In a decision dated January 11, 2024, Deputy Registrar of Patents Jacqueline Bracha addressed the procedure for considering a third party’s claim that an Israeli patent term extension order had already lapsed following the revocation of a reference patent abroad. The proceedings were brought by Teva Pharmaceutical Industries Ltd. against Bristol-Myers Squibb Holdings Ireland Unlimited Company. The Deputy Registrar held that a third party could not create a separate procedure simply by demanding publication of a notice of lapse. Where a third party seeks to shorten the term of an extension order or have it cancelled, the proper procedure is an application under Section 64K of the Israeli Patents Law and Regulations 3 and 4 of the Patent Term Extension Regulations. The decision concerned procedure only; it did not determine at that stage whether the extension order had actually lapsed.
Full procedural decision of January 11, 2024 (PDF, Hebrew)
The dispute concerned Israeli Patent No. 160693, relating to the active substance apixaban in the medicine Eliquis. The substantive question was subsequently decided in the Deputy Registrar’s decision of November 28, 2024, which was followed by a District Court judgment on appeal.
The Events Leading to the Proceedings Before the Israel Patent Office
The extension order for Patent No. 160693 was granted on October 22, 2018, and was scheduled to expire on May 20, 2025. Alongside the Israeli protection, there were reference patents and extension orders in several recognized states, including the United Kingdom.
According to the decision, on December 20, 2022, the holder of the extension order notified the Israel Patent Office that an English court had revoked the UK reference patent and the extension granted on its basis, in a judgment dated April 7, 2022. On July 20, 2023, the company reported that the English appeal had been dismissed and the revocation upheld. It nevertheless clarified that these reports were submitted out of caution and that, in its view, the UK revocation did not cause the Israeli extension order to lapse.
On December 12, 2023, Teva filed an application entitled “Application for Publication of a Notice Concerning the Lapse of an Extension Order or for Its Cancellation.” Similar applications were subsequently filed by the Manufacturers Association of Israel and Unipharm Ltd. All three applicants argued that revocation of the UK reference patent triggered Section 64J(3) of the Patents Law.
When filing its application, Teva requested directions concerning the appropriate procedure. The Deputy Registrar invited the parties to explain why the matter should not be treated as an ordinary application to cancel an extension order under Section 64K and Regulation 4. Her January 11, 2024 decision resolved that procedural question.
Teva’s Position: The Order Lapsed by Operation of Law and the Registrar Should Publish the Lapse
Teva argued that Section 64J(3) causes an extension order to lapse by operation of law when a specified event occurs. In its view, no further constitutive judgment or decision is required for the order to lapse; the Registrar must publish notice of that event under Section 64P(3) of the Law.
On that basis, Teva sought to distinguish between proceedings in which a third party asks to cancel an existing extension order and an application drawing the Patent Office’s attention to an event that has already caused the order to lapse. If the Patent Office does not publish the notice on its own initiative, Teva argued, a third party should be entitled to request publication.
Teva emphasized the importance of the integrity and accuracy of the Patent Register. In its submission, the Register should not continue to record an extension order that has lapsed, and publication of the lapse should not be conditional on a generic pharmaceutical company initiating full cancellation proceedings. Alternatively, and as a precaution, Teva requested that its application also be considered as an application to cancel the extension order.
Bristol-Myers Squibb’s Position: Third Parties Must Follow the Statutory Procedure
Bristol-Myers Squibb argued that when a third party seeks to shorten or terminate the period of protection, the statutory route is an application under Section 64K. The procedure for such applications is governed by Regulation 4 of the Patents Regulations (Extension of the Period of Protection: Procedures for Applications for Orders, Oppositions and Cancellation Applications), 5758-1998.
The company did not reject in principle the possibility that the Registrar might investigate an event capable of causing an extension order to lapse or its term to be shortened on the Registrar’s own initiative. It maintained, however, that such an inquiry would take place with the holder of the extension order and would not confer party status on a third party in a new procedure not established by legislation.
