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October 2017

On 12 October 2017, the European Commission published its much anticipated "Public consultation on supplementary protection certificates (SPCs) and patent research exemptions". The consultation is part of the Commission's Single Market Strategy, adopted in October 2015, in which it is looking for ways to improve the patent system in Europe, in particular for pharmaceutical and other industries whose products are subject to marketing authorisations.

We previously reported on the Commission's proposed reforms which include the creation of a unitary SPC, updating the scope of the Bolar exemption and introducing an SPC manufacturing waiver.

The Consultation follows the publication by the Commission of its "Inception Impact Assessment' which sets out, in detail, the Commission's specific policy objectives for the Strategy and its proposed options for reform.

Broadly, the Strategy aims to 'deepen and make the internal market fairer, thus stimulating sustainable jobs, growth and investments, with a special positive impact on innovative SMEs. The objectives of the initiative also support the sustainability of public health budgets, as well as access to medicines in the EU and in third countries.'

The proposed options for reform are aimed at recalibrating certain aspects of patent and SPC protection, focusing on three elements: (i) creating a European SPC title; (ii) updating the scope of EU patent research exemptions; and (iii) introducing an SPC manufacturing waiver.

Creation of a European SPC title - a "Unitary SPC"

The Commission believes that a unitary SPC title would bring enhanced certainty to industries whose products are subject to regulated market authorisations, compared to the current system in which SPCs are granted by national patent offices (which can take varying approaches to grant, and have only national territorial effect - see our earlier article here).

Update of the scope of EU patent research exemptions

The “regulatory review defence” (or the “Bolar exemption”) provided by Directive 2001/83/EC, has been implemented in a number of different ways by the national legislatures of the EU member states. These differences have led to inconsistent application of Bolar by the national courts. With greater consistency in mind, and in view of the upcoming establishment of the Unified Patent Court, the Commission is considering whether to remodel the Bolar exemption according to best practice, which is widely considered to be the broader German exemption and now the new UK research exemption (see our earlier article here). The Commission hopes that an updated Bolar exemption will 'impact economically in terms of keeping the European pharmaceutical sector as a hub for clinical trials and bringing market opportunities to EU-based suppliers of APIs.'

Introduction of an SPC manufacturing waiver

The Commission is considering a targeted SPC manufacturing waiver for export purposes that could allow EU-based manufacturers of generic and biosimilar medicines manufacturing during the SPC term to export their products to countries with no SPC protection, putting them on equal footing with competitors from non-EU countries (see our earlier article here).

The consultation runs until 4 January 2018 and can be completed by research-based organisations, generics companies, associations representing stakeholders in the pharmaceuticals industry, lawyers, patent attorneys and the public.

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