EGA Press Release

Thursday, 11 March 2010

EGA SEEKS URGENT PATENT SYSTEM REFORM AND
WELCOMES FOLLOW UP TO THE SECTOR INQUIRY

"If the patent system is not reformed in Europe, drug manufacturers will encounter increasing hurdles to competition and real innovation." This was the message delivered by Greg Perry, director general of the EGA, in his opening address to delegates at the 6th EGA legal affairs forum on 11 March 2010, in Munich, Germany.

As the follow-up to the pharmaceutical Sector Inquiry gathers pace, the EGA seeks to continue constructive dialogue with the European Patent Office (EPO). The aim is to improve the efficiency of Europe's patent system in line with proposals from the European commission. The EPO must look to improve the quality of patent examinations and applications and accelerate examination and opposition proceedings, the EGA stresses.

It supports EPO proposals to "raise the bar" in this area in order to end patent speculation. THE EGA also backs the introduction of an "Information Disclosure Statement", a requirement for applicants to provide the results of earlier relevant patent office searches to aid the European examination procedure. However, the EGA remains concerned about the possibility of evading EPO rules that limit the filing of divisional applications.

Patent litigation discrepancies across Europe are also problematic. This disparity could be solved by the establishment of a well-balanced, central European Patent Court with technically-qualified, experienced judges. This would create an opportunity to streamline and simplify patent disputes and reduce forum shopping, the EGA believes.

"Patent linkage, which delays the market entry of generics, remains a cause for concern," Mr Perry said. The situation is critical, for example, in Portugal, where some 260 judicial proceedings against generic companies are pending. The EGA supports a legally-certain Bolar provision that would permit all administrative acts needed to market a generic and keep them out of the scope of the patent protection. This includes applying for and receiving a marketing authorisation, price and reimbursement.

Mr Perry concluded that "the follow up to the Pharmaceutical Sector Inquiry is now clearly taking place. Recent moves by DG competition to investigate actions that hinder the market entry of generic citalopram* and Spain's move to accelerate pricing decisions for generic medicines were evidence of this."

 

*The European Commission opened formal proceedings against pharmaceutical manufacturer Lundbeck, citing potential anti-competitive behaviour (Press release Reference: IP/10/8; Date: 07/01/2010)

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For further information contact Lidia Mallo
Tel: +32 (0)2 736 84 11