Is the UPC setting the bar too high for infringement and imminent risk of infringement in the pharmaceutical market?

Is the UPC setting the bar too high for infringement and imminent risk of infringement in the pharmaceutical market?

Introduction

Close to expiry of the patents protecting a successful pharmaceutical product, there always arises a tension between the originator and generics. On the one hand, originator pharmaceutical companies, investing substantial time, capital, and resources into the research and development of innovative medicines, have an interest in ensuring that their exclusive rights deriving from the ownership of a pharmaceutical patent, covering their originator drug, are respected by third parties until its natural expiry. On the other hand, generic pharmaceutical companies have an interest in launching their generic medicine on the market as soon as the originator company’s exclusive rights have expired. Moreover, the launch of generic drugs serve a vital public health function since it leads to a drastic reduction in drug prices, increased access for patients, and substantial savings for national healthcare systems.

The challenge usually arises in the window of time just before the expiration of a patent or SPC. During this period, originator companies may seek preliminary injunctions against generic competitors  whom they believe are preparing to launch at risk infringing products, or whose preparatory actions for a market introduction can already be considered an act of infringement. To succeed, however, they must demonstrate that an infringement is not only possible but imminent, or that the acts (mostly promotional) qualify as infringement (offers). How the UPC has so far applied these standards in the context of pharmaceutical disputes can be seen in a recent decision of the Lisbon Local Division (“LD Lisbon”) and two earlier decisions by the Düsseldorf Local Division (“LD Düsseldorf”). Based on those decisions, the UPC appears to be very careful in the evaluation of the concrete circumstances which characterize the behaviour of the alleged infringer.

Imminent risk according to the LD Lisbon in Boehringer v. Zentiva

The standard for what constitutes “imminent risk” was recently discussed by the LD Lisbon. In its order dated 8 May 2025 rendered in the proceedings between Boehringer Ingelheim International GmbH (“Boehringer”) and Zentiva Portugal, LDA ( “Zentiva”), LD Lisbon addressed the pivotal and recurring issue within the pharmaceutical industry: how to determine when there is an “imminent risk” of patent infringement.

At the heart of the dispute is the conflict between two legitimate but often opposing interests.

Key Facts of the case

Before delving into the specific circumstances that the LD Lisbon deemed relevant to demonstrate the imminence of the generic drug’s market launch and the associated risk of imminent infringement, here below the facts that led to the initiation of the proceedings between the parties before the UPC:

• Boehringer holds European Patent EP 1.830.843 (“EP ‘843”), which is set to expire on 21 December 2025. This patent, entitled “Indolidone derivatives for the treatment or prevention of fibrotic diseases“, claims protection for the use of nintedanib or nintedanib esylate in the treatment of idiopathic pulmonary fibrosis.
• This active ingredient for the treatment of idiopathic pulmonary fibrosis is marketed by Boehringer under the brand name Ofev^®, one of its most successful pharmaceutical products, which in Portugal is restricted to prescription for hospital use only.
• In Portugal, a Prior Evaluation Procedure (“PEP”) is required for the purchase of prescription-only medicines. This procedure aims to establish the conditions under which relevant public entities can acquire medicines, including maximum prices and reimbursement by the State, as well as their therapeutic indications.
• Since 30 August 2024, the generic company Zentiva obtained in Portugal two marketing authorizations (MAs) from Infarmed – National Authority of Medicines and Health Products – for generic versions of the drug Ofev^®. Subsequently, on 12 December 2024, Boehringer became aware that Zentiva had obtained, in addition to the two MAs, the aforementioned PEP and that a notice was addressed to public health entities informing the latter about the availability of the generic drug and the possibility of purchasing it from that moment onwards. In particular in the notice it was written that: “As of the date of this notification, entities under the supervision of the Government official responsible for the health sector will be able to purchase this medicine, under the terms of article 26(2), for use in the indication that has now been approved, and under the terms of article 27-A, the MA holders have one year to start commercialising it”.

Given these circumstances, Boehringer decided to file an application for provisional measures before the UPC pursuant to Rule 206 and following of the Rules of Procedure (ROP).

