In Administrative Appeal (Tel Aviv District Court) 40718-02-24, Genentech Inc. v. State of Israel – Registrar of Patents, Designs and Trademarks (August 23, 2026), Judge Gershon Gontovnik dismissed an appeal against a decision of the Deputy Registrar of Patents holding that the patent term extension order for Israeli Patent No. 213353 had lapsed following the revocation of a European reference patent. The central question was whether an extension order already granted in Israel could lapse before the additional period of patent protection it was intended to confer had begun, and whether, following its lapse, the application could be revived by relying on the original notice of intention to grant an extension order.
The Court answered the first question in the affirmative and the second in the negative. It distinguished between the legal effect of an extension order from the date on which it is granted and the commencement of the additional protection under that order upon expiry of the basic patent. The Court held that the notices preceding the grant of the order are subsumed into it. Consequently, the examination of the application cannot be reopened after the order has lapsed, even where several years remain before the basic patent expires.
Read the full judgment in Appeal 40718-02-24 (PDF, Hebrew)
Tecentriq and the Extension Order for Israeli Patent No. 213353
Genentech holds Israeli Patent No. 213353, which concerns antibodies targeting the PD-L1 protein and their use in enhancing T-cell activity. The patent is associated with Tecentriq, whose active ingredient is atezolizumab and which is used to treat various types of cancer. The basic patent is due to expire on December 8, 2029, subject to payment of renewal fees.
The company’s patent term extension application was examined under the framework established by the Israeli Patents Law, 5727-1967, which links eligibility for an extension in Israel to marketing authorizations and extension orders for reference patents in recognized states. Initially, a notice of intention to grant an extension order was published under Section 64E(e)(1), at a stage when not all the requirements relating to foreign patent extensions had yet been met.
Extension orders were subsequently granted in France and Spain on the basis of European reference patent EP2376535, and an extension was also granted for a reference patent in the United States. Once the requirements had been fulfilled, a supplementary notice was published on October 29, 2020 pursuant to Section 64E(e)(3). On February 14, 2021, an Israeli extension order was issued for 161 days, intended to provide additional protection after expiry of the basic patent, until May 18, 2030.
On December 20, 2022, the European reference patent was revoked. The European extension orders based on it were consequently cancelled. The Israel Patent Office announced that, as a result, the Israeli extension order had lapsed. Genentech challenged the determination, but Deputy Registrar of Patents Jacqueline Bracha rejected its challenge on December 21, 2023. That administrative decision is discussed separately in the review of the Deputy Registrar’s decision in the Genentech matter.
The Central Argument on Appeal: The Two-State Requirements Could Be Met Again While the Basic Patent Remained in Force
Genentech did not dispute that revocation of a foreign reference patent or its extension order could trigger the lapse provision in Section 64J(3). Its argument was that this consequence should not bring the proceedings to an end when the Israeli extension order had not yet begun to provide its additional period of protection.
The company relied on Section 64H(b), under which an extension order takes effect upon expiry of the basic patent. In its view, as long as the Israeli patent remained in force until December 2029, the extension proceedings could still be updated to reflect changes in the status of foreign reference patents. It sought to distinguish between an extension order whose additional protection had already begun and one whose practical effect lay in the future.
Genentech further argued that Section 64J(3) expressly addresses the lapse of notices of intention to grant an extension order under Sections 64E(c) or 64E(e)(3), but does not mention an initial notice under Section 64E(e)(1). It sought to infer that, following cancellation of the order and the supplementary notice, the initial notice remained in force. On that approach, the applicant could return to the earlier stage, await new extension orders in recognized states and seek a fresh assessment of whether the two-state requirements were satisfied.
In support of its position, Genentech also presented developments in the European patent system. During the appeal, it was permitted to submit additional evidence concerning the grant of a patent arising from another European application, EP4209510, and its intention to seek an extension based on that patent. It argued that the possibility of securing new European protection made it unjustified to permanently rule out an extension in Israel.
The Positions of the Registrar of Patents and the Manufacturers Association
The State argued that an extension order that has been granted and recorded constitutes a completed administrative decision. The notices preceding it are intermediate procedural steps, not independent rights that continue to exist alongside the order indefinitely. Once the order is granted, the application can no longer be treated as pending. Revocation of the European reference patent therefore triggers Section 64J(3) in respect of the Israeli order.
The State also referred to Section 64D(4), which requires that no extension order have previously been granted for the basic patent or the substance. Allowing an applicant to return to its original application and obtain a new order after a previous order had lapsed would, in the State’s view, require an exception to that condition without any statutory authorization.
