Advocate General's Opinion in SPC referral - infringement test rejected

As previously reported in our e-newsletters, InFocus - January 2011 and InFocus - October 2010, there have been a number of recent referrals to the CJEU on various aspects of the SPC Regulation.

Today, the opinion of Advocate General Trstenjak was released in the joined cases of Medeva BV (C-322/10) and Georgetown University (C-422/10). The opinion addresses the interpretation of articles 3(a) and 3(b) of the SPC Regulation. The conclusions are:

• Whether a product is "protected by a basic patent in force" in accordance with article 3(a) should be decided according to the rules governing the basic patent. However, the opinion specifically rejects the use of the infringement test.
• For article 3(b), the fact that a marketing authorisation covers additional "products" does not preclude the grant of an SPC for the patented product(s). This means that an SPC can be granted for a single component of an authorised multi-disease vaccine.

The opinion is non-binding and it remains to see whether it will be adopted by the CJEU.

Other referrals, Yeda (C-518/10) and University of Queensland (C-630/10), which relate to similar aspects of the SPC Regulation, are still pending.

Lawyers Matthew Royle