New SPC Referral: France Too Wants Clarification Of The CJEU On 3d) And Neurim's Interpretation (Santern)

Author:Mr Francois Pochart, Mathilde Rauline and Loïc Lemercier
Profession:August & Debouzy

France refers a question to the CJEU on article 3d) of Regulation 469/2009 and Neurim's interpretation:

Where does the limit of the "new application" need to be placed: veterinary versus human MA, new medical indication, new mode of action of the active ingredient, new dosage, new mode of administration, new formulation? Should the criteria be stricter than the one of patentability? Should the scope of the basic patent correspond with the one of the MA? Article 3d) of Regulation 469/2009 states that a SPC may only be granted if the MA on which it is based is "the first authorization to place the product on the market as a medicinal product".

The rule seemed clear: if the active ingredient has already been authorized on the market, the same active ingredient will no longer be able to obtain a SPC, even for a new therapeutic indication. In 2012, the Neurim1 judgment interpreted article 3d) differently: another SPC may be granted for a different "application" from the first MA when the patent on which the SPC is based protects this new application. In Neurim, the first MA was a veterinary MA, and the second was a human MA; the reasoning of the CJEU seemed to clearly indicate that the judgment would have been the same with two human MA2.

Following this decision, the national patent offices had to decide on Neurim's scope. The French PTO mentions that the Dutch PTO strictly limited its application to the case underlying Neurim (human MA versus veterinary MA), whereas the British judge went as far as questioning the necessity to encompass new formulations of know products. The French PTO intends to apply Neurim in a balanced way, but questions where to draw the line for article 3d) and Neurim: may a new therapeutic indication, the treatment of a new species (veterinary MA versus human MA), a new mode of action of a known active ingredient, a new mode of administration, a new dosage, a new formulation, allow the right to have a SPC ? This is the purpose of the question referred to the CJEU. The Paris Court of Appeal also asks for clarification on the requirement degree: should it be more stringent than those applied to patentability? At last, should the scope of the patent on which the SPC is based correspond with the one of the MA?

These questions are close to those of Mr Arnold J who also asked the CJEU in January 2017 to clarify how article 3d) should be interpreted (Abraxis3).

The Paris Court of Appeals decided4, after having obtained the...

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