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: Morris, Nichols, Arsht & Tunnell LLP; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Case Identification: 1:23-cv-00133, D. Del., 02/03/2023
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva Pharmaceuticals, Inc. is a Delaware corporation. For Defendant Teva Pharmaceutical Industries Ltd., an Israeli corporation, venue is alleged to be proper in any district where it is subject to personal jurisdiction, with the complaint asserting substantial and continuous business contacts with the United States and the State of Delaware.
• Core Dispute: Plaintiff alleges that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Plaintiff's ORIAHNN® pharmaceutical product constitutes an act of patent infringement.
• Technical Context: The technology concerns a combination oral pharmaceutical therapy for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 217650. The complaint states that Plaintiff received a notice letter from Teva on December 21, 2022, containing a Paragraph IV certification that the patents-in-suit are invalid, unenforceable, and/or would not be infringed by Teva's proposed generic product. This lawsuit, filed within 45 days of that notice, triggers an automatic 30-month stay on the FDA's approval of Teva's ANDA.

Case Timeline

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

U.S. Patent No. 10,881,659 - "Methods of Treating Heavy Menstrual Bleeding," issued January 5, 2021

The Invention Explained

• Problem Addressed: The patent describes uterine fibroids as the most common benign tumors in women, which can cause symptoms severe enough to warrant therapy, most notably heavy menstrual bleeding (HMB) (’659 Patent, col. 1:16-19, col. 1:41-44). The background section notes that existing long-term medical therapies are lacking, and surgical options like hysterectomy carry significant risks and may be undesirable for women wishing to preserve fertility (’659 Patent, col. 2:3-16, col. 2:41-48).
• The Patented Solution: The invention is a combination therapy designed to control HMB while mitigating side effects. It uses a gonadotropin-releasing hormone (GnRH) antagonist (elagolix) to suppress ovarian hormones, thereby reducing bleeding. To counteract the side effects of this suppression (such as bone loss and hot flashes), the method includes co-administering low doses of an estrogen and a progestogen as an "add-back" therapy (’659 Patent, Abstract; col. 12:12-32). This combination aims to provide the benefits of bleeding reduction without the significant drawbacks of GnRH antagonist monotherapy.
• Technical Importance: This "add-back" approach represented an effort to create a viable, long-term oral medical treatment for HMB, potentially avoiding the need for surgery in many patients (’659 Patent, col. 2:36-48).

Key Claims at a Glance

• The complaint asserts infringement of at least one claim, with independent claim 10 being representative of the co-packaged product format (Compl. ¶¶59-60).
• Independent Claim 10 requires a method for managing HMB associated with uterine fibroids by orally administering for at least 84 days:
  • A first daily dosage form comprising elagolix sodium (equivalent to 300 mg free acid), 1.0 mg of estradiol, and 0.5 mg of norethindrone acetate.
  • A second daily dosage form comprising elagolix sodium (equivalent to 300 mg free acid).
  • Administering the two dosage forms once daily in the morning and evening, respectively.
  • The method results in the reduction of menstrual blood loss to less than 80 mL per cycle and by at least 50% from baseline.
• The complaint reserves the right to assert other claims, which may include dependent claims (Compl. ¶60).

U.S. Patent No. 11,045,470 - "Methods of Treating Heavy Menstrual Bleeding," issued June 29, 2021

The Invention Explained

• Problem Addressed: The ’470 Patent, a continuation of the application for the ’659 Patent, addresses the same technical problem: the need for a safe and effective long-term medical therapy for heavy menstrual bleeding (HMB) caused by uterine fibroids, as an alternative to surgery (’470 Patent, col. 1:16-19, col. 2:40-49).
• The Patented Solution: The solution is the same combination therapy of a GnRH antagonist (elagolix) with an estrogen/progestin add-back therapy. A key aspect highlighted in the claims of this patent is the therapy's ability to manage HMB while also limiting the side effect of bone mineral density (BMD) loss, a known risk of estrogen suppression (’470 Patent, col. 36:10-15).
• Technical Importance: This patent further refines the therapeutic profile by claiming not only the management of HMB but also a specific safety outcome related to bone health, reinforcing its suitability for longer-term use (’470 Patent, col. 36:10-15).

