SPC in Malta

A Malta Supplementary Protection Certificate (Medicinal) grants a further term of protection of maximum 5 years over and above the Malta standard term of patent protection of 20 years.

An SPC can be applied when the patent is still in force i.e. before the expiry date and the renewal of the SPC will start from the 20th year onwards according to the extension granted.

Malta standard term of Patent Protection	Further term (SPC)
← 20 Years →	+5 Years (max.)

The SPC is normally granted with regard to patents in the pharmaceutical field since the owner(s) of the patent would not have been able to apply for the patent due to the necessary marketing authorisation which very often is a lengthy procedure.

Requirements

Filing requirements for Malta SPC Applications:

1. Product Identity
   
   • Product (i.e. active ingredient or combination of active ingredients) for which a certificate is requested
   • Information that the product at is protected by the basic patent
   
   
2. The market authorization document:
   The Medicinal Product indicated on the Marketing Authorisation Certificate (MAC) issued by the European Commission, which must be the first one granted to place the active ingredient on the market.
   • Country which granted the first such Authorisation
   • Authorization Number(s)
   • Authorization Date
   • Identity of product thus authorised
   
   
3. The Power of Attorney;

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Pediatric Studies

An SPC granted in Malta can be extended for 6 months due to pediatric studies.

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Pharmaceutical Patents in Malta

The lack of applications for pharmaceutical patents, provides fundamental opportunities for generic pharmaceutical companies to develop and produce in Malta.
The reasons why the generic pharmaceutical industry has become one of Malta's most influential industries are mainly based on initiatives by Malta Enterprise (Government Agency) to expand the generic pharmaceutical sector and Malta's geographical location.
These offer a unique and very attractive marketing perspective for generic pharmaceutical manufacturers.

Why patenting Pharmaceuticals in Malta?

• Bolar exemption in the Maltese Patent Legislation;
• Malta's geographical location and its marketing perspectives for generic pharmaceutical manufacturers:
  • Easy access to existing trade routes;
  • Malta as an EU Member State;
  • Easy access to North African markets;
• Pharmaceutical initiatives by Malta Enterprise (Malta Enterprise: Government Agency which coordinates commercial development, trade and foreign investment);