Prior to initiating these proceedings before the UPC, Boehringer had already sought relief from the Portuguese Intellectual Property Court. Specifically, Boehringer asked the Court to obtain an injunction against Zentiva to prevent the manufacturing, offering, storing, placing on the market, selling, and/or using of the medicinal product Nintedanib Zentiva within Portuguese territory. This application for a preliminary injunction was not opposed by Zentiva and was partially granted on 23 March 2025.

The assessment of the imminent risk of infringement by the Lisbon Local Division

As already mentioned, the LD Lisbon, in this order, addressed the assessment of the risk of imminent infringement within the pharmaceutical sector.

More broadly, the requirement of imminent infringement is a necessary condition for granting applications for provisional measures under Article 62 of the UPCA and Rule 206 ROP. Article 62 explicitly states that: “The Court may, by way of order, grant injunctions against an alleged infringer or against an intermediary whose services are used by the alleged infringer, intended to prevent any imminent infringement…”. Similarly, Rule 206 ROP provides that: “An Application for provisional measures shall contain: […] (c) the reasons why provisional measures are necessary to prevent a threatened infringement, to forbid the continuation of an alleged infringement or to make such continuation subject to the lodging of guarantees”.

The requirement of imminent infringement must be assessed concretely, taking into account the specific and overall circumstances of the case. Therefore, the LD Lisbon appropriately considered the characteristics of the relevant market—namely, the pharmaceutical sector. The LD Lisbon emphasized that, in the pharmaceutical industry, the actual commercialization of products is subject to the prior completion of specific administrative procedures, which may vary under the national laws of the Member States. These may include not only the application for and granting of marketing authorization, but also the negotiation with the competent public authorities of the product’s price and its reimbursement by the national health system.

However, the fact that these administrative steps may be regulated differently across the territories of individual Member States is not relevant. In fact, as clarified by the LD Lisbon, national law shall not be taken into account in the assessment of the requirement of imminent infringement, which must exclusively rely on the interpretation of Article 62 UPCA and Rule 206 ROP. These provisions require the applicant to prove that the alleged infringer has taken steps making it more likely than not that it intend to offer or place the product on the market before the patent expires. This standard is confirmed in the order itself, which states: “Imminent infringement must then be assessed from the point of view of the concrete likelihood that, in the light of the circumstances of the case, the Defendant is more likely than not to commit an act of infringement”.

In the case at hand, the applicant relied in particular on the fact that the defendant had obtained the PEP in Portugal. This procedure represents the final administrative step required to sell a generic product to public hospitals (whereas a simple marketing authorization suffices for sales to private hospitals). In response, the defendant argued that in the pharmaceutical sector, it is standard practice for generic companies to complete such administrative procedures well in advance of patent expiry. This allows them to be ready to launch their generic product immediately upon the patent’s expiration.

Following its analysis of the overall circumstances of the case, the LD Lisbon ultimately found that there was no imminent risk of infringement of the applicant’s patent and therefore dismissed the application for provisional measures.

First of all, the LD Lisbon disagreed with the applicant’s argument that the mere obtaining of the PEP constituted a sufficient indication of imminent infringement. In this regard, it highlighted that Article 62 UPCA and Rule 206 ROP require that such risk must arise from the conduct of the defendant. In this case, the defendant had not “taken any other steps that indicate it will market the medicine, the administrative steps alone taken by the Defendant do not establish a risk of imminent infringement”.

Moreover, the LD Lisbon found that the statement in the notice issued by Infarmed—indicating that the defendant had a one-year period to begin marketing its product, failing which the PEP would expire—was not relevant for establishing imminent infringement. On this point, it emphasized that “The risk of the PEP expiring lies with the Defendant for requesting it prematurely” and concluded that this circumstance was not suitable to indicate the actual date on which the generic medicine would be placed on the market.

Finally, the LD Lisbon found that there was no imminent risk of infringement with respect to the sale of the generic medicine to private hospitals. This is because, even though the defendant had already been in a position to begin commercialization since 30 August 2024, having completed all the necessary administrative steps, the applicant failed to provide any evidence that the defendant had actually undertaken any actions indicating an intention to initiate marketing.

