ISRAEL Law and Practice Contributed by: David Gilat and Matan Kovacs, Gilat, Bareket & Co, Reinhold Cohn Group
2.3 Acceptable Pre-Launch Preparations The 1998 Amendment of the Patents Law intro - duced a Bolar-type defence as Section 54A of the Patents Act, colloquially known as a “regula - tory exemption”. This “regulatory exemption” applies if a given experimental act – which might otherwise be deemed to infringe the patent – is made in order to obtain regulatory 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 sub - ject 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) dis - trict 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 reg - istered or were previously registered in the drug register of the State of Israel. The information includes the composition of the active ingredi - ents and their quantity, the indication approved in Israel, the form of administration of the medi - cine, the dose, the name of the manufacturer and the owner of the registration in Israel, the types of packaging, the registration number and the price. However, that information only becomes available to the public upon entry into effect, meaning that information regarding pend - ing applications is not publicly available. Gener -
According to the Pharmacists Ordinance, the Israeli Ministry of Health will not issue a market - ing approval in Israel to a new drug containing the active moiety of an NCE (the registration of which is based on confidential data (safety and efficacy data) filed for a previous drug containing the NCE) unless: “(a) 6 years have lapsed from the registration date of the previous drug containing the NCE in the Israeli Pharmaceutical Register; or (b) 6.5 years from the registration date thereof in a Rec - ognized Country (the U.S., Canada, a member of the European Union, Switzerland, Norway, Ice - land, Australia, New Zealand, Israel, and Japan), whichever is earlier.” The marketing exclusivity is further dependent on the previously registered pharmaceutical preparation being the first registration of the chemical entity it contains. In addition, the mar - keting exclusivity period may be disregarded if the owner of the previous pharmaceutical prepa - ration gave their consent to use the confidential information; if, in the framework of the registra - tion of the new pharmaceutical preparation, full data to prove the safety, effectiveness, and qual - ity of the new registration was provided; or in case of a national emergency. It is important to note that the exclusivity pro - vided under Israeli law relates only to the mar - keting of a follow-on drug, and a third party may seek registration of a follow-on drug on the basis of the data at any time. In general, a third party seeking registration of a follow-on drug product will be required to provide bioequivalence data. No additional exclusivities exist (eg, orphan drug or paediatric exclusivity).
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