Patent law harmonisation continues

Introduction of Bolar exemption
As of 18th December 2009, Norway amended its Patents Act to introduce a Bolar-type exemption from the exclusive right of the patent owner. Implementing Article 10(6) (amended) of Directive 2001/83/EC (introduced by Directive 2004/27/EC) and Article 13(6) of Directive 2001/82/EC (introduced by Directive 2004/28/EC), the new Section 3(3)(5) of the Patents Act now reads:

The exclusive right shall not include:... 5. 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 Organization.

Under Article 10(6) of Directive 2001/83/EC, certain applications set out in paragraphs 1 to 4 of Article 10 are exempted (eg, generic applications and biosimilar applications). However, the new exemption is more far reaching. It is not limited to the specific types of application mentioned by the directive, but also includes tests and trials that are required for applications relating to any type of marketing authorisation - for example, in respect of original pharmaceuticals. The territorial scope is also wider than that required under the directive, in that it is defined as having a marketing authorisation issued in any contracting state of the Agreement establishing the World Trade Organisation.

The strict language of the directive was implemented in Sweden, so that only tests and trials necessary to obtain marketing authorisation for generic pharmaceuticals as described by Article 10 of the directive in a member state of the European Economic Area are exempt. Like Norway, Denmark also exempts tests and trials needed to obtain marketing authorisation for generic and original pharmaceuticals, but extends this to include applications in all countries. Thus, three of the Nordic countries (ie, Sweden, Denmark and Norway) have implemented the directive in different ways.

Amendments to novelty requirement
In a decision of 7th January 2010 the Second Division of the Norwegian Patent Office (appeal board) stated that the novelty requirement in Norwegian patent law should no longer include a requirement that, to be deemed novel, an invention should show a “reasonable technical difference” from the state of the art. The Second Division referred to the practice of the European Patent Office and German courts, and stated that an invention should be considered to be novel if it cannot be "derived directly and unambiguously from one reference in the art”, also in view of common general knowledge and any documents referred to in the reference considered.

Thus, Norwegian patent law is now in line with European Patent Office (and German) practice on novelty.


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