The Commission’s objectives include:
- increasing the global competitiveness of EU-based manufacturers
- increasing business predictability and legal certainty and in doing so increase the attractiveness of Europe as a hub for innovation and manufacturing
- facilitating research and clinical trials by reducing the fragmentation in the internal market associated with the current Bolar system, and to provide the upcoming Unitary Patent Court with clear best practice in relation to patent exemptions, and
- increasing the reliability of the registration and enforcement of SPCs, and maximising the benefits of the Unitary Patent system to those sectors relying on SPC protection.
Any policy or legislative changes could have significant and far-reaching consequences for the life sciences industry in Europe, and so companies should continue to monitor the Commission’s progress as announcements are made.
The Commission’s concerns
The Commission is concerned that the current SPC and Bolar provisions are not suited to a model of changing trade and innovation, and do not create a level playing field for EU-manufacturers of medicines by comparison with companies based elsewhere.
In respect of SPCs for example, the Commission is exploring whether the prohibition on manufacturing whilst an SPC is in force may place EU-based companies at a disadvantage in eventually entering the EU or export market, compared with manufacturers based in countries where there is no SPC, or one of a shorter duration. If this were the case, the consequences might be reliance on non-EU manufacturers, thereby driving European manufacturers of generic and biosimilar medicines to move production outside of the EU in order to remain globally competitive.
In respect of Bolar, the Impact Assessment acknowledges the general recognition that the Bolar patent exemption has been inconsistently implemented by Member States, resulting in uncertainty as to whether these exemptions apply to tests conducted by originator, generic and biosimilar manufacturers for the purpose of obtaining marketing authorisations in non-EU as well as EU countries. The UK system was of course reformed in this respect by the Legislative Reform (Patents) Order in 2014. Furthermore, some Member States do not allow the supply of patented active pharmaceutical ingredients (APIs) for the purpose of seeking marketing authorisations under the Bolar patent exemption. The latter was the subject of a CJEU referral (C-661/13 Astellas Pharma) which was withdrawn and so remains uncertain.
As for the new Unitary Patent system, the Commission notes concern about the fragmentation resulting from the national grant and enforcement of SPCs under the current system. As a first step to address these concerns, the Commission has stated that it intends shortly to issue guidance on how the upcoming Unitary Patent will dovetail with national SPCs.
Policy and legislative options
The Commission is evaluating specific policies intended to address its concerns, both for export and EU-market entry, whilst at the same time maintaining a high level of SPC protection in the EU. As well as contemplating that no change may be necessary, and in addition to non-legislative instruments aimed at improving the implementation of existing EU legislation, the Commission is considering the following possible legislative changes:
- the introduction of an SPC manufacturing waiver for export purposes
- the modernisation of the existing SPC Regulations (eg amendments to SPC-eligibility, scope of protection, registration procedures, etc)
- the clarification and recalibration of the scope of the patent Bolar exemption, and/or
- the creation of a single European SPC title (and a “virtual authority” for European SPCs combining expertise currently residing in national patent offices).
The Commission has stated that an inter-service steering group will monitor the progress of the initiative. A formal open online public consultation on the issues, objectives and policy options is expected to be launched before the end of Q1 2017.
Read the Inception Impact Assessment in full
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