Guest blog | A guide to the SPC manufacturing waiver
The BIA has published a new guide for members on the supplementary protection certificate (SPC) manufacturing waiver, which has recently been introduced in the EU. Here, the lead author, Andrew Hutchinson, explains why the BIA’s IP Advisory Committee has produced the guide.
Supplementary protection certificates (SPCs) were introduced in Europe in the 1990s to provide supplementary patent-based protection for medicines that took a significant time to obtain regulatory approval and enter the European market. In this way, an SPC provides a scope of protection based on an underlying patent and marketing approval that comes into effect following patent expiry for up to a maximum period of five years (plus six months if the medicine is accompanied by a paediatric investigation plan).
In 2015, the European Commission’s Single Market Strategy raised the issue of introducing a waiver to permit the European manufacture of medicines that were otherwise protected by SPCs for the purposes of export. This was particularly described to be on the premise that SPCs put European manufacturers at a competitive disadvantage compared to those outside the EU, especially in relation to the manufacture of generic and biosimilar products.
As a result, there has been considerable activity, consultation and debate as to the legal and economic implications of implementing such a waiver, which culminated in a proposal for new legislation in May 2018 (on which the BIA has previously set out its position). This proposal concluded with a new Regulation, which changes the European law governing SPCs and introduces waivers relating to ‘making’ for the purpose of exporting and also for stockpiling.
Many BIA members will already be SPC holders or will have filed or contemplate filing SPC applications to protect their products in the future. There will also be members with the capacity to produce generic and biosimilar versions of medicines that are (or will be) protected by SPCs. In this way, BIA members will be impacted by the waivers both as holders of rights subject to them as well as those intending to benefit from them. The BIA’s IP Advisory Committee (IPAC) therefore view the new legislation as an important new aspect of the European IP regime that life science companies should familiarise themselves with.
After considering briefly the new legislation and the SPCs that it will affect, the guide covers the two main substantive issues, namely the acts falling within the waivers and the compliance requirements to benefit from them. We have included further information in the annexes, including some key issues to consider from the perspectives of both SPC holders and ‘makers’.
Depending on if and how the UK leaves the EU, the waiver regime may need to change. The Government has consulted on proposed changes that it would introduce in the event of a no-deal, to which the BIA has responded, but it is still unclear what will happen. The guide will be updated when we have more certainty.
The new law will impact a significant proportion of SPCs, including rights already granted as well as all future applications. The BIA and IPAC encourage members to consider the new regulations in detail to help assess the impact on the sector and their own businesses.
The guide can be downloaded here. Andrew Hutchinson is Partner at Simmons & Simmons and specialises in IP litigation in the life sciences.