Mylan Labs. Ltd. v. U.S. Food & Drug Admin.

• Decision Date: 27 December 2012
• Docket Number: Civil Action No. 12–1637 (JDB).
• Citation: 910 F.Supp.2d 299
• Parties: MYLAN LABORATORIES LTD.; Mylan Pharmaceuticals, Inc., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants, and Ranbaxy Laboratories Limited, Intervenor–Defendant.
• Court: U.S. District Court — District of Columbia

910 F.Supp.2d 299

MYLAN LABORATORIES LTD.; Mylan Pharmaceuticals, Inc., Plaintiffs,

v.U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants,andRanbaxy Laboratories Limited, Intervenor–Defendant.

Civil Action No. 12–1637 (JDB).

United States District Court,

District of Columbia.

Dec. 27, 2012.

Edward Anthony Figg, Rothwell, Figg, Ernst & Manbeck, PC, Washington, DC, Eric R. Hunt, Lara E. Fitzsimmons, William A. Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, Sharon Lynch Davis, Rothwell, Figg, Ernst & Manbeck, P.C., Washington, DC, for Plaintiffs.

Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Intervenor–Defendant.

MEMORANDUM OPINION

JOHN D. BATES, District Judge.

On September 28, 2012, the Food and Drug Administration (“FDA”) decided that Ranbaxy Laboratories Limited (“Ranbaxy”) had not forfeited its eligibility for 180–day exclusivity to market generic valsartan tablets. Because of this decision, plaintiffs Mylan Laboratories Limited and Mylan Pharmaceuticals, Inc. (“Mylan”) are blocked from marketing their generic valsartan tablets. Mylan brings this action challenging FDA's decision under the Administrative Procedure Act (“APA”) and the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch–Waxman Act”), as amended by the Medicare Modernization Act of 2003. Before the Court are Mylan's motion for a preliminary injunction to set aside FDA's September 28, 2012 decision and to require FDA to grant final approval to Mylan's abbreviated new drug application, FDA's motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), or in the alternative, for summary judgment, and intervenor-defendant Ranbaxy's motion for summary judgment. Upon consideration of the parties' motions and accompanying memoranda, the motions hearing held on December 7, 2012, and the entire record herein, the Court will deny Mylan's motion for a preliminary injunction and grant FDA's and Ranbaxy's motions.

BACKGROUND

I. Statutory and Regulatory Background

This is a dispute about the right to 180–day marketing exclusivity under the Hatch–Waxman Act, codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, 282, as amended by the Medicare Modernization Act, Pub.L. No. 108–173, §§ 1101–23, 117 Stat.2066 (2003).

To gain FDA approval to market a new drug, a pharmaceutical company must submit a new drug application (“NDA”) that must include, among other things, information on the drug's chemical composition, clinical trial results showing the drug's safety and effectiveness, a description of the methods of manufacturing the drug, and proposed labeling for the drug. See21 U.S.C. § 355(b)(1). An NDA must also include information on any patent that claims the drug or a method of using the drug. Id. FDA lists this patent information in Approved Drug Products with Therapeutic Equivalence Evaluations, a publication also known as the “Orange Book.” See Mylan Pharm., Inc. v. Sebelius, 856 F.Supp.2d 196, 200 (D.D.C.2012); 21 C.F.R. § 314.53(e)-(f).

Pursuant to the Hatch–Waxman Act, a pharmaceutical company seeking to market a generic version of an approved drug is not required to submit an NDA and hence can avoid conducting costly and time-consuming clinical trials to show safety and effectiveness. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir.1998). Instead, it can submit an abbreviated new drug application (“ANDA”) showing that the generic drug is “bioequivalent” to the approved drug and meets certain chemistry and labeling requirements. See21 U.S.C. § 355(j)(2)(A). One requirement for chemistry relates to a drug's strength, quality, and purity. “Monographs” setting forth test methods and drug specifications for determining strength, quality, and purity are published in an official compendium called the United States Pharmacopeia (“USP”), and if a USP monograph exists for an approved drug, an ANDA referencing that drug must meet the standards set forth in the monograph to gain FDA approval. See21 U.S.C. §§ 321(j), 351(b).

In addition, an ANDA must contain one of four certifications as to each Orange Booklisted patent claiming the approved drug or a method of using the approved drug. The four certifications are: (I) that there is no patent information; (II) that the patent has expired; (III) that the patent is set to expire on a certain date (“paragraph III certification”); or (IV) that the patent is invalid or will not be infringed by the generic drug (“paragraph IV certification”). Id. § 355(j)(2)(A)(vii)(I)-(IV). If an ANDA applicant makes one of the first two certifications, FDA may approve the ANDA immediately. Id. § 355(j)(5)(B)(i). If an ANDA applicant makes a paragraph III certification, FDA may grant tentative approval of the ANDA, to be made effective on the date the patent expires. Id. § 355(j)(5)(B)(ii).

