How can an SPC title be granted and maintained?
SPC protection in Greece can be obtained subject to an application at the Patent Office supported by relevant documentation. Depending on the actual duration of an SPC title annuities are due annually for each term of SPC protection.
What are the requirements for obtaining SPC protection?
An SPC is granted upon 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 by the Greek Patent Office are the following:
- a pharmaceutical or a plant protection agent which the SPC is applied for;
- a basic patent conferring protection to the product according to the scope of the patent’s claim(s);
- a market authorization (MA) for the product; an MA may be a Greek one or a central European one;
- a Supplementary Protection Certificate is granted by the Greek Patent Office without prior examination of the provisions of Article 3, paragraphs c. and d. of the Regulation (EC) 469/2009 resp. Article 3, paragraph 2 of the Regulation 1610/96; insofar the Title is granted at the risk of the applicant.
- MA must be the first in the market (EEA) for the SPC term to be calculated;
- 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 a product, then more SPC applications may be filed. The same SPC applicant is entitled to the grant of an SPC for a different application/ use of the same product provided that the application is within the scope of the protection conferred by the basic patent.
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 SPC protection term is granted. Such extension is available provided that a pediatric investigation protocol (PIP) has been approved. Once a certificate of pediatric extension is granted by the GPO, the SPC holder will enjoy additional six months of SPC protection for his product.
How is a pediatric extension of an SPC protected against infringement?
An SPC with pediatric extension enjoys full SPC protection including cease and desist claims, compensation for material and/or moral damages, preventive measures and preliminary judicial protection. To this end appropriate legal means must be raised such as a civil action and, under circumstances, a petition for interlocutory injunction.
What are the legal means of the applicant in case of rejection by the GPO of an application for grant of an SPC or its pediatric extension?
The GPO’s decision rejecting an application for grant of an SPC or a pediatric extension of an SPC is an ordinary administrative act. As such it may be challenged through a petition for cancellation before the Supreme Administrative Court.