The Israeli Supreme Court recently issued a decision on a patent term extension (PTE) for Patent No. 148756, which covers Nintedanib, a drug developed by Boehringer Ingelheim. The case revolved around whether Israel’s Patent Registrar was correct in basing the PTE duration on the shorter of two European Supplementary Protection Certificates (SPCs) granted for Nintedanib.
The Dispute
Boehringer Ingelheim applied for a PTE in Israel after obtaining marketing approval for Nintedanib under two different brand names and indications: Vargatef (for lung cancer) and Ofev (for pulmonary fibrosis). Two European SPCs were granted: one based on the first regulatory approval and another for a later-approved indication.
The Israeli Patent Registrar determined that the Israeli PTE should align with the shorter of the two SPCs. Boehringer Ingelheim challenged this decision, arguing that only the first SPC, linked to the earliest marketing approval, should be considered.
The Supreme Court’s Ruling
The Supreme Court sided with Boehringer Ingelheim, ruling that:
- The Israeli PTE calculation should rely on the first SPC, which corresponds to the earliest regulatory approval of the active ingredient.
- The second SPC, granted under an exception in European patent law, should not be used to shorten the Israeli extension.
This decision is unlikely to have a significant impact on the Israeli pharmaceutical market, as cases where a drug is approved under two different brand names for separate indications and receives two SPCs are rare.