Celgene Corp v. Deva Holding As

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Celgene Corporation (Delaware)
  • Defendant: Deva Holding A.S. (Turkey)
  • Plaintiff’s Counsel: Saul Ewing LLP
• Case Identification: 2:25-cv-13687, D.N.J., 07/23/2025
• Venue Allegations: Venue is alleged to be proper because the defendant is a foreign corporation organized under the laws of Turkey and may be sued in any judicial district.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application for generic pomalidomide capsules constitutes an act of patent infringement under the Hatch-Waxman Act, as the proposed products would infringe patents related to specific pharmaceutical formulations of the drug.
• Technical Context: The patents relate to stable, oral dosage formulations of pomalidomide (marketed as Pomalyst®), an immunomodulatory compound used in the treatment of cancers such as multiple myeloma.
• Key Procedural History: The complaint's certification pursuant to local rules discloses an extensive history of prior litigation initiated by Celgene against numerous other pharmaceutical companies based on some of the same patents-in-suit and for generic versions of the same Pomalyst® drug product. This history suggests a well-established litigation strategy by Celgene to protect its pomalidomide franchise.

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 Issues
2018-06-12	U.S. Patent No. 9,993,467 Issues
2020-02-11	U.S. Patent No. 10,555,939 Issues
2025-06-09	Earliest Date Defendant Sent Paragraph IV Notice Letter
2025-07-23	Complaint Filing Date

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,” Issued Sep. 9, 2014

The Invention Explained

• Problem Addressed: The patent background notes that active drug substances must be formulated with excipients to achieve advantageous physical and pharmaceutical properties, such as bioavailability and stability, and that a need exists for such dosage forms for the compound pomalidomide (’427 Patent, col. 1:21-53).
• The Patented Solution: The invention provides specific oral dosage forms, particularly capsules, containing pomalidomide combined with a select group of excipients in specific amounts. The formulation uses pregelatinized starch, sodium stearyl fumarate as a lubricant, and spray dried mannitol as a filler to create a stable composition suitable for administration (’427 Patent, Abstract; col. 7:35-8:11).
• Technical Importance: The specified formulations provide stable, orally administrable single-unit dosage forms of pomalidomide, facilitating consistent and effective delivery of the active ingredient for treating conditions like cancer (’427 Patent, col. 4:26-45).

Key Claims at a Glance

• The complaint asserts one or more claims of the patent; independent claims 1, 3, 5, 7, 9, and 11 are directed to oral dosage forms with different specific weights and compositions (Compl. ¶24; ’427 Patent, col. 32:2-62).
• Essential elements of independent claim 1 include:
  • An oral dosage form in the form of a capsule which weighs 62.5 mg
  • comprising 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
  • spray dried mannitol at an amount that brings the total weight of the composition to 62.5 mg
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,993,467 - “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione,” Issued Jun. 12, 2018

The Invention Explained

• Problem Addressed: As a continuation of the application leading to the ’427 Patent, this patent addresses the same technical problem of creating stable and effective oral formulations for pomalidomide (’467 Patent, col. 1:21-53).
• The Patented Solution: The invention provides an oral dosage capsule formulation for pomalidomide defined by the weight percentages of its components and the ratio of its binder/filler excipients, rather than by absolute weights. The key components are pomalidomide, a lubricant, and a binder or filler comprising a specific ratio of mannitol and starch (’467 Patent, Abstract; col. 5:1-6:10).
• Technical Importance: This approach provides a more flexible definition of the formulation, potentially covering a wider range of dosage strengths and manufacturing variations while maintaining the desired stability and bioavailability characteristics (’467 Patent, col. 4:26-45).

Key Claims at a Glance

• The complaint asserts one or more claims of the patent; independent claim 1 is the sole independent claim (Compl. ¶33; ’467 Patent, col. 32:35-49).
• Essential elements of independent claim 1 include:
  • An oral dosage form in the form of a capsule
  • comprising 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 70 to 99 weight percent of the total weight, wherein the binder or filler is a mixture of mannitol and starch
  • wherein the ratio of mannitol:starch is from about 1:1 to about 1:1.5
• The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsule

• Patent Identification: U.S. Patent No. 10,555,939, “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione,” Issued Feb. 11, 2020.
• Technology Synopsis: This patent, part of the same family as the ’427 and ’467 patents, is also directed to stable oral dosage formulations of pomalidomide. The claimed solution focuses on compositions defined by the weight percentages of pomalidomide and a specific binder/filler mixture of mannitol and starch in a defined ratio (’939 Patent, col. 1:21-53, col. 32:35-49).
• Asserted Claims: The complaint asserts one or more claims; independent claim 1 is the sole independent claim (’939 Patent, col. 32:35-49; Compl. ¶42).
• Accused Features: The complaint alleges that Defendant's proposed generic pomalidomide capsules, as described in its ANDA submission, will infringe one or more claims of the ’939 patent (Compl. ¶42).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are “Deva’s Proposed Products,” identified as generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg dosage strengths, for which Deva seeks FDA approval via ANDA No. 220237 (Compl. ¶1, ¶18).

