DCT
2:25-cv-16878
Celgene Corp v. Sandoz Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Celgene Corporation (Delaware)
- Defendant: Sandoz Inc. (Delaware)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 2:25-cv-16878, D.N.J., 10/23/2025
- Venue Allegations: Plaintiff Celgene alleges venue is proper in the District of New Jersey because Defendant Sandoz maintains a regular and established physical place of business in the district and has conducted and continues to conduct business there, including activities related to its Abbreviated New Drug Application (ANDA).
- Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the U.S. Food and Drug Administration (FDA) seeking approval to market generic versions of Celgene’s Pomalyst® drug product constitutes an act of patent infringement.
- Technical Context: The patents-in-suit relate to specific pharmaceutical formulations of pomalidomide, an immunomodulatory drug used for treating certain types of cancer, including multiple myeloma.
- Key Procedural History: The complaint certifies that the current matter is related to numerous prior patent infringement lawsuits filed by Celgene against other pharmaceutical companies that sought to market generic versions of the same Pomalyst® product, indicating a history of active enforcement of this patent portfolio.
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 |
| 2025-09-12 | Earliest Date Sandoz Directed Notice Letter to Celgene |
| 2025-10-23 | 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, titled “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione,” issued on September 9, 2014.
The Invention Explained
- Problem Addressed: The patent background describes the general challenge in pharmaceutical science of creating effective drug formulations. It notes that active drug substances require specifically tailored excipients (inactive ingredients) to achieve "advantageous physical and pharmaceutical properties" such as bioavailability, ease of administration, and stability (’427 Patent, col. 1:20-34).
- The Patented Solution: The invention provides specific oral dosage forms of pomalidomide, an immunomodulatory compound. The solution involves creating pharmaceutical compositions, specifically for capsules, containing precise amounts of pomalidomide combined with selected excipients, including pregelatinized starch, sodium stearyl fumarate, and spray dried mannitol, to create a stable and effective formulation (’427 Patent, Abstract; col. 4:27-39).
- Technical Importance: The claimed formulations provide stable, orally administrable dosage units for pomalidomide, a compound identified as useful for treating, preventing, or managing cancer and inflammatory diseases (’427 Patent, Abstract).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" without specifying particular claims (Compl. ¶26). Independent claims 1, 3, 5, 7, 9, and 11 are directed to specific oral dosage forms with different pomalidomide potencies.
- The essential elements of representative independent claim 1 are:
- 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
- Comprising pregelatinized starch at an amount of 35 mg
- Comprising sodium stearyl fumarate at an amount of 0.16 mg
- Comprising spray dried mannitol at an amount that brings the total weight of the composition to 62.5 mg
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, titled “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione,” issued on June 12, 2018.
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’427 Patent, the ’467 Patent addresses the same general problem: the need for stable and effective dosage forms of pomalidomide with advantageous physical and pharmaceutical properties (’467 Patent, col. 1:19-43).
- The Patented Solution: The ’467 Patent also discloses oral dosage forms of pomalidomide but claims them with different scope. Rather than reciting exact weights of each component, the claims define the formulation by the weight percentage of pomalidomide, the weight percentage of a "binder or filler" comprising a mixture of starch and mannitol, and a specific ratio of mannitol to starch (’467 Patent, Abstract; col. 4:28-39).
- Technical Importance: This patent provides an alternative, and potentially broader, scope of protection for stable oral pomalidomide formulations compared to the ’427 Patent.
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" (Compl. ¶35). Independent claim 1 is the sole independent claim.
- The essential elements of independent claim 1 are:
- 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
- Comprising a binder or filler at an amount of 90 to 99 weight percent of the total weight of the composition, where the binder or filler is a mixture of starch and mannitol
- Wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5
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, titled “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione,” issued on February 11, 2020.
- Technology Synopsis: Belonging to the same patent family as the ’427 and ’467 patents, the ’939 patent discloses stable oral dosage forms of pomalidomide (’939 Patent, Abstract). The technical solution involves combining pomalidomide with specific excipients, such as mannitol and starch, in defined ratios and percentages to create a stable and effective pharmaceutical composition for oral administration (’939 Patent, col. 4:29-40).
- Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶44). The sole independent claim is claim 1.
- Accused Features: The complaint alleges that Sandoz's proposed generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg strengths infringe the ’939 patent (Compl. ¶20, ¶44).
III. The Accused Instrumentality
Product Identification
- The accused products are Sandoz's proposed generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg strengths ("Sandoz's Proposed Products") (Compl. ¶20).
