ISRAEL Law and Practice Contributed by: David Gilat and Matan Kovacs, Gilat, Bareket & Co, Reinhold Cohn Group
3.4 Publicly Available Drug and Patent Information See 2.4 Publicly Available Drug and Patent Information . 3.5 Reimbursement and Pricing/Linkage Markets See 2.5 Reimbursement and Pricing/Linkage Markets . 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Under Israeli law, the term of a pharmaceutical patent 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 previ - ously registered APIs. Assuming the patent in question claims the eli - gible subject matter described above and that the application for a PTE order was filed by the applicant of a pending application, the owner
ally, the information in the database is updated once a week. 2.5 Reimbursement and Pricing/Linkage Markets In Israel, granting of marketing authorisation is not linked to patent status but rather to whether a given product has already received authorisa - tion in the United States and in the EU. As for pricing and reimbursement, those are also not linked to patent status, but are subject to cer - tain governmental arrangements, which include pricing control and a national reimbursement programme (which is indication-specific). Israeli HMOs are generally not required to purchase non-reimbursed drugs; while legal action over such refusal could theoretically be filed, the chances of success would seem generally slim. 3. Biosimilar Market Entry 3.1 Infringing Acts See 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity As noted in 2.2 Regulatory Data and Market Exclusivity , the limited marketing exclusivity provided under Israeli law only mentions new chemical entities. This led the Israeli Ministry of Health to adopt the view that biologics would not enjoy marketing exclusivity. The issue is yet to be resolved by way of judicial review. How - ever, the requirements for obtaining marketing authorisation for biosimilars in Israel require for - mer authorisation in one of several other coun - tries – in which there is data exclusivity – leading to a de facto exclusivity. 3.3 Acceptable Pre-Launch Preparations See 2.3 Acceptable Pre-Launch Preparations .
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