The European Generic Medicines Association (EGA) is calling for a reform of the European patent system. The agency stresses that the quality of patent examinations and applications should be improved, and that examination and opposition proceedings should be accelerated.
Speaking at the sixth EGA legal-affairs forum held in Munich last week, Greg Perry, director general of the EGA, said, "If the patent system is not reformed in Europe, drug manufacturers will encounter increasing hurdles to competition and real innovation."
The importance of the patent system was highlighted in the European Commission's Pharmaceutical Sector Inquiry, which was launched in 2008 to determine why few novel medicines were being brought to market. The final report, released in 2009, called for the strengthening of the European patent system and also suggested the establishment of a single European patent. Both views were supported by the European Patent Office (EPO), which has been trying to "raise the bar" to help end patent uncertainty.
In a press statement, the EGA said that it supports the EPO's efforts and 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.
EGA remains concerned about some issues, however. First, the agency is worried about the possibility of evading EPO rules that limit the filing of divisional applications. Second, the EGA adds that patent litigation discrepancies across Europe are problematic. "This disparity could be solved by the establishment of a well-balanced, central European Patent Court with technically qualified experienced judges," said the press statement. "This would create an opportunity to streamline and simplify patent disputes."
Following on from the inquiry, the EGA has said that it will continue dialogue with the EPO with the aim of improving the efficiency of the patent system in line with proposals from the European Commission.
"The follow up to the Pharmaceutical Sector inquiry is now clearly taking place. Recent moves by the European Commission's DG competition to investigate actions that hinder the market entry of generic citalopram and Spain's move to accelerate pricing decisions for generic medicines are evidence of this," said Perry.