ISRAEL Law and Practice Contributed by: David Gilat and Jacob Kasulin, Gilat, Bareket & Co, Reinhold Cohn Group
court usually has one or more judges to which patent litigation cases are usually referred, and the Patents Law further allows the court to nominate an independ ‑ ent scientific adviser (assessor) to assist in hearing the evidence and to advise the court. Judges may reflect different tendencies, but this is not dependent on the location of the court.
that the defence will not be recognised. The matter is not adequately resolved by case law. 2.2 Regulatory Data and Market Exclusivity Israeli law allows for a fairly short marketing exclusivity (six to six and a half years) and only for new chemical entities (NCEs). Section 47D of the Pharmacists Ordinance defines an NCE as a “drug which does not contain an active moi ‑ ety, whether by itself or together with another active moiety, in a registered preparation or a preparation which was registered in the Register”. According to the Pharmacists Ordinance, the Israeli Ministry of Health will not issue a marketing approval in Israel to a new drug containing the active moiety of an NCE (the registration of which is based on confi ‑ dential data (safety and efficacy data) filed for a previ ‑ ous 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 Recognized Country (the U.S., Canada, a member of the European Union, Switzerland, Norway, Iceland, 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 marketing exclusivity period may be disregarded if the owner of the previous phar ‑ maceutical preparation gave their consent to use the confidential information; if, in the framework of the registration of the new pharmaceutical preparation, full data to prove the safety, effectiveness, and quality of the new registration was provided; or in case of a national emergency. It is important to note that the exclusivity provided under Israeli law relates only to the marketing of a follow-on drug, and a third party may seek registra ‑ tion 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.
2. Generic Market Entry 2.1 Infringing Acts
Under Israeli law, exploiting an invention claimed in a patent without permission is considered an infringe ‑ ment. “Exploitation” means either of the following: • where the invention is a product – production, use, offer for sale, sale, or import for purposes of one of the said acts; and • in respect of an invention that is a process – the use of the process, and with respect to a product directly resulting from the process – any of the fol ‑ lowing acts: manufacturing, using, offering for sale, selling or importing for any of the aforementioned purposes. There are statutory exemptions (Sections 1 and 54A of the Patents Law) where the infringement is, among other things, for non-commercial use, experimen ‑ tal use and experiments conducted with the aim of obtaining regulatory approval (a marketing authorisa ‑ tion). It so follows that producing a patent-protected prod ‑ uct – including a small molecule pharmaceutical product – would be infringing, as well as offering it for sale or actually selling it. While asking for – and even obtaining – a marketing authorisation would not be considered infringement, any attempt to enter the market on the basis of such authorisation during the patent term (even if the actual entry will take place once the patent lapses) would seem to amount to infringement. Israeli law on exhaustion is not fully settled, especially in cases where an exclusive licensee is recorded on the register. In the latter situation, there is a likelihood
99 CHAMBERS.COM
Powered by FlippingBook