On 28 October, the European Commission presented its strategy for a ‘deeper and fairer Single Market’, containing a number of proposals intended to modernise the Single Market in a way that improves the way in which it functions and guarantees appropriate protection. The strategy contains targeted actions in three key areas:
- Creating opportunities for consumers, professionals and businesses
- Encouraging and enabling modernisation and innovation
- Ensuring practical delivery that benefits consumers and businesses in their daily lives.
A section on consolidating Europe's IP framework, in particular, focuses on the Unitary Patent. As the Commission notes, the main challenge now is to 'get the endgame right', which it identifies as including addressing uncertainties as to how the Unitary Patent will work with national patents and national SPCs, and the possible creation of a unitary SPC title. A Unitary SPC would, the Commission suggests, lead to enhanced certainty for industries subject to regulated market authorisations and improve transparency and certainty for both manufacturers of novel and generic/biosimilar medicines. The Commission goes further and states that it intends to explore ‘recalibration’ of certain aspects of patent and SPC protection more generally, noting that an SPC manufacturing waiver could lead to significant new job creation in the EU and that an update of the scope of the patent research exemption would lead to a smooth supply of active pharmaceutical ingredients throughout the Single Market.