• December 15, 2022

ILPTO Update: Second medical use SPCs are irrelevant in determining the term of IL PTEs

In a recent judgment, the IL Supreme Court clarified that supplementary protection certificates (SPCs) granted in the EU5 countries, which are not based on the first marketing authorization for an active ingredient, should not be considered in determining the term of IL PTE orders.

Boehringer Ingelheim filed a petition for PTE in Israel with respect to nintedanib which is the active ingredient in the drug Vargatef (indicated for the treatment of non-small lung cancer) and in the drug Ofev (indicated for treatment of idiopathic pulmonary fibrosis). Two SPCs were granted in the EU5 countries with respect to nintedanib. The first SPC, having a duration of 1,826 days, was based on the EU MA for the drug Vargatef. The second SPC, having a duration of 1,490 days, was based on a later EU MA for the drug Ofev. Despite being a second medical use product, the EU MA for Ofev constituted a basis for the second SPCs in view of the CJEU’s Neurim ruling (C-130/11).

Under the Israeli patent law, the IL PTE period is linked to the shortest PTE/SPC period and earliest expiry date of a PTE/SPC in the US/EU5 countries. The ILPTO held that both SPCs issued in the EU5 countries should be considered in determining the duration/expiry date of the IL PTE for nintedanib. The Tel-Aviv District denied Patentee’s appeal.

The Supreme Court reversed and held that in determining the term of IL PTE orders, only the SPCs in the EU5 countries which are based on the first MA for the active ingredient should be considered. The Supreme Court’s ruling is based on the statutory language and the legislative history of the relevant PTE provisions. This ruling, however, is unlikely to have far reaching implications in view of the CJEU’s Santen ruling (C-673/18) which effectively reversed the Neurim decision and precludes the grant of SPCs for a second medical use of previously authorized products.

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.

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