The effect of a paragraph IV certification is more complex. By statute, making a paragraph IV certification constitutes an act of patent infringement. See35 U.S.C. § 271(e)(2)(A). An ANDA applicant that makes a paragraph IV certification must notify the patent holder of the certification, and the patent holder then has 45 days to bring a patent infringement suit against the ANDA applicant. See21 U.S.C. § 355(j)(2)(B), (5)(B)(iii). If the patent holder does not bring suit within 45 days, FDA may approve the ANDA immediately. See id. § 355(j)(5)(B)(iii). But if the patent holder sues the ANDA applicant, then FDA must delay approval for 30 months. See id.

To incentivize generic manufacturers to risk exposing themselves to patent infringementlitigation, and thereby to bring lower-priced generic drugs to consumers faster, Congress provided that, for a given drug, the “first applicant” to file an ANDA containing a paragraph IV certification is eligible for a 180–day period of marketing exclusivity. 21 U.S.C. § 355(j)(5)(B)(iv). During this period, FDA may not approve any later-filed ANDAs, thus allowing the first applicant to sell its generic drug without competition from other generic manufacturers. See Mylan, 856 F.Supp.2d at 201.

The 180–day exclusivity period may be forfeited, however. In the Medicare Modernization Act of 2003, Congress added to the Hatch–Waxman scheme six “forfeiture events”; if any one of these events occurs, a first applicant forfeits its entitlement to 180–day exclusivity. See21 U.S.C. § 355(j)(5)(D)(i)-(ii); Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1306 (D.C.Cir.2010). One such forfeiture event, and the only one at issue here, is “[f]ailure to obtain tentative approval.” See21 U.S.C. § 355(j)(5)(D)(i)(IV). A first applicant forfeits exclusivity if it “fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.” Id. FDA has interpreted this forfeiture provision to establish a “bright-line rule” and has made clear that to invoke the exception to the rule, a first applicant cannot show merely that FDA changed or reviewed the requirements for approval but must also show that “one or more issues holding up tentative approval at the 30 month date [was] causally connected to the approval requirements that FDA reviewed or changed.” Mem. from Martin Shimer, Branch Chief, Regulatory Support Branch, Office of Generic Drugs (“OGD”), on 180–Day Exclusivity for Valsartan Tablets 1–2 (Sept. 28, 2012) [AR 1–12] (“Forfeiture Memo”).

But-for causation is not required to meet this exception. Id. That is, “[i]f one of the causes of failure to get tentative approval by the 30–month forfeiture date was a change in or review of the requirements for approval imposed after the application was filed, an applicant will not forfeit eligibility even if there were other causes for failure to obtain tentative approval by the 30–month forfeiture date that were not caused by a change in or review of the requirements for approval.” Id. Hence, “an applicant need only show that acceptability of one aspect of the ANDA (e.g., chemistry) was delayed due to a change in or review of the requirements for approval, irrespective of what other elements may also have been outstanding at the 30–month date.” Id.

II. Factual and Procedural Background

On December 28, 2004, Ranbaxy filed an ANDA to market a generic version of valsartan tablets (40 mg, 80 mg, 160 mg, and 320 mg), a hypertension drug currently marketed by Novartis Pharmaceuticals Corp. under the brand name Diovan. Id. at 3. Three patents for Diovan are listed in the Orange Book: U.S. Patent Nos. 5,399,578 (the '578 patent), 5,972,990 (the '990 patent), and 6,294,197 (the '197 patent). Ranbaxy's Mem. in Supp. of Mot. for Summ. J. [ECF 38] (“Ranbaxy MSJ”) 11. Ranbaxy's ANDA contained a paragraph III certification as to the '578 patent, a paragraph IV certification as to the '197 patent, and, not relevant here, a “section viii statement” for the '990 patent. Id.¹Because Ranbaxy's ANDA was the first to contain a paragraph IV certification as to a Diovan patent, Ranbaxy was a “first applicant” eligible for 180–day exclusivity. See id.

Ranbaxy did not receive tentative approval within 30 months, however. As of June 28, 2007, 30 months after Ranbaxy's ANDA was filed, bioequivalence had been found acceptable, but the elements of chemistry and labeling remained outstanding. Forfeiture Memo 5. Between the filing of Ranbaxy's ANDA and the June 28, 2007 forfeiture date, there had been changes to the approval requirements for both labeling and chemistry. First, on November 22, 2006, FDA approved a labeling supplement for Diovan that consisted of changes to three sections of the drug's labeling. Id. at 7 & n. 11. Second, on May 1, 2007 (about two months before the 30–month forfeiture date), a new USP monograph for valsartan became official. See id. at 4–5. Ranbaxy thereafter submitted, on June 26, 2007, a...