Mazurek v. Armstrong

Holding that "a plaintiff's motion for preliminary injunctive relief has a "requirement for substantial proof is much higher" than a defendant's summary judgment motion

Citizens to Preserve Overton Park v. Volpe

Holding a decision is committed to agency discretion when there is "no law to apply"

Camp v. Pitts

Holding that "the focal point for judicial review" of whether agency action is arbitrary and capricious "should be the administrative record already in existence, not some new record made initially in the reviewing court"

Wisconsin Gas Co. v. F.E.R.C

Holding that to establish irreparable harm the movant must "substantiate the claim that irreparable injury is 'likely' to occur. . . . Bare allegations of what is likely to occur are of no value."

Washington Metro. Area, Etc. v. Holiday Tours

Holding that, "[w]ithout such a substantial indication of probable success, there would be no justification for the court's intrusion into the ordinary processes of administration and judicial review"

Cityfed Fin. v. Office of Thrift Supervision

Holding that a moving party's failure to make a showing of irreparable injury "alone is sufficient" to deny a motion for a preliminary injunction

Mova Pharmaceutical Corp. v. Shalala

Holding that danger of loss of market share due to denial of a preliminary injunction satisfied the third Rule 24 factor

Ethyl Corp. v. Environmental Protection Agency

Holding that the same language from section 211 plainly means that emissions merit regulation even if they are not the only source of air pollution

Serono Laboratories v. Shalala

Holding deference “is owed to the decisionmaker authorized to speak on behalf of the agency, not to each individual agency employee”

Virginia Petroleum Job. v. Fed. Power Com'n

Finding if “adequate compensatory or other corrective relief” will not be available later in the litigation this factor weighs toward a finding of irreparable harm

Section 706 - Scope of review

Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

Section 355 - New drugs

Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

Rule 44 - Proving an Official Record

Permitting the lack of a foreign record “to be evidenced by an attested summary with or without a final certification”

Section 156 - Extension of patent term

Granting five-year extension of patent term based upon regulatory review of the product Abilify® (aripiprazole) by the FDA

Section 314.94 - Content and format of an ANDA

Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

Section 314.3 - Definitions

Defining "reference listed drug"

Section 10.30 - Citizen petition

Describing the requirements for filing a citizens' petition

Section 201.56 - Requirements on content and format of labeling for human prescription drug and biological products

Disallowing claims or suggestions of drug use on labeling if there is a lack of substantial evidence

Section 314.127 - Refusal to approve an ANDA

Listing reasons the FDA will refuse approval of an ANDA, none of which concern patent litigation under § 271(e)

Section 320.1 - Definitions

Section 320.24 - Types of evidence to measure bioavailability or establish bioequivalence

Providing that the FDA may require either in vivo or in vitro studies to demonstrate bioequivalence

Section 320.25 - Guidelines for the conduct of an in vivo bioavailability study