The Düsseldorf Court of Appeal referred certain questions to the CJEU for a preliminary ruling as to whether, in the case of a generic company seeking to shelter under the Bolar exemption, a third party who supplies active ingredients to that company is also sheltered (C-661/13).
The Düsseldorf district court had ruled that a supplier would need to be a co-organiser of tests or studies in order to benefit from the Bolar exemption.
The parties, Japanese pharmaceutical company Astellas Pharma Inc and Polish company Polpharma S.A. Pharmaceutical Works, have settled their dispute and the case has been withdrawn.
If the Bolar exemption is personal to the party carrying out the tests to obtain the marketing authorisation, the exemption is severely limited. Generic companies wishing to carry out the tests will be forced to turn to suppliers outside the EU in countries where there is no patent protection. This is not in the interests of European industry for whom the exemption was enacted. On the other hand, permitting the stockpiling by generics suppliers of patented drugs within the EU for the uncertain purpose of supplying customers who may or may not use them for Bolar test purposes would represent an erosion of the traditional patent monopoly.