Mere existence of earlier authorisation veterinary medicinal product does not preclude SPC for different application within basic patent
18-09-2012 Print this page
Mere existence of earlier authorisation veterinary medicinal product does not preclude SPC for different application within basic patent.
"27. In the light of all the above considerations, the answer to the first and third questions is that Articles 3 and 4 of the SPC Regulation are to be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC."
Article 13 SPC Regulation: marketing authorisation (MA) of product which is within basic patent.
"31. It follows from the above that the answer to the second question is that Article 13(1) of the SPC Regulation is to be interpreted as meaning that it refers to the MA of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC."
Irrelevant whether same active ingredient is present in two medicinal products, second MA required full application, or product was within different patent which belonged to other proprietor.
"35. Consequently, the answer to the fourth and fifth questions is that the answers to the preceding questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive MAs, the second MA required a full application in accordance with Article 8(3) of Directive 2001/83, or if the product covered by the first MA of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant."
IPPT20120719, CJEU, Neurim v Comptroller-General of Patents
C-130/11 - ECLI:EU:C:2012:489
