Nostrum Pharmaceuticals, LLC v. United States Food & Drug Admin.
| Decision Date | 05 July 2011 |
| Docket Number | Civil Action No. 11-3111 (JAP) |
| Parties | NOSTRUM PHARMACEUTICALS, LLC, Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendants. |
| Court | U.S. District Court — District of New Jersey |
NOT FOR PUBLICATION
Plaintiff Nostrum Pharmaceuticals, LLC ("Nostrum" or "Plaintiff) brings this action challenging certain decisions of the United States Food and Drug Administration ("FDA" or "Defendant") relating to Nostrum's Abbreviated New Drug Application ("ANDA") for carbamazepine 300 mg extended-release capsules. Nostrum alleges that the FDA incorrectly determined that Nostrum's statutory exclusivity period for marketing its generic carbamazepine product has expired as to U.S. Patent No. 5,912,013 ("the '013 patent") and may be shortened as to U.S. Patent 5,326,570 ("the '570 patent") by reason of pending expiration of that patent. Apotex Inc. ("Apotex"), a subsequent ANDA filer for carbamazepine extended-release capsules, has intervened in the matter as a defendant. Presently before the Court is a motion by Nostrum for a preliminary injunction enjoining the FDA from approving any competing carbamazepine ANDAs until after November 16, 2011, on which date Nostrum will have had the full statutory 180 days of marketingexclusivity. Alternatively, Nostrum seeks an order enjoining the FDA from approving competing ANDAs without advance notice to both Nostrum and the Court sufficient to permit Nostrum to move the court for relief to protect its exclusivity. The FDA and Apotex have filed opposition the motion. The Court heard oral argument on the motion June 27, 2011, and Plaintiff has requested the Court issue an expedited decision in light of the time-sensitive nature of the issues in order to allow it to take a prompt appeal. For the reasons below, Nostrum's motion is denied.
Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), the FDA is authorized to regulate the manufacture, distribution, and sale of drugs in the United States. In accordance with the FDCA, pharmaceutical companies seeking to market new drugs (often referred to as "pioneer" or "branded" drugs) must first obtain FDA approval by filing a new drug application ("NDA") containing extensive scientific data demonstrating the safety and effectiveness of the drug. U.S.C. §§ 355(a), (b). An NDA applicant must also submit information on any patent that claims the drug, or a method of using the drug, and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. 21 U.S.C. §§ 355(b)(1), (c)(2). The FDA publishes this patent information in the "Approved Drug Products with Therapeutic Equivalence Evaluations" list, commonly known as the "Orange Book." Id.; see also 21 C.F.R. § 314.53(e).
The approval of generic drugs is governed by the FDCA as modified by the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Amendments"), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282. Theseamendments were designed to balance the interests of encouraging innovation in the development of new drugs and accelerating the availability of lower-cost generic alternatives to branded drugs.
Under the Hatch-Waxman Amendments, a manufacturer submits an abbreviated new drug application ("ANDA") requesting approval of a generic version of an approved drug product. 21 U.S.C. § 355(j). The ANDA must include, among other things, data showing that the generic drug product is the bioequivalent to the branded drug product. 21 U.S.C. § § 355(j)(2)(A)(iv); (j)(4)(F). With respect to Orange Book listed patents for the branded drug, an ANDA must contain one of four certifications:
21 U.S.C. § 355(j)(2)(A)(vii). This certification is typically referred to as a "paragraph I," "paragraph II," "paragraph III," or "paragraph IV" certification.
An applicant wishing to challenge the validity of a patent or to claim that the patent would not be infringed by the product covered by the ANDA submits a paragraph IV certification. The filing of a paragraph IV is an act of infringement, 35 U.S.C. § 271(e)(2)(A), and if a suit is brought within 45 days of receipt of notice of the certification by the patent owner or NDA applicant, the FDA must stay approval of the ANDA for up to 30 months. 21 U.S.C. § 355(J)(5)(B)(iii). If no action is brought within the requisite period, the FDA may approve the ANDA immediately. 21 U.S.C. § 355(J)(5)(B)(iii).
