Supplementary Protection Certificates and Paediatric Extensions
Supplementary protection certificates (SPCs) are not granted as EU-wide rights, but rather as national rights. It was therefore not necessary for the UK and the EU to agree the creation of a comparable right to ensure continued protection of existing SPCs in the UK at the end of the Transition Period.
SPCs granted in the UK before the end of the Transition Period will not be affected; they will continue to exist and take effect at the end of the relevant patent term, remaining in force (subject to the usual criteria) for the duration originally granted.
Furthermore, Article 56 of the Withdrawal Agreement together with the Patent Regulations 2019 ensure there will be very little change in relation to pending and future SPC applications.
Thus, the current EU SPC Regulations (Regulations (EC) No 1610/96 and No 469/2009) will continue to apply to any UK SPC applications pending during the Transition Period, including those filed in the UK between 1 February and the end of the Transition Period.
These EU regulations will also continue to apply to any UK SPC applications which are still pending at the end of the Transition Period. Any SPC which is granted based on those applications will provide the same protection as existing SPCs.
Following the end of the Transition Period, i.e. from 1 Jan 2021 any new SPC applications in the UK will be dealt with under equivalent UK domestic law. However, this will cause little change because the current EU regulation will be retained in domestic law, although certain references to EU directives and EU agencies will be replaced by UK equivalents. These changes will be implemented via the Patents (Amendment) (EU Exit) Regulations 2019.
Examples of such changes include replacing references to the EU medicines authorisation under Directive 2001/83/EC with the relevant UK authorisation and to the EU paediatric regulation with the corresponding UK Human medicines regulation.
Paediatric Extensions
During the Transition Period pending applications for paediatric extension (to an SPC) will be dealt with under the current EU Regulation. Therefore, it will still be necessary to provide evidence of corresponding authorisations in the EEA during this time.
Applications for paediatric extension which are still pending at the end of the Transition Period will also continue to be processed under the current EU Regulation.
After the end of the Transition Period paediatric extensions will continue to be available based on equivalent provisions in the UK Human Medicines Regulations. However, under the UK provisions, it will not be necessary to provide evidence of corresponding authorisations in the EEA.
Practice Point: There will be no need to refile SPC applications. Because SPC applications are examined by the UKIPO and because the law and regulations governing them will not change (at least in the short-medium term) there will be essentially no change to the way we obtain SPCs.
Practice Point: Members should be aware that some references to the European Economic Area (EEA) will be retained according to the Patent Regulations 2019. Under the current EU Regulation, when applying for an SPC, the details of the first marketing authorisation for the product in the relevant country must be provided along with the first marketing authorisation in the EU/EEA. In practice, these are generally one and the same thing – a centralised EU marketing authorisation covering all member states. From the end of the Transition Period, it will be necessary to obtain a separate UK marketing authorisation. Under the UK SPC legislation, it will be necessary to provide details of the relevant UK marketing authorisation as well as the earliest EEA marketing authorisation, if this predates the UK authorisation (Article 8 (a)(iv) and (v)). Under the new UK domestic SPC regulation, the duration of the SPC will be based either on the first authorisation in the UK or any earlier authorisation in the EEA.
EU marketing authorisations, which have been granted before the end of the Transition Period, will be converted to equivalent UK marketing authorisations. The UKIPO may request information regarding the converted marketing authorisations.
Pending applications for EU marketing authorisation will need to be refiled at the UK MHRA.
Practice point: It is good practice when dealing with SPCs for members to ensure that they or their clients maintain good communication with those colleagues responsible for obtaining marketing authorisations, and this will be especially important as the above changes are implemented.
SPC Manufacturing Waiver
The SPC regulation was amended with effect from 1 July 2019, by virtue of the new Regulation (EC) 2019/933. This permits generic and biosimilar manufacturers in Europe to manufacture medicines protected by an SPC for export to countries where parallel protection does not exist. The waiver also permits stockpiling during six months prior to SPC expiry, to enable launch in Europe immediately on SPC expiry. The waiver will not apply to SPCs in force on 1 July 2019, but will apply to SPCs applied for after that date. For SPCs pending on 1 July 2019 the waiver will apply as from 2 July 2022. At the end of the Transition Period, this new Regulation will be retained in UK domestic law, and as with other EU regulations it will be amended by means of an SI, to ensure it will function correctly.
Date published: 3 February 2020
