Federal Act
on Patents for Inventions
(Patents Act, PatA)¹

¹ Upon ap­plic­a­tion the IPI shall is­sue a pae­di­at­ric sup­ple­ment­ary pro­tec­tion cer­ti­fic­ate (pae­di­at­ric cer­ti­fic­ate) for act­ive in­gredi­ents or act­ive in­gredi­ent com­pos­i­tions of medi­cin­al products with a pro­tec­tion peri­od of six months from the ex­piry of the longest term of the pat­ent, provided the au­thor­isa­tion (Art. 9 TPA²⁷⁸) of a medi­cin­al product con­tain­ing the product:

a.

con­tains con­firm­a­tion that the in­form­a­tion on the medi­cin­al product re­flects the res­ults of all stud­ies per­formed in ac­cord­ance with the pae­di­at­ric test concept (Art. 11 para. 2 let. a no 6 TPA) con­sidered in the au­thor­isa­tion pro­cess; and

b.

was ap­plied for no later than six months after the ap­plic­a­tion for ini­tial au­thor­isa­tion in the European Eco­nom­ic Area of a medi­cin­al product con­tain­ing the product in which the cor­res­pond­ing medi­cin­al product in­form­a­tion re­flects the res­ults of all stud­ies per­formed in ac­cord­ance with the pae­di­at­ric test concept con­sidered for the au­thor­isa­tion.

² A pae­di­at­ric cer­ti­fic­ate shall only be is­sued if no sup­ple­ment­ary pro­tec­tion cer­ti­fic­ate in ac­cord­ance with Art­icle 140aex­ists.

³ Art­icle 140b para­graph 1 ap­plies mu­tatis mutandis.

⁴ The term of pro­tec­tion of a pae­di­at­ric cer­ti­fic­ate may not be ex­ten­ded.