The UPC's Life Sciences Revolution: From Skepticism to Strategic Imperative

When the Unified Patent Court (UPC) launched in June 2023, pharmaceutical and medical device companies watched with some reserve. The system of national patent assertion may have (had) its challenges, but it was established – so why risk the UPC and potential UPC-wide patent revocation? 

Nevertheless, case law from this sector has shaped the emerging jurisprudence of the UPC from the outset; and the UPC has evolved from an experimental alternative into a critical enforcement venue, for life sciences as well as other sectors —one that demands immediate attention and strategic recalibration. 

So, for those in the life sciences sector, what are the main UPC takeaways?  

Generic/biosimilar companies should consider coordinating their pre-launch activities country-by-country, whilst innovators must remain vigilant across all UPC member states to mitigate any “urgency risks”. And both sides need to budget for comprehensive technical and legal preparation from the outset. Read on for more. 

Claim Interpretation: The NanoString Framework

The very first substantive decision issued by the UPC's Court of Appeal (first panel) involved life sciences, in provisional measures proceedings in a 10x/NanoString matter¹ (relating to compositions and methods for analyte detection for use in cancer research, among other things). [Note: the succeeding party Nanostring was represented by Bird & Bird - see more here]

This landmark ruling established the UPC's approach to claim construction, holding that the “patent claim is not only the starting point, but the decisive basis for determining the protective scope of a European patent” and that “the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim”. 

The Court of Appeal clarified: “In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties”—a balancing act that directly impacts your freedom-to-operate analyses and claim drafting strategies.

In another life sciences case, between Alexion/Amgen relating to Eculizumab², the Court of Appeal provided further guidance: “A linguistic error, a spelling mistake or any other inaccuracy in a patent claim can only be corrected by way of interpretation of the patent claim if the existence of an error and the precise way to correct it are sufficiently certain to the average skilled person on the basis of the patent claim, taking into account the description and the drawings and using common general knowledge”.

The Court of Appeal also stated that the “applicant’s assertions during the grant proceedings, and in particular the TBA’s endorsement thereof, can be seen as an indication of the view of the person skilled in the art at the filing date”.

Practical implication: While the question of a full-blown “file wrapper” argument is still open, prosecution history accordingly can matter at the UPC. In any case, errors might prove fatal.

Provisional Measures (e.g. Preliminary Injunctions): The "More Likely Than Not" Standard

Life sciences also set the tone in determining the applicable standard for the issuance of provisional measures. Although the first proceedings concerned e-bikes (order granted) and milk frothers (order rejected), the Court of Appeal first developed the UPC standard in the 10x/NanoString¹ matter referred to above.

The Court of Appeal held that the Court must consider it at least "more likely than not" that the applicant is entitled to commence proceedings, that the patent is valid and that the patent is being infringed (or soon to be). 

This "more likely than not" threshold — now firmly established across UPC divisions — sets a demanding but achievable standard for preliminary relief. This standard has since been taken up and refined many times and is thus established in the best sense.

Strategic consideration: The UPC will grant preliminary injunctions, but only with robust validity, infringement and undue delay showings. Budget accordingly for comprehensive technical and legal preparation from the outset when seeking or defending urgent relief.

Threat of Infringement: Navigating Regulatory Complexity

Perhaps nowhere is the UPC's sophistication more evident than in its handling of "threat of infringement" in the pharmaceutical context — where regulatory approval processes create unique timing challenges.

In a first highly relevant case related to Omalizumab³, in 2024 the Düsseldorf Local Division (LD) rejected a threat of first infringement. The decisive question was 'whether the respondents' conduct leads to the conclusion that they would "more likely than not" intend to enter the market during the patent term without further ado'. Specifically with regard to market conditions, the LD took into account that potential customers are familiar with the particularities of the pharmaceutical industry and aware of necessary regulatory steps before actual market entry.

The LD formulated as the standard for a threat of infringement: "For an infringement to be imminent, in the present case all preparations prior to market launch must be completed such that an offer can be made at any time. Rather than considering individual events in isolation, it is necessary to undertake an overall assessment of the activities".

While there was no appeal in the Omalizumab case, the Court of Appeal recently provided valuable clarification in a case involving Nintedanib⁴: In connection with the marketing of generics, the mere application for marketing authorisation by a generic company does not necessarily establish a threat of first infringement, nor does the grant of such authorisation. In turn, the completion of national pricing and reimbursement procedures for such a generic "may" establish a threat of first infringement. The assessment must be made with due regard to the national regulatory and legislative context and taking into account the circumstances of the individual case – in this case, the “imminent infringement” was specifically tied to the situation in Portugal.

