The grant of a patent term extension order for a pharmaceutical patent is not necessarily the end of the matter. Even after the Registrar has issued an extension order, it may be argued that the statutory requirements were not satisfied, that the extension period was calculated incorrectly, or that a subsequent event has caused the protection to lapse. Where the statutory grounds are met, the Registrar may cancel the order or change its term. Such proceedings affect not only the patent holder and its competitors, but also the planning of generic market entry.
An application to cancel an extension order is distinct from an opposition filed before the order is granted. An opposition follows publication of a notice of intention to grant an extension, whereas a cancellation application concerns an order already in force. A further distinction must be drawn between cancellation by a decision of the Registrar, modification of the prescribed extension period, and statutory lapse following a later event. Different requirements and evidence apply to each route.
In Novartis v. Registrar of Patents (2024, Hebrew), the court allowed an appeal against cancellation of an extension order following deregistration of the first medicinal product, because other products containing the same active ingredient remained registered. That decision concerned statutory lapse under Section 64L(3), rather than cancellation proceedings under Section 64K.
Who May Apply to Cancel an Extension Order, and Is There a Time Limit?
Section 64K of the Israeli Patents Law, 5727-1967, empowers the Registrar, on the application of any person other than the holder of the basic patent or an exclusive licensee, to cancel an extension order or change its term if grounds exist on which the grant of the order or the prescribed term could have been opposed. Accordingly, a person who was not involved in the original extension application may bring cancellation proceedings, provided that a relevant statutory ground is established.
Significantly, Section 64K provides that limitation periods do not apply to a cancellation application under that section. Proceedings can therefore be commenced after the original opposition period has expired. This does not mean that delay is without consequence. While the extension order remains in force, the patent holder may have enforceable rights and claims, and uncertainty over the outcome may affect planned commercial activity.
By comparison, an opposition to the grant of a patent term extension order or to its term (Hebrew) must be filed within three months after publication of the relevant notice of intention under Section 64F, before the extension order is granted. A party receiving a notice or identifying an extension in the Patent Register should first establish whether the relevant instrument is a notice of intention or an extension order already granted.
What Grounds Can Justify Cancellation of an Extension Order?
The grounds under Section 64K derive from the opposition grounds in Section 64G and the conditions for granting an extension order in Section 64D. It may be argued, for example, that the basic patent does not protect the substance, process, use, medicinal product or medical equipment for which the order was granted; that the Israeli registration was not the first registration permitting use of the substance for medical purposes; or that an extension order had already been granted in circumstances prohibited by the Law.
Other grounds relate to reference patents in recognized states. Eligibility for an Israeli extension may depend on marketing authorizations and extension orders for corresponding patents, in accordance with Section 64D. The particular foreign patent, the substance it covers, the extension order actually granted, and its relationship to the Israeli basic patent must be examined. Similarities in pharmaceutical brand names or patent numbers are not enough.
A challenge alleging that the conditions for an extension order were never met must also be distinguished from proceedings to challenge the validity of the underlying patent. The basic patent may remain valid even though there is no legal basis for extending its term. Conversely, revocation of the basic patent, or its amendment so that the relevant subject matter is no longer protected, may cause the extension order to lapse under Section 64L(4).
Seeking a Shorter Extension Period Instead of Cancelling the Order
In Civil Leave to Appeal 2070/19, UCB v. Registrar of Patents (July 24, 2019, Hebrew), the Supreme Court rejected an application to increase, retrospectively by four days, the term of an extension order that had already been granted and recorded. The decision emphasized the distinction between calculating the term of an order that has not yet been granted and retrospectively changing a recorded expiry date on which competitors may have relied.
Complete cancellation is not the appropriate relief in every case. The patent holder may qualify for an extension, but the expiry date stated in the order may be later than the law permits. Sections 64I and 64J establish the method for calculating the extension period and its limits. Among other things, the term is linked to extensions granted for reference patents in recognized states and is subject to a five-year maximum beyond the basic patent term, a fourteen-year limit measured from the first marketing authorization in a recognized state, and rules governing the lapse of reference-patent extensions.
It follows that an extension order lasting less than five years is not necessarily lawful. An extension for a reference patent in a recognized state may have a shorter permitted duration, or the fourteen-year limit may expire earlier. An application for a shorter term must present calculations grounded in the dates of marketing authorizations, extension orders and their expiry, rather than a general assertion that the order is too long.
In Merck Sharp & Dohme (Hebrew), the application concerned shortening an existing extension order for Israeli Patent No. 110956. The Supreme Court considered the effect of an extension order for a reference patent in a recognized state issued after the Israeli order, and addressed the balance between compensating the patent holder and preventing excessive exclusivity that restricts competition. The legal basis for changing an extension order’s term after grant is examined in Patent Law, sections 3.2.4.9–3.2.4.10.
When Does an Extension Order Lapse by Operation of Law?
Cancellation by a decision under Section 64K differs from lapse under Section 64L. Section 64L identifies circumstances in which an extension order or a notice of intention to grant one lapses. These include the end of the permitted term; failure to pay an extension fee on time under Section 64M; cancellation of the registration of a medicinal product containing the substance; and revocation or amendment of the basic patent so that the relevant substance, use, process or medical equipment is no longer protected.
The distinction is substantive, not merely terminological. An application seeking cancellation for lack of original eligibility requires examination of the information on which the original grant was based. Where statutory lapse is alleged, the subsequent event may be central: when the medicinal product registration was cancelled, whether the fee was paid, what changed in the patent claims, or when an extension for a reference patent in a recognized state lapsed.
