The European Commission recently announced a proposal to amend the relevant legislation governing Supplementary Protection Certificates (SPCs). SPCs provide patent term extension for certain medicines and agrochemicals which need to undergo regulatory approval before being placed on the market. The proposed amendment provides for a “manufacturing waiver exemption” for SPCs which provides for a derogation from SPC protection for firms which manufacture in the EU for export to non-EU states during the term of the SPC.
The proposal envisages the waiver being effective for SPCs granted after the amendment comes into effect – which will be SPCs which have not been granted on the first day of the third month following the date of publishing the regulation in the Official Journal. See paragraph (5) of amended Article 4 of the proposed amendment to Regulation 469/2009 in context with Recitals 19 and 22.
Consequently, applicants for SPC protection where the application is still pending have an interest in securing the early grant of the application in order to avoid the effect of the proposed change if implemented.
The UKIPO has informally advised that it is possible to request accelerated examination of an SPC application in a manner analogous to that for patent applications where there is sufficient cause. A request for accelerated examination of an SPC cannot just refer to the manufacturing waiver to back up an acceleration request, as this affects all current applicants equally. If however there is a case-specific reason connected with the waiver such as a particular manufacturer can be shown to be preparing to produce a specific product, that may be a justified reason for acceleration. Each request is, though, considered on its merits.
Of course there remains the chance that the proposed amendment to the SPC Regulation will not be approved by the EU member state governments, but equally, it could proceed or be amended.
We will continue to monitor the situation and will provide further updates.
If you have any questions or require further information, please do not hesitate to contact Nick Bassil or Dayle Callaghan, or your usual Kilburn & Strode advisor.