Conclusions

The key takeaway from the LD Lisbon’s decision is that the mere completion of the administrative steps required for launching a generic medicine on the market is not, in itself, sufficient to establish the imminence of infringement. Instead, such imminence must be demonstrated with reference to the overall conduct of the defendant.

Offering according to the Local Division Düsseldorf

The LD Lisbon cites in its order an order issued on 6 September 2024 by the LD Düsseldorf in the case Novartis/Getec v. Celltrion (UPC_CFI_166/2024)[1] which also deals with imminent infringement. However, the case seems most relevant for the interpretation LD Düsseldorf gives to the term “offering”.

In the Düsseldorf case, the defendant had obtained a European marketing authorization and had begun promoting the future commercialization of its biosimilar medicine in Europe. The defendant had for example issued several press releases emphasizing its intention to launch its products as soon as possible and to rapidly expand its market share, and had attended trade fairs where it had displayed information about its product. However, it had not yet initiated price negotiations with potential customers.

The LD Düsseldorf first establishes that it must consider which requirements must be met in order for an infringement to exist, and subsequently – because the matter concerns PI proceedings – whether it is necessary to order provisional measures to prevent imminent infringement.

Regarding the first question, the LD Düsseldorf primarily examines whether the promotional activities of the defendant already qualify as an “offer”. In this context, the LD Düsseldorf observes: “It is sufficient for an offer if the act in question actually creates a demand for the product which the offer is likely to satisfy (cf. UPC_CFI_177/2023 (LD Düsseldorf), Order of 18 October 2023)”. The LD Düsseldorf then further notes: “In the present case, this would be an advertisement in which the Defendant and Defendants of UPC_CFI_165/2024 would be able to supply, in compliance with all the regulatory measures applicable to the medical market in the Contracting Member States, in particular by mentioning a specific price, if a potential customer wished to place an order”. This appears to set a high standard, with the LD Düsseldorf pointing out that market participants are aware of how the market operates: “It should be noted that potential customers are familiar with the practices of the pharmaceutical industry. They are more likely to regard statements about future market entry as vague announcements when regulatory measures and pricing and reimbursement conditions have not yet been finalised”.

Finally, the LD Düsseldorf also addresses the question of when an infringement could nonetheless be considered “imminent”: “In order for an infringement to be imminent, in the present case means that all pre-launch preparations must have been completed in such a way that an offer can be made at any time. Rather than looking at individual events in isolation, it is necessary to make an overall assessment of the activities”.

Since the promotional materials did not include a concrete timeline or price, no samples were provided, and no price negotiations took place, the LD Düsseldorf concludes that there was neither an infringement nor an imminent infringement.

Comparison with national practices

When the foregoing is compared to what we observe in national proceedings, it appears that the UPC sets the bar for infringement, and consequently also the threat of infringement, relatively high or at least take into careful consideration all the circumstances that collectively connote the conduct of the alleged infringer.

The Netherlands

According to Dutch case law, the term ‘offering’ of a patented product is to be interpreted broadly and does for example not necessarily need to be aimed at achieving a specific sale transaction. To constitute an offer, it is sufficient that the conduct influences the market behaviour of (potential) customers and thereby hinders the exclusive exploitation of the patent. The exclusive exploitation of a patent may for example be hindered when a competitor promotes, before the expiry date of a patent, a generic medicine will be available after the expiry date (Supreme Court of The Netherlands 22-06-2012, ECLI:NL:HR:2012:BW4006). Even the mere inclusion of a product in a product catalogue without a price or any further specifics on availability, and accompanied by a disclaimer that “no orders or deliveries prior to the expiry date of valid patents and SPCs are possible”, has been regarded as an offer for this reason (Court of Appeal of Amsterdam, 26-03-2024, ECLI:NL:GHAMS:2024:761).

