No application for SPC before the date on which the plant protection product has obtained the MA

Print this page 17-12-2013
IPPT20131017, CJEU, Sumitomo v Patent und Markenamt

PATENT LAW

 

Article 3(1)(b) of Regulation No 1610/96 must be interpreted as precluding the issue of a supplementary protection certificate for a plant protection product in respect of which an emergency MA has been issued under Article 8(4) of Directive 91/414.

 

"38. Accordingly, the answer to the first question is that Article 3(1)(b) of Regulation No 1610/96 must be interpreted as precluding the issue of a supplementary protection certificate for a plant protection product in respect of which an emergency MA has been issued under Article 8(4) of Directive 91/414.

 

34. Article 3(1)(b) of Regulation No 1610/96 refers to a MA granted ‘in accordance with Article 4 of Directive 91/414’. It is true that, it has been held that there is no need to interpret that provision of that regulation in a manner which would have the effect of excluding from the application of that provision products which have been granted a provisional MA under Article 8(1) of Directive 91/414 (Hogan Lovells International, paragraph 46).


35. However, that interpretation rests on the link of functional equivalence which exists between the criteria set out in Article 8(1) of Directive 91/414 as transitional measures and those laid down in Article 4 of that directive (Hogan Lovells International, paragraphs 33 to 46). There is no such link of functional equivalence between the criteria laid down in Article 8(4) of Directive 91/414 and those in Article 4 thereof.


36. It is apparent from the very definition of the emergency MA laid down in Article 8(4) of Directive 91/414 that it concerns ‘plant protection products not complying with Article 4’. That type of MA is therefore not intended to ensure that plant protection products thus authorised meet the same scientific requirements as to reliability as those granted an MA on the basis of Article 4 of Directive 91/414. Thus, Article 8(4) of that directive does not require the Member States to carry out scientific risk evaluations prior to issuing such an MA. That derogating provision does, however, strictly limit the use of that type of MA, stating that it applies only to ‘special circumstances’, and the issue of an emergency MA for a period not exceeding 120 days must appear ‘necessary because of an unforeseeable danger which cannot be contained by other means’.


37. In those circumstances, it is not possible to apply Article 3(1)(b) of Regulation No 1610/96 to an emergency MA, which is restricted to products which do not comply with the requirements of Article 4 of Directive 91/414 and in respect of which that directive does not require a prior scientific evaluation of the risks."

 

No application for SPC before the date on which the plant protection product has obtained the MA.

 

"45. Accordingly, the answer to the third question is that Articles 3(1)(b) and 7(1) of Regulation No 1610/96 must be interpreted as precluding an application for a supplementary protection certificate being lodged before the date on which the plant protection product has obtained the MA referred to in Article 3(1)(b) of that regulation."

 

IPPT20131017, CJEU, Sumitomo v Patent und Markenamt

 

C‑210/12 - ECLI:EU:C:2013:665