Index

• Author: Kenneth Dorsney
• Pages: 767-809

767

Index

A

aaiPharma Incorporated v. Thompson,

257n130, 258–259, 258n130

AAPA. See Access to Affordable

Pharmaceuticals Act (AAPA)

Abbott Laboratories, Inc. v. Apotex, Inc.,

44n72, 127n157, 169n72

Abbott Laboratories and AstellasPharma,

Inc. v. Sandoz, Inc., 167

Abbott Laboratories v. Andrx

Pharmaceuticals, Inc., 181n3,

184nn24–27, 196n93, 197n95,

254n104, 262n160

Abbott Laboratories v. Baxter Healthcare

Corp., 93n21

Abbott Laboratories v. Baxter

Pharmaceutical Products, 171

Abbott Laboratories v. Mylan Pharm.,

Inc., 49n93, 94n27, 116n76, 117n77

Abbott Laboratories v. Sandoz, Inc.,

48n91, 65nn212, 213, 68n232,

132, 144n21, 186n39, 187,

204nn128,129, 226n86, 253nn95,

96, 254n104, 255n113, 255nn116,

117, 261n155, 262nn162, 159, 344,

344n58, 345nn59–61

Abbott Laboratories v. Syntron

Bioresearch, Inc., 183n15

Abbott Laboratories v. TorPharm, Inc.,

160, 170, 172, 230–231, 230n105,

231nn106–110, 268n201, 271,

270nn220–222, 272n223, 230,

231, 232

Abbott Laboratories v. Young, 7n31

Abbreviated New Drug Application

(ANDA)

in drug approval process, 29–31

establishment of, 3–4

exclusivity and, 8

obligations to negotiate/review, 61–62

patent litigation and, xvii–xix

proper defendant in, 90

subject-matter jurisdiction over,

109–111

Abbreviated New Drug Application

(ANDA) filers

bioequivalence and, 18–19

declaratory judgment by, 13–14

discovery from, 145–146

establishment of, 17

incentives for, 17

infringement and, 10–14, 16, 17, 20,

21, 22

180-day exclusivity and, 22–24

safe harbor and, 10, 20–22

thirty-month stay and, 14–17

Abbreviated New Drug Application

(ANDA) litigation, managing. See

Managing ANDA litigation

Abbreviated New Drug Application

(ANDA)-specific local rules,

80–83

Abbreviated New Drug Submission

(ANDS), 466, 467

ABPI. See Association of the British

Pharmaceutical Industry (ABPI)

Abramic, John L., 89n1

Abraxis Bioscience, Inc. v. Navinta, LLC,

108nn12, 15, 16, 109n24, 174,

174n93, 330n4

Abridged-hybrid applications, 508

Abridged procedure, 490–491, 493,

497, 498

Abuse of discretion, 65, 262, 266,

271–272

Abuse of power, 500n117

INDEX

768

A.C. Aukerman Co. v. R.L. Chaides

Constr. Co., 333n30, 334nn32, 33

Access to Affordable Pharmaceuticals Act

(AAPA), 4, 15, 16

Accession Treaties, 475n37

Acco Brands, Inc. v. ABA Locks Mfrs. Co.,

240n144

Acepromazine maleate, 109

Active client communications, 536–537

Active ingredient

bioequivalence and, 18, 19

defined, 7

drug approval process and, 29

Active moiety, defined, 6–7

Actos, 530–531

Adalat, 313

Adams Respiratory Therapeutics, Inc. v.

Perrigo Co., 49n93

Adarand Constructors, Inc. v. Slater,

139n240

Additive Controls & Measurement

Systems, Inc. v. Flowdata, Inc., 268

Administrative changes, 468

Admissibility, 176

Admitted facts, 340

Adult exclusivity, 9

Advanced Cardiovascular Sys., Inc. v.

Scimed Life Sys., Inc., 118n89

Adverse witnesses, 364–365, 370–371, 389

Advisory Committee Notes, 430

Advocate General, 502

Affidavit evidence, 445–446, 471

Affidavits, 217–218, 269

Agency theory, 95, 118

Agenzia Italiana del Farmaco (AIFA),

477n45

Agricultural Chemicals Regulation Act,

520n171

AIA. See Leahy-Smith America Invents

Act (AIA)

AIFA. See Agenzia Italiana del Farmaco

(AIFA)

AIPLA 2011 Annual Survey, 540

AK Steel Corp. v. Sollac & Ugine, 130n174

Akro Agate Co. v. Master Marble Co.,

3n11

Aktiebolag v. Andrx Pharm., Inc., 414n34

Aktiebolag v. Kremers Urban Dev.

Co., 44n72

Albany Molecular Research, Inc. v.