To encourage generic drug companies to bear the costs and potential risks associated with submitting a paragraph IV certification, the Hatch-Waxman Amendments provide a "180-day exclusivity period" to the applicant who is the first to file an ANDA containing a paragraph IV certification. 21 U.S.C. § 355(j)(5)(B)(iv). During this period, the applicant who is the first to file may market its product while FDA approval of all other ANDAs covering the same product are delayed. Under the statutory provisions relevant to this action,1 the 180 period begins to run the earlier of (1) the first commercial marketing of the generic drug by the first ANDA filer; or (2) "the date of a decision of a court ... holding the patent which is the subject of the certification to be invalid or not infringed." 21 U.S.C. § 355(j)(5)(B)(iv) (2002).
The relevant facts in this matter are undisputed. Shire Development Inc. ("Shire") is the reference listed drug manufacturer for carbamazepine extended-release capsules, marketed under the brand name Carbatrol. Two patents are listed in the Orange Book for Carbatrol: the '013 patent and the '570 patent.
On March 26, 2003, Nostrum was the first to file an ANDA for the 300 mg strength of carbamazepine containing paragraph IV certifications as to the '013 and '570 patents. On September 18, 2003, Shire commenced patent infringement litigation against Nostrum. Shire Labs. v. Nostrum Pharms. Inc., Civil Action No. 03-4436-MLC (D.N.J.). In 2006, the matter was stayed and, thereafter, the stay was extended a number of times. On March22, 2010, the parties ultimately settled. This settlement included a license giving Nostrum the right to sell carbamazepine extended release capsules on or after October 1, 2010. According to Nostrum, it was prepared to market its generic product as of that date; however, its release was subject to FDA approval, which had not yet been granted.
Nostrum's ANDA received final FDA approval on May 20, 2011. In its approval letter, the FDA recognized that Nostrum was the first to file an ANDA for carbamazepine containing a paragraph IV certification as to the '013 and '570 patents and, therefore, was eligible for the 180-day exclusivity period. Mulye Decl. Ex. A at 2. However, the FDA determined that such exclusivity would be based only upon the '570 patent because, as the FDA advised Nostrum, it concluded that the exclusivity period for the '013 patent had been triggered by a 2009 judgment in the matter Shire Labs, Inc. v. CorePharma, LLC, Civil Action 06-2266 (D.N.J.). Id. Shire was a patent infringement action in which the court had granted a motion for summary judgment and entered final judgment in favor of defendant CorePharma LLC on July 14, 2009. Thus, according to the FDA, upon approval of Nostrum's ANDA, the exclusivity period for the '013 patent had long since expired.
Nostrum began marketing its product immediately upon approval and, as such, there is no dispute that the start of the exclusivity period as to the '570 was triggered on that date. The '570 patent expires on July 23, 2011.2 See Notice at D.I. 30. It is the FDA's position that, for reasons described more fully below, upon expiration of the '570 patent any later-filed carbamazepine ANDA that is otherwise eligible for approval may be approved after that date.
Nostrum's challenge to the FDA's action is two-fold. First, Nostrum argues that the FDA's determination that the '013 patent exclusivity period was triggered by the 2009 CorePharma decision reflects an incorrect application of the relevant standard. Second, Nostrum argues that the FDA's determination that it may approve competing ANDAs upon expiration of the '570 patent and thereby cut short Nostrum's exclusivity period is contrary to the governing law. In its complaint, Nostrum seeks declaratory and injunctive relief. By way of this motion, Nostrum seeks a preliminary injunction barring the FDA from approving competing ANDAs for 300 mg carbamazepine until at least November 16, 2011. In the alternative, Nostrum seeks an order enjoining the FDA from approving subsequently filed ANDAs without first providing notice to Nostrum and the Court sufficient to permit Nostrum to move this Court for relief "to protect Nostrum's exclusivity period." Pl. Br. at 36.
When evaluating a motion for preliminary injunctive relief, a district court must consider: "(1) whether the movant has shown a reasonable probability of success on the merits; (2) whether the movant will be irreparably injured by denial of the relief; (3) whether granting preliminary relief will result in even greater harm to the nonmoving party; and (4) whether granting the preliminary relief will be in the public interest." McTernan v. City of York, 577 F.3d 521, 526 (3rd Cir. 2009). A preliminary injunction "should not be granted unless the movant, by a clear showing, carries the burden of persuasion." Masurek v. Armstrong, 520 U.S. 968, 972, 117 S.Ct. 1865, 138 L.Ed.2d 162 (1997). Preliminary injunctive relief is an "extraordinary and drastic remedy", id., which "should issue only if the plaintiff produces evidence sufficient to convince the district courtthat all four...
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