Court Opinion

ID: 8408356
Source: CourtListenerOpinion
Date Created: 2022-11-02 16:42:18.449445+00
Date Added: 2024-06-11T16:47:34.066065
License: Public Domain

PAULINE NEWMAN, Circuit Judge,
dissenting.
I
After this appeal was argued, and apparently in view of Food and Drug Administration amended regulations issued on June 18, 2003, all of the challenged 30-month stays were terminated by the FDA, and SmithKline Beecham Corporation (now GlaxoSmithKline or GSK) requested withdrawal of the disputed patents from the Orange Book. The FDA on July 30, 2003, gave final approval to Apotex’s Abbreviated New Drug Application (ANDA), authorizing immediate sale of the Apotex generic counterpart to GSK’s product Pax-il ®.
This case is over. Apotex has received the full relief it requested: the final approval of its ANDA.1 The controversy no longer exists among these parties. See U.S. Bancorp Mortgage Co. v. Bonner Mall Partnership, 513 U.S. 18, 21, 115 S.Ct. 386, 130 L.Ed.2d 233 (1994) (a case or controversy ... must exist at all stages of appellate review). I respectfully dissent from my colleagues’ sua sponte stretch to decide issues now moot, as well as issues not considered by the district court and issues not involving these parties.
DISCUSSION
My colleagues agree that the issue is now moot of whether additional stays may be invoked based on these patents. The court nonetheless presents an assortment of advisory opinions on various non-issues; the justification offered for this venture into dictum is that there might arise a future conflict between Apotex and some other generic manufacturer, based on competing claims for 180-day exclusivity. This is not an issue of this appeal. It was not raised, briefed, or argued in the district court, not briefed on appeal, and not in controversy in this case. The majority opinion excuses this fatal flaw, reasoning that because “Apotex did not contest the validity of the FDA’s [180-day regulations or policies],” Apotex “did not need to present arguments for that issue.” Maj. op. at 1346. This is a curious mode of circumventing the fundamentals of Article III jurisdiction.
In addition, the various issues now decided are unripe for judicial attention. In Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), the Court explained that “The basic rationale [of requiring ripeness for judicial action] is to prevent courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties.” 387 U.S. at 148-49, 87 S.Ct. 1507. This rule is particularly apt here, where the actions that the court discusses are the province of an administrative agency.
The court also volunteers to decide the questions of whether the FDA has the duty to screen Orange Book submissions and to determine the technical scope of fisted patents; these questions may be of general interest, but they are not here at *1355issue. The court also decides a due process non-issue, and a non-issue interpreting the requirement that ANDA applicants must file paragraph IV certifications. The court also decides the non-issue of the effect of NDA supplements and a “gap filling” regulation. The court also decides the moot issue of retroactivity. None of these questions remains in controversy. Further, they were not briefed and not argued. They were not raised on appeal, are not in dispute, or were not before the district court. Such issues are not subject to appellate decision. See Swift & Co. v. Hocking Valley R. Co., 243 U.S. 281, 289, 37 S.Ct. 287, 61 L.Ed. 722 (1917).
As concerns Apotex’s rights vis-a-vis other potential generic producers of paroxetine hydrochloride, those producers are not party to this case, although their interests would be directly affected. It is irregular, and unfair, to decide adversarial issues in the absence of the adversary. In United States v. Fruehauf, 365 U.S. 146, 157, 81 S.Ct. 547, 5 L.Ed.2d 476 (1961) the Court reminded us that it is inappropriate to give opinions on legal issues not “pressed before the Court with that clear concreteness” provided by the adversarial context.
The issues that are now decided in the majority opinion are either mooted by events, or are decided without briefing, without argument, and without the perspective of those directly affected. From this court’s excursion beyond our jurisdiction, I must, respectfully, dissent.

. Apotex listed four "issues” in its appellate brief. Issues 1, 2, and 3 request final approval of the Apotex ANDA, now achieved. Issue 4 relates to certifications concerning listed patents, mooted by the approval of the Apotex ANDA.