Pfizer Inc v. Shalala, Donna E.

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• holding that, for purposes of ripeness, company’s voluntary decisioii to incur litigation expenses did not constitute hardship
• “the legal rights that will be affected are not Pfizer’s but those of its competitors, about which Pfizer is not in a position to complain”
• “An administrative agency, which is not subject to Article III of the Constitution of the United States and related prudential limitations, may issue a declaratory order in mere anticipation of a controversy or simply to resolve an uncertainty.”
• “An administrative agency, which is not subject to Article III of the Constitution of the United States and related prudential limitations, may issue a declaratory order in mere anticipation of a controversy or simply to resolve an uncertainty.”
• “The critical fact remains that the FDA may never approve [the ANDA] —whether because it decides in the end that the dosage form of [the generic] is different . . . or for some entirely different reason, such as a lack of bioequivalence.”
• “Pfizer voluntarily incurred the expense of preemptive patent litigation in order to get a substantial statutory benefit, namely, a stay of the FDA’s approval of Mylan’s ANDA. In sum, Pfizer suffers no hardship because it ‘is not required to engage in, or to refrain from, any conduct.’ ”

Source: CourtListener parenthetical corpus (CC0).