DCT

2:25-cv-06320

Celgene Corp v. USV Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-06320, D.N.J., 05/30/2025
  • Venue Allegations: Plaintiff alleges venue is proper because the Defendant is a foreign corporation, which may be sued in any judicial district, and because Defendant has systematic and continuous contacts with the District of New Jersey.
  • 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 constitutes an act of infringement of three patents related to pharmaceutical formulations of pomalidomide.
  • Technical Context: The technology concerns specific oral formulations of pomalidomide, an immunomodulatory compound used in the treatment of cancers, particularly multiple myeloma.
  • Key Procedural History: This action is a Hatch-Waxman lawsuit triggered by Defendant’s filing of an ANDA with a Paragraph IV certification, asserting that the patents-in-suit are invalid and/or will not be infringed. The complaint notes that Plaintiff Celgene has engaged in extensive prior litigation against numerous other generic drug manufacturers over the same drug product and some or all of the same patents.

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
2025-04-17 Earliest Date Defendant Notified Plaintiff of ANDA Filing
2025-05-30 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 September 9, 2014

The Invention Explained

  • Problem Addressed: The patent’s background section describes the general technical challenge of formulating active drug substances with appropriate excipients to achieve advantageous physical and pharmaceutical properties, such as stability and ease of manufacture (’427 Patent, col. 1:21-47). For pomalidomide specifically, the patent notes a need for dosage forms with such advantageous properties (’427 Patent, col. 1:48-52).
  • The Patented Solution: The patent discloses specific oral dosage formulations of pomalidomide, the active ingredient in Pomalyst®. The invention combines pomalidomide with a specific set of excipients—namely pregelatinized starch, spray dried mannitol, and sodium stearyl fumarate—in precise weight-based amounts to create stable, uniform capsules suitable for oral administration (’427 Patent, Abstract; col. 7:4-col. 8:10). The detailed description provides specific formulations for various dosage strengths, such as 0.5 mg, 1 mg, and 2 mg capsules (’427 Patent, Tables 1-3).
  • Technical Importance: This technology provides stable and manufacturable oral dosage forms for pomalidomide, an important immunomodulatory drug for treating certain cancers, thereby enabling consistent and reliable patient dosing (’427 Patent, col. 1:36-47).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specification (Compl. ¶24). Independent claims 1, 3, 5, 7, 9, and 11 are asserted as representative claims for the various dosage strengths.
  • The essential elements of independent claim 3, covering the 1 mg dosage strength, are:
    • An oral dosage form in the form of a capsule;
    • which weighs 125 mg;
    • and comprises: 1) pomalidomide (or salt/solvate) at an amount that provides 1 mg of 100% pure pomalidomide;
      1. pregelatinized starch at an amount of 70 mg;
      1. sodium stearyl fumarate at an amount of 0.32 mg; and
      1. spray dried mannitol at an amount that brings the total weight of the composition to 125 mg.
  • Standard practice suggests the right to assert dependent claims is implicitly reserved.

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: As a continuation of the application leading to the ’427 Patent, this patent addresses the same technical problem: the need for stable and effective oral formulations of pomalidomide (’467 Patent, col. 2:1-12).
  • The Patented Solution: The patented solution is similar, involving formulations of pomalidomide with mannitol and starch. However, the claims define the invention differently, focusing on the weight percentages of the components and the ratio between the primary excipients, rather than absolute milligram amounts (’467 Patent, col. 5:2-col. 6:67). This approach claims the formulation concept more broadly across a range of potential dosage sizes.
  • Technical Importance: The invention provides patent protection for the core formulation concept, focusing on key component ratios that deliver advantageous properties, independent of the specific total weight of the final dosage form (’467 Patent, Abstract).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims without specification (Compl. ¶33). 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 which comprises:
      1. pomalidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition;
      1. a binder or filler at an amount of 70 to 99 weight percent of the total weight, where the binder or filler is a mixture of mannitol and starch; and
    • wherein the ratio of mannitol:starch is from about 1:1 to about 1:1.5.
  • Standard practice suggests the right to assert dependent claims is implicitly reserved.

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 of the application leading to the ’467 Patent and addresses the same technical challenge of creating stable, manufacturable oral formulations for pomalidomide (’939 Patent, col. 2:1-12). The patented solution is defined by compositions comprising pomalidomide with a binder/filler of mannitol and starch in a specific ratio, similar to the ’467 Patent (’939 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of one or more claims (Compl. ¶42). The independent claims of the ’939 Patent are identical to those in the ’467 Patent.
  • Accused Features: The complaint alleges USV's proposed generic pomalidomide capsules infringe by containing the claimed formulations (Compl. ¶18, 42).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant USV’s proposed generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg dosage strengths, for which USV submitted ANDA No. 220322 to the FDA for approval (Compl. ¶1, 18).

Functionality and Market Context

  • The complaint alleges these products are generic versions of Celgene’s Pomalyst® drug products, which are used for treating certain types of cancer (Compl. ¶1, 2). The act of infringement alleged is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2), which allows for patent litigation before the generic product is commercially launched (Compl. ¶24, 33, 42). The complaint alleges that USV seeks to market these generic products prior to the expiration of the patents-in-suit (Compl. ¶22).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart or specific factual allegations mapping the accused product's formulation to the elements of any specific claim. The infringement theory is inferred from the allegation that USV's ANDA for pomalidomide capsules in specified strengths infringes the patents-in-suit.