The company further argued that a genuine legal dispute existed over whether the UK revocation was an event causing lapse. Determining such a dispute required an orderly process involving pleadings and evidence, rather than administrative publication following a third party’s demand.
The Distinction Between the Registrar’s Powers and a Third Party’s Standing
The Deputy Registrar began with Section 64J(3), which provides that an extension order lapses no later than the relevant date on which a reference-patent extension expires or a reference patent is revoked in a recognized state. Section 64P(3) requires the Registrar to publish online a notice concerning the lapse of an extension order.
However, the existence of a power to publish such a notice does not resolve who may initiate contested proceedings before the Registrar. The Law expressly provides two avenues for third parties: opposing the grant of an extension order or its proposed term before grant under Section 64F, and applying for cancellation of an order or modification of its term after grant under Section 64K.
The Deputy Registrar explained that the Law does not establish a separate third route through which a third party may compel an inquiry into alleged lapse outside those statutory procedures. She noted that correction of Register entries under Section 170 may be available in some circumstances, but not where a specific statutory procedure already governs the requested correction. Here, Section 64K provided that route.
As to the integrity of the Register, the Deputy Registrar accepted Teva’s underlying premise: proceedings before the Registrar serve to ensure that the Register is accurate and reflects the true legal position. That purpose, however, did not justify inventing a new procedure. The procedure prescribed by the Regulations was itself intended to ensure a sound determination, so maintaining the Register’s accuracy was consistent with requiring parties to use the established route.
The decision did not exclude action by the Registrar on the Registrar’s own initiative. If the Registrar considers that an event causing lapse has occurred, the Registrar may exercise the relevant powers after giving the holder of the extension order an opportunity to be heard. In such an ex officio inquiry, the Deputy Registrar explained, a third party is not a party to the proceedings. Where it is the third party that initiates a contested claim, the procedure laid down in the Law and Regulations must be followed.
Consolidation of the Three Applications and Procedural Directions
The parties agreed in principle to consolidate the applications filed by Teva and the Manufacturers Association of Israel. Unipharm indicated that it did not object to consolidation of its application as well. Bristol-Myers Squibb argued that Unipharm’s application sought publication of a lapse rather than cancellation and should therefore be dismissed at the threshold.
The Deputy Registrar directed that the three applications seeking to shorten the extension order’s term be heard together. The order holder’s objections to the form of Unipharm’s application could be raised in its response, and were not decided in the procedural ruling.
The consolidated proceedings were to be conducted under Regulations 3 and 4 of the Patent Term Extension Regulations. Since no evidence had yet been filed and there appeared to be no substantial factual dispute at that stage, the Deputy Registrar directed the holder of the extension order to file its statement of case and evidence within three months. Costs relating to the application were reserved for determination at the end of the proceedings.
Significance of the Decision and Its Relationship to the Later Rulings
The January 11, 2024 decision clarifies the distinction between the substantive effect of the statutory provisions, under which an extension order may lapse by operation of law, and the procedure for resolving a dispute over whether the event causing lapse has occurred. An administrative demand for publication does not, by itself, give a third party standing in a new procedure that the Law does not provide for.
The distinction is particularly significant for pharmaceutical patents, where the precise expiry of exclusivity may affect generic market entry and commercial disputes. Assessing the legal position requires more than simply consulting the date recorded in the Register. Where lapse is contested, the proper procedure must be invoked and the factual and legal basis examined.
In the substantive decision of November 28, 2024, the Deputy Registrar held that the UK revocation had caused the Israeli extension order to lapse on October 31, 2023, and made no order for costs. In the appeal decided on May 11, 2026, the District Court rejected the patent holder’s attempt to exclude retrospective revocation of a reference patent from the application of Section 64J(3). The later substantive outcome does not alter the nature of the January 2024 ruling, which dealt only with procedure.
For further analysis of patent term extension lapse, the Registrar’s powers and cancellation proceedings, see Yonatan Drori, Patent Law (2023), Chapter 3.2.4, and the guide to cancelling or changing the term of a patent term extension order in Israel.
