SPC protection for a derivative of an active substance in Germany – Paliperidonpalmitat

Birgit Kramer

In its decision file no. 14 W (pat) 25/16 of 5 September 2017, the German Federal Patent Court had to decide under which circumstances an own SPC can be obtained for a derivative of a pharmaceutical active substance. The context is Art. 3c Reg. no. 469/2009 (that there may not be more than one SPC for a product), Art. 3d Reg. no. 469/2009 (a SPC can only be granted with regard to the first marketing authorisation for a product) and the fact that a SPC for a product covers the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent, e.g. its various derived forms such as salts and esters (CJEU, C 392/97 – Farmitalia).

In its decision of 5 September 2017 the Federal Patent Court explained that it is not excluded though that an active substance and its derivative are different products as required under Art. 3c/d Reg. no. 469/2009. The Court clarified under which circumstances this may be the case. If the active substance and its derivative are subject-matters of patents in which they are specifically claimed, the active substance and its derivative can be different products if they have different pharmaceutical effects. That the active substance and its derivative have to be subject-matter of patents in which they are specifically claimed considers the principles set up in C-322/10 – Medeva (excluding a SPC relating to active ingredients not specified in the wording of the claims of the basic patent) and in C-443/12 – Actavis (saying that a substance can only be considered a different product if it is separate innovation covered by another patent). If these requirements are met, an active substance and its derivative can be different products due to their different pharmaceutical effects whereas the latter is defined as in C-631/13 – Forsgren as own pharmacological, immunological or metabolic effect. The Federal Patent Court explained that although the term “product” was to be determined autonomously under Reg. no. 469/2009, the valuation of Art 10 II b Dir. 2001/83 could be applied that different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.

Demanding an own innovation of a substance to qualify it as a different product as done in Actavis at first sight seemingly mixes up the terms of invention and product. The approach of the Federal Patent Court referring to a regulatory criterion for determining whether a different product is concerned seems more appropriate in this respect, in particular considering that the SPC shall provide for a compensation for the costs accrued due to the regulatory requirements for market approval. However considering the underlying objective of Art. 3c/d Reg. no. 469/2009 to avoid an “evergreening” of patent/SPC protection, there is a valid reason to also include the “Actavis” criterion.

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