Module 6

03/10/2024

Duration of SPC – example 2

Patent granted

Patent filed

MA granted

1 Jan

1 Jan

31 Jul

1990

1991

1992

1993

1994

1995

5 years – 4 years 7 months = negative 5 month SPC

If 6 month paediatric extension available, term = -5 months + 6 months = 1 month

The Organisation for Professionals in Regulatory Affairs

SPCs

43

Value of SPCs

• Abbvie’s Humira (treats rheumatoid arthritis, psoriatic arthritis and psoriasis):

• Worldwide sales in 2016 >$16bn

Amgen’s/Pfizer’s Enbrel

•

• Worldwide sales in 2016 >$8bn

The Organisation for Professionals in Regulatory Affairs

SPCs

44

22