Last updated: February 19, 2026
This document analyzes the patent litigation between Sanofi-Aventis U.S. LLC and Breckenridge Pharmaceutical, Inc. concerning Sanofi's Lantus® (insulin glargine) product. The core of the dispute centers on the validity and infringement of Sanofi's U.S. Patent No. 7,714,079, which claims a method of producing insulin glargine. Breckenridge sought to launch a biosimilar insulin glargine product.
What is the Key Patent at Issue?
The primary patent in this litigation is U.S. Patent No. 7,714,079. This patent claims a method for producing insulin glargine. The method involves specific steps and conditions critical for achieving the desired purity and quality of the active pharmaceutical ingredient. Sanofi asserts that Breckenridge's proposed biosimilar product infringes this patent.
What is the Product at Stake?
The litigation concerns Sanofi's insulin glargine product, marketed as Lantus®. Lantus® is a long-acting basal insulin analog used to treat type 1 and type 2 diabetes. Breckenridge aimed to introduce a biosimilar version of insulin glargine, which would compete directly with Lantus®.
What is Breckenridge's Defense Strategy?
Breckenridge's defense strategy has primarily focused on challenging the validity of Sanofi's U.S. Patent No. 7,714,079. Specifically, Breckenridge argued that the patent is invalid due to:
- Obviousness: The claims of the patent would have been obvious to a person of ordinary skill in the art at the time of the invention.
- Lack of Enablement: The patent specification does not adequately describe how to make and use the claimed invention, failing to meet the enablement requirement of 35 U.S.C. § 112.
- Indefiniteness: The claims are indefinite and do not clearly define the scope of the invention, also under 35 U.S.C. § 112.
Breckenridge also asserted non-infringement, contending that its manufacturing process and resulting product do not fall within the scope of the claims in U.S. Patent No. 7,714,079.
What Were the Key Court Rulings?
The litigation involved several key rulings from the U.S. District Court for the District of New Jersey:
- Claim Construction: The court conducted a Markman hearing to construe the disputed claim terms of U.S. Patent No. 7,714,079. This process is critical for determining infringement and validity. The court issued its claim construction order on March 15, 2018.
- Summary Judgment Rulings:
- On May 14, 2018, the court granted summary judgment of non-infringement in favor of Breckenridge on certain claims.
- However, on the same date, the court also denied Breckenridge's motion for summary judgment of invalidity, finding that there were genuine disputes of material fact regarding obviousness and enablement.
- Trial and Verdict: A jury trial was held. On June 12, 2019, the jury returned a verdict finding U.S. Patent No. 7,714,079 not invalid and infringed by Breckenridge.
- Post-Trial Motions and Judgment: Following the jury verdict, both parties filed post-trial motions. The court issued its final judgment on October 9, 2019, upholding the jury's verdict of infringement and denying Breckenridge's motions for judgment as a matter of law or a new trial. The court entered a permanent injunction against Breckenridge.
What Were the Grounds for Appeal?
Breckenridge appealed the district court's decision to the United States Court of Appeals for the Federal Circuit. Key grounds for the appeal included:
- Claim Construction Errors: Breckenridge argued that the district court erred in its construction of certain claim terms in U.S. Patent No. 7,714,079.
- Invalidity Findings: Breckenridge challenged the jury's finding that the patent was not invalid, particularly regarding obviousness and enablement. They contended that the evidence presented at trial was insufficient to support the jury's verdict.
- Infringement Findings: Breckenridge contested the jury's finding of infringement, arguing that their product and process did not fall within the construed claims.
- Evidentiary Rulings: Breckenridge may have also appealed certain evidentiary rulings made during the trial that they believed were prejudicial.
What Was the Outcome of the Appeal?
On December 3, 2020, the U.S. Court of Appeals for the Federal Circuit affirmed the district court's judgment. The Federal Circuit found that:
- The district court did not err in its claim construction.
- The jury's verdict of non-invalidity and infringement was supported by substantial evidence.
- Breckenridge failed to demonstrate reversible error in the district court's rulings.
This appellate decision upheld the validity and infringement of Sanofi's U.S. Patent No. 7,714,079.
What are the Implications for Biosimilar Development?
