In Re Lipitor Antitrust Litigation

855 F.3d 126, 2017 WL 1359474
CourtCourt of Appeals for the Third Circuit
DecidedApril 13, 2017
Docket14-4202, 14-4203, 14-4204, 14-4205, 14-4206, 14-4602 & 14-4632; 15-1184, 15-1185, 15-1186, 15-1187, 15-1274, 15-1323 & 15-1342
StatusPublished
Cited by75 cases

This text of 855 F.3d 126 (In Re Lipitor Antitrust Litigation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Lipitor Antitrust Litigation, 855 F.3d 126, 2017 WL 1359474 (3d Cir. 2017).

Opinion

OPINION OF THE COURT

FISHER, Circuit Judge.

A pharmaceutical company holding the patent on a drug sues the manufacturer of a generic version of that drug for patent infringement. The patent-holder and the generic manufacturer later settle, with the former paying the latter not to produce a generic until the patents at issue expire. In FTC v. Actavis, Inc., — U.S. -, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013), the Supreme Court recognized that such a settlement — commonly known as a “reverse payment” — where large and unjustified, can sometimes unreasonably diminish competition in violation of the antitrust laws. To answer the antitrust question, Actavis explained, “it is not normally necessary to litigate patent validity” because “the size of the unexplained reverse payment can provide a workable surrogate for a patent’s weakness.” Id. at 2236-37.

These two sets of consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market of generic versions of those drugs. The companies did so, plaintiffs say, by engaging in an overarching monopolistic scheme that *134 involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. With a single exception, every complaint asserts one of these monopolization claims against the patent-holders. The cases were assigned to the same district judge, who ultimately dismissed the bulk of plaintiffs’ claims.

In this opinion, we address two questions of federal jurisdiction. First, do plaintiffs’ allegations of fraudulent procurement and enforcement of the patents require us to transfer these appeals to the Court of Appeals for the Federal Circuit? That court has exclusive jurisdiction over appeals from civil actions “arising under” patent law. 28 U.S.C. § 1295(a)(1). But not all cases presenting questions of patent law necessarily arise under patent law. See Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 108 S.Ct. 2166, 100 L.Ed.2d 811 (1988). Where, as here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims, jurisdiction lies in this Court, not the Federal Circuit.

The second jurisdictional question we confront is confined to one of the Lipitor appeals, RP Healthcare, Inc. v. Pfizer, Inc., No. 14-4632. That case, brought by a group of California pharmacists, involves claims solely under California law and was filed in California state court. Following removal the District Court declined to remand the case to state court, citing potential patent defenses. That was error, as federal jurisdiction depends on the content of the plaintiffs complaint, not a defendant’s possible defenses. Before final judgment, however, the remaining non-diverse defendants were voluntarily dismissed, thus raising the possibility that, notwithstanding the District Court’s failure to remand the case, it possessed diversity jurisdiction before the time it- entered judgment. See Caterpillar Inc. v. Lewis, 519 U.S. 61, 117 S.Ct. 467, 136 L.Ed.2d 437 (1996). But because the state of the record before us is unclear with regard to the citizenship of the parties, we cannot reach the merits of this appeal until that question is resolved. We will accordingly remand the RP Healthcare appeal to the District Court so it can conduct jurisdictional discovery and address the matter in the first instance.

I

It is necessary to begin by discussing the regulatory framework that forms the foundation for the issues presented by these appeals.

A

“Apparently most if not all reverse payment settlement agreements arise in the context of pharmaceutical drug regulation, and specifically in the context of suits brought under statutory provisions allowing a generic drug manufacturer (seeking speedy marketing approval) to challenge the validity of a patent owned by an already-approved brand-name drug owner.” Actavis, 133 S.Ct. at 2227. With the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, as amended, known as the Hatch-Waxman Act, Congress “attempted to balance the goal of ‘makfing] available more low cost generic drugs’ with the value of patent monopolies in incentivizing beneficial pharmaceutical advancement.” King Drug Co. v. Smith-Kline Beecham Corp., 791 F.3d 388, 394 (3d Cir. 2015) (alteration in original) (quoting H.R. Rep. No. 98-857, pt. 1, at 14-15 .(1984)), cert. denied, — U.S. -, 137 S.Ct. 446, 196 L.Ed.2d 328 (2016). “The Act seeks to accomplish this purpose, in part, by encouraging ‘manufacturers of generic drugs ..to challenge weak or inval *135 id patents on brand name drugs so consumers can enjoy lower drug prices.’ ” Id. (alteration in original) (quoting S. Rep. No. 107-167, at 4 (2002)). In Actavis, the Supreme Court identified four relevant features of Hatch-Waxman’s regulatory framework. 133 S.Ct. at 2227-29; see also King Drug, 791 F.3d at 394-96.

First, a drug manufacturer seeking to market a new, “pioneer” prescription drug must obtain approval from the Food and Drug Administration (FDA). See 21 U.S.C. § 356(b)(1). This approval process involves testing that is “long, costly, and comprehensive.” Actavis, 133 S.Ct. at 2228.

Second, following FDA approval of a brand-name drug, a generic manufacturer can file an Abbreviated New Drug Application (ANDA) indicating that the generic “has the same active ingredients as, and is biologically equivalent to, the brand-name drug.” Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405, 132 S.Ct. 1670, 182 L.Ed.2d 678 (2012) (citing 21 U.S.C. § 355(j)(2)(A)(iv)). The ANDA process furthers drug competition “by allowing the generic to piggy-back on the pioneer’s approval efforts.” Actavis, 133 S.Ct. at 2228.

Third, the Hatch-Waxman Act “sets forth special procedures for identifying, and resolving, related patent disputes.” Id. The new drug applicant is required- to list any patents issued relating to the drug’s composition or methods of use. See 21 U.S.C. § 355(b)(1). If the FDA approves the new drug, it publishes this patent information, without verification, in its Orange Book (officially known as Approved Drug Products with Therapeutic Equivalence Applications). King Drug, 791 F.3d at 395 & n.5 (citing Caraco, 566 U.S. at 405-06, 132 S.Ct. 1670).

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855 F.3d 126, 2017 WL 1359474, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-lipitor-antitrust-litigation-ca3-2017.