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Inside Life Sciences

SPC and patent research exemptions consultation: views sought from across industry
Inside Life Sciences

Inside Life SciencesIssue 3 | November 2017

Date
08 November 2017

Nina O'Sullivan Legal Director, Professional Support Lawyer

A wide-ranging consultation on a 'recalibration' of the EU regime for supplementary protection certificates and patent research exemptions has been launched by the European Commission.


SPC and patent research exemptions consultation: views sought from across industry

A wide-ranging consultation on a 'recalibration' of the EU regime for supplementary protection certificates and patent research exemptions has been launched by the European Commission. As well as seeking views from established stakeholders including originators, the EU-based generic, biosimilars and plant protection products industry, and active pharmaceutical ingredients suppliers, the Commission is also seeking input from those in innovative sectors whose products require pre-market regulatory authorisation, but which are currently not eligible for SPCs. This paves the way, for example, for the medical devices industry to set out its stall in relation to SPC protection.

The consultation raises a number of questions, focusing on three issues:

  • The creation of a European SPC title – this is in the context of the forthcoming Unitary Patent, which, subject to resolution of a constitutional challenge in Germany, could potentially be in force from some time in 2018. At present, there is no scope for a Unitary SPC in the Unitary Patent regime (national SPCs would be granted based on a Unitary Patent).
  • An update of the scope of EU patent research exemptions – the approach to patent research exemptions across the EU is inconsistent (with the potential for further inconsistency once the Unified Patent Court is up and running).
  • The introduction of an SPC manufacturing waiver – the EU generics/biosimilars industry has long called for an SPC manufacturing waiver to allow it to export products during the EU SPC term of the reference medicine to countries with no SPC protection.

Responses to the consultation should be submitted by 4 January 2018.

Of course, Brexit looms over any future changes to the regime for SPCs and patent research exemptions at the EU level. If changes take effect before the UK leaves the EU, they will continue to apply to the UK post-Brexit, given the intended approach to existing EU regulations on Brexit-day (albeit subject to any potential review in the future). However, in any event, businesses operating across the EU will be subject to the new EU regime and should therefore make sure their views are heard in the consultation.