But even before there is an offer or another legally reserved act under patent law, the patent holder can take action in PI proceedings when the threat thereof is sufficiently concrete. The mere application for an MA does not yet constitute a sufficiently serious threat. However, the publishing of a product in the G-Standard of the Netherlands does (Supreme Court 22-06-2012, ECLI:NL:HR:2012:BW4006). The G-Standard is a national database which plays a central role in the supply chain of medicines. It serves as an important reference for pharmacists, prescribing healthcare professionals and health insurance companies. Inclusion in this database is, in practice, regarded as a signal that the product will be placed on the market. Therefore, it constitutes a probable infringement of the patent for which a preliminary injunction will normally be granted.

Germany

Offering a product and bringing the product on the market are different activities which each can constitute a patent infringement. Both terms are interpreted broadly under German law. Relevant is the factual qualification and not their legal qualification. An offer in the sense of the patent law does not need to be a legally binding offer with all pre-requisites of the German Civil Code. Further it needs to be seen that an action against an infringer can be taken when (1) an infringing activity has taken place (even in a single case), then a danger of repetition, or (2) if there is an imminent threat that such activity will take place which is called a danger of first infringement. The imminent threat must be sufficiently concrete in substance and time. The distinction may look rather academically but can become relevant. A danger of repetition can only be removed by a cease-and-desist declaration. A danger of first infringement can be replaced by a simple actus contrarius which is a serious, manifested abandonment of the intend to infringe.

The distinction between offering and brining on the market can become relevant for the pharmaceutical industry. Like in the Netherlands an actionable activity is the application for reimbursement in the IFA list which has a similar function than the G-Standard in the Netherlands. The MA (alone) is not sufficient. If an application for registration is applied for in the IFA list a danger of first infringement may be given with respect of offering and brining the product onto the market. With the registration in the IFA list an offering in principle already takes place so that we have a danger of repetition while a danger of repetition for the bringing onto the market will only take place with the actual availability of the product which usually is a few days after the listing at IFA. Problems arise when the generic during the term of the patent applies for IFA registration after patent expiry. The question also becomes relevant if the generic starts marketing activities under the term of the patent for sales after the patent expiry. These questions are not finally settled by the courts. The IFA listing application under the term of the patent with publication of the listing after expiry may not infringe the patent because the relevant infringement activities are after the patent term. That may be different for marketing activities under the term which constitute an offer, unless one sees them only as an offer for sales after the term. Still such marketing activities can negatively influence sales of the originator product during the patent term.

France

Under French law, any act aimed at presenting a patented product to the public is considered an offer and, therefore, an infringing act. The fact that the product is not ultimately sold after the offer is irrelevant. Even if such a sale would have been impossible (e.g., due to the lack of market authorisation in France), the act still constitutes infringement (Tribunal de grande instance de Paris, 16 April 2008, 06/16242). Furthermore, if an offer is made in France, the product does not need to be destined for the French market to be considered an infringing act (Cour de Cassation, Chambre commerciale, 30 January 2001, 98-13.641). For pharmaceutical products, the mere obtention of a market authorisation or the official publication of their price are not considered an offer (Tribunal de grande instance de Paris, 30 January 1998).

However, for these products, a patent holder may still initiate preliminary injunction proceedings against an alleged infringer under certain circumstances. For pharmaceutical products, the procedure for obtaining a price includes an obligation to launch the product within six months of the price’s publication. If patents covering the drug have been declared to the authority granting the price, and these patents remain in force during this period, the authority will request the drug producer to confirm their ability to launch the product on time despite the pending patent rights. If the drug producer provides such confirmation, the authority will notify the patent holder. In this scenario, the imminence of infringement can be characterised (Cour d’appel de Paris, 23 May 2013, 12-16016). If all other criteria for granting a PI are satisfied, the PI may be granted.