’427 Patent Infringement Allegations

Claim Element (from Independent Claim 3) Alleged Infringing Functionality Complaint Citation Patent Citation
An oral dosage form in the form of a capsule USV’s proposed 1 mg pomalidomide product is an oral capsule. ¶18, 24 col. 32:15-16
which weighs 125 mg The total weight of USV's proposed 1 mg pomalidomide capsule is 125 mg. ¶18, 24 col. 32:16
and comprises: 1) pomalidomide... at an amount that provides 1 mg of 100% pure pomalidomide USV’s proposed 1 mg capsule contains a potency equivalent to 1 mg of pure pomalidomide. ¶18, 24 col. 32:17-19
2) pregelatinized starch at an amount of 70 mg USV’s proposed 1 mg capsule contains 70 mg of pregelatinized starch. ¶18, 24 col. 32:20
3) sodium stearyl fumarate at an amount of 0.32 mg USV’s proposed 1 mg capsule contains 0.32 mg of sodium stearyl fumarate. ¶18, 24 col. 32:21-22
and 4) spray dried mannitol at an amount that brings the total weight of the composition to 125 mg USV’s proposed 1 mg capsule contains spray dried mannitol as the balance of the formulation to reach a total weight of 125 mg. ¶18, 24 col. 32:23-25

’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: USV’s proposed pomalidomide products are oral capsules. ¶18, 33 col. 32:47-48
1) pomalidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition The amount of pomalidomide in USV’s proposed capsules is between 0.1% and 3% of the total capsule weight. ¶18, 33 col. 32:49-51
2) a binder or filler at an amount of 70 to 99 weight percent... wherein the binder or filler is a mixture of mannitol and starch The excipients in USV’s proposed capsules constitute 70% to 99% of the total weight and are a mixture of mannitol and starch. ¶18, 33 col. 32:52-55
and wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5 The ratio of mannitol to starch in USV’s proposed capsules is between approximately 1:1 and 1:1.5. ¶18, 33 col. 32:56-58
  • Identified Points of Contention:
    • Scope Questions: For the ’427 Patent, infringement analysis will likely be a direct factual comparison of the formulation disclosed in USV's confidential ANDA with the specific milligram amounts recited in the claims. For the ’467 and ’939 Patents, a central question may be the scope of the term "about" as it applies to the mannitol:starch ratio. The dispute may focus on whether USV's formulation, if not strictly within the 1:1 to 1:1.5 range, is nevertheless close enough to be captured by the term "about."
    • Technical Questions: A primary technical question is whether USV’s formulation uses different excipients, or the same excipients in different amounts or ratios, to achieve a similar result, potentially supporting a non-infringement argument. The complaint does not provide sufficient detail for analysis of USV's specific formulation.

V. Key Claim Terms for Construction

  • The Term: "about 1:1 to about 1:1.5" (’467 Patent, cl. 1; ’939 Patent, cl. 1)
  • Context and Importance: This term is critical because infringement of the ’467 and ’939 Patents may depend on its interpretation. Practitioners may focus on this term because if USV's ANDA specifies a mannitol-to-starch ratio slightly outside the 1:1 to 1:1.5 range (e.g., 1:1.6), the infringement determination will hinge on whether that value is encompassed by "about."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The repeated use of "about" throughout the patent specification when discussing quantitative values suggests an intent to not be limited to the exact numbers recited, but to include a reasonable degree of approximation (’467 Patent, col. 4:10-14).
    • Evidence for a Narrower Interpretation: The specification provides specific examples of formulations where the mannitol-to-starch ratio is approximately 1:1.3 (’467 Patent, Table 2; col. 7:10-12). A party may argue that "about" should be construed narrowly in light of these specific embodiments and that the range disclosed should not be significantly expanded beyond what is exemplified as functional.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement and contributory infringement for all asserted patents. The inducement allegation is based on the assertion that USV, with knowledge of the patents, will encourage direct infringement by end-users through its product labeling and instructions (Compl. ¶27, 36, 45). The contributory infringement allegation is based on the assertion that USV's products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶28, 37, 46).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (Compl. ¶31, 40, 49). This allegation is predicated on USV’s knowledge of the patents-in-suit, as evidenced by its filing of a Paragraph IV Certification and sending a notice letter to Celgene (Compl. ¶20-22).

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

  • A core issue will be one of compositional identity: does the confidential formulation disclosed in USV's ANDA contain the exact components in the specific milligram amounts required by the asserted claims of the ’427 Patent, or the specific component ratios required by the ’467 and ’939 Patents?
  • A key legal question will be the definitional scope of "about": for the ’467 and ’939 Patents, how much numerical deviation from the recited 1:1 to 1:1.5 mannitol-to-starch ratio does the term "about" permit, and does USV's proposed formulation fall within that scope?
  • A central validity question, though not raised in the complaint, will likely be obviousness: given that mannitol and starch are common pharmaceutical excipients, does the claimed combination and ratio represent a non-obvious advance over prior art formulation techniques, or would it have been an obvious-to-try modification for a skilled formulator?