In a decision dated December 21, 2023, Deputy Registrar of Patents Jacqueline Bracha rejected an objection filed under Section 161 of the Israeli Patents Law concerning Genentech Inc.’s Israeli Patent No. 213353. The company had argued that revocation of a European reference patent could not cause an Israeli patent term extension order to lapse while the basic patent remained in force. The Deputy Registrar held that an extension order already granted in Israel lapses following revocation of the reference patent or the extension order on which it relies, pursuant to Sections 64J(3) and 64L(1) of the Patents Law, 5727-1967, even where the additional protection it was intended to confer has not yet begun. She also rejected the request to return the extension proceedings to the earlier stage of the notice of intention to grant an order, so as to await new foreign extensions.
Read the full Deputy Registrar’s decision (PDF, Hebrew)
The Tecentriq Patent and the Extension Granted in Israel
The objection concerned Patent No. 213353, relating to anti-PD-L1 antibodies and their use in enhancing T-cell activity. The patent protection concerns Tecentriq, whose active ingredient, atezolizumab, is used in oncology treatments. The basic Israeli patent is scheduled to expire on December 8, 2029, subject to payment of renewal fees.
Genentech filed an application for an extension order in 2017. At the initial stage, extension orders had not yet been issued in the reference states required by law. Accordingly, on December 31, 2017, a notice of intention to grant an extension order was published pursuant to Section 64E(e)(1), subject to satisfaction of the outstanding conditions.
Extension orders were subsequently granted in France and Spain on the basis of European reference patent EP2376535. In 2020, the Israel Patent Office received supplementary information concerning an extension order for US reference patent No. 8,217,149. Once the so-called “two-state requirement” had been met, a supplementary notice was published on October 29, 2020, under Section 64E(e)(3). No oppositions were filed, and on February 14, 2021, an Israeli extension order was granted for 161 days. Had the event causing lapse not occurred, the additional protection would have begun when the basic patent expired and continued until May 18, 2030.
Revocation of the European Reference Patent and the Patent Office’s Decision
On December 20, 2022, European reference patent EP2376535 was revoked. As a result, the extension orders granted on its basis in the recognized European states were also cancelled. Genentech notified the Patent Office of this development in February 2023, while noting that further European extension orders covering the substance claimed in the patent might be granted before expiry of the Israeli basic patent. It reserved its rights in that regard.
The Deputy Superintendent of Patent Examiners determined that revocation of the reference patent and the European extension orders caused the Israeli extension order to lapse. Genentech challenged that determination. It presented its arguments at a hearing before the Registrar on May 1, 2023. After the file was transferred to the Deputy Registrar following the retirement of Registrar Ofir Alon, Genentech was given an opportunity to supplement its submissions and provide an update on the European proceedings. In September 2023, the company reported that the status of the European extension orders had not changed, although another European patent application remained pending.
The determination did not concern the patentability of the invention or the scope of the Israeli patent claims. The issue was the legal consequence of revocation of a reference patent after an Israeli extension order had been granted but before the additional protection it was intended to provide had begun.
Genentech’s Argument: An Extension Order That Has Not Taken Effect Cannot Lapse
Genentech sought to distinguish between the grant of an extension order and its entry into effect. Section 64H(b) of the Law provides that an extension order takes effect upon expiry of the basic patent. Because the Israeli patent remained valid until December 2029, the company argued that revocation of European protection should not irreversibly extinguish the possibility of an Israeli extension.
The company proposed an interpretation based on the stages of examination under Section 64E. In its view, revocation of the reference patent could cause the supplementary notice published under Section 64E(e)(3) to lapse, but not the initial notice under Section 64E(e)(1), which is not expressly included among the notices subject to lapse under Section 64J(3). Genentech therefore sought to return the file to the initial-notice stage and continue awaiting the possibility that the two-state requirement would be satisfied again before expiry of the basic patent.
It argued that a contrary outcome would undermine the purpose of the patent term extension mechanism, which is intended to compensate for regulatory periods during which a medicine could not be marketed. Genentech further submitted that new patent protection might be obtained in Europe, potentially allowing an extension there while precluding one in Israel.
Section 64J(3): The Distinction Between a Pending Application and an Order Already Granted
The Deputy Registrar rejected the objection. Her starting point was Section 64J(3), which provides that the term of an extension order or a supplementary notice expires no later than the first date on which an extension order for a reference patent expires or a reference patent is revoked in a recognized state where marketing authorization was granted. Section 64L(1) incorporates the time limits prescribed by Section 64J among the grounds on which an extension order lapses.
