At long last, a referral to the Court of Justice of the EU (CJEU) was expected to clarify the scope of the European Bolar exemption with regard to the supply of patented products. More particularly, the CJEU was asked whether the supply of patent-protected products to a generics company which intends to use the product in tests necessary to obtain marketing authorisation is exempt from patent infringement under the Bolar provisions in Europe. For a report on the background to the case click here.
However, disappointingly, the matter was removed from the CJEU register in July 2014. The case had originated from a referral by the Düsseldorf Appeal Court during the course of an appeal, Astellas Pharma Inc. v Polpharma SA Pharmaceutical Works. We understand that the appeal was subsequently resolved in a way which rendered the referred questions obsolete for this case. The Düsseldorf Appeal Court therefore withdrew the questions referred to the CJEU inC-661/13, resulting in the case being closed.
Whilst the questions referred by the Düsseldorf Appeal Court were no longer relevant to the Astellas appeal, the answers to the questions could have provided much needed guidance on the scope of the Bolar exemptions. We can only hope that a new referral on this issue will be made in the near future.