Boehringer Ingelheim vs. Sun Pharma: Settlement in SGLT2 Patent Case

Updated on Dec. 5, 2025 | Written by Patsnap Team

Introduction

After nearly six years of litigation, pharmaceutical giants Boehringer Ingelheim and Sun Pharmaceutical Industries have reached a negotiated settlement in their high-stakes patent dispute over blockbuster diabetes drugs JARDIANCE® (empagliflozin) and GLYXAMBI® (empagliflozin/linagliptin). The Delaware District Court, presided over by Chief Judge Colm F. Connolly, consolidated multiple related cases under Case No. 1:19-cv-01500, closing proceedings on July 30, 2025.

This SGLT2 inhibitor patent infringement case represents a significant resolution in pharmaceutical patent litigation. The settlement consolidates nine related civil actions spanning 2018 to 2021, highlighting the complexity of defending blockbuster drug portfolios against generic challenges. For patent attorneys tracking Delaware court patent cases and R&D teams concerned with diabetes therapeutic development, this Boehringer Sun Pharmaceutical patent case analysis offers crucial insights.

Case Summary

Case Overview

The Parties

Plaintiff Boehringer Ingelheim is a global pharmaceutical leader with Boehringer Ingelheim International GmbH, Boehringer Ingelheim Corporation, and Boehringer Ingelheim Pharmaceuticals, Inc. collectively asserting patent rights over their diabetes franchise.

Defendant Sun Pharmaceutical Industries ranks among the world’s largest generic manufacturers. Sun Pharmaceutical Industries Limited, Sun Pharmaceutical Industries, Inc., and Ohm Laboratories, Inc. sought market entry through abbreviated new drug applications (ANDAs).

The Patent at Issue

US10258637B2 covers pharmaceutical formulations related to empagliflozin, an SGLT2 inhibitor treating type 2 diabetes. Research patent families on Patsnap Eureka IP to explore related patent claims and prosecution history.

The Accused Products

Sun sought FDA approval for generic versions of JARDIANCE® (empagliflozin) and GLYXAMBI® (empagliflozin/linagliptin), representing substantial commercial value in the diabetes market.

💡 Key Insight: Multi-patent portfolios protecting blockbuster drugs create significant litigation complexity—this case consolidated nine separate civil actions over four years.

Litigation Timeline & Procedural History

• ⚖️ August 9, 2019: Case 1:19-cv-01500 filed following earlier 2018 actions
• ⚖️ 2020-2021: Additional cases filed as Boehringer expanded patent assertions
• ⚖️ Consolidation: Nine proceedings merged across three consolidated dockets
• ⚖️ July 30, 2025: Settlement reached; all cases closed

The six-year duration reflects typical pharmaceutical patent litigation timelines involving patent validity challenges, claim construction disputes, and substantial commercial stakes. Track litigation trends with Patsnap Eureka IP for comprehensive case monitoring.

The Verdict & Legal Analysis

Outcome

The parties reached a negotiated settlement resolving all consolidated actions. Specific settlement terms—including any authorized generic entry dates—were not publicly disclosed in court filings accessible via PACER.

Verdict Cause Analysis

This Hatch-Waxman infringement action was triggered by Sun’s ANDA filings. Key considerations in pharmaceutical settlements typically include:

• 📊 Patent validity assessments regarding obviousness and enablement
• 📊 Claim construction implications for infringement findings
• 📊 Commercial timing for generic market entry negotiations

Legal Significance

Per 35 U.S.C. § 271(e)(2), ANDA filings constitute acts of infringement, triggering litigation. This settlement illustrates multi-patent assertion strategies while demonstrating Delaware’s sophisticated handling of complex pharmaceutical IP disputes.

⚖️ Strategic Note: Consolidating nine related cases may have strengthened Boehringer’s negotiating position while creating significant litigation burden for Sun—a pattern observed in ANDA litigation.

Strategic Takeaways

For Patent Holders:

• 🔬 Maintain robust prosecution pipelines for continuation patents
• 🔬 Leverage consolidation strategies demonstrating portfolio depth
• 🔬 Delaware venue selection remains common for pharmaceutical assertions

For Generic Challengers:

• ⚖️ Conduct early freedom-to-operate (FTO) assessments across patent families
• ⚖️ Budget for cumulative litigation costs in consolidated proceedings
• ⚖️ Evaluate paragraph IV certification strategies holistically

Analyze patent landscapes on Patsnap Eureka IP to assess competitive positioning and prior art landscapes.

Industry & Competitive Implications

The JARDIANCE® market represents substantial stakes in diabetes therapeutics. SGLT2 inhibitors have become first-line treatments with demonstrated cardiovascular benefits, making 2025 pharmaceutical patent litigation outcomes commercially significant.

Market Impact: Settlement terms likely define Sun’s generic empagliflozin launch timeline, directly affecting competitive dynamics and pricing.

Sector Trends: This joins a pattern of SGLT2 inhibitor patent settlements as multiple generics challenge innovator portfolios. Companies may wish to monitor related diabetes drug patent cases.

Explore similar cases on Patsnap Eureka IP for comprehensive pharmaceutical litigation intelligence.

Key Takeaways

⚖️ For Patent Attorneys:

• Multi-case consolidation may strengthen negotiating leverage
• Six-year duration reflects pharmaceutical patent dispute norms
• Delaware remains a common venue for complex ANDA proceedings

📊 For IP Professionals:

• Portfolio depth enables sustained assertion campaigns
• Monitor settlement filings for competitive intelligence on generic entry

🔬 For R&D Teams:

• SGLT2 inhibitor development benefits from thorough FTO analysis
• Generic entry timing affects competitive planning horizons

FAQ

What patent was involved in Boehringer v. Sun Pharmaceutical? US10258637B2, covering empagliflozin formulations for JARDIANCE® and GLYXAMBI®.

Why was this case consolidated? Nine civil actions (2018-2021) were consolidated for judicial efficiency under Delaware District Court procedures.

What does this settlement mean for generic JARDIANCE®? Settlements typically establish authorized generic entry dates; specific terms remain confidential. Start your patent research on Patsnap Eureka IP for ongoing monitoring.

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Disclaimer: This article is provided for informational and educational purposes only and does not constitute legal advice. The analysis presented reflects publicly available case information and should not be relied upon for legal decision-making. Readers should consult with qualified legal counsel for advice regarding specific patent litigation matters or intellectual property strategies.