Norway (in addition to Finland) only accepted product patents on active ingredients in medicaments from 1. January 1992. Prior to this date only "analogous method of preparation" type of claims where accepted. This means that we still have active patents in Norway comprising such claims until the end of 2011 and Supplementary Protection Certificates (SPCs) until the end of 2016 (July 2017 if pediatric extensions is included).Because of this Norway is an interesting market for producers of generic medicaments produced by synthetic routs which differ from, and thereby not infringe, the methods claimed and exemplified by the patent owner. There are several recent examples of copy medicines in the Norwegian market for which the patent owner has failed to stop the providers to enter the Norwegian market with their generic products.
To be successful in circumventing the "analogous method of preparation" patents the synthetic methods must be sufficiently different not to infringe the synthetic pathway. In this exercise the courts rely on expertise in organic chemistry evaluating the obviousness of the method of the generic provider in relation to the patent in question. The method of the patent must be deduced from the patent claims and the method should be exemplified in the experimental section. Listing possible methods of synthesis in the description will not be sufficient to obtain protection for such methods. This is of course a challenge for the patent owner because the patent application originally were filed as product patents with limited focus on the method of preparation and with only one or a few such methods.
There are only a few court decisions to rely on in Norway in such cases and only one from the Supreme Court. Depending on the actual patent situation at hand, the outcome of trials in this area is difficult to predict and decisions in the lower courts are normally appealed.
The Norwegian policy has been to encourage competition on medicaments and the Norwegian Medicines Agency provides exchange lists of medicaments for the pharmacies. Only the cheapest medicaments on the list will be fully refunded (except for a defined self payment amount). The Norwegian Medicines Agency does not have any responsibility to evaluate the patent situation which is left to the courts to decide.
In this situation the Norwegian medicines market is attractive to generic producers and will continue to be so as long as the "analogous method of preparation" patents are in force.
For patents filed after 1. January 1992 the law and practice correspond to the law and practice in other western countries.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
