ISRAEL Law and Practice Contributed by: David Gilat and Matan Kovacs, Gilat, Bareket & Co, Reinhold Cohn Group
of a granted patent, or the exclusive licensee in such, the Patent Office would examine whether the following conditions – listed in Section 64D of the Patents Law – have been met. • The PTE application was filed in good faith. • The basic patent is in force. • The pharmaceutical preparation of the drug containing the API is registered in the Israeli Pharmaceuticals Register. • There are no other PTE applications for the same API or for the same basic patent. • The registration in the Pharmaceuticals Reg - ister of a drug containing the API is the first one made. • Marketing authorisation was issued in the United States and in any of five European countries (the UK, France, Germany, Italy and Spain), and a US PTE, UK SPC and/or EU SPC (respectively) was granted before the expiry of the basic patent (the “reference countries” and the “reference patents”). Assuming that all of these conditions have been satisfied and that the applicant had acted in accordance with the timeframes and procedures set out in the Patents Law and applying regula - tions, the term of the patent would be extended. The duration of an Israeli PTE order shall equal the shortest term of extension in any of the ref - erence countries in which PTE or SPC orders were issued and, in any case, would not exceed 14 years from the issuance of the first market - ing approval in any of the reference countries. In addition, under the current PTE regime in Israel, a PTE order would expire upon the revocation of any reference PTE/SPC orders (or underlying ref - erence patents) in any of the reference countries. Any person may oppose the issuance of a PTE order before such is granted, as well as move for
a post-grant revocation of a PTE order, on the basis that the above-listed conditions were not met or that the procedural requirements were not adhered to. 4.2 Paediatric Extensions At present, paediatric extensions are not avail - able in Israel. 4.3 Paediatric-Use Marketing Authorisations At present, paediatric-use marketing authorisa - tions are not available in Israel. 4.4 Orphan Medicines Extensions At present, extensions for orphan medicines are not available in Israel. Under Israeli law, issuance of an interlocutory injunction is conditioned on the deposit of an in personam undertaking by the applicant to com - pensate the respondent (against which the order is directed) for whatever damages are incurred as a result of the issuance of the injunction if the injunction is revoked or if it is reduced in scope. Such an undertaking must be attached to the motion for interlocutory injunction. In addition to the in personam guarantee, and in the absence of extraordinary circumstances requiring otherwise, the court shall order the deposit of an in rem guarantee at a sufficient amount at the discretion of the court. 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief Securities As the interlocutory injunction remains in place until a final judgment is entered (if not revoked
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