Litigation concerning Supplementary Protection Certificates
(SPCs) frequently involves referrals to the Court of Justice of the
EU (CJEU), as reported here. It is therefore refreshing that the UK
High Court has just issued a decision in Sandoz v Searle without
requesting further guidance from the CJEU.
At issue was the validity of SPC/GB07/038 for a product
described in the SPC as "Darunavir or the pharmaceutically
acceptable salt, ester or prodrug thereof". The key question
in this case was whether the anti-retroviral Darunavir is
'protected by a basic patent in force', as required by
Article 3 (a) of the SPC Regulation.
The claims of the basic patent define a group of compounds by
reference to a Markush formula (a formula which consists of a
specified backbone that may have various different substituents ).
Darunavir is a specific compound that falls within the scope of
this formula. However, Darunavir is neither explicitly recited in
the claims, nor explicitly
