Index

• Pages: 387-393

387

Index

Abbreviated New Drug Application

(ANDA), 41, 42, 137, 138, 142,

149–151, 163–164, 181, 182–266

ANDA. See Abbreviated New Drug

Application (ANDA)

antitrust law

barriers to entry and, 17–19

biosimilars and, 272–287

grantbacks and, 25–26

group boycotts and, 44–54

intellectual property acquisition and,

7–26

intellectual property ownership and,

34–56

intellectual property procurement and,

27–34

joint ventures and, 22–24

licensing and, 19–22, 57–69

modes of analysis in, 323–335

overview of, 1–6

standard essential patents and, 289–314

tying and, 54–56

antitrust safety zones, 67–69

appellate jurisdiction, 117–119

barriers to entry, 17–19

Biden, Joe, 1

bifurcation, in litigation, 121–124

Biologics Price Competition Act (BPCIA), 4,

266–267

biosimilars

antitrust issues with, 272–287

approved drugs, 268–269

disparagement and, 284–286

litigation with, 266–287

statutory basis with, 266–269

boycotts, group, 44–54

bundling restraints, 83–88

Cartwright Act, 81–82

Clayton Act, 14, 154–155

collusion allegations, lack of, 142–143

copyright misuse, 175–178

copyrights, securing, 33–34

cross-licensing, 346–348

agreements, 105–108

intellectual property acquisition and,

24–25

settlements with, 108

customer restraints, 69–71

defenses

copyright misuse, 175–178

in litigation, 172–179

patent misuse, 172–175

trademark misuse, 178–179

Delrahim, Makan, 1

Department of Justice (DOJ)

actions with standard essential patents,

309

licensing guidelines, 58–69, 315–352

Department of Justice (DOJ), licensing

guidelines, 117

discriminatory royalties, 90

disgorgement, 156

disparagement, biosimilars and, 284–286

DOJ. See Department of Justice (DOJ)

duty to disclose obligations, 291–292

equitable relief, 156

European Commission, 312–313

exclusionary restraints, 107

exclusion orders, 301–308

exclusive dealing restraint, 77–80,

345–346

exclusive grant restraint, 73–77

exclusivity, licensing and, 66–67, 72–80

fair, reasonable, and nondiscriminatory

terms (FRAND), 5, 13, 289,

290–291

fair, reasonable, and nondiscriminatory

terms (FRAND) rate, 292–301

Federal Trade Commission (FTC)

actions with standard essential patents,

309–311

licensing guidelines, 58–69, 117,

315–352

reverse-payment settlement agreements

and, 183–187

field-of-use restraints, 71–72

fixing royalties, 92

foreign actions, with standard essential

patents, 312–314

Foreign Trade Antitrust Improvements

Act (FTAIA), 124, 141

FRAND. See fair, reasonable, and

nondiscriminatory terms

(FRAND)

FTC. See Federal Trade Commission

(FTC)

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