Article 13 Duration of the certificate

The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in F1the area comprising the European Economic Area and the United Kingdom, reduced by a period of five years.

Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.

The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where F2regulation 58A of the Human Medicines Regulations 2012 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.

Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years.

An extension of the duration of a certificate in accordance with paragraph 3 in respect of—

on condition that the territorial protection conferred by the extension does not exceed that conferred by the certificate.