Paediatric extensions: the extra six months, and how to check for one

What it is

The Paediatric Regulation of 2006 made companies study new medicines in children. In return it offered a reward: a six-month extension of the supplementary protection certificate for any product whose agreed paediatric investigation plan (PIP) has been completed and whose results appear in the product information. The reward is granted whether or not the studies showed a benefit in children; what is rewarded is doing the work.

Six months sounds minor. On a product selling hundreds of millions of euros a year across Europe it is not, and because it attaches to the SPC, which is the last exclusivity to run, it moves the real loss-of-exclusivity date for everyone else.

How the dates work

The extension is added to the end of the SPC in each country where it is granted. It is available only where an SPC exists, which is why companies apply for zero- or even negative-term SPCs: a certificate of no length on its own still carries six months once extended.

The application has a deadline. It must be made no later than two years before the SPC expires (a shorter six-month window applied until January 2012). An originator that leaves the PIP late can find itself unable to claim the reward in time, which is the gap generics planners watch for.

Conditions

Four things must be true for the extension to be granted in a country:

• An agreed PIP, completed, with the studies conducted in compliance with it.
• The results of those studies included in the summary of product characteristics (and, where relevant, the package leaflet), and the product authorised in all member states, which in practice means the centralised product or a complete set of national authorisations.
• An SPC in force, or applied for, in that country.
• No orphan market exclusivity on the product. Orphan medicines get a different reward: their ten-year market exclusivity is extended by two years instead.

Each national patent office grants the extension to its own certificate. It is possible for the extension to be granted in one country and refused or never sought in another, and the national register is the only reliable record.

Why it matters commercially

For generics and biosimilar planners, the extension is the difference between a launch in March and a launch in September. Plans built on the SPC date alone are wrong by six months whenever an extension is granted, and the application can be made up to two years before SPC expiry, so a product can look clear and then acquire six more months of protection.

For parallel traders, the opposite: the brand stays protected, and alone on the market, for six months longer in each country where the extension is granted, and the countries may not all line up.

For buyers, a known extension is a known date; an unknown one is a budgeting surprise. The extension status of the products you buy most is worth knowing a year ahead.

Where to check

The extension is recorded against the SPC in each national register: the UK IPO’s patents register, the German DPMAregister, the French INPI, the Dutch Octrooicentrum, and so on. The EPO’s register does not grant or record SPCs. For the PIP itself, the EMA publishes decisions on agreed plans and on compliance.

A practical sequence: find the SPC in the national register; look for an entry showing an application for, or grant of, an extension; note the new expiry date; and check the product’s EMA page for the PIP compliance decision if the register shows nothing yet, because an application may be coming.

MPA Search records the SPC, its expiry and any paediatric extension for each product in each country, flagged as granted or pending, with the register reference.