Important commercial pharmaceutical products (as well as medical devices) may have the term of patents covering them extended by up to five additional years, beyond the normal patent term of 20 years. The conditions under which such a patent is eligible for patent term extension are complex and at times raise complicated questions.
The patent term extension (PTE) legal framework in Israel is complex and the PTE provisions have been amended several times in the past decade. The issuance of an Israeli PTE order is influenced by a drug’s marketing approval and the issuance of corresponding PTE and/or SPCs outside Israel (the US and 5 European countries). The duration of the Israeli PTE order is calculated based on the corresponding PTE and SPCs and the expiry of the order is influenced by the status of these foreign term extensions.
Luzzatto and Luzzatto has established a dedicated PTE team of patent attorneys and lawyers with substantial IP litigation experience, ensuring that PTE applications are submitted in a form that will best address litigation, if and when it happens. Generic companies do appeal against the issuance of PTE orders, and important cases may end up being litigated even at the Supreme Court. Our firm has seen important commercial drugs through a successful PTE process, providing years of effective protection for our clients beyond their regular term.
With Luzzatto and Luzzatto, clients benefit from highly qualified and experienced patent attorneys and advocates, who have extensive experience in all aspects of PTE and a deep understanding of the steps necessary to secure a patent term extension. They will expertly guide you towards extending the duration of your patent.
