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    Practice Areas

    Patent Term Extension

    While the "normal" patent term protection is 20 years, when it comes to commercial pharmaceutical products (as well as medical devices), in some cases it can be extended by up to five additional years.

    Obtaining a patent term extension (PTE) is challenging at times, as the terms that determine whether a patent is eligible for a term extension are complex, and raise complicated queries, especially since generic companies have a tendency to appeal against PTE orders issuance, and the Supreme Court is often required to rule on such significant cases where the parties appealed. 

    In Israel, the legal framework for the patent term extension (PTE) is complicated and PTE provisions have been changed several times over the past decade. Issuing an Israeli PTE order is affected by a drug’s marketing approval and issuing PTEs and/or SPCs outside Israel (including the US and five European countries). The duration of the Israeli PTE order is calculated by taking into account the corresponding PTE and SPCs. The expiry of the order is influenced by the status of these foreign term extensions. 

    Our firm, alongside the Group's patent law firm, Luzzatto and Luzzatto’s experienced and professional team, specializes in PTE litigation and has extensive experience in highly important and complex PTE cases. 

    Between our clients you can find the leading international pharmaceutical and medical devices companies, and multinational corporations, which we represent in PTE landmark cases regarding important commercial drugs, pharmaceutical products and medical devices.We have a deep understanding of the issues involved and will help guide you towards extending the duration of your patent, taking all the necessary steps to secure the patent term extension, including litigation, when needed.

    We have seen important commercial drugs through a successful PTE litigation process, providing years of effective protection for our clients beyond their regular term.

    FAQs

    What is patent term extension?

    Patent Term Extension (PTE) is a tool that enables extending the Patent duration beyond the period stipulated by law of 20 years.  PTE is optional only for defined cases in the field of medicines and medical devices. Its purpose is to compensate the patent owner for the long approval period that exists in this field.

    What is the maximum protection period a patent can have?

    The maximum protection period a patent can have is 25 years. Still, the period is usually shorter, as there are factors that influence the Patent Term Extension, such as extensions in other jurisdictions (the U.S.A., Italy, Germany, Spain, France, and the U.K.) and the date of the marketing authorization in these mentioned countries.

    What industries can enjoy patent term extension?

    Patent Term Extension (PTE) is not relevant for all industries, but only in the Medical and Pharma Industry, and can only be approved for new medicines (active ingredient) and medical equipment that requires licensing. Since a long approval period exists in this field, PTE is supposed to compensate the patent owner for the long waiting period.

    Relevant Articles

    The Luzzatto Group Wins a Landmark Ruling
    Regarding Patent Term Extensions in Israel
    On March 27, 2024, the Israeli District Court in Jerusalem rendered a significant ruling in a Novartis case concerning Patent Term Extensions (PTEs), which has broad implications for pharmaceutical patent owners. The court accepted an appeal against a decision of the Registrar of Patents to revoke a PTE, which establishes the principle that PTEs in Israel are linked to the active ingredient and not to the first pharmaceutical preparation used to file the PTE application.
    Read more....
    How Was 2022 for Israel in Intellectual Property? – THE US-ISRAEL LEGAL REVIEW 2022
    The past two years have brought many COVID-19-related challenges in almost every aspect, but as far as IP in Israel is concerned, it also created opportunities.
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    Legal Business magazine – Israel 2022: The advantages and the disadvantages of a small country
    The past two years have brought many Covid-19 related challenges in almost every aspect, but as far as intellectual property (IP) in Israel is concerned, it also created opportunities. Israel was not unprepared; its extensive experience in dealing with crises, coupled with its top technological abilities, have proven themselves equal to coping with the pandemic.
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