Life sciences
7 min read
The five years most biotechs forget
A medicine can spend a decade in development before it is sold, eating into its patent term. Supplementary protection certificates give some of that time back — if you apply on time.
Oona Keating
Senior associate · Life sciences
Published
Length
7 min read
In short
SPCs can add up to five years for authorised medicinal products.
Overall protection is capped at fifteen years from first authorisation.
Apply within six months — there is no discretion to extend.
UK and EU certificates now follow separate tracks.
Oona Keating
Senior associate · Life sciences
Published
Length
7 min read
In short
SPCs can add up to five years for authorised medicinal products.
Overall protection is capped at fifteen years from first authorisation.
Apply within six months — there is no discretion to extend.
UK and EU certificates now follow separate tracks.
Most of a medicine’s patent life is spent before it reaches a patient.
Patent term is lost to regulation
A patent lasts twenty years from filing. For a medicinal product, a large part of that term is consumed by trials and regulatory review before the product can be sold. Supplementary protection certificates exist to restore part of that lost time.
An SPC can extend protection for the authorised product by up to five years, subject to an overall cap of fifteen years of protection from the first marketing authorisation. A further six months may be available where agreed paediatric studies have been completed.
The deadline that is not forgiving
The application must be made within six months of the first marketing authorisation, or of the grant of the patent if that comes later. Late applications are refused. Since the end of the Brexit transition, UK certificates are applied for separately from those in EU member states, with their own practice and their own timetable.
Plan it at the filing stage
Which patent the certificate is based on, and how the product is defined in the claims, decides what the SPC will cover. Those choices are best made years before authorisation, when the claims are still being drafted.
The deadline is six months from the marketing authorisation. There is no discretion to miss it.
What to do next
If an authorisation is expected in the next two years, send us the patent family and the regulatory timetable. We will map the SPC strategy and the deadlines against it.
Life sciences
7 min read
The five years most biotechs forget
A medicine can spend a decade in development before it is sold, eating into its patent term. Supplementary protection certificates give some of that time back — if you apply on time.
Oona Keating
Senior associate · Life sciences
Published
Length
7 min read
In short
SPCs can add up to five years for authorised medicinal products.
Overall protection is capped at fifteen years from first authorisation.
Apply within six months — there is no discretion to extend.
UK and EU certificates now follow separate tracks.
Oona Keating
Senior associate · Life sciences
Published
Length
7 min read
In short
SPCs can add up to five years for authorised medicinal products.
Overall protection is capped at fifteen years from first authorisation.
Apply within six months — there is no discretion to extend.
UK and EU certificates now follow separate tracks.
Most of a medicine’s patent life is spent before it reaches a patient.
Patent term is lost to regulation
A patent lasts twenty years from filing. For a medicinal product, a large part of that term is consumed by trials and regulatory review before the product can be sold. Supplementary protection certificates exist to restore part of that lost time.
An SPC can extend protection for the authorised product by up to five years, subject to an overall cap of fifteen years of protection from the first marketing authorisation. A further six months may be available where agreed paediatric studies have been completed.
The deadline that is not forgiving
The application must be made within six months of the first marketing authorisation, or of the grant of the patent if that comes later. Late applications are refused. Since the end of the Brexit transition, UK certificates are applied for separately from those in EU member states, with their own practice and their own timetable.
Plan it at the filing stage
Which patent the certificate is based on, and how the product is defined in the claims, decides what the SPC will cover. Those choices are best made years before authorisation, when the claims are still being drafted.
The deadline is six months from the marketing authorisation. There is no discretion to miss it.
What to do next
If an authorisation is expected in the next two years, send us the patent family and the regulatory timetable. We will map the SPC strategy and the deadlines against it.