Europese Commissie waarschuwt pharmaceutisch bedrijf AstraZeneca inzake eerste Losec antitrust-onderzoek naar patentmisbruik (en)

The European Commission has sent a Statement of Objections (SO) to the Anglo-Swedish group AstraZeneca outlining its preliminary findings that it may have misused the patent system and other regulatory procedures for the marketing of pharmaceutical products. The Commission believes that this was abusively done with the purpose of blocking or delaying market entry for generic products. The sending of an SO marks the opening of a formal antitrust investigation. AstraZeneca now has the opportunity to present its defence in writing and may, subsequently, request an oral hearing.

"We have taken considerable care to examine the file in detail and AstraZeneca will now have ample opportunity to present its defence," said Commissioner Mario Monti. He added: "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 has come to the preliminary conclusion that AstraZeneca may have infringed Article 82 of the EU Treaty and Article 54 of the EEA Agreement. Two practices are under scrutiny.

The first suspected abuse involves misrepresentations by AstraZeneca before a certain number of national patent offices with a view to obtaining so-called supplementary protection certificates (SPCs) for the medicinal product Losec. Towards the end of the 1990s, Losec had become the world's best-selling prescription medicine ever. Losec revolutionised the treatment of stomach ulcers and other acid-related diseases.

SPCs 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⁽¹⁾. According to the SPC legislation, products such as Losec which were already on the market when the legislation entered into force, were only entitled to extra protection if the first market authorisation in the EU was granted after certain cut off dates.

According to the evidence in the Commission's possession, AstraZeneca concealed from these patent offices the date at which it received its first marketing authorisation for Losec, thereby enabling AstraZeneca to obtain extra protection for Losec in certain countries. In the Commission's view, the company could not have obtained the extra protection in the absence of its misrepresentations.

The second practice under scrutiny relates to the alleged misuse of rules and procedures applied by the national medicines agencies which issue market authorisations for medicinal products. Specifically, the practice relates to 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. De-registration is relevant for generic producers because generic products, can, in principle, only obtain a marketing authorisation and parallel importers can in principle only obtain import licenses if there is an existing reference authorisation.

The Commission believes that both practices were intended to block or delay access to the market for generic versions of Losec and that the second practice was also intended to prevent parallel imports of Losec capsules. The Commission would like to emphasise that the present case under Article 82 of the EU Treaty and Article 54 of the EEA Agreement does not concern the alleged misuse of intellectual property rights, but the alleged misuse of governmental procedures.

Misrepresentations before patent offices and misuse of regulatory procedures for the authorisation of medicines have previously been held to be antitrust violations by US Courts and the US Federal Trade Commission.

Background

The case arose out of complaints in 1999 from two generics companies, which claimed that AstraZeneca was misusing patent and other regulatory rules to obtain extra protection for Losec.

AstraZeneca is the product of a merger in 1999 between Sweden's Astra AB and the UK company Zeneca Plc. The Statement of Objections (SO) is addressed to AstraZeneca AB (Sweden) and its UK parent company AstraZeneca Plc.

^{(1)SPCs are granted pursuant to Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ L 182, 2.7.1992, p.1).}