In a decision dated November 28, 2024, Deputy Registrar of Patents and Intellectual Property Adjudicator Jacqueline Bracha held that the patent term extension order for Israeli Patent No. 160693, relating to the medicine Eliquis, had lapsed on October 31, 2023 following the revocation of a reference patent and its extension in the United Kingdom. The decision arose from consolidated applications filed by Unipharm Ltd., the Manufacturers Association of Israel and Teva Pharmaceutical Industries Ltd. against Bristol-Myers Squibb Holdings Ireland Unlimited Company. The Deputy Registrar held that the wording of Section 64J(3) of the Israeli Patents Law, referring to revocation of any reference patent in a recognized state, did not permit the Israeli order to remain in force merely because reference patents and extension orders in other recognized states had not been revoked.
The decision also addressed Bristol-Myers Squibb’s argument that retrospective revocation of a UK reference patent was equivalent to a situation in which that patent had never been granted in the first place. The argument was rejected. The decision was subsequently challenged in an appeal before the Jerusalem District Court, which was dismissed on May 11, 2026. The November 2024 decision should therefore be read together with the appellate judgment, which upheld its outcome.
Full decision of November 28, 2024 (PDF, Hebrew)
Background: The Apixaban Patent and Extension Orders in Israel and Europe
Israeli Patent No. 160693 concerns the active ingredient apixaban, used in Eliquis to prevent the formation of blood clots. The basic patent expired on September 18, 2022. An extension order granted on October 22, 2018 extended the protection by 976 days, until May 20, 2025. At the time of grant, reference patents whose terms had been extended remained in force in the relevant recognized states.
One of the reference patents was EP(UK)1427514 in the United Kingdom. Proceedings before the UK Patents Court resulted in revocation of that patent and the extension granted in respect of it. The decision was appealed, but the appeal was dismissed, and the UK Supreme Court refused permission for a further appeal. On the basis of those developments, the revocation became final on October 31, 2023.
Bristol-Myers Squibb informed the Israel Patent Office of the UK proceedings but maintained that they did not constitute an event causing the Israeli extension order to lapse. The company emphasized that the marketing authorizations and extension orders in other recognized states remained valid.
Proceedings also took place in Spain concerning the reference patent and extension order there. According to a notice submitted by the extension-order holder on August 9, 2024, the Spanish appellate court reversed a lower-court decision revoking the reference patent, with the result that the patent and its extension remained in force in Spain. The company sought to characterize the UK revocation as an exceptional outcome that did not reflect the overall position of the European patents.
The Consolidated Applications and the Procedural Decision
Teva commenced the proceedings on December 12, 2023, seeking publication of a notice that the extension order had lapsed, or alternatively its cancellation under Section 64K of the Patents Law. The Manufacturers Association filed a similar application on December 21, 2023, and Unipharm applied for a declaration of lapse on January 2, 2024. All three argued that revocation of the UK reference patent was an event triggering Section 64J(3).
In a procedural decision dated January 11, 2024, the Deputy Registrar directed that the applications be heard together under the procedure for cancelling an extension order or modifying its term, pursuant to Regulations 3 and 4 of the Patent Term Extension Regulations. That earlier decision concerned the procedural route; the November decision determined the substantive issue of lapse.
On April 11, 2024, the holder of the extension order filed its submissions and an expert opinion by Daniel Charles Brook, a lawyer involved in the UK proceedings. The parties presented oral summations on May 9, 2024. The principal facts were agreed, and the dispute primarily concerned the interpretation of Israeli law and the legal effect of the UK revocation.
The Applicants’ Position: Section 64J(3) Is Triggered by Revocation of a Reference Patent
Unipharm, Teva and the Manufacturers Association argued that, under Section 64J(3), the Israeli extension order must expire 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 in which marketing authorization was granted. They contended that the UK revocation became final on October 31, 2023, so the Israeli order had lapsed no later than that date.
