HD
This is NOT, "In line with the Congress intent and the Court (Moss) ruling, FDA will grant NCE for 2012-2017." DOJ states "FDA’s interpretation would fail at step two of Chevron" page 3 of the most recent appeal filing on 9-15-2015. This is the motion to dismiss Watson appeal.
When step two of Chevron is breached there is no fix in the statute, if so Judge Moss would be obligated to order FDA grant NCE starting from statute date; date of approval.
"If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute . . . Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute."
"the statute" is silent on when to start NCE after decision is delayed for 18 months then wrongly assigned.
"Based on permissible construction of the statute"....Amarin has NOT benefitted from NCE yet, Otherwise they wouldn't have me and you bickering about when it starts!
When to start exclusivity is being discussed by Amarin and FDA. I'd guess FDA shared intent to start at the day of update not approval with Watson...this is likely the redacted portion of this filing.
BB
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Info on step two Chevron:
The Court, in an opinion by Justice John Paul Stevens, upheld the EPA's interpretation. A two-part analysis was born from the Chevron decision (called the "Chevron two-step test"), where a reviewing court determines:
First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute . . . Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.
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Full DOJ (Not FDA) Motion to dismiss Watson appeal:
This action under the Administrative Procedure Act was instituted by Amarin Pharmaceuticals, challenging a determination by the Food and Drug Administration. Appellant Watson Laboratories was not a party to the district-court proceedings. The district court vacated the FDA decision and remanded the matter to FDA for further proceedings.
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has not appealed. But after the district court’s decision, Watson moved to intervene and filed a notice of appeal. Watson’s appeal should be dismissed for lack of jurisdiction. Watson is not a party to this case. And even if Watson were a party, it could not appeal the district court’s order, which did not finally resolve the matter but instead remanded the case to FDA for further proceedings.
STATEMENT
Amarin Pharmaceuticals manufactures Vascepa, a drug that has been approved by FDA as an adjunct to diet to reduce triglyceride levels. Amarin sought a five-year period of marketing exclusivity, known as “new chemical entity” or “NCE” exclusivity, that is available for certain approved new drugs. See 21 U.S.C. §§ 355(c)(3)(E)(ii), 355(j)(5)(F)(ii). FDA concluded that Vascepa was not eligible for five-year NCE exclusivity and denied Amarin’s request. Amarin instituted this lawsuit under the Administrative Procedure Act. On May 28, 2015, the district court granted summary judgment to Amarin. The district court agreed with Amarin that the statute unambiguously foreclosed FDA’s interpretive approach. Summ. J. Op. 18- 36; see Chevron U.S.A. v. Natural Res. Def. Council, 467 U.S. 837, 842 (1984).
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The court also concluded, in the alternative, that FDA’s interpretation would fail at step two of Chevron, and was arbitrary and capricious. Summ. J. Op. 36-39. The district court thus “vacated” FDA’s “decision denying Amarin’s claim for exclusivity” and “remanded to the FDA for proceedings consistent with this Opinion.” Id. at 40. FDA is currently engaged in the remand proceeding required by the district court’s order.
On July 22, 2015, Watson Laboratories, which was not a party to the case, moved to intervene for purposes of filing a notice of appeal. Watson contended that its own applications for drug approval were affected by whether Amarin was entitled to a five-year period of exclusivity, and that it sought to appeal the district court’s order. Watson contemporaneously filed a notice of appeal, which caused this Court to docket this appeal. Amarin and the government both opposed Watson’s intervention motion, and the district court has not yet acted on it.
ARGUMENT
1. Because the district court has not yet acted on Watson’s motion to intervene, Watson is not a party to this case. As a nonparty, Watson has no right to appeal. See Marino v. Ortiz, 484 U.S. 301, 304 (1988) (“The rule that only parties to a lawsuit, or those that properly become parties, may appeal
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an adverse judgment, is well settled.”). Until the district court acts on Watson’s motion, Watson has no right to pursue an appeal in this Court.
