DCT

1:16-cv-00648

Novartis Pharma Corp v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-00648, D. Del., 07/29/2016
  • Venue Allegations: Venue is alleged to be proper based on Defendants' incorporation in Delaware, registration to do business in Delaware, systematic and continuous contacts with the state, and derivation of substantial revenue from products sold in Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic deferasirox tablets constitutes an act of infringement of a patent covering the compound deferasirox.
  • Technical Context: The technology concerns pharmaceutical compounds known as metal chelators, which are used to treat iron overload in the body, a condition that can cause severe organ damage.
  • Key Procedural History: This action was triggered by Defendant Teva’s submission of ANDA No. 209223 to the U.S. Food and Drug Administration (FDA), seeking approval to market generic versions of Novartis’s JADENU® drug product. As part of this process, Teva sent a "Notice Letter" with a "Paragraph IV certification," asserting that the patent-in-suit is invalid, unenforceable, and/or will not be infringed.

Case Timeline

Date Event
1996-06-25 ’504 Patent Priority Date
2002-10-15 ’504 Patent Issue Date
2015-03-30 FDA Approval of Novartis's JADENU® NDA No. 206910
2016-06-15 Date of Teva's Notice Letter to Novartis regarding ANDA No. 209223
2016-07-29 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 6,465,504, “Substituted 3,5-Diphenyl-1,2,4-Triazoles and Their Use as Pharmaceutical Metal Chelators,” issued October 15, 2002.
  • The Invention Explained:
    • Problem Addressed: The patent describes medical disorders linked to an excess of metals in body tissues, specifically iron overload (haemosiderosis) (Compl. Ex. A, '504 Patent, col. 1:10-15). This condition, which can result from repeated blood transfusions required for anemias like thalassaemia, can lead to severe organ damage and death if untreated (Compl. Ex. A, '504 Patent, col. 1:26-30). Existing treatments, such as Desferrioxamine B, were noted to have low activity when taken orally and required inconvenient and costly parenteral administration, such as slow subcutaneous infusions (Compl. Ex. A, '504 Patent, col. 1:40-55).
    • The Patented Solution: The patent discloses a class of compounds, substituted 3,5-diphenyl-1,2,4-triazoles, that function as orally active iron chelators (Compl. Ex. A, '504 Patent, Abstract; col. 2:1-17). These compounds are designed to bind with trivalent metal ions, particularly iron, allowing for their excretion from the body and thereby treating the iron overload condition through a more convenient oral dosage form (Compl. Ex. A, '504 Patent, col. 1:59-62; col. 2:13-17).
    • Technical Importance: The invention provided a potential solution for a widespread and serious health problem by proposing an orally active therapy, which could improve patient compliance and reduce treatment costs compared to existing infusion-based therapies (Compl. Ex. A, '504 Patent, col. 1:46-62).
  • Key Claims at a Glance:
    • The complaint asserts claims 1-6, 8, and 9 (Compl. ¶40). Independent claim 1 is the broadest asserted claim.
    • Independent Claim 1:
      • A compound of formula II (a substituted 3,5-diphenyl-1,2,4-triazole structure)
      • Wherein R₁, R₅, R₂, R₄, R₃, R₆, and R₇ are selected from specified Markush groups of chemical substituents,
      • With a proviso that R₃ is not a phenyl substituted in certain ways if other R-groups are of a specific type.
    • The complaint notes that the right to assert additional claims is reserved.

III. The Accused Instrumentality

  • Product Identification: The accused products are the 90 mg, 180 mg, and 360 mg "Teva Generic Deferasirox Tablets" described in Teva's ANDA No. 209223 (Compl. ¶2, 28).
  • Functionality and Market Context: The complaint alleges that the active ingredient in Teva's proposed generic tablets is deferasirox (Compl. ¶29). By filing its ANDA, Teva represented to the FDA that its product has the same active ingredient, dosage form, and strengths as Novartis's JADENU® product and is bioequivalent to it (Compl. ¶30). The product is intended for oral administration to treat iron overload and, if approved, would be marketed as a generic substitute for JADENU® (Compl. ¶2, 21).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Teva's notice letter does not contest infringement of claims 1-6, 8, and 9 of the ’504 Patent (Compl. ¶32). The infringement theory is based on the act of filing an ANDA under 35 U.S.C. § 271(e)(2) for a product that, if commercialized, would infringe the asserted claims (Compl. ¶33). The active ingredient in the accused product, deferasirox, is alleged to be the compound 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid, which is a species explicitly covered by asserted dependent claim 5 (Compl. ¶27, 40).

