Index

• Author: Kenneth Dorsney
• Pages: 915-957

915

Index

Please note that defined terms are in

bold.

A

aaiPharma Inc. v. Thompson, 337n133,

338n134

AAPA. see Access to Affordable

Pharmaceuticals Act (AAPA)

AB Hassle v. Canada, 595nn122,123

Abaxis, Inc. v. Cepheid, 236n49, 237n50

Abbott Laboratories & Astellas Pharma,

Inc. v. Sandoz, Inc., 240, 240n68

Abbott Laboratories & Geneva Pharms.

Inc., In re, 360, 360n8

Abbott Laboratories v. Andrx Pharms.,

Inc., 253n2, 257nn27–30, 258n35,

270n104, 271n106, 274n120,

334n108, 335n117, 345n174

Abbott Laboratories v. Apotex Inc.,

198n168, 242n77

Abbott Laboratories v. Baxter Healthcare

Corp., 100n21

Abbott Laboratories v. Baxter

Pharmaceutical Products, 245,

245n90

Abbott Laboratories v. Canada, 591n102,

592, 592nn104,105,107,108,

596n125

Abbott Laboratories v. Lupin Ltd., 231n12

Abbott Laboratories v. Mylan Pharms.,

Inc., 53n94, 101n31, 187nn87,90

Abbott Laboratories v. Sandoz, Inc.,

52n92, 70nn219,220, 203, 216n20,

259n46, 260, 260n58, 303n98,

304n103, 334n108, 335nn99,102,

342n169, 343nn176,177, 420,

420nn51–54

Abbott Laboratories v. Syntron

Bioresearch, Inc., 256n18

Abbott Laboratories v. TorPharm, Inc.,

232, 232n20, 242n74, 243, 243n85,

244, 244n86, 245, 245nn91,94,

309–310, 309n124, 310nn125–129,

352, 352nn243–246

Abbott Laboratories v. Young, 9n43

Abbott Laboratories v. Zenith

Laboratories, Inc., 151–154,

151n11, 152nn12–15,19,20,

153nn22–26, 154nn27–30, 171,

171n168

Abbreviated New Animal Drug

Application (ANADA), 161

Abbreviated New Drug Application (ANDA)

FDA process for securing approval

under, 33–35

statutory and regulatory scheme and,

4, 5, 10

Abbreviated New Drug Application

(ANDA) approval date, 18, 322–325

Abbreviated New Drug Application

(ANDA) filers

bioequivalence and, 20–22

claim construction specific to, 253,

267–276

discovery from perspective of,

217–218, 219

infringement and, 12–16

180-day exclusivity and, 25–27

related corporate entities actively

involved in preparing, 192–193

safe harbor and, 22–25

subject-matter jurisdiction over,

179–180

30-month stay and, 16–20

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INDEX

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Abbreviated New Drug Application

(ANDA) form, 697

Abbreviated New Drug Application

(ANDA) litigation

inter partes review in (see Inter partes

review (IPR) in ANDA litigation)

managing (see Litigation, managing)

non-paragraph IV, 77–78

Abbreviated New Drug Application

(ANDA)-specific local rules, 85–88

Abbreviated new drug submission

(ANDS), 584, 586, 588, 590, 600

Abramic, John L., 95n

Abraxis Bioscience, Inc. v. Navinta, LLC,

177n11, 178nn14,17, 179n23, 247,

247n99, 248n100, 406n3

Abridged applications for MA, 617–620,

625

Abuse of discretion, 69, 225, 343, 347,

353, 355

Abuse of power, 627n252

Accent Packaging, Inc. v. Leggett & Platt,

Inc., 293n62

Access to Affordable Pharmaceuticals Act

(AAPA), 5, 17, 19

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

320n164

Acepromazine malate, 179

Acorda Therapeutics, Inc. v. Mylan

Pharmaceuticals Inc., 51n88, 82n4,

101n32, 102nn38,39, 185, 185n73,

186, 188

Act for Ensuring the Quality, Efficacy,

and Safety of Pharmaceuticals and

Medical Devices, 640, 640n286

Actavis, Inc. v. Demahy, 520, 529

Actavis Elizabeth LLC v. U.S. Food &

Drug Admin., 9n45

Active ingredient, 8–9

Active moiety, 8–9

Activevideo Networks v. Verizon

Commc’ns, 494n22

Actos, 658

Adams Respiratory Therapeutics, Inc. v.

Perrigo Co., 53n94

Additive Controls & Measurement

Systems, Inc. v. Flowdata, Inc., 349,

349n219

Administrative order, 499

Administrative Supreme Court, 633

Admitted facts, 415–416

Adult exclusivity, 11

Adv. Cardiovascular Sys., Inc. v. Scimed

Life Sys., Inc., 189n101

Affidavits

in Australia, 561

in Canada, 589

remedies and, 350

summary judgment and, 292–294

Aggrenox Antitrust Litigation, In re, 381,

381n15

Agreements. see also Settlements

co-promotion, 381, 383–384 (see also

Nonmonetary agreements)

monetary, 380–381

no-AG, 381–382

nonmonetary, 381–383

pay-for-delay, 299, 360, 364, 378, 384,

386, 387, 398 (see also Reverse-

payment settlement)

separate, 383–384

settlement (see Settlement agreements)

technology transfer, 576, 579, 580–581

AIA. see Leahy-Smith America Invents

Act (AIA)

