In December 2013 the CJEU handed down its ruling in Eli Lilly v HGS (C493-12), please refer to our previous bulletin for further details, which sought to clarify Article 3(a) of the SPC regulation (469/2009/EC). In that judgement the CJEU ruled that a functional definition of an active ingredient in a claim is enough to obtain an SPC, provided the claims relate implicitly but necessarily and specifically to the active ingredient in question. The UK Patents Court has now interpreted the CJEU’s judgment and concluded that a claim directed to an antibody that binds specifically to a recited antigen is considered to implicitly but necessarily and specifically define an active ingredient.
The Patents Court first considered the validity of HGS’ SPC for its anti-Neutrokine-α antibody belimumab in 2012 when Eli Lilly objected to the SPC on the basis that the antibody which formed the active ingredient was not protected by the basic patent in force (EP0939804), as required by Article 3(a) of the SPC regulation. Eli Lilly reasoned that HGS’ SPC was invalid because a functionally defined antibody does not fulfil the CJEU’s requirement that in order to comply with Article 3(a) of the SPC regulation the active ingredient must be specified in the wording of the claims (Medeva; C-322/10). It was decided that further guidance on the interpretation of Article 3(a) was required and the CJEU was asked to clarify “what are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation [No 469/2009]?”
In response to the Patents Court’s referral the CJEU ruled that in order to be considered to be protected by a basic patent in force it is not necessary for an active ingredient to be identified in the claims of the patent by a structural formula. Rather, a functional definition of an active ingredient in a claim is enough to obtain an SPC provided the claims, interpreted in light of the description, relate implicitly but necessarily and specifically to the active ingredient. However, the CJEU did not comment further on the circumstances under which Article 3(a) of the SPC regulation would be considered to be fulfilled and in the present decision the CJEU’s ruling is criticised for not providing the clear guidelines which the reference was designed to obtain. The deficiencies in the CJEU’s ruling are apparent in the present decision since both parties argued that the CJEU’s ruling should be interpreted in their favour.
Having considered both parties’ arguments in the present case, the Patents Court concluded that in requiring the claims to relate implicitly but necessarily and specifically to the active ingredient, the CJEU merely intended to exclude from SPC eligibility active ingredients which fall within the scope of a claim merely due to the inclusion of open “comprising” language. In arriving at this interpretation the Patents Court has effectively limited the CJEU’s ruling to that previously handed down in Medeva (C-322/10) where the CJEU rejected the infringement test and confirmed that the active ingredient must be specified in the wording of the claims in order to be considered protected by the basic patent in force under Article 3(a) of the SPC regulation.
The UK Patents Court’s decision indicates that we can expect SPCs based upon functional claims to be considered valid in the UK. However, Eli Lilly have been granted leave to appeal and we may therefore not have heard the final word on this issue.