In Bristol-Myers Squibb Holdings Ireland Unlimited Company v. Unipharm Ltd., Appeal No. 60673-01-25 (Jerusalem District Court, May 11, 2026), Judge Arie Romanov dismissed an appeal against the Deputy Registrar of Patents’ decision that a patent term extension order for an Israeli pharmaceutical patent had lapsed. The court held that the revocation of a reference patent or the cancellation of an extension granted in a recognized state triggers the lapse of the Israeli extension order under Section 64J(3) of the Israeli Patents Law, 5727-1967, even where the foreign revocation or cancellation operates retroactively rather than prospectively.
The judgment addresses a question of considerable significance to the pharmaceutical industry: should the law distinguish between a country in which no patent term extension was ever granted and one in which a patent and its extension were granted but subsequently revoked or cancelled with retroactive effect? The court held that, for the purposes of Section 64J(3), the decisive event is the loss of protection in the recognized state, not whether the foreign decision operates retrospectively or only from the date on which it was made.
Full judgment of May 11, 2026 (PDF, Hebrew)
Factual Background: The Extension Order for the Eliquis Patent
Bristol-Myers Squibb held Israeli Patent No. 160693, which provided patent protection for Eliquis, a medicinal product containing the active ingredient apixaban, used to prevent blood clots.
The basic patent’s term expired on September 18, 2022. Previously, on October 22, 2018, the company had been granted an extension order extending protection by an additional 976 days, until May 20, 2025. The order was based on the medicinal product’s marketing authorization and on the existence of reference patents and extension orders in the states recognized under the Israeli Patents Law. Earlier proceedings, addressed in the Registrar’s decision of September 16, 2015 and a decision of July 19, 2016, had concerned different issues relating to the date of the first marketing authorization and calculation of the extension period. Those questions were distinct from the lapse issue considered in the present appeal.
At the time, corresponding protection was also granted in other jurisdictions, including the United States and recognized European states. Litigation subsequently took place in the United Kingdom concerning the validity of the reference patent and its extension.
On May 25, 2022, the extension relating to the UK reference patent was cancelled. During the proceedings before the Israeli Registrar of Patents, Bristol-Myers Squibb reported that the UK Patents Court had ordered the revocation of the reference patent and the cancellation of its extension. The company pursued appeals in the United Kingdom, but these did not alter the outcome. The cancellation of the extension became final on October 31, 2023.
Separate cancellation proceedings concerning the extension order took place in Spain and ended with a decision to maintain it in force. The differing outcomes illustrate the difficulty faced by the patent holder: protection remained effective in some recognized states but had been cancelled in the United Kingdom.
Following the UK developments, Unipharm Ltd., the Manufacturers’ Association of Israel and Teva Pharmaceutical Industries Ltd. submitted separate applications to the Israeli Registrar of Patents, asking the Registrar to publish notice of the lapse of the Israeli extension order or to declare that it had lapsed. The applications were consolidated before Deputy Registrar and Intellectual Property Adjudicator Jacqueline Bracha, following her January 11, 2024 procedural decision.
In her decision of November 28, 2024, the Deputy Registrar accepted the position that the cancellation of protection in the United Kingdom had caused the Israeli extension order to lapse, notwithstanding the continued validity of extension orders in other recognized European states. Bristol-Myers Squibb appealed to the Jerusalem District Court.
The Legal Framework: Granting an Extension Order Versus Its Subsequent Lapse
Under Section 52 of the Israeli Patents Law, the ordinary patent term is twenty years from the filing date of the patent application. For patents covering pharmaceuticals and medical equipment, the legislature established a special regime permitting an extension of protection where specified conditions are met.
The regime principally addresses the time required to secure regulatory authorization for marketing medicinal products. Development, clinical trials and approval procedures may substantially reduce the period during which a patent holder can commercially exploit an invention, even though the twenty-year patent term continues to run from the application filing date.
Israel’s extension regime does not depend solely on an independent assessment of the period of regulatory delay in Israel. Instead, eligibility for an extension, its length and its continuing validity are linked to reference patents and extensions in the recognized states specified by the Patents Law.
Sections 64D(5) through 64D(7) prescribe conditions relating to marketing authorizations and extension orders in recognized states. Where marketing authorizations were granted in the United States and at least one recognized European state, valid extension orders must exist in the United States and in that European state.
This is the basis of what Israeli case law calls the “two-country requirement.” An extension order in Israel does not require an extension to have been granted in all five recognized European states. Satisfaction of the statutory conditions in the United States and one of those European states is sufficient. The conditions for obtaining an Israeli extension order, however, are not the same as the conditions governing its continued validity.
Section 64I governs the calculation of the extension period by reference to the shortest applicable extension period granted for the reference patents. Section 64J imposes further limits, including a maximum extension of five years and a ceiling of fourteen years from the first marketing authorization in a recognized state.
