In a decision dated July 19, 2016, Registrar of Patents Asa Kling rejected an application by Bristol-Myers Squibb Company and Pfizer Inc. to reconsider his decision of September 16, 2015, which had calculated the proposed extension period for Israeli Patent No. 160693, relating to Eliquis, by reference to the date of the European marketing authorisation. The application relied on a subsequent judgment of the Court of Justice of the European Union in Seattle Genetics, holding that, for the purposes of European law, the relevant marketing authorisation date is the date on which the decision is notified to its addressee, rather than the date on which it is adopted. The Registrar found no justification for reopening his earlier decision after the period for challenging it had expired, a notice of intention to grant an extension order had been published, the opposition period had ended, and the applicants had failed to establish that applying the European ruling would change the calculation in Israel.
Full decision of July 19, 2016 (PDF, Hebrew)
The decision addresses the limits of the Israel Patent Office’s power to reconsider an earlier decision and the balance between changes in legal interpretation, legal certainty and public reliance. It does not concern the lapse of the extension order following revocation of a reference patent, an issue that arose in later proceedings concerning the same Israeli patent.
Background: A Two-Day Dispute over Eliquis’s Marketing Authorisation
Patent No. 160693 concerns, among other things, the active substance apixaban, which is included in the medicinal product Eliquis. In proceedings to extend the patent’s protection, a dispute arose over the calculation of the fourteen-year limit prescribed by Section 64J(2) of the Israeli Patents Law, 5727-1967.
According to the European documents, the European authority adopted its decision authorising the marketing of the medicinal product on May 18, 2011, but the authorisation holder was not notified of that decision until May 20, 2011. The pharmaceutical companies argued that the statutory period should not begin before notification, since they could not effectively make use of the authorisation before then.
In his first decision, dated September 16, 2015, the Registrar rejected the companies’ position. He relied on extension orders issued in recognized European states, particularly the Italian order, which used May 18, 2011. He therefore directed publication of a notice of intention to grant an extension order for 974 days, until May 18, 2025. The notice was published in Patents Journal 10/2015.
The European Development: The Seattle Genetics Judgment
On October 6, 2015, approximately three weeks after the Registrar’s decision, the Court of Justice of the European Union delivered its judgment in Case C-471/14, Seattle Genetics Inc. v. Österreichisches Patentamt. Interpreting Regulation (EC) No. 469/2009 concerning supplementary protection certificates, the Court held that the relevant date of the first marketing authorisation for calculating the protection period is the date on which the authorisation decision is notified to its addressee.
That ruling supported the interpretation the pharmaceutical companies had advanced in Israel before the first decision. They argued that, following the European judgment, the Israel Patent Office had begun applying the notification-date principle in several other cases. In their view, this indicated a change in the Office’s practice that justified a retrospective adjustment in the case of Patent No. 160693.
On March 17, 2016, the companies filed an application for reconsideration. They also relied on a German extension order recording May 20, 2011 as the marketing authorisation date. They contended that these new circumstances required the Israeli extension period to be recalculated.
The Procedural Obstacle: The Appeal Period and Opposition Period Had Expired
The Registrar emphasized that the Seattle Genetics judgment had been delivered on October 6, 2015, while the deadline for challenging his original decision expired on November 16, 2015. Nevertheless, the reconsideration application was filed only on March 17, 2016, approximately five months after the European judgment and six months after the Israeli decision.
In the meantime, the notice of intention to grant an extension order had been published and the opposition period had expired. The Registrar attached particular significance to this procedural stage. Publication of a notice under Section 64E(e)(1) is not a purely technical step. Once the period for opposing the notice has elapsed, the grounds of opposition become restricted under Section 64G(b), creating a degree of certainty concerning the proposed extension period.
The Registrar did not rule out, as a matter of principle, an administrative authority’s power to amend an earlier decision. He distinguished, however, between the existence of such a power and justification for exercising it in a particular proceeding. A reconsideration application should not serve as a substitute for an appeal whose filing deadline has passed, especially where the decision has already affected the position and expectations of third parties.
Reconsidering an Administrative Decision: Finality versus a Change in Policy
In his decision, the Registrar referred to the case law in Kashi v. Kashi and Strauss Marketing v. Orman, which addressed the exceptional nature of reconsideration of judicial decisions and the prohibition against using that process to circumvent an appeal deadline. He also examined the principles governing administrative decisions, where the authority to revise an earlier decision is broader but not unlimited.
On administrative law, the Registrar referred, among other authorities, to the Pinchasi judgment and Director of the Israel Tax Authority v. Eisinger. These authorities establish that an administrative decision is not necessarily immune from later review, but changing an individual decision requires consideration of finality, certainty, reasonable expectations and reliance. The freedom to change a general policy is not the same as the freedom to reverse a specific determination already made in particular proceedings.
The Registrar also distinguished between applying a change of policy prospectively and applying it retrospectively. Even if the notification date was preferred in other cases following Seattle Genetics, that would not, by itself, establish a general change in policy automatically applicable to applications previously decided.
Particular caution is required for patent term extension orders, since every additional day of exclusivity affects generic pharmaceutical companies and the public. Although the application sought only two further days of protection, the Registrar considered that the proposed change could not be assessed solely from the patent holder’s perspective. The interests of others who had relied on the published notice also had to be taken into account.
No Sufficient Substantive Basis for Changing the Result
In addition to his procedural reasoning, the Registrar found that the new material did not establish that the Israeli calculation should be changed. The first decision had relied on the data in the Italian extension order, and the reconsideration application did not establish that the marketing authorisation date used to calculate the extension in Italy had been corrected.
As to Germany, the applicants produced an extension order referring to May 20, 2011. But even taking that order into account, they had not established why the later date should prevail over the earlier date used to calculate the Italian extension. The Israeli statutory scheme relies on limits and shorter periods in recognized states, rather than necessarily adopting the date most favorable to the patent holder.
The Registrar held that the application of a European judgment in several individual cases did not, in itself, prove a general change in policy. In particular, it did not replace evidence about the relevant legal position and facts in the case at hand. Even if reconsideration were procedurally available, the applicants had not provided material capable of changing the result.
The Outcome and the Status of the 2015 Decision
The Registrar dismissed the application for reconsideration. His decision left standing the September 16, 2015 determination concerning publication of the notice of intention to grant an extension order for 974 days. This was a refusal to revisit a determination made at the notice-of-intention stage; it was not a judicial ruling on the validity of the extension order in subsequent years.
An extension order was subsequently issued for Patent No. 160693 on October 22, 2018. A later decision from 2024 referred to an extension period of 976 days ending on May 20, 2025. The refusal to reconsider the 2015 decision does not, by itself, explain the difference between the proposed term calculated in 2015 and the term recorded in the final order.
Years later, a new and separate dispute arose: whether revocation of the UK reference patent required the Israeli extension order to lapse even though extension orders in other recognized states remained in force. That issue was addressed in the Deputy Registrar’s decision of November 28, 2024 and was subsequently considered on appeal by the District Court.
The July 2016 decision illustrates that a relevant legal development in a reference state does not invariably require the Israel Patent Office to reopen an earlier decision. The procedural stage, elapsed deadlines, third-party reliance and evidence demonstrating that the development actually changes the Israeli calculation must all be examined. For a systematic discussion of patent term extensions, see Yonatan Drori, Patent Law (2023), Chapter 3.2.4 (Hebrew).
