DCT

2:19-cv-10099

Celgene Corp v. Sun Pharma Global FZE

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-10099, D.N.J., 04/16/2019
  • Venue Allegations: Plaintiff alleges venue is proper based on Defendant Sun's systematic and continuous contacts with New Jersey, including maintaining U.S. headquarters and physical places of business in the state, deriving substantial revenue from the district, and committing the act of infringement under 35 U.S.C. § 271(e)(2) by sending its notice letter to Celgene's headquarters in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's REVLIMID® drug product constitutes infringement of patents related to specific crystalline polymorphic forms of lenalidomide.
  • Technical Context: The dispute centers on polymorphism, the ability of a solid chemical compound to exist in multiple crystalline forms, which can affect a drug's stability, solubility, and bioavailability.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Sun's filing of ANDA No. 211846 and its Paragraph IV Certification alleging that Celgene's patents are invalid, unenforceable, or will not be infringed. The complaint also notes that the various Sun entities have previously consented to jurisdiction in the District of New Jersey in numerous other patent cases.

Case Timeline

Date Event
2003-09-04 Earliest Priority Date for ’357, ’219, and ’598 Patents
2011-07-12 U.S. Patent No. 7,977,357 Issued
2012-06-05 U.S. Patent No. 8,193,219 Issued
2013-04-30 U.S. Patent No. 8,431,598 Issued
2018-05-30 Date on or after which Sun sent its Paragraph IV Certification Notice Letter to Celgene and the earliest date Sun's ANDA was pending
2019-04-16 Complaint Filed

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

U.S. Patent No. 7,977,357 - Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

The Invention Explained

  • Problem Addressed: The patent's background section explains that chemical compounds can exist in different solid crystal forms, or polymorphs, which can have significantly different physical properties such as solubility and stability. In pharmaceutical development, identifying and selecting a specific, stable polymorph is critical for ensuring consistent safety, efficacy, and manufacturability of a drug product (’357 Patent, col. 2:25-50).
  • The Patented Solution: The invention discloses the discovery and characterization of several distinct polymorphic forms of the compound lenalidomide. The patent provides detailed analytical data, such as X-ray powder diffraction (XRPD) patterns and differential scanning calorimetry (DSC) thermograms, that serve as unique fingerprints for each crystalline form, allowing them to be identified and distinguished from one another (’357 Patent, col. 3:59-65; col. 6:21-36). For example, Figure 1 of the patent provides a representative XRPD pattern for what the inventors designated as "Form A" (’357 Patent, Fig. 1).
  • Technical Importance: By isolating and characterizing specific polymorphs, the invention provides a basis for developing a consistent, stable, and effective solid dosage form of lenalidomide for treating cancer and other diseases (’357 Patent, col. 2:50-57).

Key Claims at a Glance

  • The complaint does not specify which claims it asserts, alleging infringement of "one or more claims" (Compl. ¶54). Independent claim 1 is representative.
  • Essential elements of Independent Claim 1:
    • The unsolvated crystalline Form A of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,
    • which has a differential scanning calorimetry thermogram having an endotherm at approximately 270° C.
  • The complaint does not explicitly reserve the right to assert dependent claims but its general pleading may encompass them.

U.S. Patent No. 8,193,219 - Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

The Invention Explained

  • Problem Addressed: As with the ’357 Patent, this patent addresses the technical challenge that different crystalline forms of a drug compound can affect its physical properties and, consequently, the performance and regulatory approvability of the final drug product (’219 Patent, col. 2:25-50).
  • The Patented Solution: The invention claims pharmaceutical compositions comprising specific polymorphic forms of lenalidomide, formulated for oral administration in particular dosage amounts. The claims define the required crystalline form by its characteristic XRPD pattern—a set of peaks at specific angles that uniquely identifies the crystal structure (’219 Patent, col. 21:56-67; Fig. 1). The invention thus covers not just the chemical substance itself, but the formulated drug product containing that specific crystalline form.
  • Technical Importance: This invention provides protection for a finished drug product with predictable and stable characteristics, which is essential for commercializing a safe and effective oral medication (’219 Patent, col. 2:50-57).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" (Compl. ¶65). Independent claims 1, 8, and 12 are representative.
  • Essential elements of Independent Claim 1:
    • A pharmaceutical composition for oral administration
    • comprising between 5 mg and 25 mg of an unsolvated crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
    • having an X-ray powder diffraction pattern comprising peaks at approximately 8, 14.5, 16, 17.5, 20.5, 24, and 26 degrees 2θ
    • and a pharmaceutically acceptable excipient, diluent, or carrier
    • wherein the composition is a solid dosage form.
  • The complaint's general pleading may encompass dependent claims.

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 8431598, Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione, issued April 30, 2013 (the "’598 Patent").
  • Technology Synopsis: Similar to the other patents-in-suit, the ’598 Patent is directed to specific crystalline forms of lenalidomide. It claims solid forms and pharmaceutical compositions defined by a combination of characteristics, including DSC endotherms, XRPD peaks, and thermogravimetric analysis data, to ensure the selection of a stable and manufacturable form of the drug (’598 Patent, col. 2:25-57).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶76). Independent claims 1, 5, and 14 are representative.
  • Accused Features: The accused features are Sun's proposed generic lenalidomide capsules, which are alleged to contain a solid form of lenalidomide falling within the patent's claims (Compl. ¶74-76).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Sun’s proposed generic 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg lenalidomide capsules, identified as "Sun's ANDA Products" (Compl. ¶1, 47).

