American Sales Co. v. Warner Chilcott Co.

814 F.3d 538, 2016 U.S. App. LEXIS 3049
CourtCourt of Appeals for the First Circuit
DecidedFebruary 22, 2016
DocketNos. 14-2071, 15-1250
StatusPublished
Cited by36 cases

This text of 814 F.3d 538 (American Sales Co. v. Warner Chilcott Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
American Sales Co. v. Warner Chilcott Co., 814 F.3d 538, 2016 U.S. App. LEXIS 3049 (1st Cir. 2016).

Opinion

TORRUELLA, Circuit Judge.

This appeal arises from several pharmaceutical antitrust actions that were consolidated and transferred to the United States District Court for the District of Rhode Island by the United States Judicial Panel on Multidistrict Litigation.

Defendant Warner Chilcott (“Warner”) is a brand-name drug manufacturer that owns the patent covering the oral contraceptive Loestrin 24 Fe (“Loestrin 24”). After defendant Watson Pharmaceuticals, Inc. (“Watson”) notified Warner that it would seek to introduce a generic version of Loestrin 24, Warner sued Watson for patent infringement. The parties settled on conditions that Watson delay entry of its generic version of Loestrin 24 and, in exchange, Watson entered into favorable promotional deals with Warner and received promises that Warner would not introduce its own generic version of Loest-rin 24, among other things. Shortly thereafter, defendant Lupin Pharmaceuticals, Inc. (“Lupin”) announced that it would introduce a generic version of Loestrin 24. Warner brought a patent infringement suit against Lupin. Again, the parties settled on terms that Lupin wait to introduce its generic Loestrin 24 in exchange for attor[542]*542neys’ fees and Warner’s agreement to enter into favorable side deals with Lupin.

Two putative classes of plaintiffs — the Direct Purchaser Plaintiffs (“DPPs”), a group comprised of corporate entities that purchased Loestrin 24 directly from Warner, and End Payor Plaintiffs (“EPPs”), which consist of health and welfare benefit plans that have indirectly purchased, paid for, and provided reimbursement for their members’ purchase of Loestrin 24, and individuals who purchased or paid for some or all of the purchase price of Loestrin 24 — subsequently brought antitrust claims that the settlement agreements were violations of § 1 of the Sherman Act, 15 U.S.C. § 1.1 They contend that these agreements constitute illegal restraints on trade under FTC v. Actavis, — U.S. —, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013), which subjected certain patent settlement agreements between generic drug and brand-name drug manufacturers to antitrust scrutiny where they involve “reverse payments.” As described in more detail herein, a reverse payment typically arises where a brand-name drug manufacturer pays the generic manufacturer to delay entpy of its generic equivalent, thereby protecting the brand’s market from generic competition.

Specifically, this antitrust case queries whether, following Actavis, such settlement agreements are subject to federal antitrust scrutiny where they do not involve reverse payments in pure cash form. The district court found that Actavis only applied to monetary reverse payments and dismissed on the basis that the EPPs and DPPs had alleged the existence of non-cash reverse payments only. Because we disagree with the district court’s limited reading of Actavis, we vacate and remand. We begin with the relevant statutory and legal background, which provides the framework for understanding the facts in this appeal.

I. Regulatory Background

The Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585, commonly known.as the Hatch-Waxman Act, stipulates the process by which pharmaceutical firms may gain approval from the Food and Drug Administration (“FDA”) to bring medications to the public marketplace. The Supreme Court in Actavis identified “four key features of the relevant drug-regulatory framework” under the Hatch-Waxman Act. 133 S.Ct. at 2227-29.

First, to market a new prescription drug, a brand-name drug manufacturer must submit a New Drug Application (“NDA”) to the FDA and undergo a laborious and expensive approval process. 21 U.S.C. § 355(b)(1); see Actavis, 133 S.Ct. at 2228. Among other things, the NDA must include “the patent number and the expiration date of any patent which claims the drug ... or which claims a method of using such drug.” 21 U.S.C. § 355(b)(1). Upon receiving FDA approval, the brand manufacturer must publish a description of any patents associated with that drug in the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, [543]*543— U.S. —, 132 S.Ct. 1670, 1676, 182 L.Ed.2d 678 (2012).

Second, the Hatch-Waxman Act promotes the availability of cheaper generic alternatives by allowing generic drug manufacturers to bypass certain aspects of the NDA process. Instead of filing an NDA, a generic manufacturer may file a less cumbersome Abbreviated New Drug Application (“ANDA”) “specifying that the generic has the ‘same active ingredients as,’ and is ‘biologically equivalent’ to, the already-approved brand-name drug.” Actavis, 133 S.Ct. at 2228 (quoting Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1676); 21 U.S.C. § 355(j)(2). But, “[b]eeause the FDA cannot authorize a generic drug that would infringe a patent, the timing of an ANDA’s approval depend? on the scope and duration of the paténts covering the brand-name drug.” Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1676.

Third, the Hatch-Waxman Act establishes procedures for resolving patent disputes between brand and generic drug manufacturers. 21 U.S.C. § 355(j)(2)(A)(vii); Actavis, 133 S.Ct. at 2228. When seeking FDA approval, the generic manufacturer must certify that it will not infringe the brand manufacturer’s patents. 21 U.S.C. § 355(j)(2)(A)(vii); Actavis, 133 S.Ct. at 2228. It can make this certification in one of four ways:

It can certify that the brand-name manufacturer has not listed any relevant patents. It can certify that any relevant patents have expired. It can request approval to market beginning when any still-in-force patents expire. Or, it can certify that any listed, relevant patent “is invalid or will not be infringed by the manufacture, use, or sale” of the drug described in thefANDA].

Actavis, 133 S.Ct. at 2228 (quoting 21 U.S.C. § 355(j)(2)(A)(vii)(IV)).

The fourth alternative, also known as the Paragraph IV route, “counts as patent infringement and often ‘means provoking litigation’ ” by the brand manufacturer. Id. (citation omitted) (quoting Caraco Pharm. Labs., Ltd., 132 S.Ct. at 1677). Should the brand manufacturer bring a patent suit within forty-five days of the generic manufacturer making a Paragraph IV certification, the FDA may not approve the generic manufacturer’s ANDA for a thirty-month period. 21 U.S.C. § 355(j)(5)(B)(iii); Actavis, 133 S.Ct. at 2228. Paragraph IV litigation between generic and brand-name drug manufacturers is particularly relevant here as it has led to the settlement arrangements identified in Actavis.

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Bluebook (online)
814 F.3d 538, 2016 U.S. App. LEXIS 3049, Counsel Stack Legal Research, https://law.counselstack.com/opinion/american-sales-co-v-warner-chilcott-co-ca1-2016.