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The Netherlands implements Bolar legislation for generic medicines

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The Netherlands implements Bolar legislation for generic medicines

The Netherlands implements Bolar legislation for generic medicines

A medicine may be placed on the market only when a special authorization to do so has been granted. To obtain such authorization, it is required to test the medicine clinically.

According to a judgment of the Supreme Court in ICI v. Medicopharma (December 18, 1992), performing clinical tests intended to be used for obtaining a marketing authorization is regarded as patent infringement in the Netherlands when the medicine falls within the scope of protection of a patent in force. Only when the research is of a scientific nature and is aimed, for instance, at finding a new medical use of the patented medicine, can reliance be made on the so called experimental use exception and is no patent infringement involved.

With effect from February 1, 2007, the Dutch Patents Act 1995 will be brought into line with the Directives 2004/27/EC and 2004/28/EC. After this amendment of the law, clinical tests serving to demonstrate that a medicine is a generic version of a (patented) reference medicine will no longer be regarded as patent infringement. Such tests are required in the context of an accelerated registration procedure of a medicine when a marketing authorization has previously been granted to another applicant for the same medicine in the same dosage for the same indication. For other medicines, the situation remains unchanged.

This amendment relates to both human and veterinary products.

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