A few countries have recently geared up for the ratification of the UPC Agreement. Although the date of its entry into force is yet unknown it is hoped that the Unified Patent Court will start its operation before the UK leaves the EU. This means that the Unitary Patent may also become available before March 2019. Indeed, EU Regulations No 1257/2012 and No 1260/2012 entered into force on 20 January 2013 will apply from the date of entry into force of the UPC Agreement. However, the issue of the Unitary Supplementary Protection Certificate still has to be resolved.

In 2015, the EU Commission announced that as part of the Single Market Strategy, an initiative of the European Commission’s plan to unlock the full potential of the Single Market, the Commission would ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’. The Strategy thus aimed at exploring a recalibration of certain aspects of patent and supplementary protection certificate protection. According to the EU Commission, this could comprise the following three elements: (1) the creation of a European Supplementary Protection Certificate title, (2) an update of the scope of EU patent research exemptions, and (3) the introduction of an SPC manufacturing waiver.

The promised consultation process finally took place between 12 October 2017 to 4 January 2018 and a total of 231 replies were provided. Its outcomes are summarised in the “Summary of the replies to the public consultation on Supplementary Protection Certificates and patent research exemption for sectors whose products are subject to regulated market authorisations

It transpires from it that a very large majority of the respondents across all categories favour the creation of a unitary Supplementary Protection Certificate”, extending unitary patents when such patent rights expire.

Regarding the benefits of a unitary Supplementary Protection Certificate the participants declared the following:

(I)t could boost the value of investments, that it would reduce red tape relating to registration and to litigation, that it would provide uniform protection across the Union as well as legal certainty, that it would reduce maintenance costs, that it would offer a specialised court, and that it would make licensing easier. A large majority of generics/biosimilars (‘G/B’) manufacturers, including SMEs, share these views.

One Member State considered that it would also simplify and enhance the efficiency of the SPC application process.

Opinions diverge regarding the practicalities for implementing such a new title. While some respondents favour the grant of that title by a virtual office composed of national experts working on behalf of an EU agency, others prefer either to entrust the EPO with this task, or to set up a new EU agency to do so.

Amongst SMEs manufacturing G/Bs, half of them favour the grant of unitary SPCs by a new EU agency, while the other half favour the EPO for this purpose.”

Concerning the languages to be used for a unitary Supplementary Protection Certificate:

(A) clear majority favoured the EPO language regime (English, French, German), which is the regime that is applicable to the EU unitary patent. However, SMEs manufacturing generics and biosimilars prefer the five language regime of the EUIPO (English, French, German, Italian and Spanish), whilst one of these favours the EPO regime.

Respondents also mostly considered that national marketing authorisations should be able to be used (in addition to EU marketing authorisations) as a basis for getting a unitary SPC, even though the latter would then not be enforceable in those Member States where no marketing authorisation would have been granted (through mutual recognition or decentralisation procedure).