Triptorelin - a salty case

The SPC Blog has come across another decision of the German Federal Patent Court relating to the granting (or refusal to grant) of an SPC on salts of active ingredients - in essence no SPC for a formulation of a salt of an active ingredient if a previous marketing authorisation already exists for a different salt of the active ingredient.

In the case in question, the patent owner applied for an SPC for the peptidic product Triptorelin (as the pamoate salt) based on basic German patent DE3822459 and the marketing authorisation for Triptolrelin Pamoat Dibioclinic 11,25 mg, granted on 16 March 2004. The German Patent and Trademark Office (GPTO) refused the application on the basis that the marketing authorisation cited was not the first marketing authorisation for the peptidic active ingredient. There existed a previous marketing authorisation to the Triptorelin, but for the acetate salt.

The applicant appealed this decision at the German Federal Patent Court (GFPC), arguing that since the different salts have different properties, especially in terms of their solubilities, the marketing authorisations were for different actives.

The GFPC considered that Triptorelin pamoate was not a new product in comparison with Triptorelin acetate, making the marketing authorisation for Triptorelin acetate the first marketing authorisation for the product. An SPC can therefore not be granted because the requirement of Art. 3(d) of Regulation 1768/92 are not satisfied. In a final note, the court mentioned that even if an SPC may be issued for a different salt of an active ingredient according to recital 14 of Regulation 1610/96 (applied to Regulation 1768/92 according to recital 17 of Regulation 1610/96), the requirements of Art. 3 of Regulation 1768/92 still need to be satsified in order for an SPC to be granted for that different salt.