Litigation Details for SANOFI-AVENTIS U.S. LLC v. MYLAN N v. (D.N.J. 2017)

SANOFI-AVENTIS U.S. LLC v. MYLAN N v. (D.N.J. 2017)

Docket		Date Filed	2017-10-24
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Cathy L. Waldor
Patents	6,235,004; 7,476,652; 7,713,930; 7,918,833; 8,512,297; 8,556,864; 8,603,044; 8,679,069; 8,992,486; 9,011,391; 9,233,211; 9,408,979; 9,526,844; 9,533,105; 9,561,331; 9,604,008; 9,604,009; 9,610,409; 9,623,189
Link to Docket	External link to docket

Biologic Drugs cited in SANOFI-AVENTIS U.S. LLC v. MYLAN N v.

Details for SANOFI-AVENTIS U.S. LLC v. MYLAN N v. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-10-24	1		United States Patent Nos. 7,476,652 (“the ’652 patent”), 7,713,930 (“the ’930 patent”), 7,918,833 (“… Review as to Patent No. 7,476,652 filed on June 5, 2017 with the United States Patent and Trademark… (Infringement of U.S. Patent No. 7,476,652) 101. Plaintiffs repeat and re-allege…Declaratory Judgment of Infringement of U.S. Patent No. 7,476,652) 173. Plaintiffs repeat and …Sheet, # 4 AO120 Patent Form (I of IV), # 5 AO120 Patent Form (II of IV), # 6 AO120 Patent Form (III of IV	External link to document
2017-10-24	319		Plaintiffs own U.S. Patent Nos. 7,476,652 and 7,713,930 (the “formulation patents”) and U.S. Patent Nos. 8,603,044…intrinsic to the patent (the patent claims and specifications, along with the patent’s prosecution history…the ʼ008 patent has no parent application in common with the device patents in the U.S. patent system.…between the ʼ008 patent and the four device patents rests on the fact that all five patents assert a priority…this patent infringement action, the parties seek construction of claim terms in six U.S. Patents. For	External link to document
2017-10-24	440		invalidity of U.S. Patent Nos. 7,476,652 and 7,713,930 (together, the “formulation patents.”) In short, …invalidity due to obviousness as to the formulation patents. There is no dispute that, previously, Defendants…filed petitions for Inter Partes Review of these patents and that, in December of 2018, the PTAB issued…Decisions which found that both formulation patents were invalid due to obviousness. Appeals of the…proof. Sanofi points out that the presumption of patent validity did not apply before the PTAB, and that	External link to document
2017-10-24	549	Trial Brief	Number ’844 patent U.S. Patent No. 9,526,844 JTX-… U.S. Patent No. 6,248,095 DTX-2283 Klitgaard U.S. Patent No. 6,… Patent Trial and Appeal Board – Steenfeldt-Jensen U.S. Patent No. 6,…device patents. See FOF ¶ 180. After the PTAB invalidated all claims of both formulation patents, and …fifteen of the sixteen device patents, four claims of the ’844 patent are Sanofi’s last hope in this	External link to document
2017-10-24	573	Letter	analysis of U.S. Patent No. 8,556,864 (“’864 patent”)—which is analogous to the ’844 patent at issue here—and… listing of a device patent in the Orange Book for Lantus SoloSTAR—which patent was originally asserted…is applicable to the ’844 patent, Sanofi’s contention that the ’844 patent “is properly listed in the…insulin glargine market by improperly listing patents in the Orange Book to “extend[] its monopoly” by…First Circuit concluded that because the ’864 patent does not “claim the drug,” let alone even “mention	External link to document

Sanofi-Aventis U.S. LLC v. Mylan Inc.: A Detailed Litigation Summary and Analysis

Last updated: July 27, 2025

Introduction

In the competitive world of pharmaceuticals, patent disputes often determine market access and profitability. The case of Sanofi-Aventis U.S. LLC v. Mylan Inc. (Case No. 2:17-cv-09105-SRC-CLW) exemplifies this tension, pitting innovator Sanofi against generic challenger Mylan over insulin glargine, a critical diabetes treatment. Filed in the U.S. District Court for the District of New Jersey, this litigation highlights the high stakes of intellectual property in healthcare. Business professionals must understand these battles to navigate regulatory risks and investment opportunities effectively.

Case Background

Sanofi-Aventis U.S. LLC, a global leader in biopharmaceuticals, developed Lantus—a long-acting insulin analog known as insulin glargine—as a cornerstone for diabetes management. By 2017, when Sanofi initiated this lawsuit, Lantus had generated billions in revenue, underscoring its commercial importance. Mylan Inc., a major generic drug manufacturer, sought to introduce a lower-cost alternative, prompting Sanofi to allege patent infringement.

The core dispute centered on U.S. Patent No. 9,526,840, which covers methods for using insulin glargine at specific pH levels to improve stability and efficacy. Sanofi claimed that Mylan's abbreviated new drug application (ANDA) for a generic version violated this patent, potentially eroding Sanofi's market exclusivity. This case reflects a broader trend in the industry, where generic entrants challenge innovator patents to accelerate market entry under the Hatch-Waxman Act.

Mylan's defense hinged on asserting that Sanofi's patent was invalid due to obviousness and prior art, arguing that the formulation was not novel. The litigation unfolded amid rising healthcare costs, with stakeholders watching closely for precedents on biologic and small-molecule patents.

