Brussels, 31/07/2003 (Agence Europe) - The European Commission has sent a Statement of Objections to the Anglo-Swedish group AstraZeneca for alleged misuse of rules and procedures in order to extend protection for its Losec product, which led to the investigation proceedings. Mario Monti explained that, “This is not about the use or enforcement of patent rights which are necessary and even indispensable to foster a competitive European research-based pharmaceutical industry. It is about suspected misuses of governmental systems and procedures which have the effect of blocking or delaying entry to the market of cheaper medicines which involves savings for both health systems and patients”.
After investigation of the evidence including internal company documents obtained at the company's premises in the UK and in Sweden in February 2000 - the Commission suspects that the company may have infringed European rules on two counts The first involves misrepresentations by AstraZeneca before a certain number of national patent offices with a view to obtaining so-called supplementary protection certificates for the medicinal product Losec, a revolutionary treatment of stomach ulcers , which became the world's best-selling prescription medicine. The certificates extend the basic patent protection for medicinal products by a maximum of five years to take into account the period of time that may have elapsed between the filing of a patent application and the later authorisation to market the patented product. As Losec did not meet the necessary conditions for obtaining an extension of the brevet, the Commission suspect that AstraZeneca provided false information to obtain extra protection. AstraZeneca's switch of its Losec capsules (the original formulation) for a tablet formulation of Losec, combined with requests by AstraZeneca to certain national medicines agencies to de-register the market authorisations for the capsules, thus prevented manufactures of generic medicines and parallel importers that did not have this authorisation, from distributing their products. This led to the suspicion that the group intended to block or delay access to the market for generic versions of Losec and parallel imports of Losec capsules.