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Data exclusivity and food claims in Europe

By Johanna Gibson, David Pearce, Jeremy Phillips and Ilanah Simon.

The IPKat's attention was attracted this morning to the Commission Decision of 17 December 2009 authorising a health claim on the effect of water-soluble tomato concentrate on platelet aggregation and granting the protection of proprietary data under Regulation (EC) No 1924/2006 of the European Parliament and of the Council, which was published this morning on the Official Journal's website. By Article 2 of this Decision,

"The scientific data and other information included in the studies identified in the Annex to this Decision shall be restricted for use for the benefit of the applicant for a period of 5 years from the date of authorisation under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.".

This Decision follows an application by Provexis Natural Products Ltd, submitted nearly a year ago in relation to a health claim relating to the effects of water-soluble tomato concentrate (WSTC) I and II on the blood platelet activity in healthy people. The claim consisted of the immediately forgettable phrase ?Helps to maintain a healthy blood flow and benefits circulation?.

Regulation 1924/2006 of 20 December 2006 on nutrition and health claims made on foods, in effectively conferring protection on data relating to health claims, is part of the vast and growing body of European intellectual property law and, a little embarrassed, the Kat must confess that he missed it at the time of its passage. He wonders whether his readers, through their commercial activities or academic pursuits, have any experiences or insights as to the working of this Regulation and as to how it compares with the provisions relating to data exclusivity in the pharmaceutical sector.

European Food Safety Authority report on the product claim here

Full post as published by IPKat on December 18, 2009 (boomark / email).