Introduction
Patent litigation in Switzerland has always operated at its own pace. The Swiss Federal Patent Court — a specialised court established in 2012, based in St. Gallen — handles both infringement and validity in a single, integrated forum. That’s an advantage over the German bifurcation model. But the timeline for nullity proceedings — the validity challenges that run alongside or in response to infringement actions — has historically been open-ended, creating extended periods of commercial uncertainty for both sides.
On December 9, 2025, the Swiss Federal Patent Court published a significant procedural update on its website: nullity actions will now be expedited whenever the challenged patent forms the basis of an ongoing infringement action, with the court targeting completion of such proceedings within a maximum of 12 months. For a jurisdiction that is home to Novartis, Roche, Lonza, Straumann, and dozens of other pharmaceutical and medical technology companies with active Swiss patent portfolios, this is a material change in the litigation landscape.
This article covers what the change means, why it matters specifically for pharma and medtech IP portfolios, and what it requires from both patent holders and market entrants before proceedings begin.
How Swiss Patent Litigation Works — and Why It Differs from Germany and the US
To understand why the December 2025 announcement matters, it helps to understand what makes Swiss patent litigation distinctive.
Switzerland is not a UPC participating state. Swiss patents are governed entirely by Swiss law and litigated before the Swiss Federal Patent Court. The UPC’s pan-European enforcement reach, the EPO’s post-grant opposition procedure, and the German bifurcated model all operate separately from the Swiss system. A European patent validated in Switzerland proceeds through the Swiss FPC for both infringement and validity challenges — not through the UPC.
The FPC hears both infringement and validity in a single court. This is one of Switzerland’s key structural advantages over the German system. In Germany, infringement is heard in the regional civil courts (Landgericht) while validity is challenged at the Federal Patent Court (Bundespatentgericht) — the infamous bifurcation model that allows an injunction to issue before validity is determined. In Switzerland, the same court determines both. The practical effect: the risk of a patent holder obtaining an injunction based on a patent that is subsequently invalidated is lower in Switzerland than in Germany.
Pre-December 2025: Nullity actions ran on their own timeline. Extended proceedings — sometimes running significantly longer than 12 months — created commercial uncertainty for both patent holders and challengers. Both sides could use the timeline strategically: patent holders to delay validity determination and maintain injunction pressure; challengers to prolong market uncertainty.
Post-December 2025: When the challenged patent is the basis of an active infringement action, nullity proceedings will now be completed within a maximum of 12 months. The extended timeline as a strategic tool is removed. Both sides need to be ready to resolve validity quickly.
The 12-month target applies specifically where the challenged patent is the basis of an ongoing infringement action — not for standalone nullity actions brought independently. But in pharma and medtech disputes, the combination of infringement claim and nullity challenge is the standard pattern. The announcement directly addresses the proceedings that matter most in these sectors.
Why Switzerland Matters for Pharma and MedTech IP
Switzerland is consistently ranked as the world’s most innovative country — WIPO’s Global Innovation Index has placed it first for 14 consecutive years. It is home to 20 of the world’s largest pharmaceutical companies by revenue, and its medical technology sector — Straumann, Sonova, Ypsomed, Medartis, and dozens of others — operates at the premium end of global device markets. For pharma innovators and IP strategists in Europe, Switzerland’s patent system isn’t a secondary jurisdiction. It is the home court for some of the world’s most commercially significant patent portfolios.
The Swiss patent landscape has two distinct layers that together define the IP environment: EPO-granted European patents validated in Switzerland (which are subject to the Swiss FPC for both infringement and validity), and domestic Swiss patents granted by the Swiss Federal Institute of Intellectual Property (IPI). Companies with Swiss commercial operations need to understand both layers — and both are affected by the expedited nullity announcement.
Supplementary Protection Certificates (SPCs) are particularly relevant in this context. SPCs extend the protection of pharmaceutical and medtech patents beyond their normal 20-year term to compensate for the time lost during regulatory approval. In Switzerland, SPCs are governed by the Swiss Patent Act and can extend protection by up to 5 years. A patent forming the basis of an infringement action in Switzerland is often an SPC-extended patent approaching the end of its term — exactly the context where the 12-month nullity timeline creates the most strategic pressure.
What the Expedited Timeline Changes for Patent Holders
The December 2025 announcement is a double-edged development for patent holders — and understanding both edges is essential before commencing Swiss infringement proceedings.
The positive edge: faster validity determination removes the uncertainty window that challengers have historically used as a negotiating tool. A patent holder with a genuinely strong patent — good prosecution history, clean prior art record, well-drafted claims — now gets faster confirmation of that strength. The extended nullity timeline that previously allowed challengers to delay settlement by keeping validity proceedings open is gone. For strong patents, the expedited timeline is an enforcement advantage.
The difficult edge: a patent holder asserting a patent with validity vulnerabilities will now face those vulnerabilities being exposed within 12 months of a nullity filing. A patent that is asserted in infringement proceedings and subsequently invalidated in expedited nullity proceedings is a materially worse outcome than not asserting at all — the cost of litigation, the reputational impact, and the loss of the licensing leverage the patent previously provided all materialise simultaneously.
The practical consequence: pre-assertion validity screening is no longer optional for Swiss patent holders. Before commencing infringement proceedings in Switzerland, every patent that will form the basis of the action should be assessed for the prior art that a challenger is most likely to deploy in expedited nullity proceedings. The question isn’t whether the patent is valid in the abstract — it’s whether it will survive a 12-month challenge from a well-prepared opponent.
- Screen for non-patent literature (NPL). In pharma and medtech, the most potent invalidity arguments often come from academic papers, clinical trial publications, conference proceedings, and technical standards documents — not from prior patent filings. A validity pre-screen that covers only the patent database is structurally incomplete for Swiss pharmaceutical patent assessment.
