Supplementary Protection Certificate

Supplementary Protection Certificate (SPC) provides exclusive marketing rights to the holder of patent. The testing and clinical trials of the products take a long time and this result in loss in effective time duration of the patent of the product. The aim of the SPC is to compensate patent holders for the loss of this loss.

There are certain other products (medical devices and auxiliary substances in a medicinal product) which suffer patent term loss due to the authorisation and approval delay but do not fall under the Supplementary Protection Certificate category. These products have no direct therapeutic effect on their own so they can not enjoy the benefits offered by the Supplementary Protection Certificate

SPC protection is applicable in all 27 EU member countries.

SPC protection is also applicable to some other non-EU countries as under:

• • United Kingdom
• • Norway
• • Iceland
• • Switzerland
• • Liechtenstein
• • Albania
• • Bosnia & Herzegovina
• • Macedonia
• • Serbia

Information provided by Chemxpert for Supplementary Protection Certificate:

• Active Ingredients: Name of the chemical or active ingredient.
• Application Type: Type of application, which is NDA (New Drug Application), and ANDA (Abbreviated New Drug Application)
• Application Number: Application number or registration number for Supplementary Protection Certificate filing
• Trade name: It provides the trade name (brand name) of the product.
• Period of Extension Granted: It gives the duration for which the SPC is effective or the duration for which extension is granted under Supplementary Protection Certificate.
• Patent Expiry Date: It provides the date on which actual patent is going to expire or has expired.

For Example: There are 29 entries for Supplementary Protection Certificate of Paracetamol in our database. Information regarding one of them has been provided as under:

• Active Ingredients: Paracetamol
• Application Type: N (NDA)
• Application Number: 204767
• Trade name: Paracetamol
• Period of Extension Granted: Not Available
• Patent Expiry Date: 2030-04-19