The SPC manufacturing waiver: what it allows and what it does not

The problem it solved

An SPC stops anyone making the product in the country where it is in force. Before 2019 that meant a European generics manufacturer could not make a product in Germany for sale in a country where there was no SPC, say Brazil, while a manufacturer in India could. It also meant that on the day an SPC expired, European manufacturers had empty warehouses while competitors who had made the product elsewhere were ready to ship. The waiver, Regulation (EU) 2019/933, was the EU’s answer: a carve-out from SPC infringement for two specific purposes.

What is allowed

Making for export. During the whole SPC term, a generic or biosimilar may be made in an EU country for export to a country outside the EU where there is no protection, together with the acts strictly necessary for that (storage before export, for instance).

Making and stockpiling for day one. During the last six months of the SPC term, the product may be made and stored in the EU for sale in the EU as soon as the SPC expires.

Related acts by third parties in a contractual relationship with the maker, such as supplying the active ingredient or packaging, are covered to the extent they are strictly necessary for the exempted purpose.

The conditions

The waiver is not automatic. The maker must:

• notify the SPC holder and the national patent office at least three months before starting, giving the maker’s name and address, the countries of export (for the export limb), the SPC number and the start date; the office publishes the notice;
• mark exported product with the EU export logo on the outer packaging and, where feasible, the immediate packaging; and
• inform the supply chain in writing that the product is covered by the waiver and may not be placed on the EU market while the SPC runs.

Product made under the waiver cannot be sold in the EU before expiry, re-imported, or diverted; the usual SPC remedies apply if it is.

Which SPCs it applies to

The waiver applies to SPCs applied for on or after 1 July 2019, and from 2 July 2022 also to SPCs applied for before that date but which had not yet taken effect on 1 July 2019. SPCs that were already in force on 1 July 2019 are not covered for their whole life. For products whose SPC began before mid-2019, the waiver is therefore irrelevant; for everything newer it is standard planning.

The UK

The UK adopted the waiver before leaving the EU and has kept it. Notification goes to the UK IPO on its paper form, at least three months in advance; there is no fee. Export under the UK waiver is to countries outside the UK where no protection exists, and stockpiling in the last six months is for the UK market.

What it does and does not change

It does not move a launch date. Sale in the EU is still barred until the SPC expires, and the paediatric extension still adds six months. The waiver removes a manufacturing handicap, not an exclusivity.

It does change readiness. A generic can now be on EU shelves on expiry day rather than weeks later, which matters for the price curve in the first month and for tenders that fall just after expiry.

It is visible. Notifications are published by the national offices, which makes them an early signal that a particular generic is preparing to launch a particular product. For originators that is intelligence; for competitors too.

It interacts with the UPC’s view of imminent infringement. Notifying a waiver is a lawful act and not a threat to infringe; entering a pricing and reimbursement procedure, on the Court of Appeal’s 2025 nintedanib reasoning, can be. The two should not be confused.

For buyers and traders the practical point is simple: expect generics to be available in volume from the first day after an SPC expires, and plan stock accordingly.