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 granted an appeal against a decision of the Registrar of Patents to revoke a PTE, thus establishing the principle that PTEs in Israel are linked to the active ingredient and not to the first pharmaceutical preparation relied on in filing the PTE application.
The case centered on the interpretation of PTE regulations in Israel, particularly regarding the relationship between the active ingredient and the first pharmaceutical preparation for which marketing approval was obtained. In general, PTEs are granted based on the registration of the first pharmaceutical preparation containing a novel active ingredient, allowing patent holders to extend their exclusive rights beyond the standard 20-year term.
In this specific instance, a patent was initially granted for a new active ingredient, which was the basis for a PTE relying on the registration of a pharmaceutical preparation containing the ingredient. However, the patent owner later registered two additional pharmaceutical preparations comprising the same active ingredient. Subsequently, the owner decided to abandon the registration for the first pharmaceutical preparation, leading to the revocation of the PTE by the Patent Registrar.
This decision was in line with a June 2022 ruling by the Tel Aviv District Court, which emphasized the dependency of PTEs on the marketing permit for the first pharmaceutical preparation.
However, the recent judgment from the Israeli District Court in Jerusalem, delivered by the Honorable Judge Dorot, introduced a significant departure from this narrow interpretation. The court ruled that under the relevant sections of Israeli Patent Law, the cancellation of the registration of the first preparation should not automatically invalidate the Extension Order. Instead, the crucial factor should be whether a registration of an additional preparation containing the same active ingredient exists.
Furthermore, the court underscored that PTEs are linked to the active ingredient itself rather than solely to the first pharmaceutical preparation that was initially registered.
This decision offers patent holders clarity and flexibility, allowing them to manage their patent portfolios more effectively. It ensures that patent rights are preserved even if the first pharmaceutical preparation is abandoned as long as alternative preparations containing the same active ingredient are registered before the abandonment.
Overall, this ruling sets a significant precedent in the interpretation of PTE regulations in Israel and provides valuable guidance for patent holders navigating the complexities of patent law concerning pharmaceutical preparations.
The Patent Owner was represented by Oren Mandler, Adv., Dr. Kfir Luzzatto, and Dr. Adina Cohen of The Luzzatto Group.
For more information about this ruling, please contact PTE@luzzatto.co.il
