A Supplementary Protection Certificate (SPC) waiver has been introduced in favour of EU generic and biosimilar makers.

Regulation (EU) 2019/933 (the “SPC Waiver”) which amends Regulation (EC) No 469/2009 (the “SPC Regulation”) has introduced an exception to the protection conferred by an SPC on its holder.

Why are SPCs granted?

SPCs are granted under the SPC Regulation and are intended to provide protection in respect of a patented product’s active ingredient beyond the term afforded by the patent. The rationale for this extension is to make up for the period of the patent term during which the product could not be marketed until a marketing authorisation was granted. The maximum duration of an SPC is capped at 5 years (subject to the possibility of a single further 6-month extension in the case of paediatric applications). 

SPC Waiver to benefit EU generic/biosimilar manufacturers

The SPC Waiver allows EU based manufacturers of generics or biosimilars to manufacture SPC-protected products or medicinal products containing those products during the entire life of the SPC in the EU provided such manufacture is for export to non-EU countries where patent or SPC protection for those products have expired or never existed. Further it is important to note that the SPC Waiver extends not only to the making of the SPC protected products or a medicinal product containing that product but also to “any related act that is strictly necessary for the making in the EU… or for the actual export”. It was stated by those behind the introduction of the SPC Waiver that its main purpose is to make EU based generic and biosimilar manufacturers more competitive on the global playing field.

The SPC Waiver also permits the stockpiling of generics and biosimilars during the final six months of SPC protection to enable a “day 1” launch for those products.  The aim of this provision was said to be to improve patient access to medicines. 

Entry into force

The SPC Waiver entered into force across all Member States of the European Union on 1 July 2019. However, importantly, the Regulations provide for a 3-year transition period until 2 July 2022. During the transition period, the SPC Waiver will only apply to new SPCs that were applied for on or after the entry into force of the Regulation (i.e. 1 July 2019). After the transition period (i.e. after 2 July 2022) the SPC Waiver will apply to all new SPCs that come into effect regardless of their filing date. 

Balance of Rights

The SPC Waiver, in an attempt to safeguard the SPC holder’s rights, does impose some obligations on generics/biosimilars that have to be complied with before the waiver can be availed of. 

Generics or biosimilar producers intending to benefit from the SPC Waiver must:

• notify the national patent office that granted the relevant SPC, using a standardised form no later than three months before commencing manufacture or the first related activity.  The information to be included in this form includes:
  • the name and address of the manufacturer;
  • an indication as to whether the intended manufacture is for the purpose of export, storing, or both;
  • the EU member state where the manufacture is to take place (and, if applicable, the member state where the first related activity prior to manufacture is to take place);
  • he number of the relevant SPC, and,
  • in the case of export to third countries, the reference number of the marketing authorization in each third country of export. 

Any subsequent change to this information must also be notified to the national patent office. The relevant national patent office will then publish the notified information together with the date of notification as soon as possible;

• directly inform the SPC holder and all those involved in the commercialisation of the product, no later than three months before commencing manufacture or the first related activity; and
• for exports of products to third countries outside the EU, ensure the new “EU export” logo (shown below) is affixed to the outer packaging and, where feasible, the immediate packaging of product.

 The purpose of the export logo is to try and avoid such products (produced under the SPC Waiver) being placed on the EU market, imported or reimported. However, the provision has been criticised by originators as not going far enough as it only requires the logo to be placed on the immediate packaging where it is possible. There is a possibility that this may allow generics/biosimilars to reclassify products (originally intended for export outside the EU) as stockpiled goods for a “day 1” launch if they so wish such that they can ‘effectively’ stockpile prior to the 6-month period prior to expiry.

What next?

The EU has stated that the SPC Waiver will enable EU based generic manufactures to compete with non-EU manufacturers on “equal terms” and it is “projected to generate, over the next 10 years, additional net annual export sales of well in excess of €1bn, which could translate into 20,000 to   25,000 new jobs over that period”. However, the SPC Waiver has been criticised by the EU pharmaceutical originator industry with the European Federation of Pharmaceutical Industries and Associations (EFPIA) stating it “sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation”.

The impact of the SPC Waiver and attempts to safeguard the SPC holder’s rights will be issues to watch over the transition period.

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