In re Opana ER Antritrust Litigation

162 F. Supp. 3d 704, 2016 U.S. Dist. LEXIS 16700, 2016 WL 521005
CourtDistrict Court, N.D. Illinois
DecidedFebruary 10, 2016
DocketMDL Docket No. 2580; Case No. 14 C 10150
StatusPublished
Cited by21 cases

This text of 162 F. Supp. 3d 704 (In re Opana ER Antritrust Litigation) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Opana ER Antritrust Litigation, 162 F. Supp. 3d 704, 2016 U.S. Dist. LEXIS 16700, 2016 WL 521005 (N.D. Ill. 2016).

Opinion

[710]*710MEMORANDUM OPINION AND ORDER

Harry D. Leinenweber, Judge

This lawsuit is one of many in the federal courts involving the application of the Supreme Court’s decision in FTC v. Actavis, Inc., - U.S.-, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013), to settlements between branded and generic pharmaceutical manufacturers. In this case, Direct Purchaser Plaintiffs (“DPPs”) have brought claims under the. Sherman Act, and Indirect, or End-Payor Purchaser Plaintiffs (“EPPs”) have brought claims under state antitrust, consumer protection, and unjust enrichment laws. DPPs and EPPs (collectively, the “Plaintiffs”) allege that Endo Health Solutions Inc., Endo Pharmaceuticals Inc., Penwest Pharmaceuticals Co. (collectively, “Endo”), and Impax Laboratories, Inc. (“Impax”) (collectively, the “Defendants”) delayed the entry of generic versions of Opana ER to the Oxymorphone ER Market by entering into an illegal reverse payment agreement to settle ongoing patent infringement litigation between Endo and Impax.

Currently before the Court are two Motions to Dismiss. The Motions seek dismissal of DPPs’ First Amended Consolidated Complaint [ECF No. 118], and EPPs’ First Amended Consolidated Complaint [ECF No. 121] under Fed. R. Civ. P. 12(b)(6). For the following reasons, the Motion to dismiss DPPs’ First Amended Consolidated Complaint is denied, and the Motion to Dismiss EPPs’ First Amended Consolidated Complaint is granted in part and denied in part.

I. BACKGROUND

Except where noted, the following facts are contained in both DPPs’ and EPPs’' Complaints, documents attached to the Complaints, and documents that are referenced in, and critical to, the Complaints. Geinosky v. City of Chicago, 675 F.3d 743, 745 n. 1 (7th Cir.2012) (In resolving a motion to dismiss, the court must consider “documents attached to the complaint, documents that are critical to the complaint and referred to in it, and information that is subject to proper judicial notice.”). Plaintiffs’ factual allegations are accepted as true for purposes of deciding the motions to dismiss.

[711]*711A. Hatch-Waxman Regulatory Framework

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), manufacturers that create a new drug must obtain approval to sell the product by filing a New Drug Application (“NDA”). 21 U.S.C. §§ 301-392. An NDA must include specific data concerning the safety and effectiveness of the drug, as well as information on applicable patents. Id. at § 355(a), (b). When the Food and Drug Administration (“FDA”) approves a brand manufacturer’s NDA, the manufacturer may list in the “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”) any patents that the manufacturer believes could reasonably be asserted against a generic manufacturer that makes, uses, or sells a generic version of the brand drug. Id. at § 355(b)(1). When a brand manufacturer wishes to make changes to a drug that already has an approved NDA, the brand manufacturer must submit a supplemental new drug application (“sNDA”) to the FDA. An sNDA is required when a brand manufacturer wishes to change a drug label, market a new dosage strength, or change the way the drug is manufactured.

The Hatch-Waxman Act, enacted in 1984, simplified the regulatory hurdles for prospective generic manufacturers by eliminating the need for them to file NDAs. Under the Act’s abbreviated regulatory approval process for generic drugs, a generic drug manufacturer may file an Abbreviated New Drug Application (“ANDA”) relying on the scientific findings of safety and effectiveness in the brand drug’s NDA, and demonstrating that the proposed generic is pharmaceutically equivalent and bioequivalent (together “therapeutically equivalent”) to a brand drug. Id. at § 355(j)(8)(b).

To obtain FDA approval of an ANDA, a manufacturer must also certify that the generic drug will not infringe any patents listed in the Orange Book. Under the Hatch-Waxman Act, the ANDA must contain one of four certifications: (I) that there are no patents listed in the Orange Book that cover the brand drug; (II) that any Orange Book listed patents have expired; (III) that the generic is not seeking approval before the expiration of any unexpired patents listed in the Orange Book; or (IV) that any unexpired patents listed in the Orange Book are not infringed, are invalid, and/or are unenforceable (this is commonly referred to as a “Paragraph IV certification”). Id. at § 355(j)(2)(A)(vii).

A generic manufacturer must serve notice to the brand company of a Paragraph IV certification because such a certification creates an “artificial act” of patent infringement, permitting the brand company to file a patent infringement suit against the generic manufacturer. 35 U.S.C. § 271(e)(2)(A). If the brand company files suit within 45 days of receiving the Paragraph IV certification, final FDA approval of the generic manufacturer’s ANDA is automatically stayed until the earlier of (i) 30 months, or (ii) entry of a district court judgment finding patent invalidity or non-infringement. 21 U.S.C. § 355(j)(5)(B)(iii). During this stay, the FDA may grant “tentative approval” of the generic manufacturer’s ANDA if it determines that the ANDA would otherwise qualify for final approval absent the stay. Id. at § 355(j)(5)(B)(iv).

As an incentive for generic pharmaceutical companies to challenge suspect patents listed in the Orange Book, the Hatch-Waxman Act grants the first company to file a Paragraph IV ANDA (commonly known as the “first-filer”) a 180-day period of generic marketing exclusivity during which time the FDA will not approve a later-filed ANDA for the same brand drug. Id. at § 355(j)(5)(B)(iv). During the 180-day period of market exclusivity, the [712]*712first-filer only competes against the brand manufacturer and potentially any Authorized Generic (“AG”) marketed under the brand manufacturer’s NDA. Id. The start of the 180-day exclusivity period is triggered by the earlier of two events: (1) the first-filer’s commercial marketing of a drug product, or (2) a court decision of noninfringement or patent invalidity. Id. Only the first-filer can trigger its 180-day exclusivity period via the commercial-marketing trigger. Id. at § 355(j)(5)(B)(iv)(I). However, a subsequent Paragraph IV ANDA filer can trigger the first-filer’s 180-day exclusivity period via a successful court judgment. Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1357 (Fed.Cir.2008). This 180-day period of exclusivity “can prove valuable, possibly worth several hundred million dollars” to the first-filer. Actavis, 133 S.Ct. at 2229.

B. AB-Rated Generic Drugs

Generic drugs that are “therapeutically equivalent” to their brand counterpart receive an “AB” rating from the FDA.

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Cite This Page — Counsel Stack

Bluebook (online)
162 F. Supp. 3d 704, 2016 U.S. Dist. LEXIS 16700, 2016 WL 521005, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-opana-er-antritrust-litigation-ilnd-2016.