Mylan Pharmaceuticals Inc. v. United States Food

• Decision Date: 02 May 2011
• Docket Number: Civil Action No. 11–566 (JEB).
• Citation: 789 F.Supp.2d 1
• Parties: MYLAN PHARMACEUTICALS INC. and Matrix Laboratories Ltd., Plaintiffs,v.UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant,andRanbaxy Laboratories Limited, Intervenor–Defendant.
• Court: U.S. District Court — District of Columbia

789 F.Supp.2d 1

MYLAN PHARMACEUTICALS INC. and Matrix Laboratories Ltd., Plaintiffs,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant,andRanbaxy Laboratories Limited, Intervenor–Defendant.

Civil Action No. 11–566 (JEB).

United States District Court, District of Columbia.

May 2, 2011.

Douglas B. Farquhar, Karla Lynn Palmer, Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiffs.Andrew E. Clark, Gerald Cooper Kell, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendant.Carlos T. Angulo, Carmen Mercedes Shepard, Alexandra W. Miller, Zuckerman Spaeder, LLP, Washington, DC, for Intervenor–Defendant.

MEMORANDUM OPINION ^*

JAMES E. BOASBERG, District Judge.

The Food and Drug Administration is currently reviewing the application of Ranbaxy Laboratories to have temporary exclusive rights to market a generic drug. Matrix Laboratories, a competitor that has a subsequent application pending for the same drug, eagerly wishes to know the result of Ranbaxy's application. In fact, Matrix and its distributor Mylan Pharmaceuticals have now brought this injunctive action to force the FDA to act on Ranbaxy's application. Because the interrelated concepts of standing and ripeness preclude such expansive subject matter jurisdiction, the Court declines the invitation.

I. Factual and Procedural BackgroundA. The ANDA Process

Mylan Pharmaceuticals, Inc. and Matrix Laboratories, Ltd. are the would-be distributor and manufacturer of generic atorvastatin, a cholesterol-lowering medicine commonly known by its brand name, LIPITOR®. Compl. at ¶¶ 2, 4. Pfizer, Inc. has sold LIPITOR® without competition from generic versions for 15 years. Id. at ¶¶ 2, 34. The pediatric exclusivity period associated with certain LIPITOR® patents expires, however, on June 28, 2011, at which time drug manufacturers who are able to obtain the Food and Drug Administration's approval for their generic versions of LIPITOR® may begin to market and distribute their products. Id. at ¶ 4 n. 1.

FDA approval is required before any drug can be marketed in the United States. See Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(a). In order to obtain approval for a “pioneer” or “innovator” drug, a drug manufacturer must submit a new drug application (“NDA”) to the FDA in accordance with the requirements of § 355(b). An NDA necessarily contains the results of extensive scientific testing performed on the drug to ensure that it is safe and effective. Id. Once approved, patents for the pioneer drug are listed in Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the “Orange Book,” available at http:// www. fda. gov/ cder/ ob/. See § 355(b)(1). Since Congress enacted the Hatch–Waxman Amendments to the FDCA in 1984, manufacturers of generic versions of approved drug products may seek FDA approval by filing an abbreviated new drug application (“ANDA”). See § 355(j) ¹; Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir.1998). An ANDA applicant must show that its generic drug is the bioequivalent of the pioneer drug and has the same active ingredient, strength, dosage form, route of administration, labeling, and conditions of use. § 355(j).

An ANDA must also include, for each Orange Book patent implicated by the generic drug, one of four certifications indicating whether the proposed generic drug would infringe that patent and, if not, why not. § 355(j)(2)(A)(vii); Mova, 140 F.3d at 1063. If an ANDA applicant seeks to market its generic drug prior to the expiration of the patents for the brand name drug, it must make a “paragraph IV” certification. Such certification states 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.” § 355(j)(2)(A)(vii)(IV). Once a generic drug manufacturer files an ANDA with a paragraph IV certification, however, the ANDA applicant has by law infringed the underlying patent and may be sued by the patent-holder for infringement. See 35 U.S.C. § 271(e)(2)(A).

As an incentive to encourage generic drug manufacturers to challenge existing drug patents—often a lengthy and expensive process—and bring generic drugs to the market, the Hatch–Waxman Amendments offer the first generic drug manufacturer to file an ANDA containing a paragraph IV certification (and ultimately obtain FDA approval for its drug) a 180–day period of marketing exclusivity free from competition from other generic drug manufacturers. See 21 U.S.C. § 355(j)(5)(B)(iv). Numerous cases in this Circuit involving disputes over the 180–day exclusivity period indicate it is a coveted advantage and the cause of heated competition among generic drug manufacturers to secure their status as “first.” See, e.g., Hi–Tech Pharmacal Co., Inc. v. FDA, 587 F.Supp.2d 1, 4 (D.D.C.2008) (collecting cases).

