The system of Supplementary Safety Certificates (SPCs) has at all times straddled EU and nationwide regulation. Whereas the authorized foundation for granting them lies in EU Laws (469/2009 in respect of pharmaceutical and veterinary merchandise, and 1610/96 in respect of plant safety merchandise), they’re utilized for, examined and granted nationally by the mental property workplace of every EU member state.
Within the UK after the tip of the transition interval, the authorized foundation stays those self same EU Laws, which kind a part of the retained EU regulation that has impact as UK nationwide regulation, as amended by the Patents (Amendment) (EU Exit) Regulations 2019. These amendments require, unsurprisingly, a legitimate UK advertising and marketing authorisation to put the product available on the market within the UK, however, maybe extra surprisingly, keep the rule that the time period is set not by the date of the UK advertising and marketing authorisation, however of the earliest advertising and marketing authorisation within the UK or the European Financial Space (EEA).
Nonetheless, the state of affairs relating to SPCs within the UK has been made extra complicated by the preparations for medicinal merchandise agreed within the Northern Eire Protocol of the Withdrawal Settlement. Beneath Article 5(4) and Annex 2, title 20 of the Protocol, EU regulation on authorisation to market medicinal merchandise will apply to Northern Eire. Presently current advertising and marketing authorisations within the UK will proceed to have UK-wide impact, offered there is no such thing as a variation of their phrases. However for brand new advertising and marketing authorisations, the state of affairs is totally different. A ‘UK’ advertising and marketing authorisation issued by the MHRA will actually solely have impact in England, Wales and Scotland. Authorisation to market a medicinal product in Northern Eire will come from an EU advertising and marketing authorisation.
So how will the UK SPC system work when the related advertising and marketing authorisation in Northern Eire is an EU authorisation, and a ‘UK’ authorisation solely covers England, Wales and Scotland?
The reply has simply emerged within the type of the Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020. The consequences of those Laws on the important thing problems with an SPC utility are as follows. Particular reference is made to the Articles of EU Regulation 469/2009 referring to medicinal merchandise, however the provisions are equal in relation to plant safety merchandise.
Time period (Article 13)
Beginning with what shouldn’t be affected – because the time period of an SPC is in any case calculated just about the earliest advertising and marketing authorisation within the UK or EEA, the time period is not going to change. As at present, it will likely be calculated as [date of earliest marketing authorisation] minus [filing date of patent] minus 5 years, topic to a most of 5 years.
Deadline for submitting (Article 7(1))
An SPC utility have to be filed inside six months of the issuance of the primary advertising and marketing authorisation relevant anyplace within the territory of the UK (not the earliest advertising and marketing authorisation within the EEA, in distinction to the provisions for the time period of an SPC). Because of this utility have to be made to the UK Mental Property Workplace inside six months of the earliest of the UK-issued advertising and marketing authorisation masking England, Scotland and Wales solely (which for simplicity will probably be known as a ‘GB authorisation’), or the EU authorisation masking Northern Eire (which for simplicity will probably be known as an ‘NI authorisation’).
Advertising Authorisation Data (Article 8)
The SPC utility should give the quantity and date of the UK, GB or NI authorisation, or the place there’s a couple of such authorisation, of every authorisation. As at present, if there’s an earlier advertising and marketing authorisation elsewhere within the EEA, particulars of that authorisation have to be given as properly.
Beneath a newly-created Article 13A (1 and a couple of), if on the time of an SPC utility solely a GB or NI authorisation exists, and if earlier than the SPC is granted the authorisation within the different territory is issued, then the SPC applicant should present the small print of the opposite authorisation inside six months of its issuance. An analogous process Article 13A (three and 4), applies after the SPC is granted however earlier than it comes into power, additionally with a six month deadline.
Territory of Safety (Article 4)
Article Four of the SPC Regulation has been amended to specify that the SPC gives safety solely within the territory wherein an authorisation has been issued earlier than the SPC comes into power (the expiry of the underlying patent). Nonetheless, if the notification of a subsequent authorisation as required beneath Article 13A shouldn’t be filed throughout the specified 6 months, the SPC is not going to have impact within the corresponding territory.
Expiry (Article 14)
As talked about above, UK advertising and marketing authorisations will proceed to have impact, but when there’s a variation of the phrases of such an authorisation, it will have to be sought individually for the GB authorisation and the NI authorisation, so at that time the UK authorisation will probably be withdrawn and changed by a GB and NI authorisation. Article 14 has been amended to specify that this is not going to trigger the SPC to lapse. Nonetheless, if the authorisation is totally withdrawn in a territory, according to Article 4, the SPC will stop to have impact in that territory.
The approaching into impact of the Northern Eire Protocol will significantly complicate the process for acquiring SPC safety within the UK. Practitioners and their purchasers might want to fastidiously monitor the dates of issuance of authorisations by the UK and EU authorities to make sure that the deadlines are adhered to. The time period of the safety in Northern Eire will usually align to that in England, Scotland and Wales, however the process to be adopted will rely on which advertising and marketing authorisation points first, and the way shut the issuance dates are. Beneath some circumstances, comparable to failure to well timed submit authorisation particulars, safety in a part of the UK may very well be misplaced altogether.
Darren Smyth is a associate at EIP, London