The New SPC Manufacturing Waiver Regulation

Today, 1 July 2019,  a new EU Regulation No 2019/933 (the ‘Regulation’) amending the current SPC Regulation 469/2009 comes into force. This introduces limitations to the extent of SPC protection in respect of certain acts carried out in relation to the export of a medicinal product to a non-EU country and to the placing of a medicinal product on the EU market once the SPC has expired, an effective waiver for exporting and stockpiling.

The policy behind this new piece of legislation is to promote competitiveness in the pharmaceutical industry in the EU by allowing for makers of generics and biosimilars to carry out certain acts, thereby increasing their competitiveness in comparison with companies outside the EU and preventing delay to generic entry on the EU market following SPC expiry.

What does the waiver apply to?

1. Export to third countries

Under the Regulation, SPC protection shall not protect against the ‘making’ of a product‘, or any related act’ that is ‘strictly necessary for the making’ of a product for the purpose of export to third countries, i.e. outside the EU. The manufacturer is obliged to affix the below logo to the outer packaging and any immediate packaging. There is no time limit on this waiver.

2. Stockpiling for launch in the EU market following SPC expiry

The new Regulation also allows for the ‘making’ of a product,  six months prior to expiry of the SPC for the purpose of ‘storing’ the product in order to place it on the EU market following expiry of the SPC. It also allows for ‘any related act’ that is ‘strictly necessary’ for the ‘making’ or the ‘storing’ provided that the related act is also not carried out before six months prior to the expiry of the SPC.

What does the waiver not apply to?

The limitations of the SPC protection will not apply to any act carried out in relation to import of products into the EU for the purpose of repackaging, re-exporting or storing.

What are the notification requirements of the maker?

The manufacturer is required to notify both the relevant industrial property office in the member state where the ‘making’, ‘storing’  or the ‘related acts’ are proposed to  take place  and also the holder of the SPC no later than three months prior to the first act, which would otherwise be prohibited. The manufacturer shall use the standard form set out in the Regulation to make the notification to the industrial property office. There may be a fee associated with the notification to the industrial property office, this to be determined at the national level.

The manufacturer must supply the following information to the SPC holder:

• Name and address of the maker;
• Identify whether the act of ‘making’ is carried out in relation to export, storing or both export and storing;
• The country in which the acts will take place, and also the country in which the first related act is to take place;
• The number of the SPC granted in the country where the act of ‘making’ will take place and also the number of the SPC in the country where any ‘related act’ will take place; and
• In relation to export, the reference number of the Marketing Authorisation in each third country of export.

Other obligations of the manufacturer?

The Manufacturer must also ensure that ‘any person in a contractual relationship with the ‘maker’ who makes, stores or carries on ‘any related act’  is fully informed that those acts are subject to the Regulation, i.e. new limits of the extent of SPC protection following this Regulation coming into force.

Which SPCs are subject to the exceptions to infringement?

The waivers set out in this Regulation will apply to:

1. SPC applications which have been made on or after 1 July 2019; and
2. For SPC applications which have been applied for before 1 July 2019 and which will take effect on or after 1 July 2019, the waivers will only apply from 2 July 2022.

This means that an SPC holder who made an application before 1 July 2019 can enjoy the benefit that it may potentially enforce its rights against a manufacturer of a product in a member state where the acts are taking place until 1 July 2022.

 Is this the end of the story?

Very unlikely. Certain elements of the Regulation leave open various possibilities in its interpretation. For instance it is arguable that it is not entirely clear who the ‘maker’ is, the limits of the exemption of ‘any related acts’ is therefore, potentially a hot bed for litigation going forward.

Summary

It is clear that whilst these exemptions provide generic pharmaceutical companies new opportunities for business in the EU member states, it comes with an administrative burden in relation to the notification requirements, which will have to be made strictly in accordance with the Regulation in order to rely on the waiver.

This information is general information only and is not intended to constitute legal advice. It should not be acted on without first seeking professional legal advice.

Category: News | Author: Varuni Paranavitane | Published: July 2019 | Read more