It was held that this conclusion does not change when the order abroad was cancelled within the period of the patent in Israel. The appellant's arguments that the provisions of the law should be examined differently in respect of the aforesaid were rejected. This rejection is based on the ruling of the Supreme Court and the ruling of this court.
The appellant's argument was further rejected that upon the expiration of the extension order, and before the expiration of the basic patent, it is possible to turn back the wheel and revive the application for an extension order. In accordance with this argument, the implementation of the provisions of the law should lead to the cancellation of the notice by virtue of section 64E(e)(3) of the Law, but the notice should still be left in place in accordance with section 64E(e)(1) of the Law, until the end of the period of the basic patent. It was held that this argument has no anchor in the language or purpose of the law; and it was further held that the appellant's interpretation contradicts the arrangement established by the legislature, which sought to obtain decisions on these matters in a time-bound manner, without waiting until the expiration date of the basic patent.
The Honorable Deputy Registrar therefore determined that the extension order for 213353 patent expired on the expiration date of the reference patent in Europe, and the argument that the notice should be left in place under section 64E(e)(1) of the Law was rejected.
- Hence the appeal.
The Appeal and the Parties' Arguments
- The appellant filed her appeal, the state responded, and the Manufacturers Association also submitted its position - after joining the proceeding - according to which the appeal is dismissed. The arguments of the parties are many and branched. I will address some of them even at the stage of discussion and decision. In the rest of the case, I did not find any justification for deviating from the result I reached.
Summary of the Appellant's Arguments
- The appellant points to the implications stemming from the interpretive approach of the Honorable Deputy Registrar. According to this approach, once the reference patent is revoked or the order to extend the reference patent is revoked, after the conditions of the two countries have been met, it is no longer possible to obtain an order to extend the validity of a patent in Israel. This result will remain in place even if, down the road, the conditions of the two countries are nevertheless fulfilled due to other orders that will be issued, or due to changes that will apply to the map of the protection of the reference patent abroad. This result cannot stand while the Israeli patent is still being protected, during the life of the basic patent.
- The arrangement set out in the legislation is intended to compensate the patent owners in the field of pharmaceuticals. They are harmed when they cannot take advantage of the registration of the patent in their favor in light of the need to obtain a marketing license. This matter takes time, and therefore a mechanism was created that allows the period of protection to be extended. The law also seeks to prevent a situation in which the drug can be marketed in the countries of reference abroad, andthis is not the case in Israel. The legislature sought to allow the patent owner to meet the conditions of the two countries, in order to extend the protection, until the end of the patent period in Israel. The approach of the Honorable Deputy Registrar thwarts this basic purpose.
In most cases, when an application for an extension order is filed in Israel, an extension order has not yet been issued in the United States or in Europe, and therefore the examination in Israel is split into two parts, in accordance with section 64e(e) of the law. This allows the process to begin after a marketing permit has been granted outside of Israel in the relevant countries, and then an intention to issue an order in accordance with section 64e(e)(1) is published. Subsequently, after the extension orders are issued abroad, an additional notice is published, in accordance with section 64e(e)(3); and then the extension order is issued in Israel, which takes effect after the expiry of the basic patent period here.
18. The Appellant agrees that the focus of the dispute between the parties is section 64J(3) of the Patents Law. This instructs that if an expropriating event takes place outside of Israel, it will affect the steps taken at the local level. It states that extension orders or notice of intention to grant extension orders under section 64E(c) or section 64E(e)(3) of the Law will expire. And it still does not order that the initial declaration under section 64E(e)(1) will expire. Hence, the initial declaration of intention to take the procedure for granting its extension continues to stand.
Hence, as long as the period of the basic patent remains in place, the notice under section 64E(e)(1) will not expire. The provision regarding the expiration of the extension order in Israel cannot be relevant, since it has not yet taken effect at all. Therefore, it cannot expire either. An order that comes into effect after the period of the basic patent will indeed expire. And until this period, the notice continues to apply, and it allows the patent owner to act to meet the conditions of the two countries in the interim period, and to receive new extension orders , in accordance with developments.