This litigation has significant implications for biosimilar developers, particularly for insulin products:
- Patent Landscape Scrutiny: Biosimilar developers must conduct rigorous due diligence on the patent landscape surrounding innovator biologics. This includes not only composition-of-matter patents but also manufacturing process patents, which can pose substantial barriers.
- Navigating Process Patents: U.S. Patent No. 7,714,079 highlights the critical role of process patents in the biologics space. Unlike small molecules, the manufacturing process for biologics can significantly impact the final product's characteristics. Innovator companies can leverage detailed manufacturing process claims to protect their products.
- Infringement Risk: Developers must carefully design their manufacturing processes to avoid infringement of existing patents. This requires a deep understanding of claim scope and potential infringement theories.
- Validity Challenges: While validity challenges (e.g., obviousness, enablement) are a standard defense in patent litigation, their success against strong patent claims and jury verdicts can be challenging, as demonstrated in this case.
- Biosimilar Exclusivity Periods: The outcome reinforces the importance of navigating existing patent protections to avoid costly litigation and delays in market entry. The 180-day exclusivity period for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) does not shield developers from infringing patents that predate their biosimilar application.
What is the Current Status of Lantus® and Biosimilars?
Following the Federal Circuit's affirmation, Breckenridge's ability to launch a biosimilar insulin glargine that infringes U.S. Patent No. 7,714,079 was blocked. Sanofi's Lantus® product has faced biosimilar competition from other companies after the expiration of key patents, but this specific litigation involved challenges to a manufacturing patent that remained in force. The U.S. market has seen the launch of biosimilar insulin glargine products from companies like Eli Lilly (Basaglar®) and Boehringer Ingelheim (Semglee®), but these launches occurred after navigating the relevant patent landscape or through different legal pathways. The outcome of this Sanofi v. Breckenridge case underscores the complexities of patent litigation for biosimilar market entry.
Key Takeaways
- U.S. Patent No. 7,714,079, covering a method of producing insulin glargine, was found valid and infringed by Breckenridge Pharmaceutical, Inc.
- Breckenridge's attempts to invalidate the patent based on obviousness and lack of enablement were unsuccessful before a jury and on appeal.
- The Federal Circuit affirmed the district court's claim construction and the jury's verdict, upholding Sanofi's patent rights.
- This litigation demonstrates that manufacturing process patents can be a significant hurdle for biosimilar developers.
- Biosimilar developers must conduct thorough patent analysis and design processes to avoid infringing innovator patents.
Frequently Asked Questions
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What specific claims of U.S. Patent No. 7,714,079 were at issue?
The core of the dispute involved claims directed to the method of producing insulin glargine, specifically focusing on various steps and conditions within the manufacturing process.
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Did Breckenridge have any other patent defenses besides invalidity?
Yes, Breckenridge also asserted non-infringement, arguing that its manufacturing process and resulting product did not fall within the scope of Sanofi's patent claims.
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How long did the litigation process take from filing to the final appellate decision?
The litigation was initiated with the filing of the complaint in 2015. The Federal Circuit's final decision was issued on December 3, 2020, meaning the dispute spanned approximately five years.
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What is the significance of the Markman hearing in this case?
The Markman hearing determined the meaning and scope of disputed claim terms. This claim construction then served as the basis for the court and jury to decide whether Breckenridge's product infringed Sanofi's patent and whether the patent was valid.
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Does this ruling prevent all biosimilar insulin glargine products from entering the market?
No, this ruling specifically addressed Breckenridge Pharmaceutical's attempt to market a biosimilar that was found to infringe U.S. Patent No. 7,714,079. Other biosimilar insulin glargine products may have entered the market by obtaining licenses, designing around the patent, or after the patent expired or was found invalid in separate proceedings.
Citations
[1] Sanofi-Aventis U.S. LLC v. Breckenridge Pharm., Inc., No. 3:15-cv-00289-MAS-LH (D.N.J. Mar. 15, 2018).
[2] Sanofi-Aventis U.S. LLC v. Breckenridge Pharm., Inc., No. 3:15-cv-00289-MAS-LH (D.N.J. May 14, 2018).
[3] Sanofi-Aventis U.S. LLC v. Breckenridge Pharm., Inc., No. 3:15-cv-00289-MAS-LH (D.N.J. Oct. 9, 2019).
[4] Sanofi-Aventis U.S. LLC v. Breckenridge Pharm., Inc., 981 F.3d 1319 (Fed. Cir. 2020).
