DCT

1:15-cv-01219

Novartis Pharma Corp v. Actavis Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:15-cv-01219, D. Del., 12/30/2015
  • Venue Allegations: Venue is alleged based on Defendant Actavis Elizabeth LLC being a Delaware limited liability company and both defendants allegedly conducting systematic and continuous business in Delaware, including placing products into the stream of commerce, deriving substantial revenue, and having previously availed themselves of the forum by litigating other patent disputes in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for generic deferasirox tablets constitutes an act of infringement of a patent covering the active ingredient in Plaintiff's JADENU® drug product.
  • Technical Context: The technology concerns novel chemical compounds, specifically substituted triazoles, that act as pharmaceutical metal chelators for treating iron overload in the human body.
  • Key Procedural History: The complaint notes that the patent-in-suit was previously litigated between the same parties in the District of Delaware. It also states that the patent is listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") for the JADENU® product, and that Defendant's ANDA notice letter contained a Paragraph IV certification alleging invalidity or non-infringement, but did not contest infringement of the asserted claims.

Case Timeline

Date Event
1996-06-25 ’504 Patent Priority Date
2002-10-15 ’504 Patent Issue Date
2012 Prior litigation filed between Novartis and Actavis on the ’504 Patent
2013 Watson Pharmaceuticals, Inc. changes corporate name to Actavis, Inc.
2015-03-30 FDA approves Novartis's JADENU® (deferasirox) NDA
2015-11-20 Actavis sends Notice Letter to Novartis regarding its ANDA filing
2015-12-30 Complaint Filing Date

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

U.S. Patent No. 6,465,504 - “Substituted 3,5-Diphenyl-1,2,4-Triazoles and Their Use as Pharmaceutical Metal Chelators”

The Invention Explained

  • Problem Addressed: The patent describes disorders linked to an excess of trivalent metals in body tissues, particularly iron overload (haemosiderosis) resulting from conditions requiring repeated blood transfusions (e.g., thalassaemia) or from genetic defects (e.g., haemochromatosis) (’504 Patent, col. 1:11-29). The existing therapeutic agent, desferrioxamine B, suffered from a significant disadvantage: it was not adequately active when taken orally and required administration via a slow, costly, and cumbersome subcutaneous infusion, limiting its widespread use (’504 Patent, col. 2:40-54).
  • The Patented Solution: The invention claims a class of substituted 3,5-diphenyl-1,2,4-triazole compounds that possess pharmacological properties as metal chelators, particularly for trivalent iron ions (’504 Patent, col. 2:2-9). By binding to iron, these compounds are designed to facilitate its excretion from the body, offering a therapeutic solution to iron overload. A key objective was to develop an orally active preparation, representing a significant improvement over the existing standard of care (’504 Patent, col. 2:58-62). The general chemical structure of the claimed compounds is depicted in Formula I (’504 Patent, col. 2, Formula (I)).
  • Technical Importance: The development of an effective, orally administered iron chelator addressed a major unmet need in the treatment of chronic iron overload diseases, offering patients a more convenient and accessible alternative to parenteral infusions (’504 Patent, col. 2:55-62).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6, 8, and 9 (’504 Patent, Compl. ¶42). The primary independent claim is Claim 1.
  • Independent Claim 1 is a compound claim directed to a compound of Formula II with a specified chemical structure and a list of alternative chemical groups (substituents) at various positions.
  • The complaint places particular emphasis on dependent claim 5, which recites a specific compound:
    • A compound according to claim 4 which is 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid, or a pharmaceutically acceptable salt thereof.
  • The complaint reserves the right to assert other claims of the ’504 Patent (’504 Patent, Compl. ¶44).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant’s 90 mg, 180 mg, and 360 mg generic deferasirox tablets, for which Actavis Elizabeth LLC filed Abbreviated New Drug Application (ANDA) No. 208697 with the FDA (Compl. ¶¶ 2, 32).

Functionality and Market Context

  • The complaint alleges that the accused tablets are generic versions of Novartis's JADENU® drug product and, by virtue of the ANDA filing process, are represented to the FDA as having the same active ingredient (deferasirox), dosage form, strengths, and bioequivalence as JADENU® (Compl. ¶¶ 2, 34). Plaintiff alleges that upon approval, Defendant intends for its generic tablets to be substituted for and replace sales of JADENU® (Compl. ¶25).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Defendant’s notice letter does not contest infringement of the asserted claims, instead asserting invalidity and/or unenforceability (Compl. ¶¶ 35-36). The infringement allegations are presented as follows.

