Eurasia – First pediatric SPC granted by the EAPO
Supplementary Protection Certificate (SPCs) (or, in some countries, Patent Term Exten-sions, PTEs) for medicinal products are intellectual property rights intended to compen-sate patent holders for the loss in effective patent term that results from the time taken to receive a marketing authorization for such a product. An SPC provides an additional period of protection of up to 5 years.
The term of such an SPC may be extended in the EU/EFTA states additionally by six months in exchange for the provision of pediatric data. In accordance with Regulation (EC) No 1901/2006, when an SPC relates to a medicinal product for which data has been submitted according to a Pediatric Investigation Plan (PIP), said additional 6-months ex-tension of the protection period may be granted as compensation for the additional clini-cal trials and testing that PIPs require. This so-called pediatric SPC will be granted inde-pendently of whether or not the pediatric data have led to the grant of an authorization to use this medicament with pediatric patients.
The Eurasian patent legislation does not comprise any similar regulation which would allow for a pediatric SPC. However, in accordance with Rule 16(5) of the Patent Regula-tions under the Eurasian Patent Convention, the term of validity of a Eurasian patent may be extended in regard to those contracting states the national legislation of which allows for the grant of supplementary protection; wherein such an extension will be granted by the EAPO in accordance with the corresponding national regulations of the respective contracting state.
None of the current EA contracting states (AM, AZ, BY, KG, KZ, RU, TJ, TM) includes any provision in its patent legislation that would allow for a pediatric SPC. The Republic of Moldova (MD), however, which left the Eurasian Patent Convention on 26 April 2012 and recently became a validation state of the EPC, has since implemented new national SPC regulations which, among others, include also pediatric regulations.
Consequently, those Eurasian patents which have an international filing date of before 26 April 2012 and which, therefore, still cover the Republic of Moldova are eligible for a pe-diatric extension in the territory of the Republic of Moldova.
In connection with Janssen’s Eurasian Golumimab patent EA 009288, for which Janssen earlier obtained SPCs before the EAPO for the territories of AM, KZ and MD until 07 Au-gust 2026, a pediatric SPC has subsequently been requested for the territory of Moldova. The Eurasian Patent Office granted this pediatric SPC on 12 November 2024, thereby ex-tending the lifetime of the Moldovan SPC till 07 February 2027. Apparently this was the first pediatric SPC that was ever granted by the EAPO.
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