Supplementary protection certificates: how the SPC term is calculated

Why SPCs exist

A patent lasts twenty years from filing, but a medicine cannot be sold until it is authorised, and authorisation can take ten years or more of the twenty. The supplementary protection certificate (SPC) compensates for that lost time. It is not a patent extension in the strict sense: it is a separate right, granted by each national patent office, that takes effect the day the basic patent expires and protects the authorised product (the active substance or combination) for the remaining period.

For anyone planning a launch or a sourcing route, the SPC date is usually the date that matters, not the patent date.

The rule

The term is set by Article 13 of Regulation (EC) 469/2009, and it is one sentence long. The certificate lasts for the period between the filing date of the basic patent and the date of the first authorisation to place the product on the market in the EU, reduced by five years. Two limits apply: the term cannot exceed five years, and because of the way the arithmetic works, a product never has more than fifteen years of combined protection from its first authorisation.

Three things follow from the formula.

• A product authorised within five years of filing gets no positive term. The certificate can still be applied for (a zero- or negative-term SPC), because it is the only vehicle for a paediatric extension, but it adds nothing on its own.
• A product authorised more than ten years after filing is capped at five years. Most new chemical entities fall here, which is why “patent expiry plus five” is a common and often correct rule of thumb for compounds.
• Everything turns on two dates: the patent filing date (not priority, not grant) and the first authorisation anywhere in the EU, not the authorisation in the country where the SPC is sought.

The first authorisation: the input people get wrong

“First authorisation in the EU” means the earliest marketing authorisation for that product anywhere in the European Economic Area, by any route. A national authorisation in Sweden in 2014 fixes the SPC term in Germany even if the German authorisation came in 2016. Swiss authorisations have also counted in some circumstances because of Liechtenstein’s customs union with Switzerland.

Since the Court of Justice’s 2015 Seattle Genetics decision, the date that counts for a centralised authorisation is the date the holder was notified of the Commission’s decision, which is usually a few days after the decision itself. The difference can be days of SPC term, and several national offices have agreed to correct the expiry dates of certificates already granted on request; others have not. Expiry dates on older certificates can therefore differ between countries for the same product by a few days, and the register entry is what governs.

Conditions for a grant

Article 3 of the Regulation sets four conditions, assessed in the country where the SPC is sought: a basic patent in force there that protects the product; a valid marketing authorisation for the product in that country; no earlier SPC for the product there; and the authorisation being the first to place the product on the market in that country. The application must be filed within six months of the national authorisation (or of the patent grant, if later). Miss the window and there is no certificate.

Whether a patent “protects the product” is the question behind most SPC litigation, especially for combination products; the Court of Justice has refined the test several times and the 2024 combination-product judgment is covered in a case note.

National grant, national expiry

SPCs are granted office by office: the UK IPO, the German DPMA, the French INPI and so on. The same product can have an SPC in twenty countries and none in three, with slightly different expiry dates where offices applied the notification-date rule differently or where the national authorisation came too late. There is no single European SPC yet; a unitary SPC has been proposed and remains on the Commission’s work programme.

The example below shows a typical compound: filed in 2011, authorised in 2019, patent expiry in 2031, an SPC to 2034, and a paediatric extension to the end of 2034.

The UK after Brexit

The UK kept the SPC system when it left the EU. A UK SPC is granted by the UK IPO on the basis of a UK marketing authorisation, and the term is still calculated from the first authorisation in the UK or the EEA, whichever is earlier, so an SPC in the UK is not longer than it would have been inside the EU. The six-month paediatric extension and the manufacturing waiver both continue to apply. The practical difference is that UK SPC case law can now diverge from the Court of Justice, and in the plausibility cases of 2023 to 2025 it has.

What to check before you rely on an SPC date

1. The basic patent’s filing date and the first EEA (or UK) authorisation date, including the notification date for a centralised product.
2. The SPC’s status on the national register of each country you care about: applied for, granted, in force, lapsed for non-payment, or expired. An SPC that was never applied for in a country is not there, whatever the position elsewhere.
3. Whether a paediatric extension has been applied for or granted in that country; it adds six months and is also national.
4. Whether the basic patent has survived challenge in that country. An SPC falls with its patent, which is how the UK lost its dapagliflozin and apixaban SPCs years before their register dates.
5. Any secondary patents on formulation, use or process that outlast the compound SPC. The SPC date is when the molecule is free, not necessarily when a particular product can be sold.

MPA Search holds the patent and SPC position for each product in each country, with the register reference on every record, and the interpretation of a difficult case comes with the subscription.