One product, five clocks: the dates that decide when a medicine opens up

The five clocks

Clock	Starts from	Runs for	Set by	Can it be challenged?
Patent	Filing date	20 years	Patent law; national grant of a European patent	Yes, country by country (or at the UPC)
SPC	Patent expiry	Up to 5 years (authorisation minus filing, less 5)	Regulation 469/2009; national grant	Yes, falls with the patent or on its own grounds
Paediatric extension	SPC expiry	6 months	Regulation 1901/2006; national grant	Rarely; conditions are factual
Data exclusivity	First EU authorisation	8 years	Directive 2001/83	No; it runs
Market protection	End of data exclusivity	2 years (+1 for a new indication); 1 (+ up to 2 earned, capped at 11 in all) under the agreed EU reform, for products filed from late 2028	Directive 2001/83	No; it runs

Which clock bites

For most new chemical entities authorised eight to twelve years after filing, the SPC (with its paediatric extension) is the last clock, typically twelve to fifteen years after first authorisation. For products authorised quickly, or whose patents fell early, the regulatory clocks can be the last. For products with later formulation, use or combination patents, none of the five tells the whole story and litigation does.

The clocks also stop on different dates in different countries, because patents and SPCs are national and because the regulatory start date can differ between the UK and the EU.

The checklist

For each product, and for each country that matters:

1. Patent: which patents cover the product there, their filing dates, and whether each is in force, revoked or expired.
2. SPC: granted or not, the expiry date on the register, and whether the basic patent has survived challenge.
3. Paediatric extension: applied for, granted, or still possible (the deadline is two years before SPC expiry).
4. First EU authorisation (and UK authorisation): the date, and whether the product shares a global authorisation with an older one.
5. Regulatory dates: eight and ten years on, plus any added year; orphan status if relevant.
6. Secondary patents: formulation, use, process, combination, and their own dates.
7. Litigation: anything pending that could move any of the above.

The last date standing is the loss-of-exclusivity date for that country. Write it down with its source, and review it when any input changes.

MPA Search holds items 1 to 5 for each product and country with the register reference, and the case notes in this section cover the litigation that moves them.