RICARDO M. URBINA, District Judge.
This matter comes before the court on the plaintiffs' motion for summary judgment
The FDCA provides that before any new drug can be introduced into the U.S. market, the FDA must determine that it is safe and effective. 21 U.S.C. § 355(a). The first, or "pioneer," applicant for a given drug must submit to the FDA a new drug application ("NDA"), containing, among other things, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use. . . a full list of the articles used as components of such drug . . . [and] a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drugs." Id. § 355(b). Once approved, the pioneer drug is referred to as a "listed" drug. Id.
Companies seeking to manufacture new prescription drugs must file new drug applications ("NDAs") with the FDA demonstrating their drugs' safety and effectiveness before they can market them. Id. § 355(b)(1). Recognizing that the NDA process is costly and time-consuming, Congress amended the FDCA in 1984 pursuant to the "Hatch-Waxman Amendments." Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1316 (D.C.Cir.1998) (citing H.R.Rep. No. 98-857, pt. 1 at 14 (1984), 1984 U.S.C.C.A.N. 2647, 2647). In an effort "to make available more low cost drugs," id., the FDCA permits the manufacturer of a generic version of a listed drug to obtain FDA approval through a far simpler, abbreviated new drug application ("ANDA") containing a more limited set of information than that required for an NDA.
Among other things, the FDCA requires a drug manufacturer seeking approval to produce a generic version of a drug to certify that the patent for the corresponding brand-name version of the drug "is invalid or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted."
The plaintiffs in this action are the patent holder, manufacturer and licensee of the anticancer drug oxaliplatin, marketed under the brand name Eloxatin®, the name brand for oxaliplatin. Pls.' Statement of Facts ("Pls.' Statement") ¶ 4; Defs.' Statement of Facts ("Defs.' Statement") ¶ 1. In June and July 2007, the plaintiffs commenced a patent infringement suit in the United States District Court for the District of New Jersey against a number of drug manufacturers who sought to produce generic oxaliplatin. Pls.' Statement ¶ 3; Defs.' Statement ¶ 2. On June 30, 2009, the New Jersey district court entered judgment, ruling that the plaintiffs' patent had not been infringed. Pls.' Statement ¶ 5; Defs.' Statement ¶ 4. The FDA subsequently approved the generic drug applications of several pharmaceutical manufacturers seeking to produce and market generic oxaliplatin.
On August 10, 2009, after the Federal Circuit stayed but before it vacated the New Jersey district court's judgment, the plaintiffs filed suit in this court against the FDA and the Department of Health and Human Services, requesting an injunction that would require the FDA to rescind its approval of the generic drug applications and refrain from granting further approvals until the expiration of the thirty-month stay.
On September 14, 2009, the plaintiffs filed a motion for summary judgment, arguing that the FDA acted unlawfully in granting the generic drug applications. See generally Pls.' Mot. for Summ. J. ("Pls.' Mot."). The defendants and intervenor-defendants filed cross-motions for summary judgment on September 28, 2009. See generally Defs.' Cross-Mot. for Summ. J. ("Defs.' Mot."); Intervenor-Defs.' Cross-Mot. for Summ. J. ("Intervenors' Mot."). The motions have been fully briefed, and the court now turns to the applicable legal standard and the parties' arguments.
Summary judgment is appropriate when "the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Diamond v. Atwood, 43 F.3d 1538, 1540 (D.C.Cir.1995). To determine which facts are "material," a court must look to the substantive law on which each claim rests. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A "genuine issue" is one whose resolution could establish an element of a claim or defense and, therefore, affect the outcome of the action. Celotex, 477 U.S. at 322, 106 S.Ct. 2548; Anderson, 477 U.S. at 248, 106 S.Ct. 2505.
In ruling on cross-motions for summary judgment, the court shall grant summary judgment only if one of the parties is entitled to judgment as a matter of law upon material facts that are not genuinely disputed. Citizens for Responsibility & Ethics in Wash. v. U.S. Dep't of Justice, 658 F.Supp.2d 217, 224 (D.D.C.2009) (citing Rhoads v. McFerran, 517 F.2d 66, 67 (2d Cir.1975)). To prevail on a motion for summary judgment, the moving party must show that the opposing party "fail[ed] to make a showing sufficient to establish the existence of an element essential to that party's case." Celotex, 477 U.S. at 322, 106 S.Ct. 2548. By pointing to the absence of evidence proffered by the opposing party, a moving party may succeed on summary judgment. Id.
