Teva Pharm. United States, Inc. v. Azar
| Decision Date | 26 February 2019 |
| Docket Number | Civil Action No. 18-2394 (RDM) |
| Parties | TEVA PHARMACEUTICALS USA, INC., Plaintiff, v. Alex M. AZAR, II et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
Michael D. Shumsky, Jennifer McVey Thomas, Kurt R. Karst, Hyman, Phelps & McNamara, P.C., Thomas J. Tobin, Kirkland & Ellis LLP, Washington, DC, for Plaintiff.
Charles John Biro, U.S. Department of Justice, Washington, DC, for Defendants.
Plaintiff Teva Pharmaceuticals USA, Inc. ("Teva") brings this action to obtain "immediate injunctive and declaratory relief" barring the Food and Drug Administration ("FDA") from "depriving [Teva] of its statutory right to 180 days of marketing exclusivity for its generic version of the brand-name drug Restasis ®." Dkt. 1 at 2 (Compl. ¶ 1). Teva seeks a preliminary injunction. Dkt. 2. The FDA and intervenor defendants—Mylan Pharmaceuticals Inc. ("Mylan"), Deva Holding AS ("Deva"), and Famy Care Private Limited ("Famy Care")—oppose that motion and move to dismiss the case for lack of subject matter jurisdiction. Dkt. 25; Dkt. 27. Because Teva has failed to demonstrate that it has standing, the Court will DENY Teva's motion for a preliminary injunction and will GRANT the defendants' motions to dismiss for lack of standing.
The Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. , sets forth the procedures that manufacturers must follow to obtain FDA approval to sell pharmaceutical products. To obtain approval for a brand-name or pioneer drug, a pharmaceutical manufacturer must file a New Drug Application ("NDA") demonstrating the drug's safety and efficacy using scientific data. Id. §§ 355(a)–(b). The NDA must also include "the patent number and the expiration date of any patent ... to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug." Id. § 355(b)(1). If the patent is issued after the NDA is filed, the applicant or holder of the approved NDA must notify the FDA of the patent number and expiration date. Id. § 355(c)(2). The FDA then lists this patent information in the " ‘Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ’ or, as it is commonly known, simply the ‘Orange Book.’ " Amneal Pharms. LLC v. FDA , 285 F.Supp.3d 328, 332 (D.D.C. 2018).
Prior to 1984, companies that manufactured generic medicines, like Teva, also had to file NDAs supported by full investigative studies. See Serono Labs., Inc. v. Shalala , 158 F.3d 1313, 1316 (D.C. Cir. 1998) (). In 1984, however, Congress enacted the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984), popularly known as the "Hatch-Waxman Amendments." Among other things, the Amendments were designed "to increase competition in the drug industry by facilitating the approval of generic copies of drugs." Mead Johnson Pharm. Grp. v. Bowen , 838 F.2d 1332, 1333 (D.C. Cir. 1988). To that end, the Amendments eliminated the requirement that generic manufacturers submit full NDAs and allowed generic manufacturers to "seek FDA approval by submitting an abbreviated new drug application (‘ANDA’)." Serono Labs., Inc. , 158 F.3d at 1316 ; see also 21 U.S.C. § 355(j). Under the ANDA process, a manufacturer may "piggyback[ ] on the original manufacturer's evidence of safety and efficacy," Teva Pharms. USA, Inc. v. Leavitt , 548 F.3d 103, 104 (D.C. Cir. 2008), and need demonstrate only that the generic drug has the same active ingredient(s), route of administration, dosage form, conditions of use, and strength as the approved drug, and that the generic drug has an appropriate label and is bioequivalent to the approved drug. See 21 U.S.C. § 355(j)(2)(A) ; id. § 355(j)(4). Although far less demanding than the full NDA process, "obtaining FDA approval for an ANDA remains a prolonged" and demanding "task," which "can take years to complete." Amneal Pharms. LLC , 285 F.Supp.3d at 333.
An ANDA must also contain one of four certifications "with respect to each" of the Orange Book patents claimed by the brand-name drug. 21 U.S.C. § 355(j)(2)(A)(vii). The four certifications are as follows:
Id. A generic applicant may not enter the market until every patent in the Orange Book implicated by the generic product has expired, unless it files a Paragraph IV certification. See Mylan Pharms., Inc. v. FDA , 789 F.Supp.2d 1, 3 (D.D.C. 2011) [hereinafter " Mylan "].
