Supplementary protection certificate

With Supplementary Protection Certificates ( english Supplementary Protection Certificates , SPC ) is in the European Union , the United States can and other countries, the duration of patent protection for patents relating to products such as drugs or pesticides that are allowed a maximum of statutory criteria upon application to extend (supplement) five years.

background

The supplementary protection certificate relates to medicinal products or plant protection products. For placing on the market, d. H. The use or marketing of such products requires the fulfillment of certain approval criteria. The examination of their fulfillment, which is carried out in corresponding drug approval procedures on request, may take years during which a patent holder cannot use his patent economically. Because pharmaceutical research is considered to be particularly expensive and time-consuming, the additional protection certificate is intended to compensate for this “lost” time between the patent application and the time of approval, i.e. the opportunity to come onto the market.

Legal basis

The legal basis for supplementary protection certificates in the EU was created with Regulation (EEC) No. 1768/92 of the Council of the European Communities of June 18, 1992 on the creation of a supplementary protection certificate for medicinal products . This regulation was, due to multiple, significant changes and for reasons of clarity and clarity (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 on the supplementary Protection certificate for medicinal products replaced and newly codified.

effect

The effect relates to the respective national basic patent. The certificate is not an extension of a patent, but grants protection for a product within the scope of protection of the basic patent, for example an active substance or a combination of active substances, for which an initial authorization for placing on the market (approval) is available. The term of the basic patent and the "monopoly position" resulting from the basic patent is extended (supplemented) with regard to the approved product by up to a maximum of five years.

The term of the certificate begins with the expiry of the legal term of the basic patent for a period that corresponds to the period between the filing of the application for the basic patent and the time of the first approval for placing on the market in the (European) Community, minus a period of five Years ((EC) No. 469/2009, Article 13). According to the ECJ (C-471/14; October 6, 2015), the date of the notification regarding the granting of the first marketing authorization in the Official Journal of the European Union is to be regarded as the date of the first approval .

The certificate grants the same rights as the basic patent, but is also subject to the same restrictions and obligations ((EEC) No. 469/2009, Article 5). "Within the limits of the protection granted by the basic patent, the protection granted by the certificate extends solely to the product that is covered by the marketing authorization for the corresponding medicinal product, namely to those uses of the product as medicinal products that were made before the expiry of the Certificate “((EC) No. 469/2009, Article 4).

Formal criteria for grant

According to (EC) No. 469/2009, Article 3, the following criteria must be met for a protection certificate to be issued:

upright basic patent for the product
valid, first authorization for placing on the market (authorization)
no other certificate issued for product

Grant procedure

Supplementary protection certificates must be requested from the national patent offices within 6 months of the granting of the authorization for placing on the market or, if this occurs before that, within 6 months of the date on which the basic patent was granted ((EC) No. 469/2009, Article 7 ).

Supplementary protection certificates for valid basic patents are issued by the responsible patent offices after thorough examination. The duration of the supplementary protection certificate according to (EC) No. 469/2009, Article 13 is also determined.

Extension of a supplementary protection certificate

In order to promote studies on the usability of medicinal products in the population group of people under 18 years of age, the term can - in accordance with Regulation (EC) No. 1901/2006 of December 12, 2006, on medicinal products for children - if a marketing authorization for pediatric population groups is available of a supplementary protection certificate issued in accordance with Regulation (EEC) No. 1768/92 or (EC) 469/2009 (e.g. Article 13 (3)) can be extended by 6 months upon request.

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