Notification Date of Marketing Approval to be used in calculating PTE duration in Israel

The Israeli Patent Office (IL PTO) recently accepted the marketing authorization notification date from the European Medicines Agency (EMA) as the date to be used when calculating the duration of an Israeli patent term extension (PTE). This decision represents a change from previous practice in which the EMA marketing authorization grant date was used to calculate PTEs.

The Israeli PTE system is unique as it is based on a series of linkages to the expiration date and extension periods of an U.S. PTE and any Supplementary Protection Certificates (SPCs) granted in any of the European Union “five” (EU-5) countries (United Kingdom, Italy, France, Spain and Germany). Additionally, an Israeli PTE expires no later than 14 years from the earliest date in which a regulatory approval was obtained in the U.S. or in one of the EU-5 countries.

Prior to this change, a petition for a PTE was filed with the IL PTO for apixaban (Eliquis®). The Israeli Commissioner of Patents (Commissioner) held that the EMA marketing authorization grant date, not the EMA marketing authorization notification date, should be used to calculate the PTE. As a result, the PTE for Eliquis® would have expired in Israel two days earlier than it would have if the notification date were used to calculate the extension period. The Commissioner justified his decision by referring to the lack of uniformity between the different European Patent Offices on the issue of whether the EMA authorization grant or notification date should be used to calculate the duration of SPCs. The IL PTO reached the same conclusion when deciding the PTE petition for secukinumab (Cosentyx®), holding that an IL PTE period is calculated based on the EMA marketing authorization grant date. In this case, the PTE would have expired four days earlier than it would of if the notification date were used.

However, the IL PTO was required to reevaluate its position after the Court of Justice of the European Union (CJEU) published a binding decision in Seattle Genetics Inc. v Österreichisches Patentamt  (case C-471/14) holding that the EMA marketing authorization notification date must be used to calculate the expiration period of SPCs. The patentee argued that the IL PTO was bound to follow the final decision of the CJEU holding that the EMA marketing authorization notification date should be used rather than the grant date. As a result, the IL PTO reevaluated its position and followed the CJEU ruling.

This post was written by Lisa Mueller and Rikki Hullinger of Michael Best and Liad Whatstein of Liad Whatstein & Co.

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