Dr. Reddy’s Laboratories,

Ltd., 254n104

Alcon, Inc. v. Teva Pharmaceuticals USA,

Inc., 243n17, 264–265, 413n30

Alcon Labs, Inc. v. Allergan, Inc., 232n111

Allergan, Inc. v. Alcon Labs., Inc., 73n264,

91n13, 91nn13, 14, 161n33,

167, 332n13

AltanaPharma AG v. Teva

Pharmaceuticals USA, Inc., 48n91,

131nn185, 186, 157n7, 243n17,

250nn70, 71, 252n80, 254n105

Alter ego, 143

Alter ego theory, 118

ALZA Corp. v. Andrx Pharmaceuticals,

LLC, 133n201, 134, 134nn203–206,

161n32, 164n48, 252n82

ALZA Corp. v. Mylan Labs., Inc., 161n30,

163n42, 183n13

Am. Bankers Ass’n v. Nat’l Credit Union

Admin., 249n61

Am. Bioscience, Inc. v. Thompson, 35n18,

36nn20, 21

Am. Hoist & Derrick Co. v. Sowa &

Sons, 332n20

Amazon.com, Inc. v. Barnesandnoble.com,

201n113, 249nn58–60, 250n68,

252nn85, 86, 253n93, 262nn160,

159, 412n20

America Invents Act, 541

American Bioscience, Inc., 260n150

American Greetings Corp. v. Dan-Dee

Imports, Inc., 268nn203, 200

American Home Products, 316n95

American Patent System, 403

American Standard, Inc. v. Pfizer

Inc., 422n38

American Tel. & Tel. Co. v. Winback &

Conserve Program, Inc., 249n54

Amgen, Inc. v. F. Hoffman-La Roche Ltd.,

93n21, 346–347

An Economic Model of Legal Discovery

(Cooter and Rubinfeld), 224n78

Anchen Pharmaceuticals, 117

ANDA. See Abbreviated New Drug

Application (ANDA)

ANDA Litigation Discovery, Patent

Strategy & Management (Ragusa),

141n3, 144nn22, 23, 145nn24–27

Anderson v. Liberty Lobby, Inc., 213,

213n34, 214, 214n37, 215n41,

216nn44, 45, 240n147

AndroGel, 284, 314

Andrx Pharm., Inc. v. Biovail Corp., 1n3,

65n211, 153n75, 318nn99, 101,

319nn103, 104, 106–109

ANDS. See Abbreviated New Drug

Submission (ANDS)

Index 769

Animations, 203

Annotated Patent Digest

(Matthews), 273n241

Answer

counterclaims in, 136–138

defenses in, 127–136

Answering brief, in appeal, 433

Anticipation, 130–131, 132, 163, 335

Anticompetitive act, 299, 305

Anticompetitive agreements, 281

Anticompetitive behavior, 293

Anticompetitive conduct, 303, 324, 325

Anticompetitive device, 299

Anticompetitive effects, 289, 302, 304

Antitrust cases

FTC cases as (See Federal Trade

Commission (FTC) cases)

legal theories in (See Legal theories)

private cases and (See Private cases)

remedies and, 324–327

Antitrust claims, 137, 213, 286n36

Antitrust counterclaims, 137–138

Antitrust injury, 301, 312, 318, 319, 323

Antitrust issues

in managing ANDA litigation, 535

overview of, 293–294

Antitrust Law (Areeda), 324n138

Antitrust rule of reason, 284

Antitrust violations, 285–286, 319,

324–325

ANVISA. See National Agency of

Sanitary Surveillance (ANVISA)

Apotex, 114n55, 290–291, 291

Apotex, Inc. v. Cephalon, Inc., 310n79

Apotex, Inc. v. Eisai Inc., 55, 55n146, 150,

113–114

Apotex, Inc. v. FDA, 244n22, 244n24, 256

Apotex, Inc. v. Novartis AG, 60n182

Apotex, Inc. v. Shalala, 69n237

Apotex, Inc. v. Thompson, 35n19

Apotex-Sanofi settlement, 321n118

Appeal Board, 525

Appeal Examiners, 525

Appeals

alternatives before, 414–415

answering brief in, 433

argument in, 432

claim construction and, 182,

203–204, 220

dismissing, 425

introduction in, 429–430

in Japan, 527, 528, 531

jurisdictional statement in, 430

in litigation timeline, 87–88

managing ANDA litigation and, 540

mechanics in, 420–429

notice of, 421, 422, 423

oral argument in, 422, 423,

433–436

overview of, 417–418

post-trial and, 87–88, 393,

410, 412

preparing the shell in, 429–432

pretrial conference and, 356

scope of review in, 418–420

statement of the case in, 430

statement of the facts in, 431

statement of the issues in, 430

of summary judgment decision,

239–240, 420

summary of the argument in, 432

trial and, 382

Appearance, 337, 358, 359

Appellate Advocacy-One Judge’s Point

of View (Michel), 432n103,

434, 434n110

Appendix, 425

Applicant, defined, 90

Application record, 471

Approval review process, 518

Approved Drug Products with

Therapeutic Equivalence

Evaluations, 11, 28–29, 258, 326.

See also Orange Book

Aptix Corp. v. Quickturn Design Sys.,

Inc., 266n193

AquaTex Indus., Inc. v. Techniche

Solutions, 226n86

Areeda, Phillip E., 324n138

Argument section, in appeal, 432

Ariad Pharmaceuticals Inc. v. Eli

Lilly & Co., 132n194, 133nn195,

196, 420n27

Aristocrat Techs. Austl. Pty., Ltd. v. Int’l

Game Tech., 129nn172, 173

Ark. Carpenters Health & Welfare Fund

v. Bayer AG, 323n130

Artegodan GmbH v. Commission, 502,

502nn125, 126

ARTG. See Australian Register of

Therapeutic Goods (ARTG)

Artificial act of infringement, 98–99

Asahi Glass Co., Ltd. v. Pentech

Pharmaceuticals, Inc., 285n34,

323–324

Aspex Eyewear, Inc. v. Miracle Optics,

Inc., 109n22

Asserted claims, 148, 183, 340