Table 2 Overview of prevention strategies

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)