SPC: supplementary protection certificate
A supplementary protection certificate (SPC) extends patent protection for an authorised medicine by up to five years to offset regulatory review time.
SPCs are governed by Regulation (EC) No 469/2009, a codified version of the 1992 regulation. A certificate can be granted for a product, meaning the active ingredient or combination of active ingredients, that is protected by a basic patent in force and is the subject of a valid marketing authorisation as a medicinal product, provided it has not already been the subject of a certificate and the authorisation is the first for that product. The certificate takes effect when the basic patent expires and confers the same rights, limited to the authorised product and its authorised uses. It is granted by national patent offices, one per Member State, so an EU-wide position means a bundle of national certificates.
The term is calculated as the period between the filing date of the basic patent and the date of the first marketing authorisation in the European Economic Area, reduced by five years, with a maximum of five years. The effect is that total protection cannot exceed fifteen years from the first EEA authorisation. Where a paediatric investigation plan has been completed and the results are in the product information, Article 36 of Regulation (EC) No 1901/2006 adds a six-month extension to the certificate, which is the paediatric extension.
Regulation (EU) 2019/933 added a manufacturing waiver: during the certificate, a third party may manufacture the product in the EU for export to countries where no protection applies and, in the last six months of the certificate, may make and store product for day-one launch in the EU, provided it notifies the patent office and the certificate holder and marks export packs with the EU export logo. The Commission proposed in April 2023 a unitary SPC and a centralised examination procedure alongside the pharma package; those are separate acts and not yet in force.
What goes wrong: the application is filed more than six months after the marketing authorisation and is lost; the first EEA authorisation is miscounted because a Swiss authorisation automatically valid in Liechtenstein is overlooked; a certificate is sought for a new formulation of an already certified active ingredient, which the Court of Justice has repeatedly refused; the paediatric extension is requested after the certificate has expired; and launch planning ignores that SPC terms and grants differ by country, so the generic entry date is not one date but a map.
Timing
The SPC application must be lodged within six months of the date of the first marketing authorisation in the Member State concerned, or within six months of the patent grant if the patent is granted after the authorisation. The certificate runs from patent expiry for a term of up to five years, plus six months for a paediatric extension, which must be applied for no later than two years before the certificate expires.
Used in
Launch and lifecycle teams map SPC expiry alongside regulatory protection per market in the loss-of-exclusivity workflow.
Related terms
- LoE: loss of exclusivityLoss of exclusivity (LoE) is the date when the last regulatory or patent protection on a medicine ends and generics or biosimilars can be marketed.
- Paediatric extension: six-month SPC extension for a completed PIPThe paediatric extension adds six months to a supplementary protection certificate as a reward for completing an agreed paediatric investigation plan.
- Data exclusivity: regulatory data protectionData exclusivity is the eight years after a reference product's first EU authorisation in which generics cannot rely on its preclinical and clinical data.
- Market protection: period in which generics cannot be marketedMarket protection is the period after data exclusivity ends during which a generic or biosimilar can be authorised but not placed on the market.
- Bolar exemption: patent exemption for development workThe Bolar exemption in Article 10(6) of Directive 2001/83/EC lets generic developers run the studies needed for an application during the patent term.
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