Advocate General Niilo Jääskinen’s opinion on the interpretation of the Specific Mechanism (in the case of Merck v Sigma (Case C-539/13) was delivered on 23 October 2014.

The case of Merck v Sigma was a reference from the Court of Appeal of England and Wales. It concerned the parallel importation of Merck’s asthma treatment, Singulair, from Poland (one of the countries that joined the EU in 2004) into the UK. In 2011, Merck brought an action against Sigma alleging that Sigma’s parallel importation and marketing of Singulair infringed its rights in breach of the Specific Mechanism.

The Specific Mechanism was agreed at the time of the accession of new Member States to the EU in 2004 in recognition of the fact that a number of those new Member States had not previously allowed for patent protection for pharmaceutical products (or SPCs).  The current dispute arose out of the requirements under the Specific Mechanism for notice to be given in relation to proposed imports of affected products from the Member States that acceded to the EU in 2004.

The Court of Appeal referred three groups of questions concerning the interpretation of the Specific Mechanism to the CJEU, specifically:

  1. the conditions which must be satisfied before a patent holder may bring infringement proceedings (if any);
  2. the identity of the person who must give the notice; and
  3. the identity of the person to whom the notice must be given

Findings

With respect to the first of these questions, the Advocate General found that….”a patent owner, duly notified, of an intention to import or market pharmaceutical products covered by the Specific Mechanism …. is required to respond to such notification and demonstrate an intention to oppose the proposed import and marketing”.

Under this interpretation, the patent owner is therefore able to “use his right to prevent parallel importations, but only with respect to activities taking place after his reliance on his rights was communicated to the importer.”

On the identity of the person who must give the notice, the Advocate General found that this may be carried out by someone other than the potential importer and marketer “provided that the identity of the [importer / marketer] is clearly identified by the notifying entity”.

Finally on the identity of the person notified, the Advocate General found that the prior notification must be given to a person who has a “legal right under national law to bring proceedings to enforce the patent or supplementary protection certificate”.

Comment

If the CJEU follows the Advocate General’s approach, pharmaceutical companies will have to be very alert to notifications from parallel importers in order to ensure that they safeguard their rights.  Equally parallel importers must be careful to send compliant notification letters. We will post an update when the decision of the CJEU is given (no date is yet fixed).