Pharmacists Exemption in Dutch Patent Act

April 2019 – Silvie Wertwijn

On 1 February 2019, the so-called pharmacist exemption in the Dutch Patent Act 1995 (DPA) has become effective.

Under Article 53 DPA a patentee has the exclusive right to produce or use a patented product or patented method or carry out the other acts stated in said article. The pharmacies exemption is an exception to this exclusive right and has been laid down in Article 53(3) second sentence DPA.

The exemption is intended for the preparation of medicines for direct use for the sake of individual patients and on doctor prescription in pharmacies. This allows pharmacists to prepare the patented medicine themselves in individual cases (so-called pharmaceutical compounding), for instance if a dose or method of administration suited for an individual patient is not available. The exception is not intended to let a patented medicine be prepared on a structural scale without the consent of the patentee; for this would undermine his right.