’504 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of formula II ... wherein each of R₁ and R₅ ... is hydrogen; ... each of R₂ and R₄ ... is hydrogen; R₃ is ... aryl substituted by one or two substituents selected from ... carboxyl ...; The active ingredient in the Teva 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. This compound is a species that falls within the genus defined by claim 1. ¶27, 40 col. 7:36-65
  • Identified Points of Contention:
    • Scope Questions: The complaint states that Teva does not contest infringement of the asserted claims (Compl. ¶32). The primary dispute, as framed by Teva’s Paragraph IV certification, will therefore center on the validity and/or enforceability of the asserted claims (Compl. ¶31). The core legal question is not whether Teva's product infringes, but whether the '504 Patent's claims are valid as issued.
    • Technical Questions: A court may need to determine whether the claimed genus of compounds was obvious or anticipated by the prior art at the time of invention. This will involve a technical comparison of the claimed chemical structures and their properties against those disclosed in prior art references, which are not detailed in the complaint.

V. Key Claim Terms for Construction

The complaint does not identify specific claim terms that are in dispute, and it alleges that infringement itself is not contested by Teva. The central dispute is expected to be over patent validity. In a validity analysis, the construction of the Markush groups defining the scope of the claimed chemical genus would be critical.

  • The Term: "lower alkyl" (appears in claim 1 and throughout the specification)
  • Context and Importance: This term helps define the boundaries of the vast chemical genus claimed in claim 1. Its precise scope is fundamental to any analysis of whether a prior art compound anticipates the claim or renders it obvious. Practitioners may focus on this term because its breadth (or narrowness) could determine whether prior art falls inside or outside the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list: "Lower alkyl is, e.g., n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, tert-butyl, n-pentyl, neopentyl, n-hexyl or n-heptyl, preferably methyl, ethyl and n-propyl" (Compl. Ex. A, '504 Patent, col. 3:1-4). The use of "e.g." suggests this list is exemplary, not exhaustive, potentially supporting a broader construction that includes other alkyl groups of similar size.
    • Evidence for a Narrower Interpretation: The specification also states, "The prefix 'lower' designates a radical having not more than 7 and in particular not more than 4 carbon atoms" (Compl. Ex. A, '504 Patent, col. 2:60-62). This explicit definition could be used to argue for a strict numerical limit, precluding any interpretation that includes alkyl chains with eight or more carbons.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Teva will induce and contribute to infringement by others (e.g., healthcare professionals and patients) (Compl. ¶41). This is based on the allegation that Teva’s product label will instruct users on how to use the generic deferasirox tablets in an infringing manner, specifically for the patented therapeutic use (Compl. ¶41). The complaint also asserts the product is specially made for this use and has no substantial non-infringing use (Compl. ¶41).
  • Willful Infringement: The complaint alleges that Teva "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 actions will constitute infringement (Compl. ¶41). This allegation is supported by references to the patent’s listing in the FDA’s Orange Book and Teva’s own Notice Letter, which demonstrates actual knowledge of the patent (Compl. ¶41).

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

As this is a Hatch-Waxman action where infringement appears to be uncontested, the litigation will likely center on the validity of the '504 Patent.

  • A primary question will be one of patentability over the prior art: will Teva be able to prove by clear and convincing evidence that the asserted claims, which cover the deferasirox compound and related pharmaceutical compositions, are invalid as either anticipated or rendered obvious by prior art that existed before June 1996?
  • A related question will be the scope of the claimed genus: how broadly will the court construe the Markush groups in claim 1? The answer to this will define the universe of chemical structures covered by the patent, which is a critical predicate for the validity analysis.
  • Finally, a procedural question will be whether Novartis can secure an order under 35 U.S.C. § 271(e)(4)(A) to delay the effective date of any FDA approval for Teva’s ANDA until after the expiration of the '504 Patent, which hinges on the ultimate outcome of the validity dispute.