Functionality and Market Context

The complaint alleges that Sun filed ANDA No. 211846 with the FDA seeking approval to commercially manufacture, use, and sell these generic lenalidomide capsules in the United States prior to the expiration of the patents-in-suit (Compl. ¶1, 47). Lenalidomide is the active ingredient in Celgene's REVLIMID® product, an FDA-approved medication used for treating certain types of cancer, including multiple myeloma (Compl. ¶10). The act of infringement alleged in the complaint is the filing of the ANDA itself, which is an artificial act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶54, 65, 76). The complaint provides no specific technical details about the composition or crystalline form of the lenalidomide contained in Sun's ANDA Products.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-by-claim analysis or a claim chart summary. The infringement allegations are pleaded generally, stating that Sun's submission of its ANDA for approval to market its generic lenalidomide products constitutes infringement of one or more claims of each of the patents-in-suit (Compl. ¶54, 65, 76). The central narrative theory of infringement is that the solid form of lenalidomide that Sun intends to market, as described in its ANDA, will necessarily possess the specific physical and chemical characteristics (e.g., the XRPD pattern shown in Figure 1 of the patents or the DSC endotherm) claimed in the patents-in-suit (’357 Patent, Fig. 1; Compl. ¶52-54).

  • Identified Points of Contention:
    • Evidentiary Question: A central issue will be factual and evidentiary: does the crystalline form of lenalidomide described in Sun’s confidential ANDA submission exhibit the specific analytical characteristics required by the asserted claims? For example, does Sun’s proposed product contain unsolvated crystalline Form A having a DSC endotherm at approximately 270° C., as required by claim 1 of the ’357 Patent?
    • Scope Question: The dispute may turn on the scope of the term "approximately" as it applies to the numeric values for the XRPD peaks and DSC endotherms recited in the claims. The question for the court would be how much deviation from the recited values is permissible before a product is considered non-infringing.

V. Key Claim Terms for Construction

  • The Term: "approximately" (e.g., "approximately 270° C." in ’357 Patent, claim 1; "approximately 8, 14.5, 16..." degrees 2θ in ’219 Patent, claim 1).
  • Context and Importance: This term is critical because the infringement analysis will involve comparing analytical data from Sun's product to the specific numeric values in the claims. Practitioners may focus on this term because its construction will define the literal scope of the claims and determine whether minor experimental variations place an accused product inside or outside the bounds of the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The repeated use of "approximately" and "about" throughout the specification when discussing analytical measurements suggests the patentee did not intend for the claim values to be read with absolute precision (’357 Patent, col. 6:21-36; col. 7:1-5).
    • Evidence for a Narrower Interpretation: The specification provides specific, detailed figures showing the experimental results for each polymorph, such as the DSC thermogram in Figure 4 showing an endotherm at 270.28° C (’357 Patent, Fig. 4). A party might argue that "approximately" should be limited to the normal range of experimental error associated with such analytical techniques, as understood by a person skilled in the art at the time.
  • The Term: "unsolvated crystalline Form A" (’357 Patent, claim 1).
  • Context and Importance: The identity of the specific polymorphic form is the core of the invention. The definition of "Form A" is central to determining whether Sun's product infringes, as the claims are directed to this specific crystalline structure.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims define Form A by a single characteristic (a DSC endotherm at ~270° C.). This could support an argument that any unsolvated crystalline form meeting this thermal property is "Form A," regardless of other characteristics.
    • Evidence for a Narrower Interpretation: The specification defines Form A by reference to a collection of analytical data, including a specific XRPD pattern (Fig. 1), IR spectrum (Fig. 2), Raman spectrum (Fig. 3), and DSC/TGA data (Fig. 4) (’357 Patent, col. 6:21-36). A party could argue that for a substance to be "Form A," it must correspond to this full suite of defining characteristics, not just the single one recited in the claim.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegations are based on the assertion that Sun will, upon FDA approval, intentionally encourage direct infringement with knowledge of the patents (Compl. ¶57, 68, 79). The contributory infringement allegations are based on the assertion that Sun's ANDA Products are especially adapted for an infringing use and have no substantial non-infringing use (Compl. ¶58, 69, 80).
  • Willful Infringement: The complaint does not use the term "willful infringement." However, for each patent, it alleges that the case is "an exceptional one" and requests an award of reasonable attorneys' fees under 35 U.S.C. § 285 (Compl. ¶61, 72, 83).

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

  • A primary issue will be one of technical and evidentiary proof: What are the actual physical characteristics of the lenalidomide active ingredient in Sun’s ANDA product? The case will likely depend on a comparison of competing expert analyses of Sun's confidential ANDA data against the specific XRPD and DSC fingerprints recited in Celgene's patents.
  • A dispositive legal question will be one of claim construction: How will the court define the scope of the term "approximately" as used to qualify the numerical values defining the claimed crystalline forms? The breadth of this term will directly impact the infringement analysis and could determine whether Sun's product, even if slightly different from Celgene's data, falls within the literal scope of the claims.