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The CJEU has invited EU member states to file observations on the referral by the English High Court in Abraxis Bioscience LLC v The Comptroller General of Patents. This case was previously reported in our news item of 27 January 2017 and considered in more detail in our related briefing. The question referred to the CJEU reflects the lack of clarity provided by the court’s earlier “Neurim” decision (C-130/11). In particular, clarification is sought on the issue of whether “Neurim-type” SPCs can be granted for a new formulation of an old active ingredient. The specific question referred to the CJEU is:
“Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”
The UKIPO has invited the public to submit any comments to email@example.com by 6 September 2017. The EU member states then have until 2 October 2017 to file observations with the CJEU. Assuming that the referral leads to a hearing at the CJEU, it is likely that we will not receive an answer to the question until 2018.