In Re Lipitor Antitrust Litigation

868 F.3d 231
Court of Appeals for the Third Circuit·Decided August 21, 2017·No. 14-4202, 14-4203, 14-4204, 14-4205, 14-4206, & 14-4602; 15-1184, 15-1185, 15-1186, 15-1187, 15-1274, 15-1323 & 15-1342·Published·Cited by 89 cases

Opinion

OPINION

SMITH, Chief Judge.

This opinion addresses two sets of consolidated appeals concerning two pharmaceutical drugs: Lipitor and Effexor XR. In both sets of consolidated appeals, plaintiffs allege that the companies holding the patents related to Lipitor and Effexor XR fraudulently procured and enforced certain of those patents. Plaintiffs further allege that those companies holding the patents entered into unlawful, monopolistic settlement agreements with potential manufacturers of generic versions of Lipitor and Effexor XR. The same District Court Judge dismissed the complaints in the Lip-itor litigation and dismissed certain allegations in the Effexor litigation. Those decisions relied on plausibility determinations that are now challenged on appeal.

We begin with a brief summary of the relevant regulatory scheme applicable to pharmaceutical drugs and then detail the factual and procedural backgrounds of these two sets of consolidated appeals. The remainder of the opinion broadly covers two issues. First, in F.T.C. v. Actavis, Inc., 570 U.S. 136, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013), the Supreme Court concluded that payments from patentees to infringers through “reverse payment settlement agreements” are subject to antitrust scrutiny. Id. at 2227. In both sets of consolidated appeals, plaintiffs allege that the companies holding the pharmaceutical patents and the generic manufacturers entered into such agreements. We are asked to decide whether those allegations are plausible. We conclude, as to both sets of appeals, that they are. Second, regarding only the Lipitor consolidated appeals, we address whether plaintiffs in those appeals pled plausible allegations of fraudulent patent procurement and enforcement, as well as other related misconduct. We again determine that those allegations are indeed plausible. Accordingly, we will reverse the District Court’s dismissal of the complaints in the Lipitor litigation, reverse its dismissal of the allegations in the Effe-xor litigation, and remand for further proceedings.

*240 I

The 1984 Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”), 98 Stat. 1585, as amended,, provides a regulatory framework designed in part to, (1) ensure that only rigorously tested pharmaceutical drugs are marketed to the consuming public, (2) in-centivize drug manufactui'ers to. invest in new research and development, and (3) encourage generic drug entry, into the marketplace. As we have noted previously, the Hatch-Waxman Act contains four key relevant features. See In re Lipitor Antitrust Litig., 855 F.3d 126, 135 (3d Cir. 2017) (Lipitor III), as amended (Apr. 19, 2017); King Drug Co. of Florence v. Smithkline Beecham Corp., 791 F.3d 388, 394 (3d Cir. 2015), cert. denied, — U.S. -, 137 S.Ct. 446, 196 L.Ed.2d 328 (2016).

First, the Hatch-Waxman Act requires á drug manufacturer wishing to market a new brand-name drug to first submit a New Drug Application (“NDA”) to the Food and Drug Administration (“FDA”), see 21 U.S.C. § 355, and then undergo a long, complex, and costly testing process, see 21 U.S.C. § 355(b)(1). (requiring, among other things, “full reports of investigations” into safety and effectiveness; “a full list of the articles used as components”; and a “full description” of how the drug is manufactured, processed, and packed). If this process is successful, the FDA may grant the drug manufacturer approval to market the brand-name , drug.

Second, after that approval, a generic manufacturer can obtain similar approval by submitting an Abbreviated New Drug Application (“ANDA”) that “shows that the generic drug 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)(ii), (iv)),. This way, a generic manufacturer does not need to undergo the same costly approval procedures to develop a drug that has already received FDA approval. Actavis, 133 S.Ct. at 2228 (“The Hatch-Wax-man process, by allowing the, generic to piggy-back on the pioneer’s approval efforts, ‘speed[s],the introduction of low-cost generic drugs , to market. Caraco, [566 U.S. at 405, 132 S.Ct. 1670], thereby furthering drug competition.” (first alteration in original)).

Third, foreseeing the potential for conflict between brand-name and generic drug manufacturers, the Hatch-Waxman Act “sets forth special procedures for identifying, and resolving, related patent disputes.” Id. The Hatch-Waxman Act, as well as federal regulations, requires brand-name drug manufacturers to file information about'their patents with their NDA, Id. The brand-name manufacturer “is required to list any patents issued relating to the drug’s composition or methods of use.” Lipitor III, 855 F.3d at 135. That filing must include the patent number and expiration date of the patent. See Caraco, 566 U.S. at 405, 132 S.Ct. 1670 (quoting 21 U.S.C. § 355(b)(1)). Upon approval of the brand-name manufacturer’s NDA, the FDA publishes the submitted patent information in its “Orange Book,” more formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations. Id. at 405-06, 132 S.Ct. 1670.

Once a patent has been listed in the Orange Book, the generic manufacturer is free to file an ANDA if it can certify that its proposed generic drug will not actually violate the brand manufacturer’s patents. Id. at 405, 132 S.Ct. 1670; see also id. (The FDA “cannot authorize a generic drug that would infringe a patent.”). A generic manufacturer’s ANDA certification may, state:

(I) that such patent information has not been filed,
*241 (II) that such patent has expired,
(III) ... the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.

21 U.S.C. § 355(j)(2)(A)(vii). “The ‘paragraph IV’ route[ ], automatically counts as patent infringement .... ” Actavis, 133 S.Ct. at 2228 (citing 35 U.S.C. § 271(e)(2)(A)). As a result, a paragraph IV certification often “means provoking litigation” instituted by the brand manufacturer. Car aco, 566 U.S. at 407, 132 S.Ct. 1670.

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In Re Lipitor Antitrust Litigation, 868 F.3d 231 (3d Cir. 2017).

868 F.3d 231 (In Re Lipitor Antitrust Litigation) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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