The opposing party may defeat summary judgment through factual representations made in a sworn affidavit if he "support[s] his allegations . . . with facts in the record," Greene v. Dalton, 164 F.3d 671, 675 (D.C.Cir.1999) (quoting Harding v. Gray, 9 F.3d 150, 154 (D.C.Cir.1993)), or provides "direct testimonial evidence," Arrington v. United States, 473 F.3d 329, 338 (D.C.Cir.2006).
The APA entitles "a person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action . . . to judicial review thereof." 5 U.S.C. § 702. Under the APA, a reviewing court must set aside an agency action that is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." Id. § 706; Tourus Records, Inc. v. Drug Enforcement Admin., 259 F.3d 731, 736 (D.C.Cir.2001). In making this inquiry, the reviewing court "must consider whether the [agency's] decision was based on a consideration of the relevant factors and whether there has
Motor Veh. Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983); see also County of L.A. v. Shalala, 192 F.3d 1005, 1021 (D.C.Cir.1999) (stating that "[w]here the agency has failed to provide a reasoned explanation, or where the record belies the agency's conclusion, [the court] must undo its action").
As the Supreme Court has explained, however, "the scope of review under the `arbitrary and capricious' standard is narrow and a court is not to substitute its judgment for that of the agency." Motor Veh. Mfrs. Ass'n, 463 U.S. at 43, 103 S.Ct. 2856. Rather, the agency action under review is "entitled to a presumption of regularity." Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977).
The Supreme Court set forth a two-step approach to determine whether an agency's interpretation of a statute is valid under the APA. Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). This approach, commonly referred to as "Chevron deference," requires the court to first look to "whether Congress has spoken to the precise question at issue." Id. at 842, 104 S.Ct. 2778. If so, the court ends its inquiry. Id. But, if the statute is ambiguous or silent, the second step requires the court to defer to the agency's position, so long as it is reasonable. Id. at 843, 104 S.Ct. 2778; Sea-Land Serv., Inc. v. Dep't of Transp., 137 F.3d 640, 645 (D.C.Cir.1998) (holding that "[Chevron] deference comes into play of course, only as a consequence of statutory ambiguity, and then only if the reviewing court finds an implicit delegation of authority to the agency"). In applying Chevron, the Supreme Court has held that "[a]dministrative implementation of a particular statutory provision qualifies for Chevron deference when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority." United States v. Mead Corp., 533 U.S. 218, 226-27, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001). Indeed, "judgment about the best regulatory tools to employ in a particular situation is . . . entitled to considerable deference from the generalist judiciary." W. Union Int'l, Inc. v. Fed. Commc'ns Comm'n, 804 F.2d 1280, 1292 (D.C.Cir.1986).
The plaintiffs argue that because the Federal Circuit vacated the New Jersey
As a general rule, the "intent of the lawmaker is to be found in the language that he has used." Teva Pharm. v. Food & Drug Admin., 355 F.Supp.2d 111, 116-17 (D.D.C.2004) (quoting United States v. Goldenberg, 168 U.S. 95, 102-03, 18 S.Ct. 3, 42 L.Ed. 394 (1897)). Chevron dictates that the court first look to see if Congress has addressed the issue, 467 U.S. at 842, 104 S.Ct. 2778, and this court recognizes that "the starting point, and the most traditional tool of statutory construction, is to read the text itself," S. Cal. Edison Co. v. Fed. Energy Regulatory Comm'n, 195 F.3d 17, 23 (D.C.Cir.1999). The court should not limit itself to examining a statutory provision in isolation but must look to the language and design of the statute as a whole, as "[i]t is a fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme." Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000); S. Calif. Edison, 195 F.3d at 23.
The entry of judgment provisions state that if, before the expiration of the automatic thirty-month stay, "the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity) . . . the [FDA] approval [of generic drug applications] shall be made effective on . . . the date on which the court enters judgment reflecting the decision." 21 U.S.C. § 355(c)(3)(C)(i)(I), (j)(5)(B)(iii)(I)(aa) (emphasis added). Because the district court is the only court referred to in this section, "the court" plainly refers to the district court.
