IP LAW & PRACTICE Articles Supplementary protection certificates (SPCs)

Supplementary protection certificates (SPCs)

Supplementary protection certificates (SPCs) and pediatric extension of patents

What is an SPC and which categories of patents does it cover?

An SPC title is granted for inventions concerning pharmaceuticals and plant protection agents. It safeguards extension of the 20-years patent protection term depending on the time elapsed between the date of filing of a patent application and the date of grant of a market authorization for a specific product that falls within the scope of protection of the basic patent.

The legislative ratio of SPC protection is to partially compensate the patent holder resp. manufacturer of a product for that period of the patent duration that remained commercially unexploited until grant of the necessary market authorization.

What is the term of protection of an SPC?

The maximum term of protection for an SPC title is 5 years. The calculation module for the SPC duration is the following: date of grant of the first market authorization minus the date of filing of the basic patent application minus 5 years.

How can an SPC title be granted?

SPC protection in Greece can be obtained subject to an application at the Patent Office supported by relevant documentation. Annuities are due for each year of SPC protection.

What are the requirements for obtaining SPC protection?

An SPC is granted subject to substantial examination by the Greek Patent Office. Although EU legislation provides for the substantial SPC requirements, no central prosecution of SPC applications in the EU is available. The requirements for grant of an SPC are:

a) a pharmaceutical or a plant protection agent which the SPC is applied for;

b) a basic patent offering protection to the product according to the scope of the patent’s claim(s);

c) a market authorization (MA) for the product; an MA may be a Greek one or a central European one;

d) MA must be the first in the market (EEA) for the SPC term to be calculated;

e) no other SPC must have been granted to the same SPC-applicant for the same product. If the same SPC-applicant holds more than one patents protecting the same product, then more SPC applications may be filed.

What is a pediatric extension of an SPC?

Given that pharmaceuticals destined to be delivered to children and minors are subject to additional specific clinical trials necessary to safeguard medicinal efficacy and safety for this target group of patients, a 6-months extension of the patent protection, resp.

SPC protection term, is granted. Such extension is available provided that a pediatric investigation protocol (PIP) has been approved.

How is a pediatric extension of an SPC protected?

Once a certificate of pediatric extension is granted by the Patent Office, the holder enjoys protection through the full range of legal means of a patent holder, including cease and desist claims, compensation for material and moral damages, preventive measures, interlocutory injunction for preliminary judicial protection.

 

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