CEPHALON, INC. v. Sebelius, 2011 WL 2728120

Cephalon, Inc. sues Kathleen Sebelius and Margaret Hamburg in their official capacities under the APA challenging FDA's approval of the Watson generic version of Fentora.
Fentora is a pioneer opioid with a single active ingredient, fentanyl citrate; FDA approved it in 2006 and listed related patents in the Orange Book.
Watson Laboratories filed an ANDA for a generic Fentora on 7/10/2007; FDA approved the Watson generic on 1/7/2011.
Cephalon litigated patent issues in Delaware courts, obtaining an injunction against Watson through 2019 via a stipulation; Cephalon later sought to challenge FDA approval indirectly.
Cephalon submitted citizen petitions to FDA (7/13/2010 and 7/23/2010) arguing issues with bioequivalence and active ingredients; FDA denied on 1/7/2011.
Cephalon filed this suit on 3/15/2011; Watson intervened as a defendant; the court presently considers a 12(b)(1) motion to dismiss for lack of subject matter jurisdiction.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Is the APA claim ripe for judicial review?	Cephalon argues the FDA's final approval of Watson is subject to immediate review.	Defendants contend the case is not ripe due to contingent future events and lack of immediate hardship.	Unripe; case dismissed for lack of subject matter jurisdiction.

Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (standing requires concrete and particularized injury)
Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999) (final agency action can be unripe; review may await concrete effects)
Atlantic States Legal Found. v. EPA, 325 F.3d 281 (D.C. Cir. 2003) (hardship inquiries against speculative future agency action)
Devia v. Nuclear Regulatory Comm'n, 492 F.3d 421 (D.C. Cir. 2007) (ripeness two-prong test; fitness and hardship)
CTIA-The Wireless Ass'n v. FCC, 530 F.3d 984 (D.C. Cir. 2008) (abeyance-like reasoning; direct burdens must be present for ripeness)