The Danish guidelines on the examination of supplementary protection certificate (SPC) applications, in force since 19th October 2005, explicitly state that patents for pharmaceutical compositions cannot be designated as basic patents. This has long been the position of the Danish Patent and Trademark Office, but it has now changed its position.

A hearing before the Danish Board of Appeal on whether SPC applicants may validly designate pharmaceutical composition patents as basic patents was scheduled for 25th March 2009. However, the hearing was cancelled after the Patent and Trademark Office acknowledged in letters(1) to the appellants that neither the SPC regulation nor its preparatory work indicates that a patent protecting a pharmaceutical composition that contains the product covered by the SPC application cannot be used as a basic patent for an SPC.

The letters state that:

"In relation to the present case the Patent and Trademark Office considers that a patent that solely protects a pharmaceutical composition containing the product cannot be used as a basic patent - (see the definition of a 'basic patent' in Article 1(c) of EEC Regulation 1768/92) ... [It] acknowledges that neither [the SPC regulation], nor the preparatory work (KOM(90) 101, final edition), speaks against the position that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application can be used as a basic patent for [an SPC]."

This new position has been welcomed and is seen as a positive step in harmonising the SPC regulation at community level. It will be incorporated into the new guidelines for the examination of SPCs, which will be issued together with the long-awaited guidelines on Paediatric SPC extensions. Rumour has it that these guidelines are very close to being finalised.

Endnotes

(1) Dated 20th March 2009 and relating to Cases CA 2007 00042 and CA 2000 00008.

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com