EGA Press Release

Friday, 13 March 2009

| BETTER PATENTS MAKE BETTER MEDICINES |
IMPROVED EFFICIENCY OF THE EUROPEAN PATENT SYSTEM
WOULD STIMULATE INNOVATION AND COMPETITION
IN THE PHARMACEUTICAL SECTOR

Greg Perry, director general of the EGA, opened the 5th EGA Legal Affairs Forum on 13 March by highlighting the generic medicines industry’s role in European healthcare, and warning of increasing hurdles to competition and real innovation if the European patent system is not reformed.

“The EGA welcomes the pharmaceutical sector inquiry which expresses clear concerns on certain deficiencies in the system of granting patents and seeks to continue the constructive dialogue with the European Patent Office aimed at improving the efficiency of Europe’s patent system”, stated Mr Perry.

A key objective of this process is to improve the quality of patent assessments and particularly to strengthen the application of the “inventive step” criteria. The EGA fully supports proposals to “raise the bar” in this area, but this would require significant steps from the EPO.

A major issue yet to be solved is the problem raised by divisional applications that exactly duplicate or do not vary significantly from the claims of the parent patent. This so-called double patenting is in principle prohibited by the EPO. In an effort to end this abuse, the EGA supports the proposal by the EPO Committee on Patent Law to tighten the rules that govern the filing of divisional applications.

The EGA also welcomes the EPO’s increasing refusal rate of weak or faulty applications and the additional time examiners now have to refuse them. These measures will help stop the granting of patents which are ultimately revoked in opposition or in national invalidity proceedings.

Similarly, the EGA proposes that the duty of candour be introduced to ensure that all information relevant to the patent under examination is disclosed by the applicant. The EGA is aware that introducing this new requirement would entail amending the European Patent Convention, requiring the political support of member states.

A lengthy discussion on Supplementary Protection Certificates also took place during the day’s proceedings. The possibility of modifying the Regulation on Paediatric Medicines¹ was raised in order to clarify that a paediatric extension should not be granted when there is no SPC granted with a positive term. Mr Perry state “that zero or negative term SPCs should not be extended”.

Finally, the EGA presented its latest position paper on the European Union Patent Court. The EGA perceives the creation of a central European patent court as a very positive initiative from DG Internal Market. However, Mr Perry stated that “a central judiciary composed of experienced and technically qualified judges is regarded as essential for the new patent court to be efficient. In addition, the interest of other affected parties such as the public or the administration, not party in the litigation, should also be taken into account by the Judge when deciding on provisional measures.”
 

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¹ Regulation (EC) No. 1901/2006 on medicinal products for paediatric use

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