ISRAEL Law and Practice Contributed by: David Gilat and Jacob Kasulin, Gilat, Bareket & Co, Reinhold Cohn Group
2.5 Reimbursement and Pricing/Linkage Markets In Israel, granting of marketing authorisation is not linked to patent status but rather to whether a giv ‑ en product has already received authorisation in the United States and in the EU. As for pricing and reim ‑ bursement, those are also not linked to patent status, but are subject to certain governmental arrangements, which include pricing control and a national reim ‑ bursement 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 suc ‑ cess would seem generally slim. Israel has no patent linkage list and no equivalent to the Orange Book. Therefore, there is no list to monitor, no notification mechanism and no disclosure of gener ‑ ic applications. The only publicly available lists (such as the Israeli Drug Registry or the National Health Bas ‑ ket) concern marketing approval and reimbursement only and do not contain patent information.
No additional exclusivities exist (eg, orphan drug or paediatric exclusivity). 2.3 Acceptable Pre-Launch Preparations The 1998 Amendment of the Patents Law introduced a Bolar-type defence as Section 54A of the Patents Act, colloquially known as a “regulatory exemption”. This “regulatory exemption” applies if a given experi ‑ mental act – which might otherwise be deemed to infringe the patent – is made in order to obtain regu ‑ latory marketing approval prior to the expiration of the patent in Israel or in another country whose laws also contain a Bolar-type defence. The application of this defence is subject to the products manufactured under Section 54A not being used for any purpose other than the obtaining of a regulatory permit. In respect of this exemption, a (non-binding) district court decision provided that any action that can be reasonably related to the experimental act will also be covered by Section 54A. 2.4 Publicly Available Drug and Patent Information Israeli authorities do not rely on the Orange Book, nor do they have an equivalent thereof. The Israeli Ministry of Health operates the online-available Israeli Drug Registry. This website includes data about all the drugs that are registered or were previously registered in the drug register of the State of Israel. The informa ‑ tion includes the composition of the active ingredients and their quantity, the indication approved in Israel, the form of administration of the medicine, the dose, the name of the manufacturer and the owner of the registration in Israel, the types of packaging, the reg ‑ istration number and the price. However, that informa ‑ tion only becomes available to the public upon entry into effect, meaning that information regarding pend ‑ ing applications is not publicly available. Generally, the information in the database is updated once a week. Monitoring consists solely of reviewing the updates to the Registry, as Freedom of Information requests can ‑ not reveal pending MAAs. Holders of reference prod ‑ uct MAs are not notified of generic or biosimilar MAAs.
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 Exclu- sivity , 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. However, the requirements for obtaining marketing authorisation for biosimilars in Israel require former authorisation in one of several other countries – in which there is data/marketing exclusivity – leading to a de facto exclusivity. 3.3 Acceptable Pre-Launch Preparations See 2.3 Acceptable Pre-Launch Preparations .
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