UK IPO considers the choice between paediatric incentives

A recent decision by the UK intellectual property office (IPO) (decision BL O/321/20 dated 11 June 2020) addresses the EU framework for paediatric incentives, in particular the need (and right) to choose between 2 rewards for paediatric research: (i) a regulatory one in the form of a 1 year extension to the period of marketing protection; or (ii) an intellectual property one in the form of a 6 month extension to the duration of a supplementary protection certificate (SPC). It is not possible to have both (according to Article 36 of the Paediatric Regulation).

In this case - concerning Roche’s RoActerma (tocilizumab), a treatment for arthritis - the marketing authorisation holder and patentee secured both rewards: first, receiving the 1 year extension to regulatory protection in August 2011; and then, obtaining the SPC extension in December 2018. The regulatory protection (8+2+1) expired in January 2020. The SPC came into force in June 2015 for the (maximum) term of 5 years. But on 3 June 2020, shortly (3 days) before the end of its basic term and the extension coming into force, the SPC holders wrote to the UK IPO to seek revocation of their own SPC extension. They did so on the basis that the previous +1 year regulatory protection for the same product invalidated the (already granted) SPC extension. There is no reference to other Member States in the decision, but it seems reasonably likely that parallel SPCs (and extensions) exist and were similarly dealt with.

A week later and only a few days after the SPC extension was running, the hearing officer (L Cullen) delivered the UK IPO’s decision, acceding to the SPC holders’ request and agreeing that the SPC extension contravened the Paediatric Regulation and was invalid. The hearing officer specifically remarks that the SPC holders did not provide any information on why the paediatric extension was applied for initially, which leaves open the question as to the facts underlying the grant and subsequent unilateral revocation of the SPC extension. It also begs the question as to whether any competitors (including biosimilar companies) will be taken by surprise as to the sudden reduction in SPC term for tocilizumab resulting from this decision, or indeed whether this makes any material difference depending on the ability to adapt existing launch plans or the existence of other obstacles (IP or otherwise) relating to this product.