Supplementary Protection Certificates

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Patents

With medicines and crop protection products, usually one cannot profit from full patent protection for the maximum term of 20 years.

Apart from a patent, the producer must also obtain a market authorization from the various authorities to allow him to market his product. This usually takes quite some time because extensive research is carried out into the potential side effects and risks to public health and the environment. A short, effective term of protection is insufficient to recoup investment and therefore discourages technological innovation in these sectors. In view of this, the European Community has introduced legislation providing for two Supplementary Protection Certificates (SPCs): for medicines (Regulation 469/2009), and for crop protection products (Regulation 1610/96).

Applying for SPCs

Businesses, entrepreneurs and private individuals in the medicines and crop protection sector may apply for a supplementary protection certificate for the Netherlands. The certificate protects the active ingredient of a medicine or a crop protection product. This active ingredient must, however, already be protected with a patent valid for the Netherlands. In addition, a market authorization for marketing the active ingredient in the Netherlands as a medicine or crop protection product must have been obtained. This market authorization must be the first that has been issued for the Netherlands. A supplementary protection certificate can provide an extra 5 years of protection after the patent has expired. (see downloads for the application form - only in Dutch)

SPC term extension

Some (adult) medication is prescribed to children without having been specifically tested on this population group. Recently new legislation (Regulation 1901/2006) has been introduced by the European Community encouraging the pharmaceutical industry to carry out these extra tests. As an incentive businesses may qualify for a fixed 6-month extension of the duration of their supplementary protection certificate.

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