In her view, the fact that the basic patent was still in force did not place an extension order already granted outside the scope of the lapse provision. Nothing in the Law restricted Section 64J(3) to the period following expiry of the basic patent. She referred to previous decisions and the consolidated judgment in Administrative Appeal (Tel Aviv District Court) 46208-05-22, Newron and Amgen v. Registrar of Patents and Teva (September 21, 2023), which had rejected attempts to distinguish the basic patent term from the extension period for purposes of obligations arising under the statutory regime.
Nevertheless, the Deputy Registrar distinguished a situation in which a reference patent is revoked before the two-state requirement has been satisfied, when only an initial notice under Section 64E(e)(1) has been published in Israel, from the case before her. In the first situation, the initial notice is not among the instruments whose lapse is governed by Section 64J(3). In the second, the eligibility conditions had been satisfied, a supplementary notice had been published and an extension order had already been granted. The lapse of an order already granted does not return the proceedings to their previous stage.
A One-Way Procedure: Why the Initial Notice Cannot Be Revived
A central element of the decision was the structure of the examination procedure. The Deputy Registrar described Section 64E as a time-limited mechanism that progresses from filing an application, through publication of notices of intention to grant an order, to a determination and the issuance of an order. Once the order has been granted, the intermediate stages do not become an alternative route through which the application may be reopened if the order subsequently lapses.
The notice under Section 64E(e)(1) allows an application to remain pending when extension orders have not yet been granted in the reference states but the other requirements have been met. It does not confer an unlimited right on the patent holder to file repeated applications after an extension has already been approved and has lapsed. The Deputy Registrar considered the proposed return to the initial stage to be an attempt to secure a fresh examination of an application already determined, without any statutory authority to do so.
The company’s proposed analogy to the cancellation of acceptance of a patent application was also rejected. In the Deputy Registrar’s view, an extension order already granted is more appropriately compared to a registered patent than to an application whose examination has not yet been completed. Revocation of a patent does not, in itself, revive the patent application for a new examination. The fact that several years remained before expiry of the basic patent did not justify a different outcome.
The Understanding with the United States and the Objective of Certainty
Genentech also sought to rely on the 2010 document of understandings between Israel and the United States, which formed part of the background to Amendment No. 11 to the Patents Law. The company understood the document to permit an extension application to remain pending until expiry of the basic patent and to preclude bringing the proceedings to an end before it was known whether foreign extension orders could be obtained.
The Deputy Registrar rejected that inference. The understanding was intended to allow applications to await satisfaction of the two-state requirement before an Israeli order was granted. It did not require an application to remain open after an extension order had already been issued and then lapsed following a subsequent event. Extending the commitment to that situation was neither required by the wording of the document nor consistent with the Law.
The decision also drew on case law concerning the balance between the rights of originator pharmaceutical companies and the interests of the generic industry and the public. The purpose of the arrangement is not to guarantee the longest possible term of protection in every country, but to establish rules that provide limited compensation while ensuring certainty as to when competing products may enter the Israeli market. In this context, the Deputy Registrar referred to Supreme Court decisions in UCB and Boehringer, addressing the importance of adhering to the statutory framework and its competing objectives.
The Outcome and Subsequent Proceedings
The objection was dismissed. The Deputy Registrar held that the extension order for Patent No. 213353 had lapsed following revocation of the European reference patent and directed publication of the lapse in the Patents Journal. The additional 161-day term was therefore lost, but the validity of the basic patent until December 8, 2029, subject to payment of renewal fees, was unaffected.
Genentech appealed to the Tel Aviv District Court. In Administrative Appeal (Tel Aviv District Court) 40718-02-24, Genentech v. Registrar of Patents (August 23, 2026), the appeal was dismissed. The Court developed the distinction between the legal effect of an extension order upon its grant and the commencement of additional protection upon expiry of the basic patent, and upheld the conclusion that the initial notice could not be revived after the order had lapsed.
A related question, concerning a different patent and different circumstances, arose in the proceedings regarding Bristol-Myers Squibb’s Patent No. 160693. There, the question was whether retrospective revocation of a UK reference patent caused the Israeli extension order to lapse. See Administrative Appeal (Jerusalem District Court) 60673-01-25, Bristol-Myers Squibb v. Unipharm (May 11, 2026).
For an analysis of the statutory patent term extension mechanism, the prohibition on a previously granted extension order and the lapse of protection following revocation of a reference patent, see Yonatan Drori, Patent Law, Volume I (2023), pages 235, 243 and 250. For the administrative procedure and available relief, see also the guide to Cancellation or Modification of a Patent Term Extension Order in Israel.
