Intellectual property dispute with US still unresolved

The problem is data exclusivity for drug registration files submitted by US companies to the Ministry of Health.

The US-Israeli binational trade talks forum meeting in Washington has not yet resolved the issue of violation of intellectual property rights in Israel. Nonetheless, Ministry of Industry, Trade and Labor foreign trade administration deputy director-general Ronit Kan, who heads the Israeli delegation, said, "Progress has been made on understandings on Israel's protection of intellectual property and on cumulated rules of origin."

Kan said the US welcomed the inter-ministerial committee's conclusions on protecting ethical drug registration files in Israel, but that the discussions on various outstanding aspects would continue, especially exports to third countries that do not protect information in ethical drug registration files.

The forum also discussed the possibility of establishing accumulated rules of origin for exports to the US with other US trade partners in the Middle East and the world. Other topics discussed were possible mutual recognition agreements for standards, customs cooperation, and US backing for Israel's candidacy to the OECD.

Assistant Secretary of Commerce for Market Access and Compliance William Lash told "Globes" last week that Israel would have to show real progress on protecting intellectual property rights within the coming weeks, before the US reviews countries' compliance on protecting intellectual property rights and copyrights for its 2005 report.

Lash said Israel's violations of intellectual property rights and non-recognition of US standards had caused US-Israeli trade to fall by $1 billion in the past three years.

In the main dispute over intellectual property rights, the US is demanding that Israel amend its laws to award five years data exclusivity on information contained in ethical drug registration files submitted to the Ministry of Health for registering new drugs in Israel. In the absence of an Israeli protection law, Israeli companies, headed by Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA), use this information to register generic drugs.

In contrast to marketing exclusivity in Israel, to which Israeli drug companies have consented, data exclusivity will block Israeli generic drug makers' access to drug registration files, both for the purpose of registering generic drugs in Israel and for registering them for export to third countries.

US-Israeli trade, excluding diamonds, totaled $4.9 billion in January-May 2004, compared with $4.4 billion in the corresponding period in 2003. Israel exported $2.6 billion worth of goods to the US and imported $2.3 billion.

Published by Globes [online] - www.globes.co.il - on July 12, 2004

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