2018年12月21日

The grant of an SPC for a new therapeutic application

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On 19 September 2018 the Dutch Council of State (CiS) has decided that a new therapeutic application of a known active substance, which new application is protected by a patent, can qualify for an SPC. This article contains a short summary of the appeal proceedings in the case between Bayer Schering Pharma Aktiengesellschaft (Bayer) and the Netherlands Patent Office (NPO) that led to this judgement.

The pharmaceuticals

This case concerns the pharmaceutical Qlaira. This is a multiple phase contra conception pharmaceutical, of which Bayer is the proprietor. The active substances are estradiol valerate and dienogest and it is relevant to comment that these substances in itself are not patent-protected.

Another pharmaceutical, Climodien, comprises the same active substances however is not a contra conception pharmaceutical: Climodien is used as a hormore replacement therapy.

The SPC that was declined

Bayer has filed for an SPC for Qlaira in March 2009. NPO declined the application because there were earlier market authorisations issued for the active substances than the market authorisation Bayer has based its application on. NPO argues that the market authorisation for Climodien is one of them.

The arguments of NPO

NPO argues that article 3 of Regulation 469/2009 of 6 May 2009 (SPC Regulation), introductory words and section d would mean that for the 'product' of the active substances estradiol calerdate and dienogest a market authorisation was already issued. NPO refers to the explanatory notes to the SPC Regulation. These notes that the definition of "product" in the relevant part of article 3 of the SPC Regulation should be read as meaning the active substance or composition of active substances.

NPO refers to the judgement of the Court of Justice of the European Union (CJEU) in Neurim Pharmaceuticals and states that it is interpreted too broadly. In that judgement, the CJEU held that the fact that a marketing authorisation was already issued for the use of a known active substance in a new therapeutic veterinary treatment does not mean that an SPC should be withheld for the use of the same active substances for a new therapeutic human treatment.

Based on this judgement, NPO states that an SPC may only be granted where there is a new patent-protected therapeutic application, comprising the active substances, where the field of application differs in that the earlier marketing authorisation was issued for use in animals and the relevant authorisation concerns use in animals.

The arguments of Bayer

Bayer argues that NPO has interpreted the Neurim judgement too strict. Based on this judgement, Bayer held that an SPC can be granted for a patent-protected new therapeutic application of a known active substance, indifferent of the fact that the earlier marketing authorisation was issued for human treatment instead of veterinary treatment.

The judgement of the CiS

In first instance, the court decides in favour of Bayer, destroying the decision of OCNL to refuse the SPC. OCNL then turns to the CiS in appeal.

The CiS, as did the court, rules in Bayer's favour. It stresses the purpose of the SPC Regulation, granting sufficient protection to ensure pharmaceutical research, and decides that only the authorisation to market the first pharmaceutical that comprises the product and is granted for the therapeutic application that equals the use that is patent-protected, should be considered as a "first" authorisation. The fact that both marketing authorisations concern the product for human use, however the first use is covered by the relevant patent and the second is not, does not prevent the issue of an SPC.

This means that it is possible to be granted an SPC for the new therapeutic application of the product, Qlaira, where an SPC was granted for Climodien as well. The CiS upholds the judgement of the court, effectively ordering OCNL to grant Bayer its SPC for Qlaira.

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