Looking for legal compromise in implementation the supplementary protection certificate

Abstract

The implementation of supplementary protection of inventions on medicines need to search and to keep balance between the interests of patent holder and interests of society in such sensitive sphere as health care.The both Ukrainian drafts of law contains the article which regulates the grant of the SPC and determines the procedure. However, both drafts do not determine the basic patent for which the SPC could be granted. The big gap of the drafts is also the absence of scope of the patent rights for which the SPC could be granted. Basing on the EU experi­ence the scope of the SPC should be determined and restricted by the scope of the patent for which the first marketing authorization was granted in a market. We could not avoid the abuse of patent rights without such restriction. We also should link the right on SPC with the first appearance of medical product in the world market and its’ registration in national market in Ukraine. Ukraine should grant SPC on really innovative medical products which come to the national market not later then 1 year from the date of its’ first appearance in the market.The Article 220 of Association Agreement between Ukraine and EU determines that The Parties recognise that medicinal and plant protection products protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their market. They recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on their respective market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent.The Parties shall provide for a further period of protection for a medicinal or plant protection product which is protected by a patent and which has been subject to an ad­ministrative authorisation procedure, that period being equal to the period referred to in paragraph 1, reduced by a period of five years.In the case of medicinal products for which paediatric studies have been carried out, and the results of those studies are reflected in the product information, the Parties shall provide for a further six-month extension of the period of protection referred to in para­graph 2 of this Article.Thus, the article determines only principles of SPC, all internal legal rules could by determined by the country-party itself. Ukraine should impellent id SPC only bas­ing on the same legal grounds like in EU.