DCT

2:24-cv-00500

Celgene Corp v. Amneal Pharma Of New York LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-00500, D.N.J., 01/26/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because defendant entities maintain a regular and established place of business in the district, conduct extensive business in the state, and acts related to the preparation of the accused regulatory submission occurred in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) seeking FDA approval for generic lenalidomide capsules (a generic version of Revlimid®) constitutes an act of infringement of two patents covering specific polymorphic forms of the drug.
  • Technical Context: The patents relate to polymorphs, which are different crystalline structures of the same chemical compound that can affect a drug's stability, dissolution rate, and manufacturability, making control over the specific form critical for pharmaceutical products.
  • Key Procedural History: The complaint states this action arises from Defendant’s submission of an ANDA containing a Paragraph IV certification, which alleges that the patents-in-suit are invalid and/or not infringed. The complaint also lists over twenty-five prior infringement suits filed by Celgene in the same district against other generic drug manufacturers regarding the same product, Revlimid®, and in some cases the same patents.

Case Timeline

Date Event
2003-09-04 Earliest Priority Date for ’800 and ’217 Patents
2008-12-16 U.S. Patent No. 7,465,800 Issues
2010-12-21 U.S. Patent No. 7,855,217 Issues
2023-12-18 Defendant sends Paragraph IV Certification Notice Letter to Plaintiff
2024-01-26 Complaint Filed

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

U.S. Patent No. 7,465,800 - 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 a single chemical compound can often exist in different solid crystalline forms, or polymorphs, which can have different physical and chemical properties such as solubility and stability. For a pharmaceutical drug, these differences can impact safety, efficacy, and manufacturing, making the discovery and characterization of specific polymorphs a critical step in drug development (’800 Patent, col. 2:20-48).
  • The Patented Solution: The invention claims to have discovered and characterized several distinct polymorphic forms (designated Forms A, B, C, D, E, F, G, and H) of the compound 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione, also known as lenalidomide (’800 Patent, col. 2:57-62). The patent provides detailed physical characterization data for these forms, including X-ray powder diffraction (XRPD) patterns, which serve as fingerprints to identify each specific crystalline structure (’800 Patent, col. 5:11-14; FIG. 6). Figure 6 of the patent, for instance, depicts the characteristic XRPD pattern used to identify "Form B," a hemihydrated crystalline material (’800 Patent, col. 6:50-51; FIG. 6).
  • Technical Importance: Identifying and claiming specific, stable polymorphic forms of an active pharmaceutical ingredient provides a basis for developing consistent, safe, and effective drug products with predictable performance and shelf-life (’800 Patent, col. 2:38-48).

Key Claims at a Glance

The complaint asserts that Defendant infringes "one or more claims" of the ’800 Patent but does not identify any specific claims (Compl. ¶34).

U.S. Patent No. 7,855,217 - Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

The Invention Explained

The ’217 Patent is a divisional of the application that led to the ’800 Patent and shares an identical specification (’217 Patent, Related U.S. Application Data). Therefore, the technical problem, patented solution, and importance are the same as described for the ’800 Patent.

Key Claims at a Glance

The complaint asserts that Defendant infringes "one or more claims" of the ’217 Patent but does not identify any specific claims (Compl. ¶43).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant’s proposed generic lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg dosages, for which Defendant submitted Abbreviated New Drug Application (ANDA) No. 216213 to the FDA for approval (Compl. ¶20).

Functionality and Market Context

The subject of the litigation is not a commercial product but rather the act of submitting ANDA No. 216213. This submission seeks FDA approval to manufacture and sell a generic version of Plaintiff’s Revlimid® drug product prior to the expiration of the patents-in-suit (Compl. ¶1, ¶29). Under the Hatch-Waxman Act, this submission is a statutory act of infringement that creates a justiciable controversy, allowing the patent holder to sue before the generic product enters the market (Compl. ¶34, ¶43).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-element-level analysis of infringement. It does not identify which specific claims of the ’800 or ’217 patents are allegedly infringed, nor does it provide a claim chart or other detailed theory mapping limitations of any claim to the accused product. The infringement allegation is statutory in nature, based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a drug claimed in a patent as an act of infringement (Compl. ¶34, ¶43).

V. Key Claim Terms for Construction

The complaint does not provide a basis for an analysis of key claim terms, as no specific asserted claims from either the ’800 Patent or the ’217 Patent have been identified.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Defendant will induce infringement by "intentionally encourag[ing] acts of direct infringement with knowledge" of the patents-in-suit (Compl. ¶37, ¶46). It also alleges contributory infringement, stating that Defendant knows its proposed products are "especially adapted for a use that infringes" and that there is "no substantial non-infringing use" for them (Compl. ¶38, ¶47).
  • Willful Infringement: The complaint does not contain a separate count for willful infringement. However, it alleges that Defendant’s infringement is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (Compl. ¶41, ¶50). The factual basis for this appears to be Defendant’s knowledge of the patents, evidenced by its submission of the Paragraph IV certification and the associated notice letter sent to Plaintiff (Compl. ¶31, ¶32).

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

  • A primary technical question will be one of polymorph identification: What specific crystalline form(s) of lenalidomide are present in Defendant’s proposed generic product, and do the physical characteristics of that form (e.g., its X-ray powder diffraction pattern) fall within the scope of the asserted patent claims, once those claims are identified by the Plaintiff?
  • The case will also present a central question of claim validity: As alleged in Defendant's Paragraph IV certification, are the asserted claims of the patents-in-suit invalid for reasons such as anticipation, obviousness, or lack of enablement, thereby clearing a path for Defendant’s generic product to enter the market?
  • A third issue will be one of claim construction: The scope of the dispute will depend on how the court construes key claim terms that define the patented polymorphs, such as the specific numerical values and descriptive language ("approximately," "substantially") used to characterize the XRPD peaks and other physical properties.