The Bolar exemption must be interpreted narrowly in order not to affect the patent holder’s exclusive rights. The privilege of the generic drug manufacturers who are allowed to conduct clinical trials in order to seek regulatory approval for their therapeutic products based on patented inventions does not apply to their third-party suppliers. Thus, manufacturing of patented pharmaceutical ingredients and offering them to generic drug companies constitutes patent infringement.

The full summary of this case has been published on Kluwer IP Law.


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