Pharma Playbook: What Practitioners Can Learn from Early UPC Litigation

The Unified Patent Court (UPC) has quickly become an important forum for pharmaceutical and biotech patent disputes in Europe. In 2024 and early 2025, a consistent theme has been the interplay between UPC proceedings and existing venues like European Patent Office (EPO) oppositions and national courts. Innovators and generic or biosimilar companies are now coordinating multi-front strategies engaging the UPC for pan-European relief while leveraging EPO opposition and selecting national litigations.

In this article, we draw out practical guidance for practitioners representing innovators versus generic/biosimilar manufacturers based on recent UPC case law from 2024 and early 2025.

Leverage or Defuse EPO Oppositions

One clear lesson is that a pending strong EPO opposition can significantly influence UPC proceedings, especially requests for preliminary injunctions (PIs). The UPC will not automatically freeze its own case for an ongoing EPO challenge, but it does fold the existence and strength of an opposition into its analysis of patent validity and injunctive relief, as we saw in Alexion Pharmaceuticals v. Amgen and Samsung Bioepis and 10x Genomics v. NanoString.

For innovators, this means that defending your patent in EPO opposition is not just about the long-term validity in EPO member states. It has immediate ramifications for injunctive relief across the UPC countries. A pending, robust opposition can effectively serve as ammunition for the accused infringer in UPC to argue there is reasonable doubt on validity, forestalling fast injunctive remedies?. Conversely, a patent that has survived EPO opposition (or has a favorable preliminary opinion from the Opposition Division) will put the patentee in a much stronger position before the UPC. Thus, patent owners should anticipate and engage with opposition proceedings early.

Generic companies and biosimilar makers, on the other hand, should recognize the value of filing an opposition promptly. Even if the EPO has not yet decided, the very existence of a credible opposition can sway a UPC judge against a preliminary injunction, as seen in both Alexion and 10x Genomics.

In short, credible challenges on novelty, inventive step, or sufficiency can derail a preliminary injunction. The UPC and EPO fronts should be fought with a unified strategy. What happens in one forum will inevitably reverberate in the other.

Be ‘PI-Ready’

Preliminary injunction practice at the UPC has quickly developed its own contours rooted in the UPC Agreement’s provisions (notably Article 62 UPCA). The UPC’s early PI decisions show a few emerging patterns.

UPC judges have set a relatively high bar for patentees to obtain provisional injunctions. The patentee must persuade the court with a sufficient degree of certainty that the patent is valid and infringed.

Another critical factor is timing. The UPC expects an applicant to move quickly once an alleged infringement or threatened launch is known. Rule 211(4) of the Rules of Procedure implicitly warns against “unreasonable delay” in seeking provisional measures. In Alexion v. Amgen, for instance, the patentee’s delay in filing the PI application after learning of the biosimilar launch was noted by the court and counted against the request.

Additionally, the threat of infringement needs to be imminent. The UPC has clarified how to assess imminent infringement for PI purposes. In the Novartis/Genentech v. Celltrion PI decision, the question was whether Celltrion’s pre-launch activities for its biosimilar (such as obtaining regulatory approval, making promotional statements, or approaching potential customers) constituted an imminent threat of infringement. The UPC held that generic announcements of intent to launch “as soon as possible” and even marketing to doctors did not amount to imminent infringement if certain steps remained incomplete?. In Celltrion’s case, the court found that several pre-launch steps such as pricing and reimbursement approvals had not been initiated or obtained?. These facts led the UPC to conclude there was no imminent infringement, and thus no basis for a PI?.

For innovators, before you move for a UPC injunction, ensure your house is in order. This means having conducted internal validity checks, gathering supportive expert declarations, and considering what the EPO or other courts have said about the patent. If your patent survived an opposition or has a favorable EPO record, highlight that. If not, be ready to address any weakness. Also, move quickly. If you know a generic has regulatory approval, file at the first credible sign of infringement, and preferably within a couple of months of learning of it?, to show the court that the matter is indeed urgent.

For generics, prepare your anti-PI strategy in advance. File oppositions early, gather prior art, and perhaps maintain a low profile until you are truly ready to launch. This requires coordination between the IP, regulatory, and marketing departments. If you can show the court that you have held off certain steps?, you can argue there is no immediate need for an injunction against you.

The bottom line is that UPC preliminary injunctions, while powerful (covering many countries at once), are not easy to obtain. Both sides must come armed with evidence and a clear narrative on why an injunction should or should not be issued.

Central Revocation Actions

One of the UPC’s most significant new features is the ability to bring a central revocation action to invalidate a European patent across all participating states in a single proceeding. For the life sciences industry, where patents are often litigated country-by-country, this is a potential game-changer. Early cases show parties using revocation actions both as a sword and a shield.

