In the beginning of 2014, we posted a note regarding the "Specific Mechanism" and the request for a preliminary ruling in the pending case of Merck Canada Inc., Merck Sharp & Dohme Ltd v. Sigma Pharmaceuticals PLC (C-539/13). End-October 2014 Advocate General Jääskinen gave his preliminary opinion in the case.

As stated in our previous note, the case revolves around the fact that, under the Specific Mechanism, anyone intending to import a patented product that is protected under the Specific Mechanism must inform the national authorities that the patent owner or beneficiary has been given notice of such intention one month in advance.

In the pending case before the CJEU, the court is asked to whom such notification should be given and which persons are covered by the term "beneficiary". Further, the court is asked about the legal consequences flowing from the patent owner's/beneficiary's failure to demonstrate his intention to rely on his rights once such notification has been made.

In his analysis Advocate General Jääskinen concludes that the holder or beneficiary is required to respond to such a notice and to demonstrate his opposition to the importation within the one-month period. The patent owner may, however, withdraw his consent to parallel imports after the period if the importer is informed thereof, and with no retroactive gain.
Further, according to Jääskinen, the notification to the patent owner may be made by another party than the potential importer provided that the potential importer's (i.e. potentially the infringer's) identity is clearly identified in the notification.
Contrary to the Commission's observations, Jääskinen follows a literal approach, interpreting that, following the very purpose of the notification, this should be given to the owner of the patent or SPC or to a person who, in accordance with national law, may enforce these rights (e.g. a licensee), in order to enable him to rely on his rights. According to Jääskinen, this cannot be considered an unreasonably burdensome requirement as the identity of the patent owners is easily accessible following searches conducted in publicly available patent registers. That national law may allow notification to be made to group companies responsible for marketing authorisations or regulatory matters, does not affect the interpretation of the Specific Mechanism, according to Jääskinen.
If the opinion of the Advocate General is accepted by the court, it will have the outcome that a failure to respond to a notification under the Specific Mechanism would prevent the patent owner from claiming damages for the period before the importer was informed of the patent owner’s intention to rely on his patent rights. This may, in some jurisdictions, already be the case on the basis of general principles of tort law.