A patent infringement action brought by Arbor Pharmaceuticals, LLC, Takeda Pharmaceutical Company Limited, and Azurity Pharmaceuticals, Inc. against Turkish generics manufacturer Saba Ilac Sanayi ve Ticaret AS in the U.S. District Court for the District of Delaware has concluded with a joint stipulated dismissal without prejudice. Filed on March 18, 2022 and closed on February 5, 2024 — a span of 689 days — the case centered on three U.S. patents covering azilsartan medoxomil, the active ingredient in the branded antihypertensive product EDARBI®, in response to Saba’s ANDA filing seeking to market a 40 mg or 80 mg generic oral tablet.

The negotiated dismissal, executed under Federal Rule of Civil Procedure 41(a)(1)(A)(ii), leaves the underlying patent claims unresolved and the door open for future proceedings. For IP strategists and pharmaceutical patent practitioners, the outcome underscores how Hatch-Waxman litigation frequently resolves through commercial or regulatory developments rather than judicial adjudication on the merits — making ongoing portfolio monitoring and FTO analysis around azilsartan medoxomil formulation patents especially critical for generics developers and branded pharmaceutical companies alike.

Case Overview

The Parties

The Patents at Issue

The three patents at issue — US7157584B2, US7572920B2, and US9066936B2 — cover azilsartan medoxomil, its prodrug formulations, and pharmaceutical compositions used in treating hypertension. These patents protect both the chemical compound itself and specific oral tablet formulations, meaning generic manufacturers must either design around these claims or challenge their validity to enter the market. Real-world applications include the once-daily antihypertensive tablet marketed as EDARBI®, prescribed for millions of patients managing high blood pressure.

• • US7157584B2
• • US7572920B2
• • US9066936B2

Legal Representation

Plaintiff Counsel: DLA Piper LLP (US); McCarter & English, LLP (lead: Alexandra M. Joyce)
Defendant Counsel: Seitz Van Ogtrop & Green PA (lead: Brent A. Batzer)

Litigation Timeline & Procedural History

The case was filed in the U.S. District Court for the District of Delaware on March 18, 2022, a venue that is the preeminent forum for Hatch-Waxman ANDA litigation due to its concentration of pharmaceutical patent expertise, predictable scheduling orders, and Chief Judge Maryellen Noreika’s experience managing complex patent matters. As a first-instance district court proceeding, the case bypassed any ITC or PTAB parallel proceedings based on available data, and the parties litigated within the standard Hatch-Waxman 30-month stay framework.

The case ran for 689 days before closing on February 5, 2024 — a duration consistent with ANDA cases that proceed through fact discovery but resolve prior to trial or claim construction ruling. The basis of termination was a stipulated dismissal without prejudice under FRCP 41(a)(1)(A)(ii), meaning both Plaintiffs and Saba mutually agreed to end the action with each side bearing its own attorney fees and costs. This type of resolution commonly reflects a commercial settlement, a licensing arrangement, a consent judgment executed separately, or a decision by the generic filer to withdraw or substantially revise its ANDA, and the dismissal’s ‘without prejudice’ character preserves all claims for potential re-filing.

The Verdict & Legal Analysis

Outcome

The action was dismissed in its entirety without prejudice pursuant to a joint stipulation filed by all plaintiffs and defendant Saba Ilac under FRCP 41(a)(1)(A)(ii). No damages were awarded, no injunction was entered, and no judicial finding was made on infringement or validity of the three asserted patents. Each party was ordered to bear its own attorney fees and costs, and all claims, counterclaims, and defenses between the parties were extinguished without a merits adjudication.

Verdict Cause Analysis

The following factors explain the procedural and strategic context of this voluntary dismissal without prejudice:

• The dismissal under FRCP 41(a)(1)(A)(ii) required a stipulation signed by all parties, indicating Saba actively agreed to the termination rather than facing a unilateral plaintiff withdrawal, suggesting mutual commercial incentive.
• Because the dismissal was entered without prejudice, plaintiffs Arbor, Takeda, and Azurity retain the right to refile patent infringement claims against Saba if Saba proceeds with or revises its ANDA or otherwise enters the market.
• The absence of any damages award or injunctive relief confirms the case never reached a merits determination on the validity, enforceability, or infringement of US7157584B2, US7572920B2, or US9066936B2.
• Co-defendant Alkem Laboratories, Ltd. is listed in the case data but the stipulation specifically names Saba, suggesting the disposition between plaintiffs and Alkem may have been handled under separate terms or a distinct procedural posture.

Legal Significance

1. 1. Because no claim construction or invalidity ruling was issued, the three azilsartan medoxomil patents — US7157584B2, US7572920B2, and US9066936B2 — remain fully enforceable and have not been judicially narrowed, leaving their claim scope intact for future enforcement actions against other ANDA filers.
2. 2. The without-prejudice dismissal sets no precedent on the merits, meaning future generic challengers to EDARBI® cannot cite this case as having resolved any issue of infringement or validity, and plaintiffs retain full enforcement rights against subsequent paragraph IV certifications.
3. 3. The involvement of multiple co-plaintiffs (Arbor, Takeda, and Azurity) as joint patent owners or exclusive licensees illustrates the layered ownership structures common in branded pharmaceutical portfolios, and future ANDA challengers must ensure all necessary parties are joined to achieve a complete resolution.

Strategic Takeaways

For Patent Attorneys:

• When filing Hatch-Waxman suits with multiple co-plaintiffs holding overlapping ownership or licensing interests, confirm standing for each party at inception to avoid procedural complications if settlement with one defendant diverges from another.
• A without-prejudice dismissal preserves the 30-month stay calculus for any new ANDA filing by Saba; monitor FDA databases for any refiled or amended ANDA that could trigger a new litigation obligation and reset the exclusivity clock.
• The FRCP 41(a)(1)(A)(ii) mechanism used here is bilateral — ensure that any settlement agreement underlying such a stipulation includes adequate license or consent provisions so the dismissal does not inadvertently restrict future enforcement options.
• With Alkem Laboratories also named as a co-defendant, practitioners should track whether a separate judgment or stipulation was entered for Alkem, as piecemeal resolution of multi-defendant ANDA cases can create asymmetric exposure across the patent portfolio.

For IP Professionals:

• Monitor FDA Orange Book listings for US7157584B2, US7572920B2, and US9066936B2 to track any new paragraph IV certifications filed by other generics developers who may now view the Saba dismissal as a signal that the patents are licensable rather than litigated to judgment.
• Given the without-prejudice nature of this dismissal, update your ANDA litigation tracker to flag Saba Ilac and Alkem Laboratories as ongoing risks, and establish watch notices for any refiled ANDAs or new 505(b)(2) filings covering azilsartan medoxomil formulations.

For R&D Teams:

• Generic pharmaceutical R&D teams targeting azilsartan medoxomil should conduct a fresh FTO analysis against all three asserted patents — US7157584B2, US7572920B2, and US9066936B2 — since no claim construction narrowing occurred in this case and the full original claim scope remains in force.
• Consider evaluating whether alternative salt forms, formulation excipients, or dosing regimens could provide a design-around path that avoids the composition and formulation claims of the EDARBI® patent estate while still meeting bioequivalence requirements.