The Registrar shall not issue an extension order unless all of the following have been met:
(1) The substance, the process for its manufacture or use, the medical preparation containing the substance or the process for its manufacture or the medical equipment, is claimed under the basic patent and the basic patent is valid;
(2) With respect to a medical preparation - a medical preparation containing the substance registered in the Register of Medical Preparations [...];
(3) The registration as stated in paragraph (2) is the first registration that permits the use of the substance in Israel for medical purposes;
(4) no previous extension order was issued for the underlying patent or for the material;
(5) If a marketing permit is granted in the United States of America, an order to extend the reference patent in the United States of America has also been issued, and it has not yet expired;
Copied from Nevo(6) If a marketing permit is granted in a recognized European country, an order to extend the reference patent in that country has not yet expired;
(7) If marketing permits have been granted in the United States of America and in at least one recognized European country, orders have also been issued to extend the reference patent in the United States of America and in that recognized European country, and have not yet expired.
Thus, the legislature determined in section 64D that it is possible to order an extension of an order in our places, if a permit is granted for marketing (for example, marketing a drug that relies on the invention) abroad, and an order is also issued to extend the reference patent in that country - and that it has not yet expired. It is also possible to get the impression that the legislature applied the "two-state conditions". According to the condition, if marketing permits for a medical product were granted in a recognized country in Europe and the United States, it would be possible to issue an extension order in Israel if extension orders were issued in those countries.
- Section 64E of the Ordinance imposes restrictions on the manner in which the Registrar operates in relation to applications for an extension order submitted to it. It also establishes various features of publication regarding the submission of an application for extension orders, in order to enable the opinionof the market for the duration of the protection that will be granted to patents, and to enable those interested in objecting to the extension orders requested to do so:
64E. Examination of an Application for an Extension Order