Supplementary protection certificate
With Supplementary Protection Certificates (English: SPC for Supplementary Protection Certificates) it is in the European Union, the United States and other countries possible concerning patents products such as medicines and pesticides that are approved by the duration of patent protection according to statutory criteria at the request to extend up to five years ( supplement ).
Background
The supplementary protection certificate relates to drugs or pesticides. Placing on the market, that is, the use or marketing of such products is the fulfillment of certain eligibility criteria the requirement. The test for the fulfillment of which is carried out in appropriate drug approval process at the request, it may take years, during which a patent holder can not use his patent economically. Because the pharmaceutical research is a particularly difficult and expensive, to the supplementary protection certificate for this "lost " time between patent application and approval time, which is the chance to come on the market that provide a balance.
Legal foundations
The legal basis for supplementary protection certificates in the EU have been created with the " Regulation ( EEC) No 1768/ 92 of the Council of European Communities of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products ". This was due to multiple, substantial amendments, and for reasons of clarity and rationality ( according to Recital 1 of the codified Regulation ) by Regulation ( EC) No 469/ 2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for drug codified.
Effect
The effect refers to the respective national basic patent. The certificate is not an extension of a patent, but granted within the scope of the basic patent protection on a product, such as a drug or combination of active substances for which there is a first marketing authorization ( approval). The term of the basic patent and the hazards arising from the basic patent " monopoly " is extended with respect to the approved product, up to a maximum of five years ( completed ).
The duration of the certificate begins at the end of the lawful term of the basic patent for a period equal to the period between the filing of the application for the basic patent and the date of first marketing authorization in the (European) Community reduced by a period of five years ( (EEC ) No 469/ 09, Article 13).
The certificate confers the same rights as the basic patent, but is also subject to the same limitations and obligations ( ( EC ) No 469/ 09, Article 5). " Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product that is covered by the marketing authorization of the corresponding product, and for any use of the product as a drug, that of before the end certificate have been approved " ( (EEC ) No 469/ 09, Article 4).
Formal criteria for granting
After (EEC ) No 469/ 09, Article 3, the following criteria for the grant of a protection certificate must be met:
- Upright basic patent for the product
- Valid, first marketing authorization ( approval)
- Be issued with a different certificate for product
Grant procedure
Supplementary Protection Certificates are before the national patent offices within 6 months after the grant of the marketing authorization or, if that before entering to apply within 6 months after the date of grant of the basic patent ( (EEC ) No 469/ 09, Article 7 ).
Supplementary Protection Certificates are issued after a thorough examination of the relevant patent offices for upright basic patents. In this case, the duration of the supplementary protection certificate under Regulation (EEC ) No 469/ 09, Article 13 is determined.
Extension of a supplementary protection certificate
To promote studies on the usefulness of drugs in the population of persons under age 18, may - according to Regulation ( EC) No 1901/2006 of 12 December 2006 on medicinal products - in the presence of a marketing authorization for pediatric populations, the runtime one according to regulations (EEC) No 1768 /92 or 469/ 09 ( for example, Article 13 ( 3) ) issued and upright supplementary protection certificate be extended upon application by 6 months.