The additional limitation at the heart of the appeal appears in Section 64J(3). Under that provision, an Israeli extension order lapses no later than the earliest date on which, in a recognized state in which marketing authorization was granted, an extension of a reference patent lapses or any reference patent is revoked. The statutory definition of lapse encompasses the shortening, cancellation or deletion of a foreign extension order, as well as revocation of the reference patent itself.
The distinction between the prerequisites for granting an extension order and the events that cause it to lapse is fundamental. An Israeli extension order may have been lawfully granted, yet a subsequent event in a recognized state may cause it to lapse, even where valid extension orders remain in other states sufficient to meet the original two-country requirement.
The statutory framework governing pharmaceutical patent term extensions, including the role of reference patents, calculation of extension periods and grounds for their lapse, is examined in Yonatan Drori, Patent Law (Perelstein-Genosar, 2023), vol. I, sections 3.2.4.9 and 3.2.4.10 (Hebrew).
Bristol-Myers Squibb’s Argument: Retroactive Revocation Is Not Ordinary Expiry
Bristol-Myers Squibb did not dispute that the revocation of a reference patent or cancellation of its extension in one recognized state could cause an Israeli extension order to lapse even if effective protection remained in other recognized states. Its argument focused on the legal effect of the revocation in the United Kingdom.
The company argued that a distinction must be drawn between cancellation that operates prospectively and cancellation that operates retroactively. Where a reference patent is revoked retroactively, the legal consequence, on its submission, is that the patent and its extension must be treated as though they had never been granted.
Bristol-Myers Squibb submitted that this was equivalent to a situation in which no extension order had ever been issued in the United Kingdom. Because Israeli law does not require a UK extension specifically, but accepts qualifying extensions in the United States and at least one recognized European state, the absence of a UK extension from the outset would not have prevented an Israeli extension order from being granted.
The company sought the same result where a UK extension had originally been granted but was subsequently cancelled with retroactive effect. It maintained that the alternative interpretation produced an inconsistency: if no UK extension had ever existed, Israeli protection might continue; but if a UK extension had existed and was later cancelled as though it had never existed, Israeli protection would lapse.
In support, the company submitted an expert opinion from Daniel Charles Brook, a lawyer who had participated in its representation in the UK proceedings. According to the appellant, his opinion established that the revocation of the reference patent and cancellation of the extension in the United Kingdom had retroactive effect. The expert was not cross-examined, and the respondents did not submit a conflicting expert opinion.
Bristol-Myers Squibb also argued that its interpretation accorded with the purposes of the statutory scheme and the explanatory notes to the Patents Law (Amendment No. 13) (Extension of the Protection Period) Bill, 5772-2012, particularly the discussion of Section 64L.
The court identified this as the precise issue before it. The question was not whether cancellation of an extension in one European state was sufficient to cause an Israeli extension order to lapse. It was whether retroactive cancellation should be excluded from that rule.
The Position of Unipharm, Teva and the Manufacturers’ Association
The respondents argued that Section 64J(3) establishes an express rule that does not distinguish between different forms of revocation of a reference patent or cancellation of its extension.
In their view, the legislature intended to prevent protection under an Israeli extension order from exceeding the protection remaining in the recognized states. Once an Israeli extension order has been granted, the cancellation of protection in a relevant state activates the statutory lapse provision, irrespective of whether the foreign cancellation operates retroactively or prospectively.
The respondents emphasized that the prerequisites for granting an extension order must not be conflated with those governing its continued existence. These are separate statutory arrangements, reflecting a legislative compromise between the interests of innovative pharmaceutical companies and those of the generic industry and the public.
They also relied on the legislative history. According to their submissions, the legislature had considered a stricter requirement that extension orders be in force in the United States and all five recognized European states. Ultimately, it adopted a less demanding condition for granting an Israeli order, alongside a more stringent rule governing its lapse.
The respondents further pointed to the commercial consequences of cancelling a patent abroad. While a reference patent and its extension remain in force, they may prevent generic manufacturers from entering the relevant market. Their cancellation changes the competitive position in practice, regardless of how foreign law characterizes the temporal effect of the decision.
On this analysis, there is a practical distinction between a case in which a patent was never granted abroad and one in which a patent was granted, restricted competition for a period and was then revoked. Even if foreign law treats the revocation as retroactive, that does not alter the fact that the patent protection had existed and affected market conduct until its revocation.
The Court’s Decision: No Basis for Distinguishing Retroactive from Prospective Cancellation
The court rejected Bristol-Myers Squibb’s interpretation, holding that it had no basis in the wording of Section 64J(3) of the Patents Law.
Judge Romanov observed that the legislature had not merely enacted a general rule of lapse, but had expressly identified the events falling within it. The provision refers to the cancellation or deletion of an extension order for a reference patent and the revocation of a reference patent, without distinguishing between retroactive and prospective decisions.
The court found no indication in the statutory language that the provision was intended to apply only to prospective cancellation. Accepting the appellant’s interpretation would require adding an exception that the legislature had not included.