The Manufacturers Association of Israel participated as amicus curiae and supported dismissal of the appeal. It emphasized that the statutory rules were designed to create certainty in the pharmaceutical market, particularly regarding when generic medicines could be launched. Keeping an extension application open for years in anticipation of future changes in reference states would be inconsistent with the certainty the statutory framework seeks to ensure.
Statutory Wording: Section 64J(3) Applies to an Order Already Granted, Even if Its Extension Period Has Not Begun
The Court examined the relationship between Section 64L, which addresses the lapse of an extension order or a notice of intention to grant one, and Section 64J, which sets limits on the extension period. Section 64J(3) provides that an extension order must expire no later than the earliest date on which, in a recognized state where marketing authorization was granted, an extension order for a reference patent expires or any reference patent is revoked. The statutory definition of expiry expressly encompasses shortening or cancellation of a foreign extension.
Judge Gontovnik held that the wording of the provision directly covered the circumstances before the Court. A European reference patent had been revoked after the Israeli extension order was granted. Since the Israeli order had already been issued, there was no basis for excluding it from the provision merely because the additional protection had not yet commenced. Such a distinction has no foundation in the Law.
The appellant sought a different textual basis for its position: the initial notice under Section 64E(e)(1) was not mentioned in Section 64J(3) and therefore, it argued, had not lapsed. The Court distinguished between whether such a notice might lapse at an early stage of the proceedings and whether it continued to exist after an extension order had already been granted. It answered the second question in the negative.
The Difference Between the Order’s Legal Effect and the Beginning of Additional Protection
This distinction is central to the judgment. The Court explained that the date on which an extension order comes into legal existence as a binding administrative decision must be distinguished from the date on which the additional period of patent protection begins. The decision to grant an extension order is made and acquires legal effect upon its issuance. By contrast, under Section 64H(b), the commencement of the additional protection is deferred until expiry of the basic patent.
The interval between those two dates does not render the extension order a conditional decision that has not yet come into existence. The order has already been granted and published and has created a legal position, even though its consequences for patent protection are scheduled to commence later. The Court likened the situation to a legal norm whose creation is distinct from the date on which it begins to apply to particular legal relationships.
It followed that an event causing lapse can terminate an extension order even before the additional period of protection it was intended to confer begins. Section 64J(3) does not require the twenty-year term of the basic patent to have expired first. If the reference patent is revoked while the Israeli extension order already exists, the lapse provision may apply at that time, even if the extension period was not due to begin for several more years.
Why the Original Notice of Intention Cannot Be Revived
The Court accepted the Patent Office’s position that the examination of a patent term extension application progresses toward a final determination. Following the filing of the application, publication of the required notices and satisfaction of the eligibility requirements, an order is granted. Once issued, the order incorporates the procedural stages preceding it. Those notices do not remain parallel procedural avenues to which the applicant may return if new developments occur abroad.
It is true that Section 64J(3) does not provide for the lapse of an initial notice under Section 64E(e)(1). But that notice is issued at a stage when the requirements for granting an extension order have not yet been met. Once the requirements are fulfilled and the order is granted, the notice has served its purpose. The judge rejected the attempt to treat its omission from the lapse provision as a mechanism for reviving an application that had already been determined.
He also identified a difficulty created by the proposed interpretation when compared with applications examined through a procedure that is not divided into stages. Where all the requirements for an extension order are satisfied at the outset, no initial notice under Section 64E(e)(1) may be published at all. If Genentech’s argument were accepted, an applicant that initially proceeded through the staged procedure could revive its application after the order lapsed, whereas an applicant that had satisfied all the requirements from the start would enjoy no equivalent possibility. The Court found no justification for that distinction.
Another consideration was the absence of a procedural framework for returning to the initial-notice stage. Had the legislature intended to permit such a return, one might expect provisions governing publication of a new notice, updating the evidence and the rights of parties wishing to oppose the extension. The Law contains no such mechanism. That absence reinforced the conclusion that re-examination was not intended to be available after the grant and lapse of an extension order.
The Court also attached weight to Section 64D(4), which precludes the grant of an extension order where a previous order has already been granted in respect of the patent or substance. That requirement supports the view that granting an extension order is not merely a provisional step that can be erased and begun afresh. The fact that the first order was intended to confer protection at a future date does not change the legal significance of its grant.