The FDA may also grant meritorious ANDA applicants tentative approval, even though the applicants may not have been the first to file and even though a competitor may have exclusivity rights. See FDA Mot. at 7 (“FDA grants ‘tentative approval’ to an ANDA when all scientific and procedural conditions for approval have been met, but the application cannot be fully approved because approval is blocked by a 30–month stay, some form of marketing exclusivity, or some other barrier to approval arising from patent infringement litigation.”) (citing 21 C.F.R. § 314.105(d)).

B. Matrix and Ranbaxy

Plaintiff Matrix submitted its own atorvastatin ANDA more than two years ago, and Plaintiffs recently settled their patent infringement litigation with Pfizer. Id. at ¶¶ 4, 34. [Redacted] Plaintiffs allege that Matrix's ANDA should be eligible for approval as early as June 28, 2011, when the pediatric exclusivity period associated with certain LIPITOR® patents expires. Id. at ¶¶ 4 n. 1, 35. Matrix's ANDA, however, has not yet received FDA approval, either tentative or final. Id. at ¶ 53 (“FDA has failed to, and continues to refuse to, provide Plaintiffs with any indication or other information concerning whether Matrix's ANDA will be approvable as early as June 28, 2011, or if such approval will be delayed as a result of 180–day marketing exclusivity.”).

Although the FDA keeps the status of a pending ANDA confidential, Plaintiffs allege that another generic drug manufacturer, Intervenor–Defendant Ranbaxy Laboratories Ltd., was the first generic drug company to file an ANDA containing a paragraph IV certification and to challenge Pfizer's LIPITOR® patents. Id. at ¶¶ 6–7, 40. Plaintiffs allege that this Ranbaxy ANDA has been pending before the FDA for nearly nine years. Id. at ¶ 7 n. 2. Plaintiffs further allege that, under the terms of a settlement agreement with Pfizer, Ranbaxy's ANDA is eligible for approval no earlier than November 2011. Id. at ¶ 7. Accordingly, Plaintiffs allege, if Ranbaxy's ANDA is approved in November 2011 and Ranbaxy is eligible for a 180–day period of marketing exclusivity, then the market for atorvastatin will not be open to other generic competitors (such as themselves) until at least May 2012. Id. The FDA has not, however, granted Ranbaxy's ANDA tentative approval and has also not announced whether Ranbaxy is entitled to the exclusivity period. Id. at ¶¶ 7 n. 2, 10.

Plaintiffs also allege that Ranbaxy's ANDA is subject to a notice issued by the FDA to Ranbaxy invoking the FDA's Application Integrity Policy (“AIP”). Id. at ¶¶ 6, 42–46. Specifically, Plaintiffs allege that on February 25, 2009, the FDA sent Ranbaxy “a letter setting forth numerous allegations with respect to stability test results and other data generated from Ranbaxy's Paonta Sahib [manufacturing] site [in India], including but not limited to data relevant to several pending ANDAs.” Id. at ¶ 42. Plaintiffs allege that, pursuant to the FDCA, “if [an] ANDA does not contain reliable data and information, then FDA is expressly prohibited by statute from approving the ANDA.” Id. at ¶ 32. This is the statutory mandate, Plaintiffs allege, under which the FDA promulgated its AIP. Id. at ¶ 33; see also 56 Fed.Reg. 46,191 (Sept. 10, 1991). As Plaintiffs interpret the AIP, “Ranbaxy cannot ‘cure’ any deficiencies with an amendment to that ANDA,” but rather must submit a new ANDA and forfeit its position as first-filer (and thus its right to a period of market exclusivity). Id. at ¶ 46. The FDA has not revealed whether Ranbaxy's atorvastatin ANDA is effected by the AIP and has not publicly decided whether, if subject to the AIP, Ranbaxy's ANDA will lose its exclusivity eligibility. Id. at ¶¶ 47–48.

C. The Current Action

Plaintiffs filed their Complaint in this case on March 18, 2011. They assert two claims against the FDA under the Administrative Procedure Act. In Count I, Plaintiffs allege that the “FDA's failure to make a public decision or other determination concerning whether the Ranbaxy ANDA contains unreliable data or information, or otherwise state whether FDA will enforce the AIP against the Ranbaxy ANDA, rendering the Ranbaxy ANDA ineligible for 180–day marketing exclusivity, is ‘agency action unlawfully withheld or unreasonably delayed,’ in violation of 5 U.S.C. §§ 706 and 701(b)(2).” Id. at ¶ 68. As relief, Plaintiffs request:

1. an injunction requiring FDA to issue an immediate public decision concerning whether the Ranbaxy ANDA is eligible for 180–day exclusivity, so that other generic drug manufacturers can prepare for launch of generic LIPITOR® products; and

2. a Declaratory Judgment that FDA's failure to make a public decision or other determination concerning whether the Ranbaxy ANDA contains unreliable data or information, or otherwise state whether FDA will enforce the AIP against the Ranbaxy ANDA, rendering the Ranbaxy ANDA ineligible for 180–day marketing exclusivity, is agency action unlawfully withheld or unreasonably delayed.

Id. at ¶¶ 71–72.

In Count II, Plaintiffs allege that the “FDA's failure to approve the...