“Article 17.2 ‐ By way of derogation from the provisions of (a) of Article 17 above, the term of
protection of a patent for a pharmaceutical product, which as a medicine must be the subject
of a marketing authorization, according to the relevant legislation and regulations in force,
shall be extended upon the request of the patent holder or his/her representative, following
payment of prescribed fees, for a term equal to the number of days that have elapsed
between the expiry date of the term scheduled for the award of the marketing authorization
and the actual date on which it is granted.
The extension application referred to in the first paragraph above shall be filed by the patent
holder or his/her representative with the agency responsible for industrial property, within
three months from the date on which the product, as a medicine, became the subject of the
above‐mentioned marketing authorization.
The formalities for filing the extension application referred to in the first paragraph above shall
be laid down by regulation.”
“Article 17.3 – The extension of the term of protection referred to in the first paragraph of
Article 17.2 above shall take effect upon the expiry of the legal term of protection of the
patent, and may not exceed two and a half years.
The extension of the term of protection of the patent shall be the subject of a certificate
drawn up by the agency responsible for industrial property, handed to the applicant or his/her
representative. Mention of the extension shall be recorded in the national patent register.
This certificate shall afford the same rights as those afforded by the patent and shall be subject
to the same limitations and obligations.”
“Article 17.4 – The certificate of extension of the term of the patent referred to in the second
paragraph of Article 17.3 above shall only be issued if, on the date when the extension
application referred to in the first paragraph of Article 17.2 above is filed,:
(a) the product, as a medicine, is protected by a valid patent;
(b) the product, as a medicine, is the subject of a valid marketing authorization according
to the relevant legislation and regulations in force;
(c) the product has not already been the subject of an extension certificate; and that
(d) the authorization mentioned in (b) is the first marketing authorization.
Within the limits of the protection afforded by the valid patent, the protection afforded by the
certificate provided for in the second paragraph of Article 17.3 above shall extend to the single
product covered by the marketing authorization.
The provisions of Article 50 below shall apply to the validity extension certificate for the
patent.”