When the legislature has addressed the individual clauses, and determined what the consequences of the expiration are, this cannot be ignored. The legislature did not establish a sweeping provision regarding the expiration of publications and orders in Israel, and therefore accuracy in this matter is important, and there is no room to accept the sweeping approach of the Honorable Deputy Registrar.
19. Even the case law on which the decision of the Honorable Deputy Registrar relies cannot be of assistance, since it dealt with a completely different question, relating to the consequences of delay in reporting regarding the granting of an order to extend a reference patent. The present case does not deal with this issue at all. The appellant's position is that it is consistent with the language of the law, and the approach of the Honorable Deputy Registrar contradicts it.
In this case, too, the delicate mechanism that was cast into the provisions of the law must be zealously maintained, in accordance with the Supreme Court's order. The disqualification of an application for an extension order, even though the conditions for meeting the conditions of the two states are met, is arbitrary and far-reaching. Not only does it contradict the language of the law, but it also contradicts its purpose.
20. The purpose of the law reflects a balance between the interest of developing new drugs and the interest of certainty, which serves the generic drug companies, which are waiting for the end of the patent protection period. The balance is determined based on the life period of the basic patent. Until then, it is possible to act to obtain an extension order, and not so after the patent expires.
The appellant's approach is also supported by legislative history, since from the discussions that took place in the Constitution, Law and Justice Committee of the Knesset, it was also clear to the representatives of the generic companies that it would be possible to establish the right to fulfill the terms of the two countries until the expiration of the basic patent.
21. As is well known, the legislative amendments on the subject were made after the signing of the memorandum of understanding between Israel and the US Trade Commission. The purpose of the amendment was to adapt the period of protection granted in Israel to medical preparations to that given to them overseas. Therefore, it is illogical to create situations contrary to this purpose, in which the possibility of granting an order to extend the validity of a patent in Israel is blocked, but these orders can still be granted in European countries and the United States. It is therefore necessary that the relevant date for examining the fulfillment of the conditions of the two countries is the date of the expiry of the basic patent period in Israel. Until then, the fate of the application for an extension order should not be decided irrevocably, since circumstances may change.
With all the importance of the purpose of certainty, it must relate to the correct and just date, and the said date is the one claimed by the appellant.
- In fact, the Honorable Deputy Registrar admitted the weakness of the interpretive channel in which she took action. According to her opinion, too, when a notice was published and the conditions of the two countries had not yet been met, Section 64J(3) It cannot cancel such a notice. The situation changes only because the conditions of the two countries have been met. This distinction is not based on the language of the law. It creates an arbitrariness whereby the fate of the protection that will be given to the patent holder will change in accordance with developments abroad that may be accidental. On the other hand, adherence to the period of the basic patent in Israel as the border creates certainty on the one hand, and prevents arbitrary results on the other.
The appellant presented various cases that show that leaving the interpretation of the Honorable Deputy Registrar in place will lead to arbitrary and absurd results.
- There is no basis for the determination of the Honorable Deputy Registrar that the mechanism for examining applications for extension orders is a detailed mechanism that moves on the timeline in one direction, and it is not possible to turn back the wheel after extension orders have already been issued. As stated, this determination ignores the fact that these orders will come into effect only at the end of the regular period of protection. In accordance with the general law, such provisions are reversible, and insofar as it was in the interpretive position that was presented, the legislature should have explicitly anchored them in the law.
- Against the background of all this, the Appellant argues that the decision that determined that the extension order for the patent in Israel should be revoked, so that the patent will expire on December 8,2029.
Request to add new evidence
- Alongside the appeal, the appellant filed a motion to submit additional evidence, in order to show that after the decision of the Honorable Deputy Registrar was given, a reference patent was granted in Europe for a patent application EP4209510 (Hereinafter: Patent 510)); And until June 30,2024, the appellant intends to file motions for an order to extend the validity based on it.
Her request to submit additional evidence was granted.