Rules versus Standards: Why Certainty Prevails over Flexibility
In addition to textual interpretation, the Court devoted considerable attention to the nature of the legislative framework. Judge Gontovnik distinguished between a legal rule, which attaches a defined consequence to the satisfaction of clear conditions, and a standard, which allows the exercise of flexible judgment in light of individual circumstances. The Israeli patent term extension regime, the Court held, relies to a considerable extent on rules: specified filing deadlines, defined stages of examination, precise eligibility conditions and express mechanisms for lapse.
The adoption of rules is intended to allow participants in the pharmaceutical market to know in advance when protection will end and when competing products may enter the market. Applying a rule may sometimes produce a result that appears harsh or unjustified in a particular case. That does not, however, empower the administrative authority or the Court to alter the rule’s boundaries whenever a more flexible arrangement might be imagined.
The Court relied on Supreme Court decisions in UCB, Boehringer and Merck, which addressed the balance between compensation for innovative pharmaceutical companies and the interests of the public and generic industry, as well as the need for precision in statutory deadlines and requirements. It also referred to the decisions concerning Newron and Amgen, in which weight was given to the importance of certainty and clear statutory arrangements in patent term extension law.
In this context, the judgment expressly cited Yonatan Drori’s book Patent Law, Volume I (2023), at pages 235, 243 and 250. The Court referred to the book’s discussion of the objectives of Amendment No. 11 to the Patents Law, the prohibition against granting more than one extension order for the same substance, and the connection between the validity of an Israeli extension order and the status of extension orders in reference states.
The Understanding with the United States Does Not Permit Reopening a Lapsed Order
Genentech referred to the 2010 document of understandings signed between the governments of Israel and the United States, which formed part of the background to the amendments to the patent term extension regime. It argued that the commitment to allow completion of the two-state requirements until expiry of the basic patent supported permitting an applicant to await additional foreign extensions even after the Israeli order had lapsed.
The Court rejected that broader interpretation. The document of understandings was intended, among other things, to prevent the premature rejection of an application still awaiting extension orders in recognized states. It does not require an extension order that has already been granted and has lapsed to be treated once again as a pending application. Alongside the implementation of international commitments, the legislature sought to strengthen certainty in the domestic market, an objective reflected in the statutory timetable for examination and determination.
The Court added that the hypothetical scenarios raised by the appellant did not justify departing from the existing framework. It was unnecessary to decide in advance every possible situation in which the circumstances of registration or extension might change in other countries. If materially different factual or legal circumstances arose, they could be considered in appropriate proceedings. The present case concerned an order that had actually been granted and subsequently lapsed following revocation of a reference patent.
Dismissal of the Appeal and Implications for Patent Holders and Generic Companies
The Court dismissed the appeal and upheld the Deputy Registrar’s decision of December 21, 2023. Genentech was ordered to pay the State NIS 15,000 in legal costs. The Court observed that the company’s argument merited examination and therefore did not award costs at the higher end of the range.
The result was that the extension order intended to add 161 days of protection to Patent No. 213353 had lapsed following revocation of the European reference patent. The judgment did not revoke the underlying Israeli patent, which is due to expire on December 8, 2029, subject to payment of renewal fees. The distinction between the basic patent and its extension order matters both to patent holders and to companies planning to enter the market after patent protection expires.
For pharmaceutical patent holders, the decision demonstrates that, once an extension order has been granted in Israel, they should not assume that the possibility of relying on alternative reference patents will remain open until the basic patent expires. Revocation of a reference patent or its extension order may cause an existing Israeli extension order to lapse even before its additional protection has begun. For generic companies, the judgment strengthens the ability to rely on known lapse events and the state of the Patent Register when planning market entry.
The ruling is also related to the judgment in Administrative Appeal (Jerusalem District Court) 60673-01-25, Bristol-Myers Squibb v. Unipharm (May 11, 2026), which addressed Section 64J(3) following retrospective revocation of a UK reference patent. In both cases, the courts rejected attempts to narrow the lapse provision by drawing distinctions unsupported by its wording. The disputes were nevertheless different: Genentech concerned lapse before the commencement of the extension period and the possibility of reviving stages of the application, whereas Bristol-Myers concerned the effect of retrospective revocation of a reference patent.
For an analysis of the statutory framework and the circumstances in which modification or cancellation of extended protection may be sought, see also the guide to Cancellation or Modification of a Patent Term Extension Order in Israel. The Genentech judgment clarifies that the relevant question under this regime is not merely what rights may arise in the future, but also the finality of the Registrar’s decision once an extension order has been granted and the legal consequences of a lapse event in a reference state.