Functionality and Market Context

• The complaint alleges these products are generic versions of Celgene’s Pomalyst® drug products (Compl. ¶1). The act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2), which seeks approval to manufacture and sell these generic products prior to the expiration of the patents-in-suit (Compl. ¶24, ¶33, ¶42).
• The complaint does not provide specific details on the composition or excipients of the accused products. The infringement allegation is predicated on the basis that the formulations described in Deva's confidential ANDA will, upon approval and commercialization, meet the limitations of the asserted patent claims (Compl. ¶1).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2) based on Defendant's submission of ANDA No. 220237, but does not provide a detailed, element-by-element mapping of the accused products to the claim limitations. Consequently, a claim chart summary cannot be constructed from the provided complaint.

• Identified Points of Contention:
  • Scope Questions: A central dispute for the ’427 Patent may involve the interpretation of absolute weight limitations (e.g., "35 mg of pregelatinized starch"). For the ’467 and ’939 Patents, a key question may be whether the excipients in Deva's formulation constitute a "binder or filler" that is a "mixture of mannitol and starch" falling within the claimed ratio of "about 1:1 to about 1:1.5" (’467 Patent, col. 32:45-49).
  • Technical Questions: A primary technical question, pending discovery of the ANDA's contents, will be whether the specific composition of Deva's proposed products meets every claimed limitation. The analysis will turn on the precise identity and quantity of pomalidomide and each excipient in the accused formulations.

V. Key Claim Terms for Construction

• The Term: "about [X] mg" (e.g., "about 35 mg" in claim 1 of the ’427 Patent)

• Context and Importance: This term is critical for determining the scope of the claims reciting specific weights of components. Practitioners may focus on this term because the infringement analysis will depend on whether Deva’s formulation, which may not contain the exact recited milligram amount of an excipient, nevertheless falls within the range connoted by "about."

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification states the term "about," when used with amounts, "contemplates a dose, amount, or weight percent within 30%, 25%, 20%, 15%, 10%, or 5% of the specified dose, amount, or weight percent" (’427 Patent, col. 4:5-14).
  • Evidence for a Narrower Interpretation: The claims themselves recite highly specific weights (e.g., "0.16 mg," "62.5 mg"), which may suggest to a fact-finder that the inventors intended a narrower range of equivalents than the broader language in the specification might otherwise imply (’427 Patent, col. 32:7-8).

• The Term: "a binder or filler" (from claim 1 of the ’467 Patent)

• Context and Importance: Claim 1 of the ’467 Patent requires the "binder or filler" to be a "mixture of mannitol and starch." The definition of this term is crucial because if Deva's product contains other excipients that could be characterized as binders or fillers, it could raise the question of whether its formulation meets this limitation or if the presence of other such components alters the claimed mannitol:starch ratio.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification describes the carrier, diluent, binder, or filler as comprising mannitol and/or starch, and in one embodiment, both. It does not explicitly exclude other components from being part of the "binder or filler" system (’467 Patent, col. 6:33-65).
  • Evidence for a Narrower Interpretation: The exemplary formulations provided in the patent consistently list only pomalidomide, starch, sodium stearyl fumarate (lubricant), and mannitol, suggesting that the inventive "binder or filler" system may be limited to only the mixture of mannitol and starch (’467 Patent, Tables 1-6, col. 29-31).

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement and contributory infringement for all three patents. These allegations are based on the assertion that upon FDA approval, Deva will intentionally encourage infringement with knowledge of the patents and that its proposed products are especially adapted for an infringing use with no substantial non-infringing uses (Compl. ¶¶27-28, 36-37, 45-46).
• Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it pleads that the case is "exceptional" and requests an award of attorneys' fees under 35 U.S.C. § 285, which may serve as a basis for seeking enhanced damages or fees based on litigation conduct or pre-suit knowledge (Compl. ¶31, ¶40, ¶49). The alleged basis for knowledge is Deva's Paragraph IV certification letter sent to Celgene (Compl. ¶¶20-22).

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

• A central factual question will be one of compositional identity: does the specific formulation of pomalidomide and excipients described in Deva’s confidential ANDA filing fall within the specific weight, percentage, and ratio limitations recited in the asserted claims of the patents-in-suit?
• A key legal question will be the scope of numerical ranges: can the term "about," which the specification defines as potentially covering a variance of up to 30%, be construed broadly in the context of claims that recite highly precise numerical weights (e.g., 0.16 mg), and will that construction encompass the formulation of the accused product?
• A final issue will be one of claim differentiation: given the substantial overlap in the claims of the ’467 and ’939 patents, a question may arise regarding their distinct patentable scope and whether a finding of non-infringement or invalidity for one necessarily applies to the other.