’504 Patent Infringement Allegations

Claim Element (from Independent Claim 5) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound according to claim 4 which is 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid... The active ingredient in the Actavis Generic Deferasirox Tablets is deferasirox, which has the chemical name of 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid. ¶33, ¶44 col. 30:8-12
...or a pharmaceutically acceptable salt thereof. The complaint focuses on the active ingredient being the specified benzoic acid, and does not provide sufficient detail for analysis of whether a pharmaceutically acceptable salt is also at issue. ¶44 col. 30:12-13
  • Identified Points of Contention:
    • Technical Questions: Based on the complaint, the primary dispute does not appear to be technical. The core allegation is that the accused product contains the specific chemical compound, deferasirox, claimed by the patent (Compl. ¶¶ 33, 44). The complaint states that Defendant "does not contest infringement" of the asserted claims (Compl. ¶36), suggesting that the factual question of whether the accused product meets the claim limitations may not be a central point of dispute.
    • Scope Questions: The central issue framed by the complaint is not one of claim scope relative to the accused product, but of patent validity. The complaint notes that Defendant’s ANDA filing included a Paragraph IV certification asserting that the patent claims "are invalid, unenforceable and/or will not be infringed" (Compl. ¶35). This raises the question of whether the infringement analysis is a formality in a case that will be primarily driven by Defendant's invalidity challenges.

V. Key Claim Terms for Construction

While the complaint suggests infringement is not contested, the construction of certain terms would be foundational to any such analysis.

  • The Term: "pharmaceutically acceptable salt"
  • Context and Importance: This term appears in the asserted dependent claim 5 and defines the scope of protection beyond the specific acid form of the deferasirox molecule. The definition is critical for determining whether different salt forms of the active ingredient, if used by a generic manufacturer, would fall within the claim's scope. Practitioners may focus on this term to assess the breadth of the patent's coverage and potential avenues for non-infringing design-around attempts.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of potential salt types, including "appropriate alkali metal or alkaline earth metal salts, e.g. sodium, potassium or magnesium salts, pharmaceutically acceptable transition metal salts such as zinc salts, or salts with organic amines" (’504 Patent, col. 3:15-24). This language could support an interpretation covering a wide range of salt forms.
    • Evidence for a Narrower Interpretation: The patent's examples predominantly describe the synthesis and properties of the free acid form of the claimed compounds (e.g., Example 5, describing the synthesis of 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid) (’504 Patent, col. 8:50-60). An argument could be made that the scope of "pharmaceutically acceptable salt" should be construed in light of the specific embodiments and examples provided, which do not exemplify the full range of salts listed in the general description.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement, stating that upon FDA approval, Defendant's product will include a label that instructs healthcare professionals and patients to use the generic tablets in an infringing manner (Compl. ¶45). Contributory infringement is also alleged on the basis that the accused tablets contain deferasirox, are "specially made to infringe," and have "no substantial non-infringing use" (Compl. ¶45).
  • Willful Infringement: The complaint does not contain a formal count for willful infringement but alleges facts that may support such a claim. It asserts that Defendant "is and has been aware of the '504 Patent prior to the date of this complaint" and knows or is "willfully blind to the fact" that its product will infringe (Compl. ¶45). The alleged bases for this knowledge include the patent's listing in the Orange Book, the parties' prior litigation over the same patent, and Defendant's own notice letter (Compl. ¶45).

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

  • A core issue will be one of patent validity, not infringement. The complaint alleges that Defendant has not contested that its product would infringe, instead relying on a defense that the patent is invalid or unenforceable. The case will therefore likely hinge on the strength of Defendant's invalidity and unenforceability arguments, which are not detailed in the complaint but are the asserted basis for the underlying Paragraph IV certification.
  • The dispositive legal question will be one of statutory remedy: can Plaintiff prevent the FDA from granting final approval to Defendant’s ANDA until after the ’504 patent expires? This will depend entirely on the outcome of the substantive infringement and validity disputes within the framework of the Hatch-Waxman Act.