The SPC manufacturing waiver came into effect on 1st July 2019, by way of updates to the SPC Regulation via Regulation (EC) No. 2019/933. It allows European generics and biosimilar manufacturers (“makers”) to manufacture medicines, which are protected by an SPC, for export to markets outside the EEA where protection does not exist or has expired.
In addition, the waiver enables makers to make and stockpile medicines that are protected by an SPC in the Member States during the six months before expiry of the SPC, thus allowing them to launch the product in the EEA on the day after expiry of the SPC.
Which SPCs are subject to the waiver?
The waiver will not automatically apply to all SPCs. For example, the waiver will not apply to SPCs which were already in force on 1st July 2019. For SPCs which were applied for before 1st July 2019 but which come into force only after that date, the waiver will be applicable but only from 2nd July 2022. The waiver will automatically apply to all SPCs which were applied for after 1st July 2019.
The waiver in the event of a “no-deal Brexit”
The waiver was introduced under EU law which will no longer be applicable to the UK once it leaves the EU. The EU (Withdrawal) Act 2018 is designed to ensure that, as far as possible, the same EU rules and laws will continue to apply after the UK’s exit from the EU. Section 8 of the Withdrawal Act gives Ministers specific powers to make changes to the retained EU law but only if such changes are necessary to allow the legislation to function correctly in the UK.
As the waiver was designed to function within the context of the EU, it is inevitable that it will need to be adjusted to function properly within the UK. The UK Intellectual Property Office (UKIPO) has suggested changes to achieve this. The important suggestions can be summarised as follows:
Scope of the waiver
The manufacturing waiver is designed to function for manufacture which takes place “in the Union” and where export is to a “third country”, while stockpiling is for sale in the “market of Member States”. Of course, once the UK leaves the EU it will no longer be a Member State or part of the Union and the proposal is therefore to change the wording to state that the export is outside of the UK or that stockpiling takes place in the UK. Also, the definition of the “maker” is proposed to be amended so as to refer to a maker operating within the UK.
The EU waiver requires the maker to notify both the SPC holder, as well as the national IP authority in the country where the product will be made or where “related acts” (e.g. temporary storage prior to export, importing ingredients prior to manufacture etc.) will take place, of their intention to rely on the waiver. As the UK waiver can apply only to products manufactured in the UK, the UKIPO proposes that makers need to notify only in advance of making or “related acts” taking place in the UK.
The proposal further suggests that the requirement to file a specific form, as required by Article 5(5) of the waiver, will be abandoned and replaced by a reference to a “prescribed” form which is likely to be identified as form “SP5”. The intention is not to change the information required from the existing EU form.
Member States are entitled to charge a fee for the processing of waiver notifications if they wish to, as set out in Article 12(2) of the updated SPC Regulation. The UKIPO proposes omitting this part of the SPC Regulation from the corresponding UK provisions as the Comptroller already has the power to charge fees in relation to any service which is carried out by the UKIPO.
Under the current manufacturing waiver, the manufacturer of the waiver-protected product must ensure that a specific logo, bearing the words “EU export” and the EU emblem, is placed on the packaging of any product destined for export. The UK is not proposing to produce a logo of its own. Instead, the packaging needs to set out the export requirement in descriptive terms. This wording needs to be provided on the outer packaging and, where possible, on the immediate packaging.
The UKIPO has invited comments by 9th August 2019 on its proposed draft which will be considered once the call for views has ended. It will then issue a response and, finally, lay the instrument before Parliament. Of course, if the UK and the EU agree on a deal before Brexit the UK manufacturing waiver could still take a different form but it seems likely that, even in that case, the legislation will be similar to what has been proposed by the UKIPO.