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Archived updates for Monday, October 17, 2005

Supplementary Protection Certificate Basics

Supplementary Protection Certificates were introduced in the European Union to compensate for regulatory approval delays in bringing to market medicinal products (such as drugs) and plant protection products (such as insecticides, pesticides and herbicides). So-called "SPCs" are a sui generis form of intellectual property protection etsblished by Council Regulation (EEC) No 1768/92 for medicinal products and Regulation No 1610/96 of the European Parliament for plant protection products.

These regulations authorize certificates to be granted for products which constitute:

  • the “active ingredient”, or combination of active ingredients, of a “medicinal product”, under 1768 Art 1(b) or
  • the “active substance”, or combination of active substances, of a “plant protection product”under 1610 Art 1.8

However, the product must have received either its first authorization to place it on the market in the European Community after 1 January 1985. (Other dates may apply for medicinal products in some EC States.)

The term of a certificate is equal to the period which elapsed between the filing date of the patent and the date of the first authorization in the EC reduced by a period of five years. The term of a certificate may not exceed five years.

A certificate extends the protection conferred by the basic patent beyond the term of that patent but only with respect to the product covered by the authorization to place the corresponding product on the market. It does not extend the term of the patent itself. Applications for a supplementary protection certificate must be filed on a country-by-country basis. There is no unitary European supplementary protection certificate, but national ones only.

The International Patent Documentation Center ("INPADOC") database of the European Patent Office contains data on SPCs. However, the legal status (or "patent register service") "PRS" code used to indicate an SPC varies from country to country.

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