ISRAEL Law and Practice Contributed by: David Gilat and Matan Kovacs, Gilat, Bareket & Co, Reinhold Cohn Group
Foreign proceedings with respect to corre - sponding patents would not raise a claim of lis alibi pendens since patents are territorial. None - theless, factual findings in foreign proceedings
• where the invention is a product – production, use, offer for sale, sale, or import for purpos - es of one of the said acts; and • in respect of an invention that is a process – use of a product directly derived from that process. Infringement would encompass any of the fol - lowing acts: production, use, offer for sale, sale, or import for purposes of one of the aforemen - tioned acts. There are statutory exemptions (Sections 1 and 54A of the Patents Law) where the infringement is, among other things, for non- commercial use, experimental use and experi - ments conducted with the aim of obtaining regu - latory approval (a marketing authorisation). It so follows that producing a patent-protected product – including a small molecule pharma - ceutical 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 infringe - ment, 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. 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 moiety, whether by itself or together with another active moiety, in a reg - istered preparation or a preparation which was registered in the Register”.
may establish issue estoppel. 1.17 Patent Amendment
During litigation, the court, upon an application by the patentee, may amend the specification and the claims of the patent (Section 190 of the Patents Law). There is no empirical data avail - able on how common amendments during litiga - tion are, though it is safe to assume they are not a rarity. The court would be receptive to such an amendment application and is empowered to order the amendment of the claims even without the submission of such application. 1.18 Court Arbiter Patent infringement cases are heard before the district courts, which are intermediary-level courts (between the magistrate courts and the Supreme Court). The Israeli courts do not use a jury system, nor do they employ specialist judges. With that being said, each 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 inde - pendent 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.
2. Generic Market Entry 2.1 Infringing Acts
Under Israeli law, exploiting an invention claimed in a patent without permission is considered an infringement. “Exploitation” means either of the following:
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