ISRAEL Law and Practice Contributed by: David Gilat and Jacob Kasulin, Gilat, Bareket & Co, Reinhold Cohn Group
3.4 Publicly Available Drug and Patent Information See 2.4 Publicly Available Drug and Patent Informa- tion . 3.5 Reimbursement and Pricing/Linkage Markets See 2.5 Reimbursement and Pricing/Linkage Mar- kets .
• There are no other PTE applications for the same API or for the same basic patent. • The registration in the Pharmaceuticals Register 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”). A PTE application may be filed by the applicant of the basic patent application, the owner of the basic pat ‑ ent, or the exclusive licensee in the basic patent (or basic patent application). Where the basic patent is jointly owned, any co-owner may file the application. If some co-owners, the patentee, the patent applicant or an exclusive licensee do not join the PTE application, they must be added as respondents. Only one PTE may be granted in respect of a given basic patent, and only one PTE may be granted for a given API. Accordingly, once a PTE has been granted, a second PTE cannot be obtained by any other party for the same basic patent or the same API. Assuming that all of these conditions have been satis ‑ fied and that the applicant had acted in accordance with the timeframes and procedures set out in the Pat ‑ ents Law and applying regulations, 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 reference countries in which PTE or SPC orders were issued and, in any case, would not exceed 14 years from the issuance of the first marketing 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 reference 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 pro ‑ cedural requirements were not adhered to.
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates Under Israeli law, the term of a pharmaceutical pat ‑ ent may be extended by up to five years via an order called a Patent Term Extension Order (“PTE order”). The Patents Law provides that a patent claiming any of the following may be considered a “basic patent” eligible for a term extension, subject to the satisfaction of the below-described statutory conditions: • active pharmaceutical ingredients (APIs); • use(s) of APIs; • finished drugs; • manufacturing process(es) of APIs; • finished drugs’ manufacturing processes; or • medical devices. This means that it would not be possible to obtain a PTE order for a combination of previously registered APIs. Assuming the patent in question claims the eligible subject matter described above and that the applica ‑ tion for a PTE order was filed by the applicant of a pending application, the owner 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 con ‑ taining the API is registered in the Israeli Pharma ‑ ceuticals Register.
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