AbbVie Inc v. Teva Pharma Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: AbbVie Inc. (Delaware)
  • Defendant: Teva Pharmaceuticals, Inc. (Delaware) and Teva Pharmaceutical Industries Ltd. (Israel)
  • Plaintiff’s Counsel: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: AbbVie Inc. v. Teva Pharmaceuticals, Inc., 1:23-cv-00362, D. Del., 03/30/2023
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva Pharmaceuticals, Inc. is a Delaware corporation, and Defendant Teva Pharmaceutical Industries Ltd. is a foreign corporation subject to suit in any judicial district where it is subject to personal jurisdiction.
• Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's ORIAHNN® pharmaceutical product constitutes an act of infringement of a patent directed to elagolix sodium compositions and manufacturing processes.
• Technical Context: The technology relates to pharmaceutical compositions of elagolix sodium, a GnRH receptor antagonist used to manage heavy menstrual bleeding associated with uterine fibroids.
• Key Procedural History: This action follows a "First Suit" (C.A. No. 23-133-RGA) filed by AbbVie against Teva concerning the same ANDA but asserting different patents. This complaint was filed in response to Teva's Paragraph IV certification for the newly issued '239 patent, alleging the patent is invalid, unenforceable, and/or not infringed by its proposed generic product.

Case Timeline

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

• Patent Identification: U.S. Patent No. 11,542,239, "Elagolix Sodium Compositions and Processes," issued January 3, 2023.

The Invention Explained

• Problem Addressed: The patent addresses the challenge of manufacturing a commercial-grade active pharmaceutical ingredient (API), elagolix sodium, with a sufficiently low and controlled impurity profile to meet regulatory standards ('239 Patent, col. 1:46-52). The patent notes that because the elagolix sodium active substance is 'generally amorphous,' its purification can be more complex and challenging than for substances that have stable, well-defined crystalline forms ('239 Patent, col. 1:53-57).
• The Patented Solution: The invention provides for highly pure compositions of elagolix sodium, identified as "Compound (I)," by defining them in relation to the presence and quantity of specific impurities ('239 Patent, Abstract; col. 2:64-65). The claims are directed not just to the active compound itself, but to a composition characterized by a high weight percentage of the desired compound (e.g., at least 97%) and a low, specified maximum weight percentage of enumerated potential impurities ('239 Patent, col. 91:2-col. 92:47).
• Technical Importance: The claimed solution is directed at enabling the 'reproducible, efficient, cost-effective and safe' commercial-scale manufacturing of elagolix sodium that meets the 'exacting purity standards' required by regulatory bodies like the FDA ('239 Patent, col. 1:46-52; col. 13:58-62).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" of the '239 patent (Compl. ¶2). Independent claim 1 is representative of the asserted composition claims.
• Independent Claim 1 recites:
  • A composition comprising: Compound (I),
  • and one or more impurity selected from a group consisting of [a list of specified chemical structures],
  • wherein Compound (I) comprises at least 97 weight percent of the composition,
  • and wherein the one or more impurity is present in an amount that is greater than zero and equal to or less than 3 weight percent of the composition.

III. The Accused Instrumentality

• Product Identification: The accused instrumentality is "Teva's Generic Product," a proposed generic version of AbbVie's ORIAHNN® oral capsules, for which Teva is seeking FDA approval via ANDA No. 217650 (Compl. ¶1, ¶49).
• Functionality and Market Context: The complaint alleges that Teva's Generic Product is intended for the same indication as ORIAHNN®: the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women (Compl. ¶5). As part of its ANDA, Teva has represented to the FDA that its product is "pharmaceutically and therapeutically equivalent" to ORIAHNN® (Compl. ¶57). The complaint notes that Teva is a "leading generic drug company in the United States" (Compl. ¶24).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement allegation under 35 U.S.C. § 271(e)(2) is based on Teva's act of filing its ANDA. The central theory is that the product described in the ANDA, if commercially manufactured and sold, would meet all the limitations of the asserted claims.

'239 Patent Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Questions: The primary dispute will be factual and evidentiary. Does the product Teva intends to market, as detailed in the confidential specifications of its ANDA, actually meet the specific purity and impurity limitations of the asserted claims? The litigation will focus on the results of analytical testing of Teva's proposed product.
  • Scope Questions: Teva's non-infringement defense, as foreshadowed by its Paragraph IV certification, may argue that its manufacturing process yields a product that falls outside the claimed compositional boundaries (Compl. ¶50). This raises the question of whether Teva's product might contain different impurities than those recited in the claim, or the same impurities but in amounts that do not meet the "less than 3 weight percent" limitation.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a definitive analysis, but based on the patent and the nature of the dispute, the following terms may become central to the case.

• The Term: "at least about 97 weight percent"
• Context and Importance: The word "about" introduces ambiguity into the numerical purity threshold. Practitioners may focus on this term because its construction will define the boundary for literal infringement. The outcome could determine whether a Teva product with a purity level slightly below 97.0% (e.g., 96.8%) is infringing.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The term "about" is used repeatedly throughout the specification in relation to numerical values, which may suggest the patentee intended for some degree of flexibility and that the values are not absolute ('239 Patent, col. 2:17, col. 2:60, etc.).
  • Evidence for a Narrower Interpretation: The patent includes claims with different, higher purity thresholds, such as "at least 98 weight percent" (Claim 4) and "at least 99 weight percent" ('239 Patent, col. 19:15-16). A defendant could argue that this deliberate claiming of distinct numerical tiers implies that the numbers are precise and the scope of "about" should be narrowly construed to avoid rendering these dependent claims redundant.

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). The factual basis for this allegation is that Teva intends for its generic product to be prescribed by healthcare providers and used by patients in an infringing manner, and that Teva's proposed package insert will instruct on such infringing use (Compl. ¶60, ¶62).
• Willful Infringement: While the complaint does not use the word "willful," it alleges that Teva has knowledge of the '239 patent, as evidenced by its notice letter to AbbVie dated February 13, 2023 (Compl. ¶63). This allegation of pre-suit knowledge of the patent and the alleged infringement could form the basis for a later claim of willfulness.

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

1. A central evidentiary question will be one of compositional identity: Does the elagolix sodium API in Teva's proposed generic product, as specified in its ANDA, contain the specific impurities at the specific concentrations required to fall within the scope of the asserted claims of the '239 patent?
2. A core issue will be one of validity: Is the claimed composition, defined by its specific purity profile, non-obvious under 35 U.S.C. § 103? The court will likely need to determine whether a person of ordinary skill in the art would have been motivated to achieve, with a reasonable expectation of success, the particular purity and impurity profile for amorphous elagolix sodium claimed in the patent.
3. The case may also turn on a question of claim construction: What is the proper scope of the term "about" as it modifies the numerical weight-percent limitations in the claims? The court's interpretation of this term will directly impact the infringement analysis by defining the precise boundary of the claimed invention.