The Court of Justice clarifies certain provisions governing parallel importation

20 February 2015

News & Views
Author: Mike Snodin

On 12 February 2015, the Court of Justice (CJEU) handed down its judgement in Merck Canada, Merck Sharp & Dohme v Sigma Pharmaceuticals (C-539/13). The judgement effectively confirms the earlier opinion of Advocate-General Jääskinen and provides guidance on the interpretation of the provisions of the so-called Specific Mechanism, which governs parallel importation of certain medicinal products from the “newer” Member States of the EU (i.e. states acceding to the EU since 2003).

For a case having a connection with SPCs, the judgement in C-539/13 is fairly unusual in that the responses provided by the CJEU answer more questions than they pose.

Indeed, it is even possible for parallel importers to glean some practical tips from the CJEU’s answers – the most important of which being the necessity to conduct careful due diligence on the status and ownership of the patent and SPC protection in force for the medicinal product(s) to be imported.

Moreover, rights owners who may have inadvertently failed to invoke the Specific Mechanism within 1 month of receiving notification of proposed parallel importation can now be confident of their right to prevent future importation and sales. It may even be possible to recover losses due to past importation and sales, but only if there are convincing grounds to assert that the notification provided by the parallel importer was inadequate (i.e. if it did not meet the standards set out by the CJEU).