Court Opinion

ID: 9574563
Source: CourtListenerOpinion
Date Created: 2023-08-21 21:05:57.196621+00
Date Added: 2024-06-11T12:43:44.257779
License: Public Domain

KAREN LECRAFT HENDERSON, Circuit Judge,
dissenting:
I dissent from the majority opinion because the issue Teva seeks to litigate — its statutory eligibility vel non to exclusively market generic versions of Cozaar and Hyzaar, brand name drugs manufactured by Merck & Co., Inc. (Merck) — will not be ripe unless and until the United States Food and Drug Administration (FDA) issues its final decision either granting or denying Teva’s Abbreviated New Drug Application (ANDA). The United States Supreme Court has established a two-pronged test for determining ripeness, requiring that the court analyze: “(1) the fitness of the issues for judicial decision and (2) the hardship to the parties of withholding court consideration.” Nat’l Park Hospitality Ass’n v. Dep’t of Interi- or, 538 U.S. 803, 808, 123 S.Ct. 2026, 155 L.Ed.2d 1017 (2003) (citing Abbott Labs. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)). This action satisfies neither prong of the ripeness test as is clear from our decision in Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C.Cir.1999).
In that case, Pfizer filed a “citizen petition” with the FDA asking that the agency recognize as “a distinct dosage form” a patented “osmotic pump” used as an extended release mechanism for Pfizer’s brand drug Procardia XL. Pfizer, 182 F.3d at 977. Almost four years later — with the petition still pending — Mylan Pharmaceuticals, Inc. (Mylan) filed an ANDA to market a generic version of Procardia XL, claiming pharmaceutical equivalence notwithstanding Mylan’s product used a different release mechanism. After the FDA accepted Mylan’s ANDA for processing but before it decided whether to approve it, Pfizer filed a suit in district court challenging the FDA’s acceptance of the ANDA on the ground that the two products were not equivalent because Pfizer’s osmotic pump was a unique dosage form and thus distinct from Mylan’s mechanism. The district court held that Pfizer’s challenge to Mylan’s application was not ripe for judicial review but that its unresolved citizen petition was. Id. at 978. On appeal, we found neither challenge ripe.
We first rejected Pfizer’s argument that “once having decided, based upon the information contained in Mylan’s application, that Mylan’s drug uses the same dosage form as Procardia XL®, the FDA will not ‘alter its views with respect to the necessity of Mylan filing a suitability petition.’ ” Id. at 978. We explained:
*1320The decision to accept Mylan’s ANDA for processing as a pharmaceutical equivalent to Procardia XL® is ... merely the first step in the agency’s approval process. The critical fact remains that the FDA may never approve Mylan’s application — whether because it decides in the end that the dosage form of Mylan’s drug is different from that of Procardia XL® or for some entirely different reason, such as a lack of bioequivalence. Therefore, “depending upon the agency’s future actions ... review now may turn out to have been unneces- ■ sary” and could deprive the agency of the opportunity to apply its expertise and to correct any mistakes it may have made.
Id. (quoting Ohio Forestry Ass’n v. Sierra Club, 523 U.S. 726, 736, 118 S.Ct. 1665,140 L.Ed.2d 921 (1998)) (first ellipsis added). Teva faces the same hurdle here. We do not know whether the FDA’s final decision will approve Teva’s ANDA or what the FDA’s reasoning will be if, as the majority forecasts, maj. op. at 1308-10, it does not. The FDA may conclude Teva forfeited its eligibility upon Merck’s delisting of its patents, as Teva and the majority insist it will, or it may reject Teva’s application based on one of the other forfeiture provisions “or for some entirely different reason, such as a lack of bioequivalence.” Pfizer, 182 F.3d at 978.1 Because the FDA has not yet issued its decision we are unable to divine its substance. Given this uncertainty and the consequent possibility the court may not need to resolve the delisting/forfeiture issue after the FDA’s final decision, Teva’s challenge to the FDA’s previous decisions in other proceedings is not now fit for review under the first prong of the ripeness test. In short, “[i]t makes no sense for us to anticipate a wrong when none may ever arise.” Cronin v. FAA, 73 F.3d 1126, 1132 (D.C.Cir. 1996).
Nor does Teva fare better under the test’s hardship prong as we applied it in Pfizer. There we explained that Pfizer was not able to “point to any imminent hardship arising from the FDA’s acceptance of Mylan’s ANDA”:
Before Pfizer could suffer its claimed “economic injury from unlawful competition,” FDA approval for a pharmaceutical equivalent to Procardia XL® would have to be not only sought but granted. That has not happened. Therefore “no irremediable adverse consequences flow from requiring a later challenge.”
Pfizer, 182 F.3d at 979 (quoting Toilet Goods Ass’n v. Gardner, 387 U.S. 158, 164, 87 S.Ct. 1520, 18 L.Ed.2d 697 (1967)). For the same reason, Teva too will suffer no imminent hardship if review is postponed. See Fed. Express Corp. v. Mineta, 373 F.3d 112, 119 (D.C.Cir.2004) (hardship prong not satisfied because “postponing review ... w[ould] not be a hardship to [petitioners], let alone a hardship that is ‘immediate, direct, and significant.’ ” (quoting State Farm Mut. Auto. Ins. Co. v. Dole, 802 F.2d 474, 480 (D.C.Cir.1986))) (emphasis added). As in Pfizer, the delay will not “foreclose [the appellant’s] right ever to get meaningful judicial review,” 182 F.3d at 979; upon the FDA’s issuance *1321of an adverse final order, Teva is free to seek judicial review — forestalling generic competition and the loss of the “first-mover advantage,” maj. op. at 1311, through appropriate and immediate injunctive relief.2
For the foregoing reasons, I would find the appeal is unripe and dismiss it for lack of jurisdiction.3

