How many SPCs are required to satisfy the IL PTE eligibility requirement?

PTE grant and duration in Israel are subject to a series of linkages to PTE/SPCs granted in the US and in the five Recognized European Countries (UK, Germany, France, Italy, Spain). The key eligibility prerequisite is the Two-State rule. It provides that if a marketing approval was granted in the US, a prerequisite for IL PTE is the grant of a PTE in the US; and if a marketing approval was granted in at least one of the five Recognized European Countries, a prerequisite for IL PTE is the grant of SPC in such country. 

Is it necessary that an SPC is granted in all Recognized European Countries in which the product was approved or is SPC grant in at least one of the Recognized European Countries sufficient? This is obviously a question of significant practical implications. Until recently the ILPTO practice has been that an SPC in one of the five Recognized European Countries is sufficient to satisfy this eligibility requirement. However, somewhat surprisingly, when the pharmaceutical product is approved only in Europe, the ILPTO started to require SPC grant in all the five Recognized European Countries. 

It is questionable whether such new requirement is supported by the poorly drafted legislative text but, most importantly, it is anyhow inconsistent with legislative history and intent. Such approach also lacks rational as there is no reason to set a higher PTE eligibility threshold for a drug which was approved only in Europe as opposed to a drug which was approved in both the US and Europe. Following detailed arguments in ex-parte proceedings, the ILPTO recently withdrew its novel eligibility requirement. It was however in an unreasoned non-precedential decision and hence the question of how many SPCs are required to support a PTE for a drug that was only approved in Europe was deliberately left open and may still resurface.

This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.