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What is the relevant date of marketing authorization to determine the term of an SPC?

Authors: Dr. Oliver Ladendorf, Dr. Alexander Kleefen

For medicinal products and plant protection products, the economically useful protection term conferred by a patent in the European Economic Area (EEA) is usually restricted significantly by the fact that the respective product may not be placed on the market without a marketing authorization by the European Medicines Agency (EMA, formerly EMEA). Accordingly, the date on which the product may be placed on the market is usually delayed for several years due to the time-consuming authorization procedure. In order to compensate for this, supplementary protection certificates (SPCs) may extend the duration of protection of the basic patent for up to five years, and optionally a further six months extension may be awarded in the case of a paediatric application of
medicinal products. […]

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