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Background

Israel has a unique patent term extension (PTE) system.  Patent term extension orders are granted only for patents that claim an active pharmaceutical ingredient (API) once a marketing authorization is issued for the first time by the Israeli Ministry of Health.  A petition for PTE must be submitted within 90 days from “the date of registration of the pharmaceutical preparation” in the Israeli Drug Register. This deadline is non-extendable and late filing will result in the loss of eligibility for PTE. 

In addition, Israel’s PTE system links the entitlement, duration and validity of PTEs to the marketing authorizations and PTE and Supplementary Patent Certificates (SPCs) issued for reference patents in the United States (U.S.) and in the top five European countries (namely, Great Britain, Italy, Germany, France and Spain, collectively referred to as the “EU-5 countries”).  In other words, in Israel, PTE eligibility is subject to a “two-state” requirement.  Specifically, if a marketing authorization for a small molecule or biologic is granted in the U.S. and an EU-5 country, then PTE will only be granted in Israel if a PTE and SPC is granted in both the U.S. and at least one of the EU-5 countries.  Further, in July 2019, the Israeli Patent and Trademark Office (PTO) issued a circular clarifying the reporting requirements imposed on PTE applicants and holders in Israel. This circular affirmed that any change affecting the validity or registrability of a PTE order must be reported to the Israeli PTO.  Additionally, a cancellation, expiry or renewal of a drug registration must also be reported.

Amgen’s PTE Request for Israeli Patent No. 138857

In May 2020, a decision regarding a PTE for Israeli Patent No. 138857 (in the name of Amgen Research (Munich) GmbH), provides further guidance regarding adherence with the above requirements. Specifically, the patent at issue, Israeli Patent No.138857, claims Amgen’s API blinatumomab (BLINCYTO®).  Blinatumomab is a monoclonal antibody used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia.   Amgen received regulatory approval for blinatumomab from the Israeli Ministry of Health in October 13, 2016 and timely filed a PTE request for blinatumomab with the Israeli PTO.

For 18 months while Amgen’s Israeli PTE was pending, Amgen’s Israeli representative failed to report to the Israeli PTO any PTEs and/or SPCs granted in any corresponding jurisdiction (i.e., U.S. or any EU-5 country) for blinatumomab. It was only after the expiration of IL 138857 that Amgen’s representative continued with the PTE proceedings.  At this point: (1) technically, the PTE proceedings should have been terminated; or (2) Amgen’s representative, should have, at a minimum, filed a request for an extension of time well before the expiration date of the patent.   Not surprising, and in strict accordance with the wording of the law and regulations, the Israeli PTO refused the PTE application. The basis of the rejection was the fact that Amgen failed to inform the PTO of the EU-5 SPCs obtained within 90 days from the date of issuance and, in addition, failed to submit copies of these SPCs to the PTO.  Interestingly, Amgen’s representative took advantage of a minor ambiguity in the law and regulations as well as an inconsistency in the practice of the PTO and appealed the refusal and obtained a reversal of the PTO’s decision.  Thus, as a result, Amgen was able to obtain a PTE of 1463 days until April 23, 2023, subject to completing all requirements specified in the decision.

Key Takeaways from the Amgen Decision

In its decision, the Israeli PTO affirmed that once a PTE and SPC have been granted for a small molecule or biologic in the U.S. and in an EU-5 country, the Patent Owner has a non-extendible, 90-day period from the second granted extension (whether a U.S. PTE or EU-5 SPC) to report the grant of such PTE or SPC to the Israeli PTO.  A “second” granted extension refers to second granted extension in an EU-5 SPC (if the first extension is a U.S. PTE) or a U.S. PTE (i.e., if the first granted extension is in an EU-5 SPC country). In a situation where a first SPC issues in Spain and a second SPC issues in France, the French SPC is not considered to be a “second” granted decision.

Additionally, the Amgen decision stresses that the 90-day deadline to report the first U.S. PTE/EU-5 SPC and second EU-5 SPC/U.S. PTE to the Israeli PTO is non-extendable. Moreover, copies of the PTE/SPCs and any additional information required should be filed within reasonable time, such as, for example, within 90 days, however, this deadline can be extended, even retroactively.

Examples

For example, if a U.S. PTE is granted for small molecule X on June 1, 2020 and a first SPC is granted in France for the same small molecule X on October 1, 2020, the Patent Owner would have a non-extendible period of 90 days beginning from October 1, 2020 to report the grant of the U.S. PTE and a SPC granted in France for small molecule X to the Israeli PTO.   Failure of the Patent Owner to report the PTE and SPC to the Israeli PTO by December 30, 2020 (90 days from October 1, 2020) would result in forfeiture of eligibility for PTE for small molecule X.   Likewise, if a first SPC is granted in Great Britain for biologic Y on October 1, 2020 and a U.S. PTE is granted for biologic Y on January 15, 2021, the Patent Owner would have a non-extendible 90-day period beginning from January 15, 2021 to report the SPC and PTE for biologic Y to the Israeli PTO.  Failure of the Patent Owner to report the SPC and PTE to the Israeli PTO by April 15, 2021 (90 days from January 15, 2021) would result in forfeiture of eligible for PTE for biologic Y in Israel.

In all other circumstances, such as, for example, when a U.S. PTE grants before a EU-5 country SPC, a EU-5 country SPC grants before a U.S. PTE, or if a second EU-5 SPC grants after fulfillment of the “two-state” requirement, then the 90-day deadline is extendible, subject to the discretion of the Israeli PTO. However, it should be noted that a PTE application and the proceedings for obtaining the PTE should be conducted and preferably concluded before the expiration of the Israeli patent. Extensions of time can be obtained in the event that PTE or SPC are still pending in U.S. or Europe.

Given the complexity of the Israeli reporting requirements for PTEs issued in the U.S. and SPCs granted in the EU-5 countries, it is recommended that Patent Owners err on the side of caution and report the granting of such PTEs and SPCs to the Israeli PTO as soon as such PTEs and/or SPCs are granted to avoid running afoul of this complex reporting requirement.  Specifically, using the example recited above, if a U.S. PTE is granted for small molecule X on June 1, 2020 and a SPC granted in France for small molecule X on October 1, 2020, it is recommended that a Patent Owner report the granting of the U.S. PTE within 90 days after the grant of the U.S. PTE (i.e., 90 days after June 1, 2020, namely, August 30, 2020) and within 90 days after the grant of the SPC in France (i.e., 90 days after October 1, 2020, namely, December 30, 2020).

Please continue to watch BRICS & Beyond for updates on PTE requirements in Israel.

This post was written by Lisa Mueller and Yael Saidian of YSDN Patents

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