patent, col. 1:37-41, col. 1:46-54).
  • Key Claims at a Glance:
    • The complaint asserts infringement of "one or more" of the patent's claims (Compl. ¶33). Independent claim 1 is representative.
    • Essential elements of Independent Claim 1:
      • An oral dosage form in the form of a capsule which comprises:
      • pomalidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition;
      • a binder or filler at an amount of 90 to 99 weight percent of the total weight, where the binder or filler is a mixture of starch and mannitol; and
      • wherein the ratio of mannitol:starch is from about 1:1 to about 1:1.5.
    • The complaint does not specify dependent claims but reserves the right to assert additional claims.

U.S. Patent No. 10,555,939 - “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione”

  • Patent Identification: U.S. Patent No. 10,555,939, "Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione," issued February 11, 2020.
  • Technology Synopsis: This patent is a continuation in the same family as the ’427 and ’467 patents and addresses the same technical problem: creating stable oral dosage forms for pomalidomide. The patent claims pharmaceutical compositions comprising pomalidomide, a specific binder/filler mixture of mannitol and starch in a defined ratio, and a lubricant (’939 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" of the patent (Compl. ¶42). Independent claim 1 is representative.
  • Accused Features: The complaint alleges that Defendant's proposed generic pomalidomide capsules, as described in ANDA No. 219718, will infringe the patent (Compl. ¶¶18, 42).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are "Cipla's Proposed Products," identified as generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg strengths (Compl. ¶18). These products are the subject of Cipla's ANDA No. 219718 submitted to the FDA (Compl. ¶1).

Functionality and Market Context

The products are intended to be generic equivalents of Celgene’s Pomalyst® drug product, which is used to treat certain types of cancer (Compl. ¶¶1, 7). The complaint alleges that Cipla seeks FDA approval to manufacture, use, sell, and import these generic versions in the United States prior to the expiration of the patents-in-suit (Compl. ¶1). The act giving rise to the suit is the submission of the ANDA itself, which constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶24).

  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient detail to map specific elements of the accused products to the claim limitations. The infringement allegations are statutory in nature, based on the submission of ANDA No. 219718, which seeks approval to market a generic version of Celgene's Pomalyst® product prior to patent expiry (Compl. ¶¶24, 33, 42).

  • Identified Points of Contention:
    • For the ’427 Patent:
      • Factual Question: The independent claims of the ’427 Patent recite highly specific weights for each component (e.g., "35 mg" of pregelatinized starch, "0.16 mg" of sodium stearyl fumarate). A primary point of contention will be a factual comparison of whether Cipla's formulation, as described in its ANDA, contains these exact amounts. Any deviation, even if minor, may support a non-infringement defense against literal infringement.
    • For the ’467 Patent:
      • Scope Questions: The claims of the ’467 Patent use ranges (e.g., "0.1 to 3 weight percent") and ratios qualified by "about" (e.g., "from about 1:1 to about 1:1.5"). This suggests a potential dispute over claim scope. The key question may be how much deviation from the specified ranges and ratios is permissible under the term "about," which the specification defines as what one of ordinary skill would recognize as providing an equivalent pharmacological effect (’467 Patent, col. 4:10-20).

V. Key Claim Terms for Construction

For the ’427 Patent

  • The Term: "spray dried mannitol at an amount that brings the total weight of the composition to [e.g., 62.5] mg"
  • Context and Importance: This limitation defines the quantity of a major excipient not by a direct weight, but as the remainder required to reach a total capsule weight. Practitioners may focus on this term because its construction is critical for determining infringement if there are any variations in the weights of the other components or the final product due to manufacturing tolerances. The dispute may center on whether this requires an exact mathematical calculation or allows for standard industry variances.
  • Intrinsic Evidence for a Broader Interpretation: A party could argue that in the context of pharmaceutical manufacturing, such language is understood to accommodate normal process variability.
  • Evidence for a Narrower Interpretation: The patent's claims and examples recite precise target weights, which may support an interpretation that the "brings the total weight" language requires a strict final weight without significant deviation (’427 Patent, Table 1; col. 32:1-10).

For the ’467 Patent

  • The Term: "about"
  • Context and Importance: This term appears in the critical limitation defining the mannitol-to-starch ratio ("from about 1:1 to about 1:1.5"). The infringement analysis for the ’467 patent may depend entirely on the scope afforded to "about." Practitioners may focus on this term because if the Defendant's formulation ratio is close to, but outside, the 1:1-1.5 range, the definition of "about" will be dispositive.
  • Evidence for a Broader Interpretation: The patent specification provides an explicit definition for "about," stating it "contemplates a dose, amount, or weight percent within 30%, 25%, 20%, 15%, 10%, or 5% of the specified dose, amount, or weight percent" (’467 Patent, col. 4:10-20). Plaintiff may cite this language to argue for a flexible range.
  • Evidence for a Narrower Interpretation: A party may argue that the specific context of a finely balanced pharmaceutical formulation requires a tighter tolerance than the general definition might suggest. The patent's detailed examples showing specific formulations may be used to argue that "about" should be construed narrowly to preserve the invention's distinction over the prior art (’467 Patent, Examples 1-6).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon receiving FDA approval, Cipla will induce and contribute to the infringement of the patents-in-suit by manufacturing, using, selling, and importing its generic products (Compl. ¶¶27, 28, 36, 37, 45, 46). These allegations are based on Cipla's stated intent to market its products for infringing uses with knowledge of the patents, as evidenced by its Paragraph IV notice letter (Compl. ¶21).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, for each patent-in-suit, it alleges that the case is "an exceptional one" and seeks an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶¶31, 40, 49). The factual basis for this allegation is not detailed but is predicated on Cipla’s alleged knowledge of the patents.

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

  • A central factual issue will be one of compositional equivalence: Does the formulation detailed in Cipla's ANDA literally meet every limitation of the asserted claims, particularly the exact weights required by the ’427 patent and the weight percentages and excipient ratios required by the ’467 and ’939 patents?
  • A key legal issue will be one of definitional scope: For the claims of the ’467 and ’939 patents, how will the court construe the term "about" as it applies to the claimed mannitol-to-starch ratio? The outcome of this construction may determine whether slight variations in the accused formulation fall within the scope of the claims.