Critical takeaway: For innovators as well as generic/biosimilar competitors, this presents both opportunities and risks: from a generic/biosimilar perspective, going one step too far in "just" one country runs the risk of a UPC-wide injunction. Equally, however, from a patent holder's perspective there is also the risk of a UPC-wide loss of urgency if alleged infringements in, for example, "small" jurisdictions are not addressed promptly and uniformly.

This creates a high-stakes chess game: Generic/biosimilar companies should seek to coordinate their pre-launch activities country-by-country, whilst innovators must remain vigilant across all UPC member states to mitigate any “urgency risks”.

Second Medical Use Claims: The Sanofi/Amgen Precedent

In the Sanofi/Amgen case⁵, the LD (again Düsseldorf) created a precedent for analysing infringement of second medical use claims. It found that “in the case of a second medical use claim a substance or composition within the meaning of Art. 54(4) EPC is used for any specific use which is not comprised in the state of the art. Such a therapeutic use can be a new indication, e.g. a disease not yet treated by the claimed substance, or an indication for a new group of patients”.

To establish infringement of a second medical use claim, “the alleged infringer must offer or place the medical product on the market in such way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known that it does”.

Key considerations: The requirements for such conduct cannot be defined in the abstract, but require an analysis of all relevant facts and circumstances of the patent claim in question and (potential) use of a product — meaning product labelling, marketing materials, and sales force training all become potential evidence of induced infringement.

What This Means for Patent Strategy

The legal requirements for market participants in the life sciences sector are becoming increasingly complex, as demonstrated for example by the interplay between regulatory aspects and threat of first infringement (under patent law).

For your organisation seeking patent protection, this demands:

• Prosecution excellence: Claim drafting must consider the UPC's interpretation standards, particularly for sequence-based and second medical use claims
• Coordinated enforcement: Monitor generic/biosimilar activities across all UPC jurisdictions simultaneously — national acts can trigger pan-European consequences
• Evidence-ready preliminary injunction strategies: Build comprehensive validity and infringement cases before seeking emergency relief
• Regulatory-IP integration: Align your regulatory affairs and IP teams to assess threat-of-infringement timing across territories

For Generic Companies: Navigating a Minefield

The UPC has altered risk-reward equations and the mathematics are brutal from a generic/biosimilar perspective: going one step too far in "just" one country runs the risk of a UPC-wide injunction (and probably more, owing to the UPC's 'long arm jurisdiction' - see our article on this).

Your manufacturing scale-up, customer communications, sales force hiring, and internal launch timelines all become potential evidence of imminent infringement; your product labelling, marketing materials, and sales force training all become potential evidence of induced infringement. 

For your organization seeking to enter the market, this demands critical adjustments: 

• Don't bank on narrow claim constructions to create clearance: remember that the Court of Appeal rejected arguments for a somewhat retrospectively limiting reading of the claim.
• Consider offensive invalidity proceedings: to eliminate patent threats before you complete pricing and reimbursement.
• Re-consider staggered country-by-country launches: there is no “one size fits all” strategy. However, if one activity in one UPC country can trigger UPC wide injunctions, this may justify a unitary launch strategy (if feasible under regulatory fragmentation).

The UPC's life sciences jurisprudence reveals a court system that is technically sophisticated, procedurally rigorous, and willing to grant meaningful relief—including pan-European injunctions—when the evidence supports it. 

The UPC can no longer be viewed as an experiment. For life sciences companies, it has become the forum where patent law is being written—one precedent at a time.

For more on the development of UPC precedents in the life sciences field, please see our recent article in GRUR. 

Footnotes:

1 UPC (First Chamber of the Court of Appeal) - UPC CoA 335/2023, 26 February 2024 10x/NanoString.

2 UPC (First Chamber of the Court of Appeal) - UPC CoA 405/2024, 20 December 2024 Alexion/Amgen.

3 UPC (Düsseldorf LD) - UPC CFI 165/2024 and UPC CFI 166/2024, 6 September 2024 Novartis/Genentech/Celltrion.

4 UPC (Second Chamber of the Court of Appeal) - UPC COA 520/2025 and 446/2025,13 August 2025, preceded by: UPC (Lisbon LD) - UPC CFI 41/2025, 8 May 2025 Boehringer/Zentiva.

5 UPC (Düsseldorf LD) - UPC CFI 505/2024, 13 May 2025 Sanofi/Amgen.