When a generic applicant submits a Paragraph IV certification in its original ANDA, the applicant must provide notice to the patent owner and holder of the approved NDA "not later than 20 days after the date" on which the FDA "informs the [ANDA] applicant that the [ANDA] has been filed." 21 U.S.C. § 355(j)(2)(B)(ii)(I). The FDA issues an acknowledgement letter informing an applicant that its ANDA has been "received" after it reviews the ANDA and concludes that the application is sufficiently complete to permit substantive review. 21 C.F.R. § 314.101(b)(2) ; see also SB Pharmco P.R., Inc. v. Mutual Pharm. Co. , 552 F.Supp.2d 500, 507 (E.D. Pa. 2008). When an applicant submits a Paragraph IV certification through "an amendment or supplement to the" applicant's ANDA, the applicant must notify the patent owner and holder of the NDA "at the time at which the [ANDA] applicant submits the amendment or supplement" to the FDA. 21 U.S.C. § 355(j)(2)(B)(ii)(II).
The filing of an ANDA containing a Paragraph IV certification is treated as an act of patent infringement. 35 U.S.C. § 271(e)(2)(A) ; see also Eli Lilly & Co. v. Medtronic, Inc. , 496 U.S. 661, 677–78, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). If the patent owner fails to sue for infringement within forty-five days of receiving notice, the generic applicant may bring a declaratoryjudgment action against the patent owner. 21 U.S.C. § 355(j)(5)(C)(i)(I)(aa). If, however, the patent owner brings an infringement action, the FDA's approval of the ANDA "shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of" the required notice to the patent owner and holder of the NDA. Id. § 355(j)(5)(B)(iii). This period is referred to as the "thirty-month stay." Eli Lilly & Co. v. Teva Pharms. USA, Inc. , 557 F.3d 1346, 1348–49 (Fed. Cir. 2009). During this time, the agency is limited to issuing "tentative approval"—a "notification ... that [an] application ... meets the requirements [for approval] ... but cannot receive effective approval" because of a patent issue or outstanding period of exclusivity. 21 U.S.C. § 355(j)(2)(B)(iv)(II)(dd). If the ANDA applicant prevails in district court before the thirty-month stay expires, the FDA may immediately approve the ANDA. Id. § 355(j)(5)(B)(iii)(I). The thirty-month stay is unavailable, moreover, if the relevant patent was listed after the ANDA was submitted. Id. § 355(j)(5)(B)(iii).
Because patent litigation is both expensive and risky, Congress created an incentive to encourage generic manufacturers to submit well-founded Paragraph IV certifications. See Teva Pharms. USA, Inc. v. Sebelius , 595 F.3d 1303, 1318 (D.C. Cir. 2010) [hereinafter " Teva v. Sebelius "]. The statute provides that the "first applicant"—that is, the first generic manufacturer to file a "substantially complete" ANDA containing a Paragraph IV certification and to "lawfully maintain[ ]" that certification—is entitled to 180 days of generic market exclusivity. 21 U.S.C. § 355(j)(5)(B)(iv). A "substantially complete" ANDA is defined as an application that is "sufficiently complete" on "its face" to "permit a substantive review" and that "contains all the [requisite] information." Id. § 355(j)(5)(B)(iv)(II)(cc). The FDA represents that it does not designate a first applicant until it is ready to approve the first ANDA. See Dkt. 26 at 9. At that time, if the first applicant is approved and ready to go to market, it is entitled to 180 days of generic exclusivity. When more than one generic manufacturer meets the definition of "first applicant," the manufacturers will share the right to exclude other generics (but not each other) from the market.
The FDCA, however, contains six "forfeiture events" under which a first applicant may forfeit eligibility for the 180-day exclusivity period. Under the first, forfeiture occurs if the first applicant "fails to market the drug" by a certain date. Id. § 355(j)(5)(D)(i)(I). As is relevant here, that date is 75 days after "a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken," holding that "the patent [listed in the Paragraph IV certification] is invalid or not infringed." Id. § 355(j)(5)(D)(i)(I)(bb)(AA). Forfeiture also occurs if the first applicant withdraws its ANDA or the FDA "considers the application to have been withdrawn" because it does not meet the requirements for approval, id. § 355(j)(5)(D)(i)(II) ; the first applicant "amends or withdraws the certification for all of the patents with respect to which [the] applicant submitted a certification qualifying [it] for the 180-day exclusivity period," id. § 355(j)(5)(D)(i)(III) ; the first applicant "fails to obtain tentative approval of the application within 30 months after the date on which the...
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