Key Claims at a Glance

• The complaint asserts infringement of at least one claim, with independent claim 1 being representative (Compl. ¶¶74-75).
• Independent Claim 1 requires a method for managing HMB in a premenopausal adult human female by administering:
  • A first daily capsule comprising elagolix sodium (300 mg), estradiol (1.0 mg), and norethindrone acetate (0.5 mg).
  • A second daily capsule comprising elagolix sodium (300 mg).
  • Administering the two capsules in the morning and evening.
  • The method is effective to manage HMB while also limiting bone mineral density loss from baseline to less than 8% after 24 weeks of administration.
• The complaint reserves the right to assert other claims, which may include dependent claims (Compl. ¶75).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is "Teva's Generic Product," a generic version of Plaintiff's ORIAHNN® for which Teva seeks FDA approval via ANDA No. 217650 (Compl. ¶1).

Functionality and Market Context

• The complaint alleges that Teva's Generic Product is a combination drug product containing elagolix sodium, estradiol, and norethindrone acetate in oral capsule dosage forms (Compl. ¶1, ¶50). It is designed to be pharmaceutically and therapeutically equivalent to ORIAHNN® and will be prescribed for the same indication: the management of heavy menstrual bleeding associated with uterine fibroids (Compl. ¶3, ¶58, ¶73). As a generic product, its market purpose is to compete directly with the branded ORIAHNN® product upon receiving FDA approval (Compl. ¶1, ¶2). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’659 Patent Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Question: A central question will be one of proof regarding the functional claim limitation. What evidence will be required to demonstrate that the use of Teva's product, as instructed by its label, will "reduce[] the volume of menstrual blood loss... to less than 80 mL per cycle and by at least 50% from baseline"? While this is the intended outcome for a therapeutically equivalent drug, Teva may contest whether this outcome is guaranteed for all patients as required for direct infringement.

’470 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope & Evidentiary Question: This claim includes a dual functional limitation: managing HMB while also limiting BMD loss to a specific quantitative threshold (<8%). The infringement analysis raises the question of what evidence demonstrates that Teva's product will meet both of these functional outcomes. Teva may argue that its product label does not guarantee this specific safety outcome, raising a question about the scope of what its label induces.

V. Key Claim Terms for Construction

• The Term: "limiting bone mineral density loss from baseline in the patient... to less than 8%" (’470 Patent, cl. 1)
• Context and Importance: This term is critical because it defines a specific, quantitative safety outcome that is a required limitation of the claimed method. Practitioners may focus on this term because the infringement case hinges on whether Teva's product label instructs a use that necessarily meets this safety threshold, or whether this is merely an advantageous result not guaranteed by the instructions. The construction will determine the level of proof AbbVie must provide.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue the term should be interpreted as the average or expected outcome in a patient population, as detailed in clinical trial data, rather than a guaranteed result for every single patient. The patent's description of clinical study results could support this view ('470 Patent, FIGS. 1-5).
  • Evidence for a Narrower Interpretation: A party could argue that for a method claim to be directly infringed, the claimed steps, including this functional limitation, must be performed in their entirety. The plain language of the claim recites this limitation without reference to population averages, suggesting it must be met for the method to be practiced as claimed.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Teva's proposed product label and package insert will actively instruct and encourage healthcare professionals and patients to administer the generic product in a manner that directly infringes the claims of the patents-in-suit (Compl. ¶¶62-63, 77-78).
• Willful Infringement: The complaint does not use the word "willful" but pleads the elements that could support such a claim post-filing. It alleges that Teva has had knowledge of the ’659 and ’470 patents at least since its December 21, 2022 notice letter, and that any subsequent commercial activity would be undertaken with this knowledge (Compl. ¶¶64, 79).

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

• A primary issue will be one of claim validity. As is typical in ANDA litigation, the core of the dispute will likely be Teva's challenge to the validity of the asserted claims as being obvious or anticipated by the prior art, an argument outlined in its Paragraph IV certification but not yet detailed in court filings.
• A key evidentiary question will be one of functional infringement. Can AbbVie prove that the administration of Teva's proposed generic product, as directed by its label, will necessarily meet the specific quantitative therapeutic and safety outcomes recited in the claims (e.g., the percent reduction in blood loss and the <8% limit on BMD loss)?
• A central question of claim construction will be how to interpret the claims' functional limitations. The court will need to decide whether these outcome-based limitations require proof of achievement in an individual patient to find infringement, or if demonstrating that the drug is prescribed for that purpose with that expected outcome is sufficient.