Functionality and Market Context
- The complaint identifies these products as generic versions of Celgene's Pomalyst® drug products (Compl. ¶1). Sandoz is alleged to have submitted ANDA No. 220741 to the FDA seeking approval to manufacture and sell these products prior to the expiration of the patents-in-suit (Compl. ¶1, ¶20). The complaint does not provide sufficient detail for analysis of the specific formulation or excipients used in Sandoz's Proposed Products, as this information is contained within the confidential ANDA submission.
IV. Analysis of Infringement Allegations
The complaint alleges that Sandoz's submission of its ANDA constitutes infringement under 35 U.S.C. § 271(e)(2)(A), but does not provide a detailed mapping of claim elements to the features of the accused products (Compl. ¶26, ¶35, ¶44). The following tables summarize the infringement theory based on the asserted claims and the general allegations in the complaint.
No probative visual evidence provided in complaint.
’427 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral dosage form in the form of a capsule which weighs 62.5 mg | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶26 | col. 32:1-2 |
| comprises: 1) pomalidomide...at an amount that provides 0.5 mg of 100% pure pomalidomide; | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶26 | col. 32:2-5 |
| 2) pregelatinized starch at an amount of 35 mg; | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶26 | col. 32:5-6 |
| 3) sodium stearyl fumarate at an amount of 0.16 mg; | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶26 | col. 32:7-8 |
| and 4) spray dried mannitol at an amount that brings the total weight of the composition to 62.5 mg. | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶26 | col. 32:8-10 |
’467 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral dosage form in the form of a capsule which comprises: 1) pomalidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition; | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶35 | col. 32:48-51 |
| 2) a binder or filler at an amount of 90 to 99 weight percent of total weight of the composition, wherein the binder or filler is a mixture of starch and mannitol; | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶35 | col. 32:51-55 |
| and wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5. | The complaint alleges Sandoz’s ANDA describes a product that will meet this limitation, but provides no specific details. | ¶35 | col. 32:56-58 |
Identified Points of Contention
- Scope Questions: For the ’427 Patent, infringement will depend on whether Sandoz’s proposed formulations literally meet the exact weights recited in the claims (e.g., "35 mg" of starch). For the ’467 Patent, a key question may be whether the excipients in Sandoz's product function as a "binder or filler" as that term is understood in the patent, and whether they fall within the claimed 90 to 99 weight percent range.
- Technical Questions: The complaint does not provide sufficient detail to identify specific technical questions. However, discovery will focus on the precise composition of Sandoz's Proposed Products to determine if they meet the specific weight, weight percent, and ratio limitations of the asserted claims.
V. Key Claim Terms for Construction
- The Term: "ratio of mannitol:starch" (from Claim 1 of ’467 and ’939 Patents)
- Context and Importance: This ratio is a central limitation defining the composition of the claimed invention. The determination of whether Sandoz's products infringe will depend on how this ratio is calculated and whether the result falls within the claimed range of "about 1:1 to about 1:1.5" (’467 Patent, col. 32:56-58). Practitioners may focus on this term because of a potential ambiguity within the patent's specification.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties may argue that the term "about" allows for some deviation from the specific 1:1 to 1:1.5 range, consistent with its plain and ordinary meaning in the context of pharmaceutical formulation.
- Evidence for a Narrower Interpretation: The specification states that in one embodiment, "the ratio of mannitol:starch in the dosage form is about 1:1.3" (’467 Patent, col. 7:1-3). However, calculations based on the patent's own working examples appear to yield a different ratio (approximately 0.77:1) (’467 Patent, Tables 1 & 2). A party may argue this internal inconsistency raises questions regarding the proper construction and scope of the claimed ratio.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Sandoz will induce infringement of the patents-in-suit upon FDA approval of its ANDA. This allegation is based on the assertion that Sandoz will intentionally encourage acts of direct infringement with knowledge of the patents (Compl. ¶29, ¶38, ¶47). The complaint also pleads contributory infringement, alleging Sandoz's products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶30, ¶39, ¶48).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. It does, however, request an award of attorneys' fees under 35 U.S.C. § 285 on the basis that the case is "exceptional" (Compl. ¶33, ¶42, ¶51).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of infringement scope: does Sandoz's proposed generic formulation fall within the very specific component weights required by the claims of the ’427 Patent, and/or within the broader compositional ranges and ratios claimed in the ’467 and ’939 Patents? The outcome may differ between the patents depending on the precise details of the accused formulation.
- A second key question will be one of claim construction and validity: how should the "ratio of mannitol:starch" be construed in the ’467 and ’939 Patents, particularly in light of the apparent discrepancy between the ratio disclosed in the written description and the ratios calculated from the patent’s own examples? This could become a central issue for both infringement and potential invalidity challenges based on written description or enablement.