The applicants emphasized the purpose of the statutory arrangement: preventing a situation in which a medicinal product becomes open to generic competition in a recognized state while additional exclusivity under a patent term extension remains in force in Israel. They argued that extending Israeli protection after revocation of the UK reference patent would overcompensate the patent holder and harm competition.
They further maintained that the patent term extension mechanism does not confer an independent Israeli right disconnected from developments in the reference states. Even where valid patents and extension orders remain in other countries, a statutory lapse event of the type specified by the Law may affect the Israeli order.
Bristol-Myers Squibb’s Position: Retrospective Revocation Means the Patent Was Never Granted
Bristol-Myers Squibb argued that the UK reference patent’s revocation for invalidity operated retrospectively, ex tunc. In its view, when a court determines that a patent was invalid from the outset, the extension granted in respect of that patent must likewise be treated as though it had never existed. The company therefore contended that there had been no event involving the lapse of an existing UK extension order; rather, there had never been a valid UK order in the first place.
The extension-order holder sought to link that interpretation to the conditions for obtaining an extension order in Israel. Section 64D(7), in the version applicable to the circumstances, refers to the existence of extension orders in the United States and in at least one recognized European state. According to Bristol-Myers Squibb, because extension orders in other European states and the United States remained in force, the requirements for an Israeli extension would have been met even if an extension order had never been granted in the United Kingdom.
The company argued that it would therefore be unjustified to reach a different legal result merely because a UK patent had once been granted and was subsequently revoked with retrospective effect. It submitted that the contrary interpretation created inconsistency between the statutory conditions for granting and terminating an extension order, infringed its property rights, and undermined the objective of compensating innovative pharmaceutical companies for regulatory delays in obtaining marketing authorizations.
The holder also relied on expert evidence concerning UK law, the explanatory notes accompanying the legislative amendments, and case law in which a purposive interpretation of statutory arrangements had been preferred over a purely literal reading.
The Statutory Framework: Conditions for Grant and Conditions for Lapse
The Deputy Registrar distinguished Section 64D, which governs eligibility for an extension order, from Sections 64I and 64J, which prescribe limits on the extension period and the circumstances in which it expires. Section 64J(3) refers to the first date on which any reference patent is revoked or an order extending a reference patent expires in a recognized state.
The word any was decisive. The provision does not confine lapse to cases in which all extension orders in the recognized states have been cancelled or in which too few qualifying orders remain to satisfy the original eligibility conditions. It is therefore possible for the requirements for granting an order to have been satisfied on the basis of certain states, while an event in another recognized state subsequently brings that order to an end.
The Deputy Registrar acknowledged the difficulty that this distinction could create and examined whether the Law should instead be interpreted to align the conditions for granting an extension order with the conditions for its lapse. She did not rely solely on a literal reading, but also considered the legislative history of Amendment No. 11 to the Patents Law and the international arrangements underlying its enactment.
The Understanding with the United States and the Legislative History
As part of her analysis, the Deputy Registrar examined the 2010 document of understandings between Israel and the United States that formed the basis for amendments to the patent term extension regime. She identified a difference between one provision of that document, which referred to the expiry of a reference patent in the United States, and Section 64J(3) as enacted in Israel, which extends to additional recognized states.
The explanatory notes to the bill for Amendment No. 13, which ultimately became Amendment No. 11, described an intention to link the lapse of an Israeli extension order to events in recognized states. However, the provisions and explanatory notes did not fully resolve the relationship between the eligibility requirements in Section 64D and the stricter lapse rule in Section 64J(3).
The Deputy Registrar also considered the November 19, 2013 proceedings of the Knesset Constitution, Law and Justice Committee, which addressed the relationship among the alternatives in Sections 64D(5) through 64D(7). The discussion suggested that some of those alternatives were intended to operate disjunctively rather than cumulatively. However, she did not need to decide every possible difficulty arising from those provisions. The dispute before her concerned the revocation of a reference patent for which an extension had in fact been granted in the United Kingdom.