The court also considered it significant that retroactive patent revocation is not unusual in the pharmaceutical sector. Generic pharmaceutical companies frequently challenge patents after grant, including on the ground that an invention lacks inventive step. Where such a challenge succeeds, revocation may have retroactive effect because the decision establishes that the patent ought not to have been granted in the first place.
In this context, the court also referred to Section 75(b) of the Patents Law, under which a patent that has been finally revoked is deemed never to have been granted.
Against that background, the court reasoned that if the legislature had intended Section 64J(3) to distinguish between retroactive and prospective cancellation, one would expect the distinction to appear expressly in the law.
The fact that the expert opinion concerning the retroactive effect of the UK decision was unchallenged did not change the result. The court did not need to reject the appellant’s assumption about the consequences of that decision under UK law. It held that cancellation of that kind also falls within the Israeli statutory lapse provision.
This is the central distinction drawn by the judgment: UK law determines the legal consequences of the foreign revocation within the United Kingdom, whereas Israeli law determines the effect of that event on an extension order granted in Israel.
Strict Interpretation of the Patent Term Extension Regime
The court also relied on the Supreme Court of Israel’s approach to interpreting the provisions governing patent term extension orders.
In Boehringer Ingelheim Pharma GmbH & Co. KG v. Registrar of Patents, Designs and Trademarks, Leave to Appeal No. 386/22 (December 11, 2022), the Supreme Court addressed the objectives of the regime and the balance it strikes between pharmaceutical patent holders, generic manufacturers and the public.
The Supreme Court explained that the regime seeks to balance adequate protection for pharmaceutical innovation against the need to prevent unjustified extensions of patent exclusivity and allow market competition.
It emphasized that the statutory arrangement embodies a carefully calibrated legislative compromise and that its provisions must be interpreted strictly, even where applying them in a particular case may produce a result perceived as unfair.
Judge Romanov adopted that approach. He found no justification for departing from the express wording of Section 64J(3) merely because the distinction advanced by Bristol-Myers Squibb might appear more legally consistent.
The court also addressed the contention that the respondents’ construction produced different results in seemingly comparable circumstances. Even if an inconsistency could be identified, that would not necessarily justify departing from the statutory arrangement.
The extension order regime does not seek to establish perfect symmetry between all recognized states or every conceivable factual situation. It reflects a compromise between competing commercial and public interests, for which the legislature established different conditions for granting an order and for its continuing validity.
The court examined the explanatory notes to Amendment No. 13 to the Patents Law but found no support there for Bristol-Myers Squibb’s interpretation.
Outcome of the Appeal and Legal Implications
The court dismissed the appeal and upheld the Deputy Registrar’s decision that the cancellation of protection in the United Kingdom had caused the Israeli extension order to lapse.
Bristol-Myers Squibb was ordered to pay NIS 20,000 in legal costs to Unipharm and another NIS 20,000 jointly to Teva and the Manufacturers’ Association of Israel, for a total of NIS 40,000.
The decision underscores that the duration of an Israeli pharmaceutical patent term extension depends in part on legal developments outside Israel. An extension order that was lawfully granted does not guarantee that protection will continue until the expiry date originally specified in it.
Revocation of a reference patent or cancellation of its extension in one recognized state may affect the Israeli extension order even where patent protection continues in others. It is not necessary to show that the original two-country requirement is no longer satisfied, nor must the foreign decision operate prospectively.
This distinction affects how the validity of extension orders is assessed in commercial disputes and in proceedings to cancel an extension order or vary its term. Examining the stated expiry date of the Israeli order is not enough. Decisions in recognized states that could affect its continuing validity must also be considered.
For innovative pharmaceutical companies, the judgment reinforces the need to monitor litigation involving reference patents and extension orders in recognized states. Protection in Israel may be affected by proceedings in one country even when their outcome does not alter the status of corresponding patents elsewhere.
For generic pharmaceutical companies, the ruling clarifies that revocation of a reference patent or cancellation of its extension in a recognized state may provide grounds to challenge the continued effect of an Israeli extension order, notwithstanding valid extensions in other recognized states. Such issues may also arise in patent litigation in Israel.
The judgment does not hold that revocation of a foreign reference patent invalidates the underlying Israeli patent itself. It concerns the lapse of the extension order under the special statutory regime. The distinction between the basic patent’s validity and the extension order’s validity remains material, particularly when assessing the patent holder’s rights during different periods.
Nor does the judgment resolve the consequences of lapse for allegations of infringement committed in the past. The appeal concerned the interpretation of Section 64J(3) and whether the retroactive effect of the UK decision prevented that provision from operating.
Bristol-Myers Squibb v. Unipharm thus joins the decisions emphasizing the distinctive nature of Israel’s patent term extension regime and the strict interpretation of its rules. Its central holding is that even where foreign law treats a revoked patent as though it had never been granted, the event of revocation cannot be disregarded when applying the Israeli statutory lapse provision.