Italy

Also according to the case law of the Italian IP Divisions, the term “offering” of a patented product is to be interpreted broadly. Furthermore, in assessing the imminence of infringement, a plurality and heterogeneous set of factual circumstances are considered, from which it may be inferred that the launch of the generic product is highly likely. While it is true that in some cases the case law has held that the mere granting of a marketing authorization (MA) is not sufficient to demonstrate the imminence of infringement, it is equally true that this requirement has been deemed satisfied when the granting of the MA was accompanied by a series of additional circumstances which, taken together, could indicate the intention of the alleged infringer to enter the market (so that, for example, the absence of price negotiation does not necessarily lead to a rejection of an interlocutory petition). There is even a decision by the Court of Milan from 2017 which stated that: “It is, in principle, admissible for the holder of a pharmaceutical patent to request…an injunction to halt the ongoing procedure for obtaining a Marketing Authorization (AIC) for a drug allegedly infringing that patent. This is because the typical remedy provided by the legal system—namely, challenging the allegedly unlawful authorization before the competent Administrative Court (TAR)—is a measure granted ex post and may not effectively safeguard the asserted exclusive right”.

A sure sign of the imminence of infringement is then in Italy the inclusion of a generic drug in the AIFA’s Transparency List, which establishes reimbursement of the originator drug’s price up to the price of the generic drug.

United Kingdom

Finally, in the UK “offering to dispose of” a patented product is interpreted fairly broadly, and includes for example pre-contractual negotiations and advertising even if these would not amount to a legal binding contract under UK law. There is no requirement that a sale results from the offer. However, under UK case law negotiations to supply product after the expiry of  a patent would not constitute an infringing act even if they take place before patent expiry (Gerber v Lectra [1995] R.P.C. 383) as there is no offer to supply in breach of the monopoly. Even if there has not yet been an offer to dispose of a product it is well established in the UK that a preliminary and/or final injunction can be granted on the basis that a party threatens or intends to infringe a patent, even if they have not yet done so.

Whether or not an offer to dispose of a patented product has been made or there is a threat/intention to infringe a patent will be decided on the specific facts of the case – this could include the market in question, the nature of the parties and their past conduct, whether a marketing authorisation has been applied for or granted, any actions to clear the way of relevant patents by revocation actions, public statements made about intentions to launch, the content of any correspondence between the parties, any advertising to third parties, and any undertakings not to launch (or lack thereof). Administrative steps are important factors – in Actavis & Ors v Eli Lilly And Company [2016] EWHC 1955 the primary basis for justifying an injunction was that the defendants had engaged in the “expensive and time consuming process” of obtaining a marketing authorisation which the judge concluded “only makes sense if they are planning to sell [the product] sometime”.

It is worth bearing in mind that courts in the UK decide whether or not to grant preliminary injunctions based on what is often referred to as the “balance of convenience” test, rather than conducting a mini-trial of the merits as is standard at the UPC and in other jurisdictions. On the merits of the case it only has to be established that there is a “serious issue to be tried” between the parties. This is not a high bar. Accordingly, if the party seeking a preliminary injunction can establish that there is a serious issue to be tried about whether or not the other party has made an offer to dispose of a product and/or threatens/intends to infringe the patent then that will be sufficient for a preliminary injunction to be granted if under the balance of convenience test it is found to be appropriate to grant such an injunction.

Conclusion

The UPC’s approach to assessing imminent infringement and “offering” in the pharmaceutical sector seems to set a relatively high threshold. The Lisbon and Düsseldorf Local Divisions require concrete evidence that “all prelaunch preparations have been completed” and, for “offering” that the act “creates a demand for the product which the offer is likely to satisfy” rather than vague or preliminary announcements.

This  seems to contrast with most major European patent jurisdictions, where the threshold is lower and where actions like inclusion in databases or early promotions may suffice. By setting stricter standards, the UPC seems to make it more challenging for originator companies to obtain timely injunctive relief, potentially limiting the effectiveness of Article 62 UPCA and Rule 206 ROP as tools for early intervention by originators.

[1] [efn_note[1] An identical reasoning with regard to imminent infringement was adopted in the order issued on the same date by the LD Düsseldorf in case UPC_CFI_165/2024, which involved Novartis AG and Genentech Inc. along with other Celltrion group companies different from the one involved in case UPC_CFI_166/2024. [/efn_note]An identical reasoning with regard to imminent infringement was adopted in the order issued on the same date by the LD Düsseldorf in case UPC_CFI_165/2024, which involved Novartis AG and Genentech Inc. along with other Celltrion group companies different from the one involved in case UPC_CFI_166/2024.