Kirin Amgen Inc sells a treatment for amemia called “ARANESP” which contains the active ingredient DARBEPOETIN ALFA. Kirin Amgen requested a patent term extension in Israel on the basis that the corresponding US patent was extended by the Uruguay
Round of the TRIPS agreement under which the USPTO adopted a 20 years from filing rule. The Registrar of Patents in Israel, Asa Kling, rejected this argument. By the time the drug expires, it will have benefited from 14 years of post FDA approval in the US and also in Israel, and the extension to all pending applications in the changeover period as the US implemented TRIPS is not to be considered a patent term extension.
The Agents of the Applicant claimed that there was a lacuna in the Israel Law, but the Registrar did not accept this. Since neither the US nor any other Bolar jurisdiction awarded a patent term extension, there was no grounds under the amendment to the Israel Law to allow an extension in Israel either.