It can often be 10-15 years between the date that a patent application for a new drug is filed and the date that the marketing authorisation (MA) for that drug is granted.
This means that a company may only have 5-10 years of patent life within which to recoup the development costs for that drug.
This issue is recognised in many countries by extending either the life of the patent or the specific product for which MA has been granted. For example, in the EU, an SPC may be granted which extends patent protection for the product for which MA has been granted for up to five years; this may be extended a further six months if paediatric investigations have also been carried out.
Similar laws apply in other countries, although the period and scope of additional protection varies.