Strategic patenting (“later issued patents”) |
Obtaining patent protection on different aspects around the base compound patent |
20 years from the date of filing |
Hutchins (2003), Burdon and Sloper (2003) |
Patent term restoration |
Granting of additional market exclusivity for the time lost due to FDA approval process (Title II of Hatch–Waxman Act) |
Maximum of 5 years |
Agrawal and Thakkar (1997) |
SPC |
Protective mechanism serving as an extension to patent right |
Maximum of 5 years |
Hitchcock and Tugal (2003) |
30-month stay provision |
Filing a patent infringement suit to fight ANDA |
30 months from the date of notice or till court decision |
Bhat (2005) |
Orphan drug |
Applying for orphan drug status for an already authorized drug |
7 years of market exclusivity in US, 10 years in EU |
Haffner et al. (2008), Minghetti et al. (2000) |
Pediatric exclusivity |
Submission of pediatric clinical trials on the FDA’s request |
6 months of market exclusivity |
Kvesic (2008) |
Patent settlement agreements |
Involving in settlements with generic manufacturers to delay the market entry |
Duration of the agreement |
Bulow (2004) |