A patent term extension order in Israel may delay the date on which competing manufacturers can market a pharmaceutical product after the ordinary patent term expires. The extension mechanism is intended to address the time required to obtain regulatory approval for medicinal products or medical devices, but eligibility and duration are subject to statutory conditions. Under the Israeli Patents Law, any person may oppose the grant of a patent term extension order or the proposed duration of that order, provided the opposition is filed within the prescribed period and on a recognized statutory ground.
Unlike an opposition to the grant of a patent in Israel, an opposition to a patent term extension (PTE) does not necessarily challenge the patentability of the underlying invention. The basic patent may be valid, yet the conditions for extending its protection may not have been met. Disputes may concern a previous Israeli registration of the active substance, the absence of a required foreign reference patent extension, or an error in calculating the extension period.
For foreign pharmaceutical companies, generic manufacturers and their counsel, the decisive issues often involve records held in several jurisdictions. Israeli registration information must be examined alongside foreign patent term extensions and marketing authorizations, under the specific definitions and time limits of Israeli law.
What Is an Israeli Patent Term Extension Order?
Article B1 of Chapter Four of the Israeli Patents Law, 5727-1967, provides for extending the protection of certain basic patents relating to medicinal preparations or medical devices, subject to statutory requirements. Section 64B requires that the application be made in good faith and that the scope of protection under the extension order not exceed that of the basic patent. An additional five years of protection is not automatically available for every pharmaceutical or medical device patent.
The rights conferred during an extension period are also narrower than those available during the ordinary patent term. Section 64H(d) addresses the right to prevent marketing, and manufacture for marketing, of the medicinal preparation or medical device covered by the order. Section 64H(f) makes clear that the extension order does not confer rights beyond those specified by law.
Accordingly, the identity of the substance, medicinal preparation or medical device covered by the requested order, and its relationship to the claims of the basic patent, are central to both eligibility and opposition proceedings.
Who May Oppose an Extension Order, and What Is the Deadline?
Under Section 64F, any person may oppose the grant of an extension order or the proposed duration of that order. This includes generic manufacturers, importers, competing pharmaceutical companies and other interested parties.
The opposition must be filed within three months after publication of the notice of intention to grant an extension order.
The relevant publication is not merely the initial announcement that a PTE application has been filed. Depending on the procedure, the opposition period begins with the publication prescribed by Section 64E(c), 64E(e)(1) or 64E(e)(3). Section 164 excludes the Section 64F deadline from the Registrar’s general power to extend time limits. Foreign counsel should therefore identify the actual publication date in the Israeli Patent Journal promptly, rather than assume that the time for opposition can be extended.
Under Regulation 3(a) of the Patents Regulations (Extension of Protection Period: Procedure for Applications, Oppositions and Cancellation), 5758-1998, the opposition must be accompanied by a statement of case, supporting evidence and proof of payment of the prescribed fee. The evidence is filed at the outset, unlike the procedural sequence applicable to an ordinary opposition against the grant of a patent.
Grounds for Opposition: First Registration, Basic Patent Coverage and Foreign Reference Patents
Section 64G(a) permits opposition on any ground that would authorize the Registrar to refuse an extension order or change its proposed duration. Section 64D specifies cumulative eligibility conditions. These include the continued validity of the basic patent and whether its claims protect the substance, process, use, medicinal preparation or medical device for which the extension is sought.
For medicinal preparations, Section 64D(3) requires the relevant registration to be the first registration permitting the use of the substance in Israel for medical purposes. An earlier registration of the same substance can therefore provide a ground of opposition. Establishing this is not necessarily a matter of comparing brand names; the identity of the active substance, combinations of substances and the significance of different formulations must be examined under the Israeli statutory framework.
In Takeda v. Manufacturers Association of Israel, Administrative Appeal (Tel Aviv District Court) 15989-07-18 (12 February 2019), an appeal concerning the refusal of an extension for dexlansoprazole was dismissed because the substance was already included in an earlier registered preparation containing both enantiomers. The case illustrates the importance of the statutory first-registration test.
Section 64D(4) also requires consideration of whether an extension order had previously been granted in respect of the basic patent or the substance.
Eligibility may further depend on extension orders for reference patents in the recognized countries under Sections 64D(5)-(7). Identifying an appropriate foreign reference patent can be particularly difficult when an Israeli preparation contains a single substance but a foreign product is registered as a combination. This issue is discussed in the Israeli Merck patent term extension proceedings.
Section 64B additionally requires good faith. Material omissions or inconsistencies in the documents submitted to the Patent Office may therefore be relevant, depending on their nature and significance. Not every inaccurate statement necessarily defeats eligibility. An opponent must identify the legal requirement in issue and the effect of the alleged defect.
Opposing the Proposed Duration of a Patent Term Extension
A patent may qualify for a PTE in principle while the proposed extension period is longer than Israeli law permits.
Section 64I(a) generally ties the duration of an Israeli extension order to the shortest relevant extension period granted for reference patents in the recognized countries, subject to the statutory conditions. Section 64I(b) establishes a separate mechanism for cases in which marketing authorization was sought only in Israel, addressing the relevant regulatory period and requirements of good faith and due diligence.
Section 64J imposes additional limits. An extension may not add more than five years to the basic patent term. The total protection period must also comply with the statutory limit based on fourteen years from the first marketing authorization in a recognized country. The provision further requires consideration of the expiry or cancellation of relevant foreign reference patent extension orders.
Consequently, even a requested three-year extension may exceed the lawful period in a particular case.