Her reasoning demonstrates that, although the legislative history raised questions, it did not provide a sufficient basis for departing from the wording of the lapse provision in the circumstances of the case.
Interpretation: Balancing Originator Companies, the Generic Industry and the Public
The Deputy Registrar relied on earlier decisions concerning the patent term extension regime, particularly Civil Leave to Appeal 8127/15, Manufacturers Association of Israel v. Merck Sharp & Dohme, and Civil Leave to Appeal 386/22, Boehringer Ingelheim v. Registrar of Patents. Those cases recognized that Israel’s statutory regime reflects a delicate balance between protecting investment in pharmaceutical research and development and the public interest in competition and access to generic medicines.
Accordingly, protection should not be expanded on the basis of general considerations of fairness favoring the patent holder, just as it should not automatically be narrowed in every dispute. The starting point is the detailed arrangement enacted by the legislature. The Deputy Registrar found that Section 64J(3) clearly required account to be taken of the revocation of a reference patent in a recognized state.
She also rejected the extension-order holder’s attempt to rely on the March 27, 2024 District Court judgment in Novartis, which concerned the interpretation of a different event causing lapse, related to registration of a medicinal product. The distinction, she explained, lay in the language of the particular statutory provision. Section 64J(3) expressly refers to any reference patent, leaving less scope for the interpretation considered in the separate dispute about registration of a medicinal product.
The decision further addressed earlier rulings in the Amgen matter and the duty under Regulation 5A to report changes affecting reference patents. It distinguished the theoretical question whether revocation of any reference patent, including one that had never been extended in a recognized state, is sufficient from the circumstances before it, in which a UK reference patent that had actually been extended was revoked. A broader determination concerning every possible reference patent was therefore unnecessary.
The Decision: The Extension Order Lapsed on October 31, 2023, with No Costs Awarded
The Deputy Registrar held that revocation of the UK reference patent and the extension granted in respect of it constituted an event causing lapse under Section 64J(3). She determined that the extension order for Israeli Patent No. 160693 had lapsed on October 31, 2023, the date on which the UK revocation became final. She accordingly directed publication of a notice concerning the lapse in the Patents Journal.
The decision explained that, where an event specified in Section 64L causes an extension order to lapse, a further constitutive decision by the Registrar is not required to bring about that lapse. The Registrar’s role includes publishing a notice reflecting the legal position. In this respect, the decision developed the procedural discussion from early 2024, although it now addressed the substantive question of lapse itself.
Although the cancellation applicants prevailed, Bristol-Myers Squibb was not ordered to pay costs. The Deputy Registrar noted that the interpretive question had not been straightforward and that the proceedings had been conducted on the basis of focused legal argument.
Subsequent Proceedings and the Significance for Patent Term Extension Disputes
Bristol-Myers Squibb subsequently appealed to the Jerusalem District Court. In Appeal 60673-01-25, decided on May 11, 2026, the Court dismissed the appeal, holding that retrospective revocation of a reference patent was not excluded from Section 64J(3). The Court upheld the Deputy Registrar’s conclusion and ordered the appellant to pay costs.
The case illustrates the distinction between the conditions for obtaining a patent term extension order and events capable of causing its lapse after grant. Where the Israeli term of protection is linked to developments in recognized states, it is not enough to check the expiry date originally recorded in Israel. Proceedings concerning reference patents and their extensions in relevant foreign states must also be monitored.
Nevertheless, the decision should not be read as holding that revocation of every foreign patent, regardless of its relationship to an extension or its status as a reference patent, necessarily terminates an Israeli extension order. The case concerned a UK patent that had actually served as a reference patent and had received an extension. The precise boundaries of other situations depend on the statutory provisions and the facts involved.
For a broader discussion of the statutory provisions and procedures for cancelling an extension order or modifying its term, see Yonatan Drori, Patent Law (2023), Chapter 3.2.4, particularly the treatment of lapse and cancellation of patent term extension orders.
