Clearing the path, launching at risk and preliminary injunctions: how generic launches are fought in the UK, Germany and the UPC

The situation

The compound SPC expires in March. The originator holds a formulation patent to 2033 and says the generic infringes it. The generic thinks the patent is invalid, or not infringed, or both. The register cannot resolve that; a court can, and the question is when.

Route A: clear the path

The generic starts a revocation (nullity) action, in the UK Patents Court, the German Federal Patent Court, a national court elsewhere or, since 2023, the Unified Patent Court, far enough ahead that judgment arrives before the planned launch. In the UK that means filing two to three years out: a trial takes twelve to eighteen months to reach, the judgment follows within months, and an appeal adds a year. The EPO’s opposition procedure is a parallel track for European patents, open for nine months after grant, slower but with effect in every country at once.

The English courts expect this. The phrase “clear the path” comes from a 2003 Court of Appeal judgment holding that a generic which knows of a patent and launches without first challenging it has itself to blame if it is then injuncted; a generic that has tried to clear the path and is still waiting for judgment is treated more kindly. The same logic has shaped expedited trials: where a launch date is close, the court will often list a validity trial quickly rather than decide the launch on an interim basis.

The cost of the route is time and money, and the risk that the originator amends the patent, files a divisional, or wins.

Route B: launch at risk

The generic launches on or after the exclusivity date without a judgment. The originator applies for a preliminary (interim) injunction, usually within days, sometimes before the launch on the basis of an imminent threat. The court then decides, on an incomplete record and in weeks, whether the generic stays on the market until trial.

United Kingdom. The test is the old one: a serious issue to be tried, whether damages would adequately compensate either side, and the balance of convenience. For medicines the damages question is where it is decided. An originator argues that generic entry collapses the price irreversibly (Category M, tender losses); a generic argues it can be compensated for lost sales. The generic’s failure to clear the path weighs against it. If the injunction is granted, the originator must give a cross-undertaking in damages: if the patent later falls, it pays the generic, and in the UK the NHS, for the losses the injunction caused. These sums are real: the 2025 rivaroxaban judgment on the cross-undertaking ran to many millions, and the Court of Appeal’s 2025 handling of dapagliflozin shows the court declining to keep an injunction in place once the patent had been found invalid at first instance.

Germany. Injunctions are granted by the regional courts (Düsseldorf, Munich, Mannheim) on a summary basis, can be obtained without hearing the generic in urgent cases, and are enforced immediately against security. For years German practice required the patent’s validity to have survived at least one adversarial decision (an opposition or nullity ruling) before an injunction would issue, which protected generics launching against untested patents; the CJEU’s Phoenix Contact ruling in 2022 held that a national court cannot impose that as a rule, so the presumption of validity now carries more weight and the generic must bring a strong invalidity case to the injunction hearing itself. A generic injuncted in Germany is off the market in Europe’s largest generics market until the nullity action, which runs separately and slowly, is decided.

Unified Patent Court. One application, one order covering every participating state (eighteen as of 2026). The court requires the applicant to act with urgency, roughly within a couple of months of learning of the threat, and weighs validity, infringement, urgency and the balance of interests; it can order security and can hear the matter without the defendant in exceptional cases. The nintedanib decisions showed the court willing to treat a generic’s entry into a national pricing procedure before SPC expiry as a threatened infringement justifying relief, which is why pricing and tender preparations are now litigation events in their own right. An order is enforceable across the UPC states at once, and so is a refusal.

Elsewhere. The Netherlands’ kort geding, French référé, Spanish and Italian precautionary measures all exist with their own habits; the Dutch court in particular has a long record of deciding pharmaceutical injunctions with a full look at validity.

What the headlines mean for supply

• “Preliminary injunction granted”: the generic is off that market, usually until trial (a year or more), and stock already shipped is stranded; the originator’s price holds. If the patent later falls, the generic and, in the UK, the health service are compensated, but the supply gap was real.
• “Preliminary injunction refused”: the generic supplies, at its own risk of damages if the patent is later upheld; prices move as they would after any launch.
• “Expedited trial listed”: nothing has been decided; the launch date is now the judgment date.
• “Patent revoked at first instance”: supply usually follows, though an appeal can restore the patent, and other countries are unaffected.
• “UPC order”: read the list of states; it does not include the UK, Spain, Poland or Switzerland.

Why it matters, by role

For a parallel trader, an injunction in the destination country keeps the brand’s price up there and removes the generic from the differential calculation; an injunction in the source country does the opposite. Read the country.

For a generics or launch planner, the choice between the routes is a budget decision made two years before expiry, not a legal nicety; and in Germany and the UPC the preparations themselves, pricing filings and tenders, can trigger the fight.

For a buyer, a granted injunction after a launch is the scenario in which a contract for the generic goes unfulfilled; a clause for it is worth having on products with known secondary patents.

MPA Search records the patent and SPC position that tells you which products have this fight coming, and the case notes track the ones that are being fought.