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制药提价与抑制仿制药方式 472条(本栏目收费,不能显示细节,电话13136136841)
threat of to pharma executives, 7
7
generic delay. See also citizen petitions as delay
tactic; Generation 2.0 strategies; Generation
no- authorized- generic agreements, 61,64
61 64
Noerr- Pennington cases, 99,100, 134
99 100 134
non- patent exclusivities, 32
32
NPR’s All Things Considered, 94
94
Obama, Barack on rising costs of prescription medication, 5
5
off- label use of medication, 104
104
Opana (opiate painkiller, Edon), 94,95
94 95
Orange book, 29,30, 55
29 30 55
Orphan Drug Act, 33, 109
33 109
for Abilify (antipsychotic, Otsuka), 110,112
110 112
for Crestor (statin, AstraZeneca),108,110, 111,112
108 110 111 112
Paragraph IV certification, 22. See also Hatch- Waxman Act (U.S., 1984)defined, 29
29
duopoly and profits created by exclusivity period, 22, 30,31
22 30 31
exclusivity period elapsement for first generic filers and, 38
38
K- Dur case, 50,51, 52
50 51 52
patent infringement litigation and, 22
22
weak or misapplied patents for quick generic entry and, 29,30
29 30
allowance of patent- protected brand- name information for generic research via Hatch- Waxman Act, 26,27
26 27
business method patents, 84
84
costs to society of abuse of patent systems and, 23
23
method- of- use patents, 103
103
new drugs non- patent exclusivities in, 32,33
32 33