The Unified Patent Court and the unitary patent: what changed for pharmaceuticals

What changed on 1 June 2023

Before 2023 a European patent, once granted by the European Patent Office, became a bundle of national patents, each enforced and revoked in its own national court. The same patent could be upheld in Germany and revoked in the UK, which is the pattern behind half the case notes on this site.

The Unified Patent Court changed that for the countries that joined. A European patent in force in UPC countries can now be litigated once, before the UPC, with effect in all of them. And a new kind of right, the unitary patent, can be requested at grant: a single patent covering all participating states, which can only be litigated at the UPC.

The opt-out

Holders of ordinary European patents could, and still can during a transitional period, opt out of the UPC’s jurisdiction, keeping their patents in the national courts. Many pharmaceutical originators opted out their most valuable patents to avoid a single central revocation. An opted-out patent can be opted back in once, unless national litigation has started. So for any given product the first question is whether its patents are in the UPC system or outside it, and the answer is on the UPC’s register.

Why it matters for pharmaceuticals

One revocation, seventeen or eighteen countries. A generic company can now clear a patent across most of the EU in one action rather than country by country. The UPC’s first revocation on the merits was a pharmaceutical case, and its reversal on appeal a year later showed the other side: a first-instance win is not a clearance.

One injunction, likewise. The UPC has granted preliminary injunctions covering every participating state in one order, including against a generic that had merely entered a national pricing procedure. It has also refused them where it doubted the patent’s validity, as in the first biosimilar cases. Either way the stakes per decision are far higher than in any single national court.

Speed. The UPC aims to decide first-instance cases within about a year, faster than most national courts, which compresses the time between a challenge and a result.

The UK is outside. UK patents remain litigated in the English courts, under English law, with their own line of plausibility cases. A product can therefore be revoked at the UPC and upheld in the UK, or the reverse, and the two results carry no weight in each other’s courts.

The unitary SPC that does not yet exist

A unitary patent still needs national SPCs, country by country, because there is no unitary SPC. The Commission proposed one in 2023, together with a centralised procedure for national SPCs; the proposal remains on its 2026 work programme. Until it passes, the SPC position of even a unitary-patent product is a set of national register entries, with the national differences in expiry dates that come with them.

Reading a product’s position now

For each product:

1. Is the relevant patent a unitary patent, a European patent in the UPC system, or opted out? (UPC register; the EPO register for unitary status.)
2. For UPC-system patents: any UPC action pending or decided, and whether the Court of Appeal has ruled.
3. For opted-out patents and for Spain, Poland, Croatia and the non-EU countries: the national position as before.
4. The UK: always separately.
5. The SPCs: always nationally, whatever the patent’s status.

For generics planners, the UPC is the fast route to clear most of Europe, with the risk that a loss is equally wide. For traders and buyers, it means that European markets inside the system now tend to open, or close, together, while the UK, Spain and Poland can diverge, which is where country-by-country tracking still earns its keep.