[Ip-health] PharmaTimes- US, Israel resolve long-standing pharma battle

[Terri - Louise Beswick]

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US, Israel resolve long-standing pharma battle
23 February 2010
The US and Israel have resolved a decade-old pharmaceutical intellectual
property (IP) dispute, with Israel agreeing to amend its patent laws and
lengthen its data protection period for innovative medicines.

Israel has undertaken to change its expiry date on pharmaceuticals,
which is currently the same as the product's expiry in one of 21
markets, to the expiry date in the world's largest markets. It will also
maintain the confidentiality on data exclusivity files submitted to the
Ministry of Health for market approvals for 6.5 years from the present
5.5 years, except in the case of fast-tracked drugs, for which the data
exclusivity period will be shorter, but no less than five years.

In exchange for these concessions, Israel will be removed from the US
Trade Representative (USTR)'s Priority Watch List of serious IP
transgressors, and the US will support the nation's accession to
membership of the Organisation for Economic Cooperation and Development
(OECD), which has been held back by the pharma IP dispute.

The agreement, which was reached through a Special 301 Out-of-Cycle
Review (OCR) begun thee years ago, has been welcomed by the
Pharmaceutical Research and Manufacturers of America (PhRMA), whose
international president, Christopher Singer, praised the work of USTR
Ambassador Ron Kirk, his staff and the Israeli government for bringing
it to fruition.

"PhRMA believes this agreement will be beneficial to patients, as it
could result in the earlier introduction of new medicines into Israel,"
said Mr Singer.

The USTR's Special 301 Report for 2009, which retained Israel on the
Priority Watch List for the year, noted that the IP issues had been
under discussion with Israel "for many years." While there had been some
encouraging progress, the US remained "seriously concerned with two key
matters - Israel's inadequate protection against unfair commercial use
of undisclosed test and other data generated to obtain marketing
approval for pharmaceutical products, and measures that adversely affect
the length of patent term extension granted to compensate for delays in
obtaining regulatory approval."

The Report claimed that the effective period of data protection provided
by Israel was only in fact around three and a half years. This was due
to the lengthy approval processes at the Ministry of Health, which had
drawn complaints from US innovative companies and Israeli generics
makers, it said.

- Earlier this month, Israel was judged by Business Monitor
International (BMI) to be the "tenth least-attractive" pharmaceutical
market out of the 71 nations which the company assesses, largely because
of its "biased" IP regime and "restrictive" pricing and reimbursement
environment. During 2009-2014, Israeli pharmaceutical spending will
increase by an average of just 0.94% a year, reaching U$$1.50 billion by
2014, according to BMI's most recent forecasts.

By Lynne Taylor

http://www.pharmatimes.com/WorldNews/article.aspx?id=17435