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Sanofi-Aventis U.S., LLC v. Mylan, Inc. (In re EpiPen Epinephrine Injection, Mktg., Sales Pracs. & Antitrust Litig.)

Sanofi-Aventis U.S., LLC v. Mylan, Inc. (In re EpiPen Epinephrine Injection, Mktg., Sales Pracs. & Antitrust Litig.)

United States Court of Appeals for the Tenth Circuit

July 29, 2022, Filed

No. 21-3005

Opinion

 [*964]  BALDOCK, Circuit Judge.

"Competition is a tough weed, not a delicate flower." —George Stigler

Despite the extraordinary length of this opinion, this appeal [**3]  presents a simple question. Can a plaintiff present a triable issue of monopolization without offering any evidence of actual or threatened consumer harm? We conclude such a plaintiff cannot.

Plaintiff Sanofi-Aventis U.S., LLC ("Sanofi") sued Defendants Mylan, Inc. and Mylan Specialty, LP (collectively "Mylan") under Section 2 of the Sherman Antitrust Act. 15 U.S.C. § 2. Sanofi, one of the world's largest pharmaceutical companies, alleges Mylan, the distributor of EpiPen, monopolized the epinephrine auto-injector market effectively and illegally foreclosing Auvi-Q—Sanofi's innovative epinephrine auto-injector—from the market. The parties cross-moved for summary judgment. The district court, holding no triable issue of exclusionary conduct, granted Mylan's motion for summary judgment. Exercising jurisdiction under 28 U.S.C. § 1291, we affirm.1

The following facts are either uncontroverted, or, where genuinely controverted, are viewed in the light most favorable to Sanofi, the party opposing the grant of summary judgment to Mylan.2 Scott v. Harris, 550 U.S. 372, 378-80, 127 S. Ct. 1769, 167 L. Ed. 2d 686 (2007). ] We are mindful, however, that when "opposing parties tell two different stories, one of which is blatantly contradicted by the record, so that no reasonable jury could believe it, a court should not adopt that version [**4]  of the facts for purposes of ruling on a motion for summary judgment." Id. at 380. Sanofi's allegations of monopolization center around industry-specific practices in the prescription drug market. We must, therefore, begin with an indispensable, albeit technical, overview of the prescription drug market.

"Before a patient can go to the pharmacy (or mailbox) to pick up their prescription, the medicine must make its way from the pharmaceutical manufacturer to the pharmacy." Pharm. Research & Mfrs. of Am., Follow the Dollar 3 (2017) [hereinafter Follow the Dollar], http://phrma-docs.phrma.org/files/dmfile/Follow-the-Dollar-Report.pdf.  [*965]  The distribution chain starts with the manufacturer who sells to a wholesaler for the wholesale acquisition cost ("list price"). Wholesalers then sell to the pharmacy, who dispense the product to the patient with a doctor's prescription.

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44 F.4th 959 *; 2022 U.S. App. LEXIS 20998 **; 2022 WL 3009140

In re: EPIPEN (EPINEPHRINE INJECTION, USP) MARKETING, SALES PRACTICES AND ANTITRUST LITIGATION.SANOFI-AVENTIS U.S., LLC, Plaintiff Counterclaim Defendant - Appellant, v. MYLAN, INC., Defendant - Appellee, and MYLAN SPECIALTY, LP, Defendant Counterclaimant - Appellee.OPEN MARKETS INSTITUTE; AMERICAN ANTITRUST INSTITUTE; ALLERGY & ASTHMA NETWORK; THE COMMITTEE TO SUPPORT THE ANTITRUST LAWS; PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION; INTERNATIONAL CENTER FOR LAW & ECONOMICS AND SCHOLARS OF LAW AND ECONOMICS; THE CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; J. GREGORY SIDAK, Amici Curiae.

Subsequent History: Motion granted by Sanofi-Aventis U.S., LLC v. Mylan Inc., 2023 U.S. LEXIS 150 (U.S., Jan. 9, 2023)

Prior History: Appeal from the United States District Court for the District of Kansas. (D.C. No. 2:17-MD-02785-DDC-TJJ). (507 F. Supp. 3d 1289 [**1] ).

In re EpiPen (Epinephrine Injection, USP) Mktg., Sales Practices & Antitrust Litig., 507 F. Supp. 3d 1289, 2020 U.S. Dist. LEXIS 257557 (D. Kan., Dec. 17, 2020)

CORE TERMS

rebate, formulary, Tier, epinephrine, auto-injector, patient, foreclosure, coverage, prices, offers, health plan, discounts, exclusionary, foreclosed, consumer, antitrust, spillover, entrenched, contracts, products, anticompetitive, monopolist's, effective, launch, summary judgment, monopolization, branded, edit, bid, placement

Civil Procedure, Summary Judgment, Entitlement as Matter of Law, Appropriateness, Burdens of Proof, Implausible Claims, Judgments, Burdens of Proof, Entitlement as Matter of Law, Genuine Disputes, Antitrust & Trade Law, Consumer Protection, Torts, Products Liability, Defenses, Plaintiff Conduct, Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food & Drugs Act, Appeals, Standards of Review, De Novo Review, Materiality of Facts, Preliminary Considerations, Venue, Motions to Transfer, Governments, Courts, Judicial Precedent, Monopolies & Monopolization, Actual Monopolization, Claims, Monopoly Power, Sherman Act, Scope, Monopolization Offenses, Attempts to Monopolize, Elements, Price Fixing & Restraints of Trade, Exclusive & Reciprocal Dealing, Exclusive Dealing, Anticompetitive & Predatory Practices, Predatory Pricing, Regulated Practices, Attempts to Monopolize, Tying Arrangements, Sherman Act Violations, Per Se Rule & Rule of Reason, Per Se Rule Tests, Manifestly Anticompetitive Effects, Sherman Act, Anticompetitive & Predatory Practices, Healthcare Law, Medical Treatment, Patient Consent, Insurance Coverage, Health Insurance, Patient Obligations, Private Actions, Standing, Requirements, Conspiracy to Monopolize, Cartels & Horizontal Restraints, Remedies, Damages, Evidence, Inferences & Presumptions, Inferences, Presumptions, Creation, Scintilla Rule, Per Se Violations, Appellate Briefs, Reviewability of Lower Court Decisions, Preservation for Review