Harmonisation in Denmark: Patents covering pharmaceutical compositions may now be designated as basic patents

Casper Struve (Zacco Denmark A/S) has provided information on how the Danish Patent and Trademark Office deals with SPC applications where the basic patent is a pharmaceutical composition patent:

"The current Danish guidelines for SPC examination (as valid from 19 October 2005) explicitly states that patents on pharmaceutical compositions cannot be designated as a basic patent. This has long been the position of the Danish Patent and Trademark Office.

This position of the Danish Patent and Trademark Office have changed as explained in the following.

A hearing at the Danish Board of Appeal was scheduled for 25 March 2009 regarding the above issue of whether or not SPC applicants may validly designate pharmaceutical composition patents as basic patents. The hearing was cancelled, as the Danish Patent and Trademark Office in letters to the appellants dated 20 March 2009 acknowledges that neither the SPC regulation nor the preparatory work speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application can be used as a basic patent for a supplementary protection certificate.

In letters relating to Case No CA 2007 00042 and Case No CA 2000 00008 dated 20 March 2009 the Danish Patent and Trademark Office states the following:

"In relation to the present case the Danish Patent and Trademark Office have
considered that a patent that solely protects a pharmaceutical composition containing the product cannot be used as a basic patent, cf. the definition of basic patent in Regulation (EEC) No 1768/92, Article 1(c).
[...]
The Danish Patent and Trademark Office acknowledges that neither Regulation EEC No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, nor the preparatory work (KOM(90) 101 final edition), speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application, can be used as a basic patent for a supplementary protection certificate."

This new position adopted by the Danish Patent and Trademark Office is welcomed and seen as a positive step in harmonising the SPC regulation on community level. It should be incorporated into the new guidelines for examination of SPC's, which will issue together with the long awaited guidelines on Paediatric SPC extensions. Rumour has it that these guidelines are very close to being finalised."