PHARMACEUTICAL PRODUCTS : COMMISSION EXAMINES PATENT SETTLEMENT AGREEMENTS.

Patent settlement agreements concluded between certain pharmaceutical laboratories are in the European Commission's sights. It wants to check whether some firms may not be using them to slow the entry of generic drugs on the market. The manoeuvre consists of concluding agreements between laboratories and manufacturers of generic drugs to bring an end to litigation, but the Commission claims that in 50% of cases this has led to a restriction on market access for less costly alternatives. More than 200 cases have been identified in the EU. The Competition DG has asked certain groups, which remain unnamed, to submit copies of patent settlement agreements reached between 1 July 2008 and 31 December 2009. It wishes to examine them and their annexes, conventions and any modifications in order to have a better idea of why they were concluded, by whom and under what conditions and to determine whether EU rules on concerted agreements and abuse of dominant position may have been breached.

RISK OF RESTRICTION

The EU executive notes that there could be "a negative effect for European consumers, who are deprived of a wider choice of medicines at lower prices". Indeed, generic drugs generally cost an average of 40% less than branded equivalents. Competition Commissioner Neelie Kroes commented that "patent settlements are an area of concern, particularly where an originator pays off a generic competitor in return for delayed market entry". "This monitoring will provide us with the possibility to act should this become necessary," she added. After analysing the information received, her services will publish a report and if necessary will request further clarification from the laboratories concerned.

The British groups AstraZeneca and GlaxoSmithKline said they had been contacted by the Commission. "We will provide all relevant information," declared GlaxoSmithKline spokeswoman Claire Brough. AstraZeneca's spokesman voiced confidence in the lawfulness of the...