From December 18 2009 the Patents Act, Section 3, third subsection 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 Area). This brings the Norwegian legislation in line with for example Denmark, Germany and Finland. The exemption also applies both for generics and for newly developed pharmaceuticals, and covers pharmaceuticals for both humans and animals. Producing a small quantity of the pharmaceutical in order to conduct the necessary trials is also allowed.
However, building up a store of a (generic) copy of a pharmaceutical within the patent term with the intention of putting this copy on the market as soon as the patent protection for the original pharmaceutical expires is not allowed. The patent term covered by the exemption is the total patent term of the normal 20 years plus the extension obtained through a supplementary protection certificate (SPC). The exemption only covers pharmaceuticals and not for example patented methods or tools to be used in the trials and experiments.
This amendment will have an impact for generic producers, but also for the producers of new medicines, who 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 less exclusive right.
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| Kristine Rekdal |
Bryn Aarflot AS
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