G 2/08
G 2/08 is a decision issued by the Enlarged Board of Appeal of the European Patent Office (EPO) on 19 February 2010. The decision deals with the patentability of medications. More specifically, the decision deals with claims directed to second medical use. Second medical use claims pertain to medications to be used for particular conditions or diseases. In the case at issue, the second medical use pertains to a new dosage regime of a known substance.
The questions
The three questions referred to the Enlarged Board of Appeal were:Answers to the referred questions
The Enlarged Board of Appeal answered these questions as follows:The first two answers mean that a new dosage regime of a drug can render patent claims novel and inventive. A patent having such claims may be granted provided the other requirements of the European Patent Convention are met. More specifically, the Enlarged Board of Appeal approved the following specific uses of known medications:
- treatments of a novel group of patients,
- alternate routes or modes of administration,
- technical effects leading to genuinely new applications.