Israel has agreed to accommodate the US in legislation for protecting data exclusivity of ethical drug makers. Israel has consented to change two recommendations of the inter-ministerial committee on the subject, and make them more flexible.
The committee recommended that the five-year data exclusivity period on ethical drugs expire whenever a generic version of the drug is produced in a third country, even when the exclusivity period is still in effect, including countries without intellectual property protection.
Israel recently agreed that the marketing of a generic version of a drug in another country would not affect intellectual property protection in Israel. Israel will apparently also agree extending data exclusivity by one more year on new labels for existing drugs, such as Viagra.
The committee also recommends keeping the five-year data exclusivity period for ethical drugs in Israel as valid from the date is registered in the seller country, not when it is registered in Israel. This recommendation, which shortes the exclusivity period by six-twelve months, the difference between the registration of a drug in the US or Europe, and its registration in Israel, will be retained.
At a conference at Sheba Medical Center at Tel Hashomer on Friday, Ministry of Health legal advisor Adv. Yoel Lipschitz said Israel would probably agree to accommodate the US on the first of these two issues. Lipschitz is a member of the four-person inter-ministerial committee on data exclusivity. The other ministries on the committee are Justice, Finance , and Industry, Trade and Labor.
Sources inform “Globes” that the EU is now preparing an opinion regarding Israel's amendments to the Patents Law (1967) (amended 1998), expected to be enacted at the same time as the bill on data exclusivity, as a rider to the 2005 Economics Arrangements Law.
EU representatives, representing the interests of European ethical drug makers, object to the proposed changes in the Patents Law, which will limit the Patents Office's authority to extend patents beyond their basic period. The EU wants the Patents Office to be able to greatly extend the patents in cases of prolonged clinical trials for innovative drugs.
The parties will apparently now be able to complete the data exclusivity bill and approve it as a rider to the budget, with the consent of the US. A creative solution is expected to solve the US demand that Israel grant data exclusivity, and not just marketing exclusivity. which allows Israel to produce generic drugs during the exclusivity period, but only for export. The Ministry of Health will apparently grant Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) export licenses, without relying on ethical drug files submitted to the ministry.
Published by Globes [online], Israel business news - www.globes.co.il - on January 30, 2005