DCT

2:20-cv-02597

Celgene Corp v. Breckenridge Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-02597, D.N.J., 03/10/2020
  • Venue Allegations: Venue is alleged to be proper based on Defendants’ registration to conduct business in New Jersey, purposeful and continuous business contacts within the district, and a history of litigating in the district without challenging venue.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market generic pomalidomide capsules constitutes an act of infringement of a patent covering specific formulations of the drug.
  • Technical Context: The technology concerns pharmaceutical formulations of pomalidomide (marketed as POMALYST®), an immunomodulatory compound used for the treatment of multiple myeloma.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' filing of ANDA No. 210111 and a corresponding Paragraph IV certification alleging the patent-in-suit is invalid, unenforceable, or will not be infringed. The complaint notes prior notice letters related to other patents not asserted in this action. The patent-in-suit is subject to a terminal disclaimer.

Case Timeline

Date Event
2009-05-19 ’939 Patent Priority Date
2017-04-11 Breckenridge sends First Notice Letter regarding other patents
2018-08-22 Breckenridge sends Second Notice Letter regarding another patent
2020-02-11 ’939 Patent Issue Date
2020-03-10 Complaint Filing Date

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

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

The Invention Explained

  • Problem Addressed: The patent background describes the general challenge of formulating active drug substances, noting that properties such as bioavailability, ease of manufacture, and stability are key considerations that require excipients uniquely tailored to the active ingredient (’939 Patent, col. 2:25-44). A need exists for dosage forms of pomalidomide with "advantageous physical and pharmaceutical properties" (’939 Patent, col. 2:53-56).
  • The Patented Solution: The patent discloses specific oral dosage formulations of pomalidomide, particularly for use in capsules, that combine the active ingredient with a mixture of specific binders and fillers—mannitol and starch—in defined ratios and weight percentages (’939 Patent, Abstract; col. 6:39-50). This approach aims to create a stable and effective dosage form suitable for manufacturing, for example, through a direct-blend process (’939 Patent, col. 29:9-14).
  • Technical Importance: Developing a stable, reliable, and manufacturable oral dosage form is a critical step in making an important therapeutic compound like pomalidomide, used to treat cancer, widely available to patients (’939 Patent, col. 2:46-51).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the ’939 patent (Compl. ¶32). Independent claim 1 is the sole independent claim.
  • Independent Claim 1 recites an oral dosage form in a capsule with three essential elements:
    • pomalidomide present at an amount of 0.1 to 3 weight percent of the total composition;
    • a binder or filler present at an amount of 70 to 99 weight percent of the total composition, where the binder or filler is a mixture of mannitol and starch; and
    • a ratio of mannitol to starch between about 1:1 and about 1:1.5.
  • The complaint does not specify which, if any, dependent claims are asserted.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "Breckenridge's Proposed Products," identified as generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg strengths, for which Defendants seek FDA approval via ANDA No. 210111 (Compl. ¶1, ¶22).

Functionality and Market Context

  • The accused products are generic versions of Celgene’s POMALYST®, an FDA-approved drug for the treatment of multiple myeloma (Compl. ¶1, ¶7). Under the Hatch-Waxman Act, the filing of the ANDA itself is the statutorily defined act of infringement that gives rise to the suit, as it seeks approval to market the generic drug before the expiration of the patent-in-suit (Compl. ¶1, ¶30). The complaint does not provide specific details on the formulation contained within the confidential ANDA.

IV. Analysis of Infringement Allegations

The complaint alleges that the formulation described in ANDA No. 210111 for the accused generic pomalidomide capsules will infringe the ’939 Patent (Compl. ¶30, ¶32). The complaint does not include a claim chart or specific factual allegations detailing the composition of the accused products. The infringement theory is based on the statutory act of filing an ANDA for a generic version of Celgene's POMALYST® product (Compl. ¶1). No probative visual evidence provided in complaint.

