8th Feb 2021
Just over one month into the “real Brexit” we have already seen two very high profile consequences of its impact on the pharmaceutical industry.Firstly, the UK’s medicine agency (the MHRA) approved the BioNTech/Pfizer and Oxford University/Astra Zeneca Covid-19 vaccines faster than the European Medicines Agency (EMA). Then, at the end of January, the European Commission threatened to prevent Covid-19 vaccines passing into Northern Ireland from Ireland. I am certainly not going to explore the potential political ramifications of this (swiftly withdrawn) threat of the EU Commission – twitter commentators have had their say on that – but I am interested in whether this unique situation on the island of Ireland could have future consequences for supplementary protection certificates (SPCs) in the UK and Europe.
30th Jan 2020
It may only be the opinion of the Advocate General but after almost a decade of fog surrounding Article 3(d) of the SPC Regulation this latest offering in Santen v INPI suggests that clarity may be about to prevail.In the past the decisions and opinions of the CJEU & Advocate General have often been criticised for their lack of clarity and applicability but this is not a criticism that can be levelled at Giovanni Pitruzzella. If the CJEU choose to follow his guidance then Neurim will be scrubbed from the record books and Article 3(d) will, once again, mean what is says.As a quick reminder, Article 3(d) of the SPC regulation states that a certificate shall be issued if:“the authorization [for the product] is the first authorization to place the product on the market as a medicinal product”The “medicinal product” and “product” are defined in Article 1 of the regulation and essentially relate to “any substance or composition presented as having curative or preventive properties with regard to human or animal diseases” and “the active ingredient or the composition of active ingredients in a drug” respectively.