Israeli Patent Registrations Key to International Controversy

Representatives of Israel's drug industry and officials from the US and EU continue to clash over the status of patent exclusivity in the country. In the absence of specific Israeli legislation on the issue, pressure is growing in the US for the country to be re-included on the US Trade Representative's "Priority Watch" list of states which fall short of international norms on intellectual property protection. A key concern for the US is the existing framework's alleged capacity to shorten generic drug approval procedures, allowing generics to steal a march on rival ethical products.

Israeli government officials, faced with growing international pressure, have announced moves towards accommodating the foreign drug lobby in recent months. Israeli trade minister Ehud Olmert has pushed for new legislation to be adopted, tentatively known as the Drug Registration Law.

However, even the terms of this conciliatory measure have remained the subject of dispute, following a high-level panel's recommendation that Israel only protect confidential data files on ethical drugs for five years, from the time when the drug is registered in Israel. However, if an expiry in a major market occurs before the end of this five-year period, under the panel's recommendations such an event would trigger expiry in Israel. By contrast, the EU guarantees data protection for 10 years.

Needless to say, these proposals have not satisfied the multinational research-based industry, which has pledged to downscale R&D investment in Israel if the country fails to introduce stricter data protection terms. However, local sector groups and leading generics producer Teva have argued that already-falling multinational R&D investment in Israel has more to do with lower-cost clinical trials being offered in Eastern Europe. Clearly, the issue awaits a final resolution, although given the country's sizeable generics sector, the government's eventual decision is unlikely to be an easy one.