’939 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) pomolidomide at an amount of 0.1 to 3 weight percent of the total weight of the composition; The complaint alleges that the proposed generic products are pomalidomide capsules that will infringe the patent-in-suit, implying their composition meets this limitation. ¶1, ¶22, ¶30 col. 35:5-9
2) a binder or filler at an amount of 70 to 99 weight percent of total weight of the composition, wherein the binder or filler is a mixture of mannitol and starch; The complaint does not specify the excipients in the accused product but alleges that the product described in the ANDA will infringe the patent claims. ¶1, ¶30, ¶32 col. 35:9-13
and wherein the ratio of mannitol:starch in the dosage form is from about 1:1 to about 1:1.5. The complaint does not specify the excipient ratios in the accused product but alleges that the product described in the ANDA will infringe the patent claims. ¶1, ¶30, ¶32 col. 35:13-15
  • Identified Points of Contention:
    • Technical Questions: A central issue will be whether the specific formulation disclosed in Defendants' confidential ANDA falls within the literal scope of the asserted claims. The discovery process will focus on the precise weight percentages of pomalidomide and the binder/filler excipients, and critically, whether the ratio of mannitol to starch in the accused formulation is within the claimed 1:1 to 1:1.5 range.
    • Scope Questions: The interpretation of the claim terms may be disputed. For instance, what constitutes "a mixture of mannitol and starch" could become a point of contention depending on the specific manufacturing process (e.g., direct blend, wet granulation) disclosed in the ANDA.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim construction disputes. However, based on the technology and claim language, certain terms are likely to be important.

  • The Term: "a mixture of mannitol and starch"
  • Context and Importance: This term is central to infringement, as it defines the required nature of the main excipients. The corresponding ratio limitation depends on the presence of this "mixture." Practitioners may focus on this term because the method of combining ingredients can influence whether they constitute a "mixture" in a patent law context, potentially creating a non-infringement argument if the accused product is, for example, a multi-layered granule rather than a simple blend.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes manufacturing processes that involve directly blending the active ingredient with excipients, which could support a broad definition of "mixture" as any combination of the two specified components in the final dosage form (’939 Patent, col. 29:9-14).
    • Evidence for a Narrower Interpretation: The patent’s examples consistently use specific types of these ingredients, namely "spray dried mannitol" and "pregelatinized starch" (’939 Patent, Tables 1-5, col. 29-31). A party could argue that the term "mixture" should be construed in light of these specific embodiments, potentially narrowing the claim scope to exclude formulations made with different forms of mannitol or starch.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement that will occur upon FDA approval and commercial launch of the accused products. The inducement allegation is based on the assertion that Defendants will intentionally encourage infringement with knowledge of the ’939 patent (Compl. ¶33). The contributory infringement allegation is based on the assertion that the proposed generic products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶34).
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges the case is "exceptional" and requests an award of attorneys' fees pursuant to 35 U.S.C. § 285, which is often predicated on a finding of willful infringement or other litigation misconduct (Compl. ¶37, ¶9(J)).

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

  • A core issue will be one of evidentiary proof: Does the specific drug formulation disclosed in Defendants' confidential ANDA No. 210111, which is not public, actually meet every quantitative limitation of the asserted claims, including the weight percentages of pomalidomide and the binder/filler, and the specific ratio of mannitol to starch?
  • A second key issue will be one of patent validity: Defendants have certified that the ’939 patent is invalid and/or not infringed (Compl. ¶24). The litigation will therefore almost certainly involve a challenge to the patent's validity on grounds such as obviousness or lack of enablement, forcing the court to evaluate whether the claimed formulation was a non-obvious advance over the prior art at the time of invention.
  • A final question concerns claim construction: Can the term "a mixture of mannitol and starch," as used in the context of the patent's examples that specify "spray dried mannitol" and "pregelatinized starch," be interpreted to cover formulations made with different forms or grades of these common excipients? The answer could prove dispositive on the question of infringement.