. The FDA’s "tentative approval” of Teva’s ANDA is not, as Teva suggests, Reply Br. at 10-11, the final word on its generic drug’s equivalence. See Pfizer, 182 F.3d at 980 (although FDA’s post-oral argument tentative approval of Mylan’s generic made it "more likely that the FDA w[ould] eventually approve Mylan’s drug, the agency’s tentative approval cause[d] Pfizer no hardship at present or in the near future, nor d[id] it render Pfizer’s challenge fit for review”).

. And contrary to my colleagues' lack of confidence in judicial alacrity, maj. op. at 1311, courts make speedy decisions on injunction applications in ANDA cases all the time. See, e.g., Apotex, Inc. v. FDA, C.A. No. 06-627, 2006 WL 1030151 (D.D.C. Apr. 19 2006); Biovail Corp. v. FDA, C.A. No. 06-1487 (D.D.C. Aug. 25, 2006); Merck & Co. v. FDA, 148 F.Supp.2d 27 (D.D.C. June 2001).

. In support of ripeness, the majority asserts: “District courts routinely reach the merits of generic manufacturers' claims to exclusivity before the FDA has granted final approval to any ANDA concerning the drug at issue.” Maj. op. at 1311 (citing Teva Pharms., USA, Inc. v. Leavitt, 548 F.3d 103 (D.C.Cir.2008); Ranbaxy Labs., Ltd. v. Leavitt, 469 F.3d 120 (D.C.Cir.2006)). Leaving aside what effect a court’s routine practice may have on an issue's ripeness vel non, I know of no instance where the district court reached the merits of an ANDA before the FDA has issued any decision regarding the plaintiff and the issue raised. In the two cases the majority cites, the district court directly reviewed FDA decisions denying relief to the plaintiffs. See Teva Pharms., 548 F.3d at 105 (reviewing denial of citizen petition contesting FDA’s delisting of patent certified in its ANDA); Ranbaxy Labs., Ltd., 469 F.3d at 121 (reviewing denial of citizen petition denial). Here, by contrast, the FDA has taken no adverse action whatsoever regarding the effect of delisting on Teva’s ANDA — and apparently will not do so unless and until it denies final approval. Had Teva raised the delisting issue before the FDA in the first instance, its status here might be different.