If the district court denies Watson’s motion to intervene, Watson can appeal that order. See Alt. Research & Dev. Found. v. Veneman, 262 F.3d 406, 409 (D.C. Cir. 2001). But unless Watson obtained reversal of the denial of the motion to intervene, it could not otherwise appeal the district court’s decision. See id. at 411 (“Because the district court correctly denied intervention, NABR is not a party to the action and does not have standing to appeal [other orders of the district court]; the court dismisses the appeal from those rulings.”).
2. Even if the district court grants Watson’s motion to intervene, Watson’s appeal must still be dismissed because this Court lacks jurisdic- tion over a private party’s appeal of an order remanding a matter to an agency for additional proceedings.
“It is well settled that, as a general rule, a district court order remanding a case to an agency for significant further proceedings is not final” and thus is not appealable under 28 U.S.C. § 1291. Pueblo of Sandia v. Babbitt, 231 F.3d 878, 880 (D.C. Cir. 2000) (internal quotation marks omitted). This jurisdictional rule “promotes judicial economy and
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efficiency by avoiding the inconvenience and cost of two appeals: one from the remand order and one from a later district court decision reviewing the proceedings on remand.” Sierra Club v. U.S. Dep’t of Agric., 716 F.3d 653, 656 (D.C. Cir. 2013).
There are two exceptions to this general rule, but neither applies here. First, a remand order will be considered final if the remand is for solely “ministerial” action. Pueblo of Sandia, 231 F.3d at 881. For example, this Court concluded that a remand order was purely ministerial when it was limited to “modifying the retroactive effect of the [arbitration] award . . . to 150 days before the date of the arbitrator’s award.” Verizon Wash., D.C. Inc. v. Commc’ns Workers of Am., 571 F.3d 1296, 1301 (D.C. Cir. 2009). Such ministerial actions require no substantive work or exercise of discretion after the matter is remanded.
The order at issue here does not merely contemplate a ministerial act by FDA, but rather contemplates significant further proceedings. The order vacated FDA’s decision denying Amarin’s claim for five-year exclusivity and “remanded to the FDA for proceedings consistent with this Opinion.” Summ. J. Op. 40. This remand order requires FDA to reconsider Amarin’s claim for a five-year period of exclusivity in light of the Court’s
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opinion, and to issue a new written decision on that claim.
In a letter to FDA, counsel
for Watson stated, XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX CENSORED XXXXXXXXXXXXXXXX
???????.” Letter from James N. Czaban to FDA, June 17, 2015, at 2 (Dkt. 40, Ex. A).
Second, an order that remands a matter to an agency may be appealed by the agency itself, even if the order contemplates significant additional administrative proceedings, because “a government agency cannot later challenge its own actions complying with a remand order.” Sierra Club, 716 F.3d at 656-657. But that exception does not apply to a private party, which “may still challenge the remanded proceedings—as well as the remand order requiring them—after the proceedings are complete.” See id. at 657. In Sierra Club, an intervenor that agreed with the underlying agency decision sought to appeal a district-court order that had remanded the matter to the agency for further proceedings, although the
?
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government agency abandoned its appeal. Id. at 656. This Court dismissed the intervenor’s appeal for lack of jurisdiction, holding that the remand order at issue was not a final order and that a private party therefore had no right to appeal. Id. at 656-658.
This case is controlled by Sierra Club. Here, as there, a private party that agrees with the original agency decision seeks to appeal a district- court order remanding the matter to the agency for significant further proceedings, even though the government has declined to appeal. This appeal should be dismissed for lack of jurisdiction.
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CONCLUSION
For the foregoing reasons, this appeal should be dismissed. Respectfully submitted,
SCOTT R. MCINTOSH
s/ Daniel Tenny
DANIEL TENNY
(202) 514-1838
Attorneys, Appellate Staff Civil Division
U.S. Department of Justice 950 Pennsylvania Ave., NW Room 7215
Washington, DC 20530
?SEPTEMBER 2015
AI