The first revocation action decided by the UPC was indeed in the pharmaceutical sector. On  July 16, 2024, the UPC’s Munich Central Division revoked Amgen’s patent EP 3,666,797 in its entirety, in the case Sanofi (and Regeneron) v. Amgen?. The UPC echoed the EPO’s problem-solution reasoning: if the target is known and no unexpected technical effect is demonstrated, an antibody against that target is obvious to try. The decision set a tone that the UPC will closely scrutinize patents on biologics for inventive step and sufficiency. The court aligned with the EPO standards in many ways even citing EPO guidelines. The availability of this procedure means that a generic or biosimilar maker need not wait to be sued for infringement. They can go on the offensive to clear invalid patents.

For innovative companies, being prepared to defend your key patents in a UPC revocation action is now a necessity. The moment a high-value patent grants, think ahead: could a competitor file a central revocation? If so, plan your defense team and arguments early. The UPC moves on a relatively quick timetable?, so there is less time than in some national courts to develop experimental evidence or gather expert support. Ensure your patent specifications are robust. The UPC panels include technical judges who will parse enablement and sufficiency issues keenly.

On the flip side, for generics and biosimilars, the UPC is a powerful sword. Identify the patents that block your path and contemplate a revocation action as soon as the UPC is available for them. Filing a revocation action can also provide leverage in settlement talks. It raises the stakes for the patent owner, who risks losing everything if they litigate and lose.

One caution: a patent owner might respond by opting out similar patents from the UPC system to avoid further central attacks (if they are still able to opt out). Thus, challengers should prioritize their targets and act swiftly before opt-out windows close or get extended.

Second Medical Use Patents and Skinny Labels

The interplay between patent protection for specific medical uses of known drugs and regulatory “skinny labeling” by generics is a complex issue in pharma litigation. The UPC and national courts are already grappling with how to enforce second medical use patents in the face of generics that carve out the patented use from their product literature.

German courts have shown willingness to enjoin despite skinny labels. The Munich Regional Court (Landgericht Docket No. 21 O 14561/24) granted Novartis a preliminary injunction on December 5, 2024, against Stadapharm to prevent sales of Stadapharm’s generic version of nilotinib, even though the generic’s label had excluded the patented use?. The patent covers a method of administering nilotinib by dispersing capsules in applesauce for patients with swallowing difficulties. Stadapharm had a “skinny label” omitting that specific use. Their product literature expressly stated it was not to be used in dispersion in applesauce. However, Novartis convinced the German court that despite the label carve-out, there was an imminent risk that doctors would nonetheless use the generic in the patented manner, for example, by mixing it with applesauce for patients in need. The Munich court agreed that the label alone was not enough to avoid infringement risk and issued the injunction.

This suggests that, at least in Germany, courts may require generics to do more than just carve out an indication; they might expect measures to actually prevent the off-label use

The UPC itself is now facing these issues. There are major battles pending between Sanofi v. Amgen and Sanofi v. Dr. Reddy’s, Stada, Accord, and Zentiva. These cases will test how the UPC views the effectiveness of skinny labels and what constitutes infringement of a second medical use.

For patent owners with second medical use claims, the early cases suggest a proactive enforcement can work, but success hinges on evidence. Monitoring and evidence-gathering are key. Innovators should track how generics market their products: Are sales reps hinting at the off-label use? Are doctors likely to substitute the generic for the patented indication due to pricing or formulary pressures? In the Novartis/Stadapharm case, internal industry knowledge about clinical practice helped convince the court of likely infringement?. The burden, however, is on the patentee to show that such off-label use is inevitable.

For generics and biosimilar makers, implementing a thoughtful skinny label strategy is crucial. This goes beyond just removing the patented indication from the official label. As German national case show, you may need to prove that you actively sought to avoid infringement. Additionally, generics can seek a declaratory judgment to obtain certainty. Keep in mind, though, each company might have to do this individually. The UPC likely will not allow a “class action” style defense where one generic’s case protects all others, given the rejection of Zentiva’s intervention?. Therefore, coordination might have to happen informally, e.g., generics sharing strong non-infringement arguments or prior art for invalidity, even if each presents it separately.

Heed the Lessons

Treat Europe not as one court versus another, but as a collection of tools (UPC central, UPC local divisions, EPO opposition, and national courts) that can be deployed in concert. As more decisions come in, including the outcomes of the ongoing second medical use cases, practitioners will gain further clarity. In the meantime, those involved in life sciences disputes should heed the lessons so far: coordinate proceedings, act swiftly, substantiate everything (from validity to infringement likelihood to irreparable harm). Generic companies may need to plan European market entry not just as a regulatory exercise but as a litigation campaign, where timing, forum selection, and patent challenges are integrated into the launch strategy. And remember that patent litigation in Europe is now a multi-level game. Those who play that game thoughtfully, using the UPC alongside traditional venues, will best protect their clients’ interests.

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Author: iqoncept
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