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
2017-10-24	582	Opinion	) b. U.S. Patent No. 6,235,004 (“Steenfeldt-Jensen”) c. U.S. Patent No. 5,674,204 (“Chanoch… of patents, including the patent at issue in this trial, the ’844 patent. As to the ’844 patent, the…, “Mylan.”) Plaintiffs own U.S. Patent No. 9,526,844 (“the ’844 patent”), which is listed in the Orange…, 25, and 30 of the ’844 patent. Mylan contends that the asserted patent claims are invalid, pursuant…and 35 U.S.C. § 103. A bench trial on patent infringement and patent validity was held for 5 days, beginning	External link to document

SANOFI-AVENTIS U.S. LLC v. MYLAN N.V.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Sanofi-Aventis U.S. LLC and Mylan N.V. involves multiple facets, including antitrust claims, patent infringement, and the complexities of pharmaceutical market competition. Here, we will delve into the key aspects of the case, focusing on the antitrust and patent infringement disputes.

Antitrust Claims: Monopolization and Exclusive Dealing

Sanofi-Aventis U.S. LLC alleged that Mylan, the distributor of EpiPen, engaged in monopolistic practices that effectively foreclosed Sanofi's innovative epinephrine auto-injector, Auvi-Q, from the market. The claims were filed under Section 2 of the Sherman Antitrust Act.

• District Court Ruling: The district court granted Mylan's motion for summary judgment, finding no triable issue of exclusionary conduct. The court determined that Mylan's rebate contracts did not substantially foreclose competition, as Sanofi had access to 80% of the commercial market within two years of Auvi-Q's launch[3][4].
• Appellate Court Affirmation: The Tenth Circuit Court of Appeals affirmed the district court's decision, concluding that Sanofi failed to present sufficient evidence to support its claims of monopolization and exclusionary conduct. The court emphasized that a plaintiff cannot present a triable issue of monopolization without evidence of actual or threatened consumer harm[3].

Exclusive Contracts and Market Foreclosure

A critical aspect of the antitrust claims was Mylan's use of exclusive contracts with pharmacy benefit managers (PBMs) and other market players.

• Exclusionary Contracts: Mylan's contracts were designed to block Auvi-Q from a significant portion of the market. However, the court found these contracts to be relatively short in duration and easily terminable, which did not constitute unlawful coercion or foreclosure[4].
• Non-Contestable Demand: Sanofi argued that Mylan leveraged its non-contestable demand for EpiPen to protect its contestable demand from competition. However, the court dismissed this argument, noting that Sanofi could have neutralized Mylan's program by offering its own discounts and exclusivity deals[1][4].

Patent Infringement Claims

In a separate but related litigation, Sanofi-Aventis U.S. LLC sued Mylan for patent infringement related to Sanofi's Lantus® and Lantus® SoloSTAR® insulin products.

• Complaint and Jurisdiction: Sanofi filed a complaint alleging that Mylan's filing of a New Drug Application (NDA) with the FDA for its proposed copies of Lantus® and Lantus® SoloSTAR® constituted patent infringement. The case was filed in the District of New Jersey, where Mylan had a regular and established place of business[2].
• Patent Validity and Collateral Estoppel: Mylan moved for summary judgment of invalidity of the asserted patent claims, citing a previous Patent Trial and Appeal Board (PTAB) decision that found the formulation patents obvious. However, the district court denied this motion, reasoning that the different burdens of proof between the PTAB and the district court barred the application of issue preclusion[5].

Key Findings and Rulings

• No Antitrust Injury: The district court and the Tenth Circuit agreed that Sanofi failed to demonstrate an antitrust injury sufficient to support its Sherman Act claims. Sanofi had opportunities to compete for better placement on payors' formularies by offering bigger discounts in exchange for exclusivity for Auvi-Q[1][3].
• Insufficient Evidence: Sanofi's claims of exclusionary conduct were deemed lacking in critical respects. The court found that Mylan's challenged acts, collectively, did not have any synergistic anticompetitive effect[1].

Industry Implications

The outcome of this litigation has significant implications for the pharmaceutical industry, particularly in how companies structure their rebate agreements and exclusive contracts.

• Competition and Consumer Welfare: The courts' emphasis on consumer welfare and the need for evidence of actual or threatened consumer harm underscores the importance of ensuring that market practices do not harm consumers[3].
• Patent Strategies: The patent infringement aspect highlights the complexities of navigating patent validity and the differences in burdens of proof between administrative and judicial proceedings[5].

Expert Opinions and Market Dynamics

Industry experts and market dynamics played a crucial role in this litigation.

• Expert Testimony: Sanofi's expert economist provided evidence on Mylan's entrenched market share, but this was not sufficient to overcome the lack of evidence on exclusionary conduct and consumer harm[4].
• Market Behavior: The behavior of major market players, such as ESI, the largest dealer in the United States, was scrutinized. Despite initial claims that ESI would not switch to Sanofi's product even with a 100% discount, ESI later shifted business to Sanofi when prices were cut, highlighting the dynamic nature of market competition[1].

Key Takeaways

• Antitrust Claims Require Strong Evidence: To succeed in antitrust claims, plaintiffs must present robust evidence of exclusionary conduct and consumer harm.
• Patent Infringement Requires Careful Jurisdictional Analysis: Patent infringement cases involve complex jurisdictional and procedural issues, including the application of collateral estoppel.
• Market Dynamics Are Crucial: The behavior of major market players and the structure of rebate agreements can significantly impact the outcome of antitrust and patent infringement cases.

Frequently Asked Questions (FAQs)

Q: What were the main antitrust claims made by Sanofi against Mylan? A: Sanofi alleged that Mylan engaged in monopolistic practices by using exclusive contracts to foreclose Sanofi's Auvi-Q from the epinephrine auto-injector market.

Q: How did the courts rule on Sanofi's antitrust claims? A: The district court and the Tenth Circuit Court of Appeals granted summary judgment to Mylan, finding no triable issue of exclusionary conduct and no evidence of antitrust injury.

Q: What was the basis for the patent infringement claims against Mylan? A: Sanofi alleged that Mylan's filing of an NDA for its proposed copies of Lantus® and Lantus® SoloSTAR® constituted patent infringement.

Q: Why was Mylan's motion for summary judgment of invalidity of the patent claims denied? A: The motion was denied because the different burdens of proof between the PTAB and the district court barred the application of issue preclusion.

Q: What are the implications of this litigation for the pharmaceutical industry? A: The litigation highlights the importance of ensuring that market practices do not harm consumers and the need for careful analysis of patent validity and jurisdictional issues.

Cited Sources

1. Supreme Court of the United States, "Mylan v. Sanofi SCT Br. in Opp. 2023.03.08 FINAL" [PDF].
2. United States District Court, District of New Jersey, "Case 2:17-cv-09105-SRC-CLW Document 1 Filed 10/24/17".
3. United States Court of Appeals for the Tenth Circuit, "Sanofi-Aventis U.S. v. Mylan, et al., No. 21-3005 (10th Cir. 2022)".
4. Supreme Court of the United States, "Sanofi-Aventis US - Supreme Court of the United States" [PDF].
5. Mintz, "Collateral Estoppel Does Not Attach to PTAB Invalidity Determination".