In a decision dated September 16, 2015, Registrar of Patents Asa Kling addressed an application by Bristol-Myers Squibb Company and Pfizer Inc. for an extension order for Israeli Patent No. 160693. At issue was a two-day difference in determining the date from which the fourteen-year limit on patent protection for Eliquis should be calculated. The question was whether the date on which the European authority decided to authorise marketing of the medicine, May 18, 2011, constituted the “date of the first marketing authorisation” for the purposes of Section 64J(2) of the Israeli Patents Law, or whether the relevant date was May 20, 2011, when the decision was notified to the applicant. The Registrar preferred the earlier date and held that the notice of intention to grant an extension order should specify an extension of 974 days, until May 18, 2025.
Full decision dated September 16, 2015 (PDF, Hebrew)
The decision was made during examination of the application, before the final extension order was issued. Further proceedings concerning the same patent followed, including a request for reconsideration in 2016 and later proceedings concerning the lapse of the extension order following the revocation of a reference patent in the United Kingdom. The dispute over the calculation of the extension period must be distinguished from the subsequent dispute over its continued validity.
The Patent, the Medicinal Product and the Extension Application
Israeli Patent No. 160693, whose title refers to a composition containing a lactam or a pharmaceutically acceptable salt thereof and its use as a factor Xa inhibitor, covers, among other things, the active substance apixaban. That substance is incorporated in Eliquis, a medicinal product intended to prevent the formation of blood clots. Eliquis was first registered in Israel on June 28, 2012, in the names of Bristol-Myers Squibb and Pfizer Pharmaceuticals Israel Ltd. The decision noted that Pfizer Inc. was an exclusive licensee entitled to exploit the patent.
The application to extend the term of protection was filed on August 23, 2012. During examination, the applicants were required to provide additional information following Amendment No. 11 to the Patents Law. The information included the European marketing authorisation, granted by a decision dated May 18, 2011, and the US marketing authorisation, granted on December 28, 2012. The documents relating to the extension order granted in Italy referred to a marketing authorisation dated May 18, 2011.
The dispute did not concern the patentability of the substance or compliance with the Israeli regulatory requirements. It concerned a narrower question: which of the two dates appearing in the European authorisation documents determined the statutory time limit under Israeli law.
Section 64J(2): The Fourteen-Year Limit
Section 64J(2) of the Patents Law limits the aggregate duration of protection under the basic patent and the extension order, so that it ends no later than fourteen years after the date of the first marketing authorisation in one of the recognized states. This limit operates separately from the other rules for calculating an extension period under Sections 64I and 64J of the Law.
In this case, a two-day difference in the date of the first marketing authorisation could have produced a two-day difference in the expiry of protection in Israel. The patent examiner relied on the date stated in the Italian extension order, May 18, 2011. The applicants challenged that determination and requested an opportunity to present their arguments to the Registrar. A hearing took place on July 12, 2015.
The Companies’ Position: The Relevant Date Was Notification of the Authorisation
Bristol-Myers Squibb and Pfizer argued that the European marketing authorisation did not take effect in relation to them when the decision was adopted, but only when they were notified of it on May 20, 2011. They maintained that, until the notification was received, they could not commercially rely on the authorisation and there was therefore no justification for counting the fourteen-year period from an earlier date.
The companies submitted an affidavit from Barry Jacobson, legal counsel to Bristol-Myers Squibb, together with the European Union’s official publication. The documents expressly distinguished between the “Date of decision,” May 18, 2011, and the “Date of notification,” May 20, 2011. The European decision stipulated that the authorisation’s period of validity would run from the date of notification to its addressee.
In further support, the companies referred to a 2013 decision of the UK Registrar of Patents in the Genzyme matter, which preferred the date on which the decision was notified to the authorisation holder for the purposes of the European law governing supplementary protection certificates. In their view, using the notification date also accorded with the rationale of compensating for the time lost before the medicinal product could be marketed.
The Evidentiary Difficulty: Different Dates in Recognized European States
The Registrar did not disregard the distinction between the decision date and the notification date. He noted, however, that the evidence before him showed inconsistent treatment among the recognized European states. The extension orders in Italy, Spain and France reflected an expiry date consistent with calculation from May 18, 2011. The UK order reflected a date two days later. When the affidavit was submitted, no final information was available concerning Germany.
The applicants claimed that the authorisation date recorded in the Italian extension order was incorrect, but did not provide a satisfactory explanation for Spain’s use of the same earlier date. Following the hearing, the Registrar also afforded them an opportunity to submit an expert opinion on European law. In their notice of July 19, 2015, they elected not to submit any further opinion.
At that time, interpretation of the relevant marketing authorisation date was also awaiting a ruling by the Court of Justice of the European Union. The Registrar considered that the evidence did not allow him to disregard the dates recorded in extension orders issued by other recognized states or to conclude that those dates necessarily reflected errors.
The Decision: Reliance on the Earlier Date Used in a Recognized State
The Registrar determined that, because recognized European states, including Italy, had used May 18, 2011 to calculate the patent extension, that date should be treated as the date of the first marketing authorisation under Section 64J(2). In reaching this conclusion, he gave weight to the statutory wording referring to the first marketing authorisation “in one of the recognized states” and to the documents submitted with the application.
Accordingly, the Registrar directed that the notice of intention to grant an extension order for Patent No. 160693 specify a period of 974 days, beginning upon expiry of the basic patent on September 17, 2022 and ending on May 18, 2025. The notice was to be published in the Patents Journal under Section 64E(e)(1) of the Law.
The outcome of this decision must be distinguished from the terms of the extension order eventually granted. A decision of the Deputy Registrar dated November 28, 2024 referred to an extension order issued on October 22, 2018 for 976 days, until May 20, 2025. The 2015 decision concerned a notice of intention to grant an extension order, not the final order recorded in 2018. The documents discussed here do not, by themselves, fully explain the difference between the two periods.
Subsequent Developments: The European Judgment and the Request for Reconsideration
Shortly after the Registrar’s decision, on October 6, 2015, the Court of Justice of the European Union delivered its judgment in Case C-471/14, Seattle Genetics. It held that, under the relevant European regime, the decisive date of the first marketing authorisation was the date on which the decision was notified to its addressee. Relying on that ruling, the companies sought to reopen the calculation in Israel in 2016. In a subsequent decision dated July 19, 2016, the request for reconsideration was rejected, among other reasons because of the expiry of procedural time limits, the need for finality and the absence of an adequate basis for changing the result in the particular case.
The 2015 decision illustrates how the calculation of patent protection periods in Israel depends on the laws and regulatory documents of recognized states, while also demonstrating the limits of relying on a foreign legal interpretation without sufficient evidence concerning the states concerned. This issue differs from the dispute that arose years later over the lapse of the extension order following revocation of the UK reference patent. That later proceeding concerned Section 64J(3), not the fourteen-year ceiling under Section 64J(2).
For further discussion of the Israeli statutory framework, the calculation of extension periods and the relationship to reference patents, see Yonatan Drori, Patent Law (2023), Chapter 3.2.4 (Hebrew).