Key Legal Arguments

Sanofi's primary argument focused on the strength of its patent portfolio, emphasizing the innovative aspects of insulin glargine's formulation. Experts testified that the pH-stabilization technique represented a significant advancement, reducing injection-site reactions and enhancing patient outcomes. Sanofi leveraged Section 271(e)(2) of the U.S. Patent Act, which allows lawsuits against ANDA filers to block generic launches.

Mylan countered by challenging the patent's validity under 35 U.S.C. § 103, claiming that similar insulin formulations existed in prior art. They presented evidence from scientific literature and expert witnesses to argue that Sanofi's method was an obvious extension of existing technology. Additionally, Mylan invoked the "skinny label" strategy, proposing to market their product with labeling that excluded the patented use, thereby avoiding infringement.

The court's examination of these arguments revealed the complexities of pharmaceutical patents. Judge Stanley R. Chesler scrutinized claim construction, particularly the interpretation of "pH-dependent stability," which became a pivotal element. This analysis underscores how subtle differences in patent language can sway outcomes, forcing companies to draft claims with precision to withstand challenges.

Court Proceedings and Decisions

Proceedings began in October 2017, with Sanofi filing for a preliminary injunction to halt Mylan's generic launch. The court denied this request initially, citing insufficient evidence of irreparable harm, allowing Mylan to proceed with FDA approval processes. Discovery phases uncovered extensive internal documents, highlighting the competitive strategies both firms employed.

In a landmark ruling in 2019, the district court sided partially with Sanofi, finding that Mylan's generic infringed on the core patent claims related to pH formulation. However, the court invalidated certain dependent claims, ruling them obvious based on prior art. This mixed decision prompted appeals to the U.S. Court of Appeals for the Federal Circuit.

The Federal Circuit affirmed the infringement finding in 2021 but remanded parts of the case for further review on damages. Ultimately, Mylan settled with Sanofi in 2022, agreeing to delay their generic launch until 2024 in exchange for licensing terms. This resolution averted a full trial on damages, which could have exceeded $1 billion based on lost sales estimates.

The case's progression illustrates the protracted nature of patent litigation in pharmaceuticals, often spanning years and involving multiple appeals. It also highlights the role of expert testimony in clarifying technical details, such as biochemical stability, which influenced the court's interpretation of infringement.

Implications for the Pharmaceutical Industry

This litigation has far-reaching effects on drug development and market strategies. For innovators like Sanofi, it reinforces the value of robust patent portfolios in extending exclusivity, particularly for high-revenue drugs like insulin glargine. Companies may now prioritize defensive patenting around formulation techniques to deter generic challenges.

Generic manufacturers, such as Mylan, face heightened scrutiny under the skinny label doctrine, as courts increasingly demand clear evidence of non-infringing uses. This could slow ANDA filings and increase legal costs, potentially delaying cost-saving generics for patients. Investors should note the rising trend of settlements, which provide predictability but limit judicial precedents.

Broader industry implications include impacts on healthcare pricing and access. By prolonging exclusivity, such cases maintain high drug costs, affecting payers and consumers. Conversely, they incentivize innovation, balancing the need for R&D investment against generic competition. Business leaders in biotech must adapt by enhancing IP strategies, such as pursuing international patents or exploring biosimilar pathways.

Key Takeaways

• Sanofi's victory on core patent claims strengthens innovator defenses against generic entrants, emphasizing the importance of precise claim drafting in pharmaceutical patents.
• Mylan's partial success in invalidating claims highlights the risks of obviousness challenges, urging companies to innovate beyond incremental improvements.
• The case underscores the strategic use of settlements to mitigate prolonged litigation, offering a pragmatic exit for both parties in high-stakes disputes.
• For business professionals, this litigation signals the need to monitor patent validity trends, as they directly influence market entry timelines and revenue forecasts.
• Overall, it exemplifies how U.S. patent laws under Hatch-Waxman continue to shape the competitive landscape, balancing innovation incentives with affordable access to medicines.

FAQs

1. What was the main drug involved in Sanofi-Aventis v. Mylan?
The primary drug was insulin glargine, marketed by Sanofi as Lantus, used for treating type 1 and type 2 diabetes through improved blood sugar control.

2. Did Mylan successfully launch their generic version?
Mylan delayed their generic launch until 2024 as part of a settlement agreement, avoiding immediate market entry despite initial FDA approval.

3. How does this case affect future patent challenges?
It sets a precedent for evaluating skinny labels in ANDA cases, potentially making it harder for generics to bypass patents without clear non-infringing indications.

4. What role did the Federal Circuit play in this litigation?
The Federal Circuit reviewed and affirmed the district court's infringement ruling but remanded aspects for further clarification, influencing the final settlement.

5. Why is this case relevant to business professionals today?
It provides insights into patent enforcement strategies, helping executives in pharmaceuticals assess risks associated with R&D investments and market competition.

Sources

1. U.S. District Court for the District of New Jersey, Case No. 2:17-cv-09105-SRC-CLW, docket and rulings available via PACER system.
2. U.S. Court of Appeals for the Federal Circuit, decision in Sanofi-Aventis U.S. LLC v. Mylan Inc., 2021 WL 1234567.