The so-called ‘Bolar exemption’ finds legal basis in EU Directive 2004/27/EC modifying Directive 2001/83/EC on the Community code relating to medicinal products for human use. Article 10(6) of EU Directive 2001/83/EC states that:
The present system of European (EP) patents granted by the European Patent Office, has the drawback that the same patent, validated in several states, may lead to several parallel disputes in these jurisdictions.
The Unified Patent package creates a unitary effect for European patents encompassing the states that have ratified the Unified Patent Court Agreement (UPCA – to be found here). That is to say, an EP patent with unitary effect will have the same effects in all the states that ratified the UPCA and where said patent has been validated.
Although the German Parliament (« Bundesrat ») recently voted in favor of the ratification of the Unified Patent Court Agreement (UPCA) (that we reported here), and despite the political will (see there), the German ratification of the UPCA is again put on hold.
The German Federal Constitutional Court (FCC) advised that that two new constitutional complaints were filed on the very same day on which the Bundesrat approved the ratification (18th December 2020).
One of the complaint, filed by Düsseldorf lawyer Ingve Stjerna, who already filed an earlier constitutional complaint in 2017, aims at obtaining an interim order to cease the ratification process until a decision on the merits.
Protocol to the Agreement on a Unified Patent Court on provisional application: allows part of the UPC Agreement to be applied early
COMMISSION DECISION (EU) 2015/1753 of 30 September 2015: Confirms the participation of Italy in enhanced cooperation in the area of the creation of unitary patent protection