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SPC Manufacturing Waiver in the UK

Posted on 20 July 2020

In July 2019, a new SPC manufacturing waiver took effect in the EU. The waiver provides an exception to infringement of a supplementary protection certificate (SPC) exempting the making of medicines in the EU for export to non-EU countries where protection has expired or does not exist, or for storing products in the six months period before expiry of the SPC for a Day One EU launch.

The introduction of the EU SPC manufacturing waiver last year, discussed in more detail here, coincided with the UK getting ready for its departure from the EU, and the Government making the Patents (Amendment) (EU Exit) Regulations 2019 (the Patents Exit Regulations), to ensure that the SPC system continues to work in the UK after Brexit. At that point, a No Deal Brexit was still on the cards and, in July 2019, the UKIPO issued a consultation dealing with the impact of a No Deal Brexit on the SPC manufacturing waiver.

Subsequently, the UK and EU agreed the terms of the Withdrawal Agreement. Article 60 requires that any application for an SPC that is pending before the end of the transition period is considered in accordance with the EU law in force at that time (i.e., including the waiver). The Withdrawal Agreement also provides that any SPCs granted based on these applications shall provide the same protection as existing SPCs.

The Government has now issued its response to its July 2019 call for views on the operation of the UK export waiver post-Brexit, and has prepared draft legislation which, amongst other things, amends the Patent Exit Regulations.

The key issue for the Government to resolve under this consultation was the relevant markets for export and stockpiling under the UK version of the waiver. Its original proposal had been that the UK waiver should permit making for export to countries outside of the UK, and stockpiling for sale on the UK market post-SPC expiry. Respondents to the call for views expressed concerns that opening up exports to the EU market in this way would have an adverse impact on innovators, particularly relating to accession states where SPC protection may not have been possible. The Government has accepted these arguments and so under the draft legislation third parties will be able to:

  • manufacture in the UK for export to countries outside of the UK and EU;
  • in the final six months of the SPC, to store in the UK for sale in the UK or EU markets on expiry.

The other significant issue to resolve was a practical one - whether to require a particular logo or form of words to be applied to the packaging of products made under the waiver to ensure that they are not diverted back on to the UK market. The Government had decided against requiring a logo to replicate the 'EU Export' logo adopted under the EU manufacturing waiver, settling on the words 'UK Export' alone. Respondents expressed concern that merely requiring descriptive words would not prevent re-importation of the product – however, the Government has decided to stick with this approach, but will give itself the power to set out further conditions on how the words should be presented, if needed.  Transitional provisions are also provided to deal with the situation where a product has already been marked with the EU Export Logo or a notification has been made under the EU manufacturing waiver before the end of the transition period. 

The proposed revisions to the Patents Exit Regulations are contained in The Intellectual Property (Amendment etc) (EU Exit) Regulations 2020

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