Suppose the basic Israeli patent expires at the end of 2028 and its owner seeks protection until the end of 2032. The fact that the requested extension is shorter than five years does not settle the calculation. A shorter foreign reference patent extension or an earlier applicable fourteen-year limit may require an earlier expiry date. Israeli litigation concerning Merck Sharp & Dohme has addressed the calculation of extension periods.
A well-supported opposition to the proposed duration should set out a detailed chronology of the Israeli basic patent, the marketing authorizations, the relevant foreign extension orders and their expiry dates, explaining the application of each statutory limit. The number of additional years requested by the patent owner is not, by itself, sufficient evidence of entitlement.
Supplementary Notices: Restrictions on Later Opposition Grounds
Section 64E(e) allows, in certain circumstances, an initial notice of intention to grant an extension order to be published before all necessary foreign reference patent extension orders have been issued, followed by a supplementary notice.
Section 64G(b) limits an opposition against a supplementary notice under Section 64E(e)(3) to grounds concerning the existence of foreign reference patent extension orders. It does not allow an opponent to revive a ground that could have been raised in response to the initial notice under Section 64E(e)(1).
For example, a party wishing to argue that the Israeli registration was not the first registration of the substance should examine that ground during the first opposition window rather than postpone it until a supplementary notice is published.
Foreign extension orders also create separate reporting obligations. The Newron and Amgen decisions on reporting foreign patent term extensions address disputes concerning the timing of reports to the Israeli Registrar. The applicant’s reporting obligations should not be confused with the grounds an opponent is permitted to raise during each opposition period.
How Is a Patent Term Extension Opposition Conducted?
Regulation 3 requires the opponent to submit a detailed statement of case and supporting evidence with the notice of opposition. Under Regulation 3(b), the applicant for the extension order must file its response and evidence within three months after the opposition is filed. A failure to respond in time carries procedural consequences regarding the facts and relief alleged in the opposition.
Under Regulation 3(c), the opponent may file reply evidence within sixty days after the applicant’s evidence is submitted, limited to facts expressly denied or raised for the first time by the applicant.
The proceedings may include a hearing, examination of witnesses and expert witnesses, and written submissions. Section 64O(c) requires the Registrar to decide the opposition within one year of its filing. Under Section 64O(d), the Registrar must, insofar as possible, complete the proceedings before the expiry of the basic patent and may shorten procedural periods in appropriate circumstances.
The Israel Patent Office’s official guidance on opposition to patent term extension orders explains the filing procedure and required documents. Attorneys, patent attorneys and other representatives must submit oppositions through the Patent Office’s online filing system. The applicable official fee should be checked at the time of filing.
Opposition Before Grant Versus Cancellation of an Existing Extension Order
An opposition under Section 64F is filed following publication of an intention to grant an extension order and before the order is finally issued. Once an extension order has been granted, Section 64K may provide a separate procedure for seeking its cancellation or modification, subject to the statutory requirements. Section 64K also provides that limitation periods do not apply to an application for cancellation under that provision.
A later challenge may involve events that occurred after the order was granted, such as cancellation of a medicinal product’s registration or changes in the status of foreign reference patent extension orders. The dispute in Manufacturers Association of Israel v. Wyeth concerned the consequences of a subsequent change in the medicinal product’s registration.
The availability of a post-grant procedure does not render the original opposition period irrelevant, nor does it establish that every issue which could have been raised earlier may be presented on identical terms later. The separate grounds and procedure are considered in Cancellation or Modification of a Patent Term Extension Order in Israel.
Challenging an extension order is also distinct from challenging the validity of the basic patent itself. The validity of the basic patent may affect eligibility for an extension, but patent cancellation in Israel is governed by different statutory grounds and remedies.
Evidence to Prepare Before Filing an Opposition
The starting documents are the published notice of intention to grant an extension order, the PTE application and the claims and records of the basic Israeli patent. The opponent should compare the substance or device identified in the PTE application with the patent claims, examine earlier Israeli registrations and obtain the relevant marketing authorizations and extension records in the recognized countries.
Where duration is disputed, a complete calculation showing the effect of each statutory limit should be prepared. Where the dispute concerns the identity of the substance or the coverage of the patent claims, technical, pharmaceutical or regulatory expert evidence may be required.
An assertion that extended exclusivity adversely affects competition does not, without more, establish a statutory ground of opposition. Conversely, an opponent challenging the proposed PTE expiry date need not establish that the entire basic patent is invalid.
These proceedings form part of the broader practice of Patent Litigation in Israel, but their purpose and legal framework differ from ordinary patent opposition and infringement proceedings. Further analysis appears in Yonatan Drori, Patent Law (Hebrew, 2023), Section 3.2.4, particularly Sections 3.2.4.4 and 3.2.4.7-3.2.4.9. The principal statutory provisions are Sections 64B-64J of the Patents Law and Regulation 3 of the patent term extension procedural regulations.
Israeli Supreme Court Ruling on Foreign Reference Patent Extension Orders
In Civil Leave to Appeal 386/22, the Israeli Supreme Court clarified that not every European supplementary protection certificate (SPC), even if lawfully issued under the applicable foreign law, necessarily satisfies the Israeli statutory definition of an extension order for a reference patent under Section 64A.
In the circumstances of the case, the Court determined an extension period of 1,824 days without relying on a later European order providing an extension of 1,490 days. The decision is discussed in Boehringer v. Registrar of Patents: Extension of a Reference Patent.
For foreign patent counsel, the practical lesson is that the legal status and effect of each foreign extension order must be assessed under the specific definitions of Israeli law. It is not sufficient to assume that a valid SPC or patent term extension abroad automatically determines the corresponding Israeli extension period.
