DCT

2:18-cv-16035

Celgene Corp v. Mylan Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Celgene Corporation v. Mylan Pharmaceuticals Inc. et al., 2:18-cv-16035, D.N.J., 11/09/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because the Defendant entities conduct business in the state, have a physical presence, and the district is an intended destination for the accused generic drug products.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug POMALYST® infringes a patent covering specific pharmaceutical formulations of pomalidomide.
  • Technical Context: The technology concerns specific oral formulations for pomalidomide, a potent immunomodulatory drug used primarily to treat multiple myeloma, designed to ensure the product's stability and bioavailability.
  • Key Procedural History: The action arises from Mylan’s filing of ANDA No. 210275 and its subsequent Paragraph IV certification notice sent to Celgene, asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed. The complaint also notes several other pending lawsuits filed by Celgene against other generic manufacturers involving the same patent-in-suit.

Case Timeline

Date Event
2009-05-19 Priority Date for U.S. Patent No. 9,993,467
2018-06-12 U.S. Patent No. 9,993,467 Issues
2018-09-28 Earliest Date Mylan Sent Paragraph IV Notice Letter to Celgene
2018-11-09 Complaint Filed

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

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: The patent's background section notes the general challenge of formulating active drug substances to achieve advantageous properties, such as stability, bioavailability, and ease of manufacture (’467 Patent, col. 2:20-39). It identifies a specific "need ... as to dosage forms of pomolidomide" that possess these favorable characteristics (’467 Patent, col. 2:50-53).
  • The Patented Solution: The invention provides stable, oral dosage forms of pomalidomide by combining the active ingredient with a specific mixture of excipients (’467 Patent, Abstract). The core of the solution is a formulation comprising pomalidomide, mannitol, and starch, where these components are present in specific weight percentages and ratios to one another, designed for encapsulation (’467 Patent, col. 7:42-53).
  • Technical Importance: Developing a stable and reliable oral dosage form is a critical step in making an important therapeutic agent like pomalidomide, used for treating multiple myeloma, widely and safely available to patients (’467 Patent, col. 2:40-44).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶34). Independent claim 1 is representative of the invention.
  • The essential elements of independent claim 1 are:
    • 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 of the composition, wherein the binder or filler is a mixture of starch and mannitol; 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 explicitly reserve the right to assert dependent claims, though this is standard practice in litigation.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Mylan’s proposed pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg dosages, as described in Mylan's ANDA No. 210275 ("Mylan's Proposed Products") (Compl. ¶29).

Functionality and Market Context

  • The complaint alleges that Mylan's Proposed Products are "generic versions of Celgene's POMALYST® drug products" (Compl. ¶1). The filing of an ANDA suggests the proposed products contain the same active ingredient, pomalidomide, and are intended to be bioequivalent to the branded POMALYST® capsules used for treating multiple myeloma (Compl. ¶¶1, 9). The complaint does not provide specific details regarding the excipients used in Mylan's formulation. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that Mylan's submission of its ANDA constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2)(A), as it seeks FDA approval to market a product that, if commercialized, would infringe the ’467 Patent (Compl. ¶34). The complaint does not contain element-by-element infringement allegations or a claim chart. The infringement theory is predicated on the allegation that Mylan's proposed generic versions of POMALYST® will necessarily practice the patented formulations (Compl. ¶¶1, 10, 36). The central dispute will be a factual one resolved through discovery of Mylan's confidential ANDA.

  • Identified Points of Contention:
    • Scope Questions: A likely point of contention will be the scope of the term "about" used to qualify the numerical ranges in the claims (e.g., "about 0.1 to 3 weight percent"). Whether Mylan's formulation falls within these ranges will depend on the interpretation of this term.
    • Technical Questions: The primary technical question is whether Mylan’s formulation, as detailed in its confidential ANDA, contains the specific mixture of starch and mannitol in the claimed ratios and weight percentages. The complaint provides no direct evidence on this point, which will be a central issue for discovery and expert analysis.

V. Key Claim Terms for Construction

  • The Term: "a mixture of starch and mannitol"

    • Context and Importance: This term defines the core binder/filler system of the invention. The interpretation of what constitutes the claimed "mixture" is critical to determining the scope of the claims.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claims and specification use the general term "mixture" without further qualification, which could support an interpretation that any combination of the two excipients meeting the ratio and weight limitations is covered (’467 Patent, col. 6:39-44).
      • Evidence for a Narrower Interpretation: The patent’s examples consistently describe a specific manufacturing process where pomalidomide is pre-blended with a portion of the mannitol and starch, milled, and then blended with the remainder (’467 Patent, col. 34:16-26). A defendant may argue that the term "mixture" should be limited by this disclosed process.

  • The Term: "about"

    • Context and Importance: This term appears in Claim 1 modifying the weight percent of pomalidomide and the ratio of mannitol to starch. Its construction will be determinative of infringement if Mylan's formulation is numerically close but not identical to the recited values.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a definition suggesting flexibility: "dose, amount, or weight percent that is recognized by those of ordinary skill in the art to provide a pharmacological effect equivalent to that obtained from the specified dose, amount, or weight percent" (’467 Patent, col. 4:11-17).
      • Evidence for a Narrower Interpretation: The same definition also states that ""about" contemplates a dose, amount, or weight percent within 30%, 25%, 20%, 15%, 10%, or 5% of the specified" value (’467 Patent, col. 4:17-20). A defendant could argue this language, along with the precise values in the formulation examples (e.g., Table 1, col. 29), supports a more restrictive interpretation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Mylan will induce infringement by selling its products with knowledge of the ’467 Patent and with instructions that encourage infringing use by physicians and patients (Compl. ¶37). It also alleges contributory infringement, stating the proposed products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶38).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Mylan has and continues to have knowledge of the ’467 patent, at least since receiving the Paragraph IV notice, and that its acts encouraging infringement are intentional (Compl. ¶¶32, 37). Plaintiff seeks a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶41, Prayer for Relief ¶J).

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

  • A central factual question will be determinative: does the specific formulation disclosed in Mylan's confidential ANDA submission fall within the numerical ranges for the active ingredient, the starch-and-mannitol binder/filler, and their respective ratios as recited in the asserted claims of the ’467 patent?
  • A key claim construction issue will be the scope of the term "about". How the court defines the boundaries of this term will directly impact whether a formulation that is numerically close, but not identical, to the claimed ranges is infringing.