The European Commission has announced a proposal for a regulation on supplementary protection certificates ("SPCs") to create a unitary SPC right across participating states and/or a single "unified" procedure for granting national SPCs.
The Commission's webpage Medicinal & plant protection products - single procedure for the granting of SPCs states:
"Supplementary protection certificates (SPCs) are intellectual property rights extending patent protection for specific medicinal and plant protection products. While this regime is fit for purpose, differences between EU countries in its administration and enforcement create inefficiencies. This initiative will put in place a unitary SPC and/or a single ('unified') procedure for granting national SPCs. This will make SPCs more accessible and efficient, and benefit the health sector."
The Commission will "invite evidence" in relation to this initiative in due course.
Laura Orlando, an IP partner in our Milan office, and EMEA co-lead partner for the Life Sciences sector commented:
"The variations in approach to grant seen across the EU mean that a centralised, and thus harmonised, application procedure would be likely to be welcomed by industry. A unitary SPC for unitary patents could be a good solution to the issue of SPC protection for this new unitary right. Failing this, unitary patent holders might apply for separate national SPCs for the designations covered by the particular unitary patent. In either case a centralised application procedure would be helpful."
Background
There is currently no centralised procedure for the granting of SPCs which are separate national rights, as European patents ("EPs") are, once granted. SPCs are granted on a national basis by national patent offices by reference to the SPC Regulations (Regulation EC No 469/2009 and Regulation EC No 1610/96), but with differing approaches to grant (some jurisdictions require substantive examination whereas in others it is a mainly administrative process).
With the advent of the UPC , which is likely to commence towards the end of this year or the start of 2023, the EPO will be able to offer unitary effect for EPs at grant (a "unitary patent"). No provision has so far been made for the terms of unitary patents to be extended by unitary SPCs but there has been speculation that this would be needed in due course. These proposals may provide the means by which such a unitary patent SPC is created. Otherwise, the holder of a unitary patent would need to apply to national patent offices for separate SPCs based on its unitary patent, as happens currently EPs.
Proposals
Whilst no further details have yet been released, the outline given by the Commission, as set out above, suggests that a centralised procedure could be used to grant both SPCs for current EPs, and "unitary" SPCs. There is no indication as yet what body might be used for any centralised SPC application procedure, but the EPO or indeed the EUIPO could be an option, or even an independent body. The Commission conducted a consultation in 2018, in which an independent body of experts from individual national patent offices operating virtually was a popular option (see the Commission's summary of the replies to the consultation here).
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