- Review prosecution history for claim scope vulnerabilities. Arguments made to the Swiss IPI or EPO examiner during prosecution define the effective scope of the claims and reveal the distinctions over prior art that were made during examination. A challenger’s first task in a nullity action is to review the prosecution history — the patent holder should do this first.
- Assess SPC extension validity separately. Where the patent is SPC-extended, the SPC’s validity is a separate question from the underlying patent’s validity. Both need to be assessed before proceedings commence.
What the Expedited Timeline Changes for Market Entrants and Challengers
For generic manufacturers, biosimilar developers, and medical device companies planning Swiss market entry that requires navigating a competitor’s patent, the expedited timeline is a significant development. Our guide on opposition and nullity actions as tools for protecting your business covers the broader strategic context — for the Swiss FPC specifically, three things change under the expedited proceedings.
- Faster path to market entry certainty. A nullity action filed in response to an infringement claim will now resolve within 12 months. For generic manufacturers whose market entry is being blocked by an originator infringement claim, the uncertainty window is compressed from what could previously stretch to two or more years into a defined 12-month period. This changes the commercialisation timeline calculation: the period of market exclusion while proceedings are pending is now bounded and plannable.
- The front-loaded first submission requirement. The corollary of faster proceedings is that there is less time to develop and refine the prior art case during the proceedings themselves. Under expedited proceedings, the quality of the prior art submitted at the outset of the nullity action is decisive. There is no extended timeline to develop a second wave of arguments. Everything needs to be in the first submission — comprehensive claim construction, all relevant prior art references, element-by-element claim charts, prosecution history analysis.
- SPC expiry timing and strategic filing. For patents approaching the end of their SPC extension in the Swiss market, the expedited timeline means nullity proceedings can be initiated and resolved within the remaining SPC term. This changes the strategic calculus for generic manufacturers planning entry around SPC expiry: a nullity action filed 12 months before SPC expiry can now potentially complete before that expiry date, rather than dragging past it into the period of generic freedom.
“The expedited timeline removes the most significant strategic uncertainty tool in Swiss patent litigation — the open-ended proceedings that neither side could predict. In its place is a defined 12-month window. For both patent holders and challengers, the quality of the prior art case prepared before proceedings begin is now the decisive factor.”
The Pre-Litigation Assessment Imperative
The December 2025 announcement creates one clear imperative for both sides of Swiss patent disputes: the analytical work needs to be done before proceedings begin, not during them.
For patent holders before asserting: Conduct a comprehensive validity pre-screen on the patent before commencing infringement proceedings. Identify the most likely prior art a challenger would deploy in a 12-month nullity action. Assess the prosecution history for claim scope vulnerabilities. If the pre-screen reveals material validity risks, resolve them through continuation strategy, claim amendment, or commercial resolution before the infringement action begins — not after a nullity action is filed under expedited proceedings.
For market entrants before launching: Commission a Switzerland-specific FTO analysis covering both the Swiss patent register and EPO-granted patents validated in Switzerland. For patents that represent genuine blocking risks, conduct a prior art pre-screen to assess whether a nullity action would succeed in expedited proceedings. The 12-month resolution target means a well-prepared nullity action can now provide market entry certainty within a defined timeframe — but only if the prior art case is ready to deploy at filing.
The prior art search is the clock-setter in both directions. For patent holders, it determines whether the patent can withstand a 12-month challenge. For challengers, it determines whether the nullity action can succeed within that window. In both cases, a prior art search that is run under litigation deadline pressure — after proceedings have begun — is a prior art search that is too late.
How Our Portfolio Analysis Service Covers Swiss Patent Exposure
Our patent portfolio analysis service covers Swiss Federal Patent Court-relevant validity assessment — including prior art search against Swiss and EPO patent claims, prosecution history review, claim scope comparison against competitor products, and SPC validity assessment where relevant.
For pharma and medtech companies with active Swiss patent portfolios, we structure assessments around the specific FPC expedited nullity timeline — identifying the prior art most likely to be deployed in a 12-month nullity proceeding and giving patent holders time to address it before infringement actions are commenced. The output isn’t just a validity assessment — it’s a pre-litigation decision brief that tells you whether the patent can withstand the expedited proceedings environment before you start them.
For market entrants planning Swiss launches, we provide FTO analysis covering the Swiss patent register, EPO-granted patents validated in Switzerland, and SPC extensions — with prior art pre-screening for blocking patents that identifies whether a nullity strategy is viable under the new 12-month proceedings framework. The goal is to give you the prior art case before you need it, not while the clock is already running.
The Swiss Federal Patent Court’s expedited nullity timeline changes the pre-litigation calculus for pharma and medtech portfolios. Our portfolio analysis service covers Swiss patent validity before the clock starts running — so you know what you’re asserting before you assert it. → Contact Us
Conclusion: The Takeaway
The Swiss Federal Patent Court’s December 2025 announcement is a procedural change with real strategic consequences. A 12-month nullity target tied to active infringement proceedings removes the extended uncertainty window that both sides previously relied on. In its place is a defined, compressed timeline where the quality of the prior art case prepared before proceedings begin is the decisive factor.
For patent holders: assert only what can withstand a 12-month validity challenge. Pre-emptive validity screening before Swiss infringement proceedings is no longer optional. For market entrants: the expedited timeline creates a defined path to validity certainty — but only for challengers who arrive at filing with a comprehensive, front-loaded prior art case ready to deploy.
In Switzerland, the clock on validity is now set at 12 months. The analytical work needs to be done before it starts.
