The Bolar exemption included in The Norwegian Patents Act
As from 18 December 2009 The Patents Act, Section 3, third subsection number 5, states that the exclusive right obtained by a patent does not include: "Trials, experiments and similar of a patented medicine that are required to obtain a marketing authorisation for a medicine in a state that is a contracting party to the agreement of 15 April 1994 on the establishment of the World Trade Organisation".
The wording of this exemption to the rights conferred by a pharmaceutical patent is broad. It is worth noticing that this exception includes trials and experiments for obtaining a marketing authorisation in any country that is a party to the WTO agreement, and not only for countries within the EEA (European Economic Agreement). This brings the Norwegian legislation in line with e.g. Denmark, Germany and Finland. The exemption also applies both for generica and for newly developed pharmaceuticals, and covers pharmaceuticals for both humans and animals. It is also allowed to produce a small quantity of the pharmaceutical in order to conduct the necessary trials.
However, it is not allowed to build up a storage of a (generica) copy pharmaceutical within the patent term with the intention to put this copy medicine (generica) on the market as soon as the patent protection for the original pharmaceutical expires. The patent term covered by the exemption is the total patent term of the "normal" 20 years pluss the additional extension obtained through a SPC (Supplementary Protection Sertificate). The exemption only covers the pharmaceuticals and not e.g. patented methods or tools to be used in the trials and experiments.
This amendment will have an impact for generica producers, but also for the producers of new medicines, which now may perform trials and experiments in Norway that are necessary for obtaining the marketing authorisation prior to the expiry of the total patent term. On the other hand the patentees of original pharmaceuticals will have a somewhat less exclusive right.
By Kristine Rekdal, M.Sc. Physics, Bryn Aarflot AS
Published in Managing Intellectual Property, February Edition 2010
