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Cesar Castillo, Inc. v. Sanofi-Aventis U.S., LLC (In re Lantus Direct Purchaser Antitrust Litig.)

United States Court of Appeals for the First Circuit

February 13, 2020, Decided

No. 18-2086


 [*3]  KAYATTA, Circuit Judge. The FDA maintains a publication called Approved Drug Products with Therapeutic Equivalence Evaluations, known in the industry as "the Orange Book." The Orange Book lists patents said by their owners to claim FDA-approved drugs. The listing of a patent in the Orange Book arms the patent-owning drug manufacturer with the ability to trigger an automatic, thirty-month [**2]  suspension of the FDA's approval of a competitive product. The principal questions posed on this appeal are whether Sanofi improperly submitted a patent for listing in the Orange Book and, if so, whether Sanofi is potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly. We answer "yes" to both questions and vacate the dismissal of the plaintiffs' complaint to the extent that the district court held otherwise.

] When a drug manufacturer files an application for FDA approval of a new drug (a "new drug application," or NDA) or a supplemental application for approval of changes to an already-approved drug (a "supplemental new drug application," or sNDA), the manufacturer must

file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.

21 U.S.C. § 355(b)(1).1 The FDA reviews the submission for completeness and to see, in [**3]  Sanofi's words, whether the patent "is not facially ineligible for listing." See 21 C.F.R. § 314.53(c)(2)(ii). Upon accepting the submission, the FDA then lists the patent in the Orange Book. ] Pointing to its "scarce resources," the FDA has expressly declared that it does not "review patent information for its accuracy and relevance." 59 Fed. Reg. 50,338, 50,343, 50,345  [*4]  (Oct. 3, 1994). Rather, the agency requires the manufacturer to declare that the submitted patent claims the "drug substance," "drug product (composition/formulation)," or "one or more methods of using" the drug for which it is listed. 21 C.F.R. § 314.53(c)(2)(i)(M)—(O). The plaintiffs characterize the FDA's review of tendered Orange Book listings as purely "ministerial," noting that the FDA has refused to create any additional processes for "review[ing] the scope of [a submitted Orange Book] patent and its application to the approved drug product" or for delisting patents in the Orange Book. 68 Fed. Reg. 36,676, 36,683 (June 18, 2003).2

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950 F.3d 1 *; 2020 U.S. App. LEXIS 4565 **; 2020-1 Trade Cas. (CCH) P81,083; 2020 U.S.P.Q.2D (BNA) 52597; 2020 WL 728628

IN RE: LANTUS DIRECT PURCHASER ANTITRUST LITIGATION; CÉSAR CASTILLO, INC., on behalf of itself and all others similarly situated; FWK HOLDINGS LLC, on behalf of itself and all others similarly situated, Plaintiffs, Appellants, v. SANOFI-AVENTIS U.S., LLC, Defendant, Appellee, SANOFI GMBH, Defendant.


In re Lantus Direct Purchaser Antitrust Litig., 2018 U.S. Dist. LEXIS 216240 (D. Mass., Oct. 24, 2018)In re Lantus Direct Purchaser Antitrust Litig., 284 F. Supp. 3d 91, 2018 U.S. Dist. LEXIS 4503 (D. Mass., Jan. 10, 2018)


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Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Civil Procedure, Appeals, Standards of Review, De Novo Review, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Patent Law, Claims & Specifications, Claims, Antitrust & Trade Law, Sherman Act, Scope, Monopolization Offenses, Reviewability of Lower Court Decisions, Preservation for Review, Price Fixing & Restraints of Trade, Per Se Rule & Rule of Reason, Sherman Act, Governments, Legislation, Expiration, Repeal & Suspension, Defenses