The date a district court "enters judgment" is a specific, unambiguous event described in Federal Rule of Civil Procedure 58. See generally FED.R.CIV.P. 58. With certain exceptions not relevant here, Rule 58 provides that every judgment must be "set out in a separate document" and entered in the civil docket by the clerk pursuant to Rule 79(a). Id.; see also United States v. Indrelunas, 411 U.S. 216, 219, 93 S.Ct. 1562, 36 L.Ed.2d 202 (1973) (per curiam) (noting that "Rule 58 was substantially amended in 1963 to remove uncertainties as to when a judgment is entered"); FED. PROC. & PRAC. CIV. 2d § 2781 (explaining the importance of knowing precisely when judgment is entered because the time for appeal and post-trial motions runs from the entry of judgment). The parties agree that the New Jersey district court entered judgment ruling that the plaintiffs' patent had not been infringed on June 30, 2009. Pls.' Statement ¶ 5; Defs.' Statement ¶ 4.
The entry of judgment provisions, which address the consequences of a district
Id. § 355(c)(3)(C)(ii), (j)(5)(B)(iii)(II). In the entry of judgment provisions at issue here, which appear immediately prior to the sections quoted above, Congress makes no mention of appellate proceedings. See generally id. § 355(c)(3)(C)(i)(I), (j)(5)(B)(iii)(I)(aa).
In short, there are two ways the thirty-month stay can terminate prematurely. The first—addressed in the entry of judgment provisions—arises when the district court rules that the patent is invalid or not infringed or endorses a settlement agreement stating that the patent is invalid or not infringed prior to entering judgment. Id. § 355(c)(3)(C)(i), (j)(5)(B)(iii)(I). That scenario ends with the district court; there is no provision for what happens if the district court's judgment is appealed, see generally id. The other scenario occurs when the district court determines that the patent is valid and infringed, the judgment is appealed and the court of appeals either reverses the district court judgment and determines that the patent is invalid or not infringed or endorses a settlement agreement stating that the patent is invalid or not infringed before issuing an opinion.
These successive sections are not the only times Congress makes reference to the appellate process in the FDCA. For example, a subsequent provision of the FDCA describes a forfeiture event ("the forfeiture provision") that occurs when "a court enters a final decision from which no
Because the face of the statute is clear and unambiguous in expressly stating that the event which terminates the thirty-month stay and prompts the FDA's approval of generic drug applications is "the date on which the [district] court enters judgment," id. § 355(c)(3)(C)(i)(I), (j)(5)(B)(iii)(I)(aa), and the statute does not address the implications of a scenario in which the district court judgment is vacated, the court must "presume that Congress meant precisely what it said," Nat'l Public Radio, Inc. v. Fed. Commc'ns Comm'n, 254 F.3d 226, 230 (D.C.Cir.2001); see also Bates v. United States, 522 U.S. 23, 29, 118 S.Ct. 285, 139 L.Ed.2d 215 (1997) (explaining that the court "ordinarily resist[s] reading words or elements into a statute that do not appear on its face"); Conn. Nat'l Bank v. Germain, 503 U.S. 249, 254, 112 S.Ct. 1146, 117 L.Ed.2d 391 (1992) (holding that Congress "says in a statute what it means and means in a statute what it says"). Given that the entry of judgment provisions have a plain meaning, the court will not read into the statute any implication a vacated judgment might have on those provisions. See Goldenberg, 168 U.S. at 103, 18 S.Ct. 3 (stating that "[n]o mere omission . . . which it may seem wise to have specifically provided for, justif[ies] any judicial addition to the language of the statute"); Qi-Zhuo v. Meissner, 70 F.3d 136, 140 (D.C.Cir.1995) (holding that if the plain language of the statute is clear, the court need not inquire further into its meaning, at least in the absence of
For the foregoing reasons, the court denies the plaintiffs' motion for summary judgment and grants the defendants' and intervenor-defendants' cross-motions for summary judgment. An Order consistent with this Memorandum Opinion is separately and contemporaneously issued this 26th day of July, 2010.