AIPLA 2011 Annual Survey, 538

Akamai Techs., Inc. v. Limelight

Networks, Inc., 200n186

Akro Agate Co. v. Master Marble Co.,

3n10

Aktiebolag v. Andrx Pharm., Inc., 489n36

Albany Molecular Res., Inc. v. Dr. Reddy’s

Labs., Ltd., 334n108

Alcon, Inc. v. Teva Pharms. USA, Inc.,

324n18, 345, 345n194, 346n195,

373, 373n194, 488n32

Alcon Labs., Inc. v. Allergan, Inc.,

311n130

Alcon Res. Ltd. v. Barr Labs. Inc., 483n7

Alfuzosin Hydrochloride Patent Litig., In

re, 407n11

Alito, S., 527n88, 529

Allergan, Inc. v. Actavis, Inc., 82n4, 102n33

Allergan, Inc. v. Alcon Labs., Inc., 16n80,

17n90, 97n13, 98n14, 111n99,

160n76, 164n112, 234n33, 240,

240n69, 407n12

Allergan, Inc. v. Apotex Inc., 258,

258nn39,42,43

Allergan, Inc. v. Exela Pharmsci Inc.,

304n99, 308n117

Allergan, Inc. v. Sandoz, Inc., 128n58

Altace, 601

Altana Pharma AG v. Teva Pharms. USA,

Inc., 52n92, 202nn200,204, 229n6,

239n63, 324n18, 331nn74,75,

332n84, 334n109

Alul, Andrew M., 115n

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917

Alza Corp. v. Andrx Pharmaceuticals,

LLC, 205, 205nn222,226–229,

234n32, 237n51, 238n57, 332n86

Alza Corp. v. Mylan Labs., Inc., 234n30,

235n46, 255n16

Alzheimer’s drug, 396

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

Admin., 330n65

Am. Bioscience, Inc., v. Thompson, 39n17,

40nn19,20, 341n164

Am. Greetings Corp. v. Dan-Dee Imps.,

Inc., 350nn224,225

Am. Hoist & Derrick Co. v. Sowa & Sons,

408n19

Am. Standard, Inc. v. Pfizer Inc., 500n65

Am. Tel. & Tel. Co. v. Winback & Conserve

Program, Inc., 329n58

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

Inc., 275n124, 329nn62,63,

330nn64,72, 332nn89,90, 333n97,

343nn174,177, 486n20

Ambien CR, 372

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

100n21, 422, 422nn66,67,68

Amneal Pharm., LLC v. Endo Pharm.

Inc., 131n10, 135n40

Amneal Pharm., LLC v. Supernus

Pharm., Inc., 138n63

Amrix, 162

ANADA. see Abbreviated New Animal

Drug Application (ANADA)

ANDA. see Abbreviated New Drug

Application (ANDA)

Anderson J. Jonas, 495n29

Anderson v. Liberty Lobby, Inc., 283n18,

288, 288nn37,42, 290, 290n44,

291nn47,50, 320n167

AndroGel Antitrust Litig., In re, 366n37,

368n43

Andrx Pharms., Inc. v. Biovail Corp., 1n2,

70n218, 281n12

ANDS. see Abbreviated new drug

submission (ANDS)

Annex I, 576, 576n50

Answer

antitrust counterclaims in, 209–210

counterclaim to delist Orange Book

patent in, 208–209

defenses in (see Defenses)

form for, 709–715

Answering brief, 505, 509–510

Anticipation

experts and, 219, 220, 230, 235, 236

IPR and, 145

pretrial preparation and, 410

remedies and, 332

in responding to complaint, 201–203

summary judgment and, 283, 297, 315

Antitrust

how issues arise regarding, 377

legal theories in ANDA antitrust cases

in, 378–399

managing litigation and, 536

overview of, 377–378

remedies in, 399–403

settlement and, 360–361, 363–368, 374

summary judgment and, 288, 301–302

Supreme Court and, 527, 528

Antitrust counterclaims, 209–210

Antitrust violations, 367–368, 374

ANVISA. see Brazilian Agency of

Sanitary Surveillance (ANVISA)

A123 Sys. Inc. v. Hydro-Quebec, 193n128

Apotex, 373, 374

Apotex, Inc., In re, 92n53, 111n99

Apotex, Inc. v. AstraZeneca, 598n137

Apotex, Inc. v. AstraZeneca Canada Inc.,

598n139

Apotex, Inc. v. Bayer, 595n127

Apotex, Inc. v. Canada, 585nn77–80

Apotex, Inc. v. Daiichi Sankyo, Inc.,

16n85, 62n174, 65n189

Apotex, Inc. v. Eisai Inc., 60,

60nn150,152,153,154, 183

Apotex, Inc. v. FDA, 324n24, 336,

336n128

Apotex, Inc. v. Merck & Co., 595n126,

597nn133,134,136, 598nn140,141,

602n165

Apotex, Inc. v. Novartis AG, 62n174,

65n188

Apotex, Inc. v. Pfizer Canada Inc.,

598n142, 599nn143,144

Apotex, Inc. v. Sanofi-Aventis, 199n145,

600nn148–153, 601, 601nn154–

157,159,160, 602nn161,163–168

Apotex, Inc. v. Shalala, 73n241

Apotex, Inc. v. Takeda, 598n137

Apotex, Inc. v. Thompson, 39n18

Apotex, Inc. v. Wyeth LLC, 136n52,

143n89, 145n100

Apotex Corp. v. Alcon Res., Ltd., 143n89,

145n100

Appeal briefs, 505, 510–512

Appeals

answering brief in, 509–510

budget for, 538

in Canada, 595–596

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