The possibility that an extension order has lapsed should not be treated as a risk-free basis for launching a competing product. The Patent Register, the Registrar’s decisions and the legal implications of the event must be examined. Section 64P governs the publication of notices concerning cancellation of an extension order, changes to its term and lapse.
Withdrawal of a Drug Registration: The Case Law from Wyeth to Novartis
A significant interpretive dispute concerns Section 64L(3), where registration of the first medicinal product on which an extension order was based was cancelled but other products containing the same active ingredient remained registered in Israel. The fact of deregistration alone does not resolve the legal consequences, as different decisions have interpreted the provision differently.
In Manufacturers’ Association of Israel v. Wyeth (Hebrew), the Registrar granted an application on March 25, 2021 to cancel the extension order for Patent No. 120701. Subsequently, in Appeal (Tel Aviv District Court) 34461-05-21, Wyeth v. Manufacturers’ Association of Israel (June 30, 2022, Hebrew), the court adopted an interpretation under which cancellation of the registration of the medicinal product underlying the extension order caused the order to lapse even though another product containing the same substance remained registered.
In separate proceedings, Novartis v. Registrar of Patents (March 27, 2024, Hebrew), the court considered an extension order for Patent No. 146578 based on the registration of ONBERZ, containing the active ingredient indacaterol. After registration of the first product was cancelled, two other products containing the same substance remained registered. The District Court allowed the appeal against cancellation of the extension order, holding that under those circumstances the cancellation of the first registration did not necessarily cause the extension order to lapse.
These are District Court decisions whose relationship must be examined in light of their particular facts. It would be wrong to assume either that deregistration of the first medicinal product always causes an extension order to lapse or that the existence of any other registered product necessarily preserves it. The active ingredient, the status of the remaining registrations, the patent’s scope and subsequent developments in case law must be assessed.
How Are Cancellation Proceedings Conducted Before the Registrar of Patents?
Regulation 4 of the Patents Regulations (Extension of Protection Period—Procedure for Applications for an Order, Oppositions and Cancellation Applications), 5758-1998, applies Regulation 3, with the necessary modifications, to applications for cancellation or amendment of an extension period. The applicant must file a statement of case setting out the grounds and relief sought, supported by appropriate evidence and proof of payment of the applicable fee.
The holder of the extension order has three months to submit its response and supporting evidence. If it considers it necessary, the applicant may file reply evidence within sixty days after the extension-order holder’s evidence is submitted, addressing facts expressly denied or raised for the first time. The Registrar may subsequently direct a hearing, examination of witnesses and written submissions. Regulation 6 authorizes the Registrar to require any party to provide further documents and particulars necessary to determine the application.
Under item 5 of the Schedule to the Extension Order Regulations, the fee for a cancellation application is twice the opposition fee. The current amount should be verified before filing. Attorneys, patent attorneys and other authorized representatives submit applications through the Israel Patent Office online service for cancelling an extension order or changing its term (Hebrew). The official service page specifies the filing requirements and required documents.
Cancellation Applications During Patent Extension Infringement Proceedings
Section 64K1 distinguishes between two procedural situations. If an application to cancel an extension order or change its term is filed while court proceedings for infringement of that extension order are already pending, the Registrar may hear the application only with the court’s permission. Where permission is granted, the Registrar must give the parties to those court proceedings an opportunity to present their arguments.
If the infringement action begins after a cancellation application has already been filed with the Registrar, the Registrar may continue to hear the application unless the court directs otherwise. The sequence in which proceedings are commenced is therefore not a mere procedural detail: it may affect when and before whom the issues are determined.
An appeal against the Registrar’s decision may remain significant even if the extension order has since expired. In Novartis (2024), the court rejected the argument that the appeal had become purely academic: the decision could affect the ability to pursue claims for alleged infringement during the period between the cancellation decision and the original expiry date of the order. Challenges to the Registrar’s decisions are discussed in Appeals Against Decisions of the Israeli Registrar of Patents (Hebrew).
What Evidence Is Needed to Support a Cancellation Application?
Relevant documents include the extension order, decisions preceding its grant, the original application and its supporting materials, the claims of the basic patent, medicinal product registration records, and marketing authorization documents. An allegation that the Israeli registration was not the first relevant registration must identify an earlier qualifying registration. An allegation that the basic patent does not cover the relevant product must explain the relationship between the claim language and the substance or product. An application to shorten the term requires a detailed calculation of each applicable limitation and period.
Where a subsequent event is relied upon, such as withdrawal of a medicinal product registration, revocation of a reference patent or non-payment of a fee, official evidence and an exact date should be provided. The legal consequences of that event must also be analyzed, especially where statutory interpretation is contested. In some cases, pharmaceutical or technical expert evidence will be more important than a dispute over publication dates.
For a detailed treatment of the statutory regime, see Yonatan Drori, Patent Law (2023) (Hebrew), section 3.2.4.10, Cancellation, Lapse and Modification of the Term of an Extension Order, and section 3.2.4.9 on calculation of the extension period. The principal substantive provisions are Sections 64K–64L of the Patents Law; the procedural framework is set out in Regulations 3–4 of the Extension Order Regulations. Cancellation proceedings fall within patent litigation in Israel, but are distinct from opposition proceedings before an extension order is granted.
