Key decisions at the EPO and UPC - September edition

Part 1 – T 1741/22 – reinforcing the EPO’s strict standards for inventive step

Relevance of the decision

T 1741/22 published on July 26, 2024, confirms the standard European Patent Office (EPO) practice regarding the treatment of clarity and inventive step under Articles 84 and 56 EPC, particularly in cases involving the processing and interpretation of medical data.

Specifically, this decision highlights that generating "new data" through the processing of already measured medical data does not contribute to the technical character of an invention unless it involves direct interaction with physical reality. Consequently, T 1741/22 reinforces the strict EPO standards for inventive step, especially in cases involving mathematical or cognitive operations on previously acquired data. This decision may also be relevant for UPC cases, since the UPC is currently adopting EPO added matter standards (see decision of the LD The Hague, Abbott v Sibionics discussed in the July edition of this newsletter).

General Principles

In decision T 1741/22, the Board reaffirmed that generating new data from previously measured medical data does not contribute to the technical character of an invention unless it involves a direct interaction with physical reality, such as through actual measurements on the human or animal body.

The Board emphasized that processing existing data to generate further information, such as minimum or maximum glucose values from continuous glucose monitoring data, is primarily a non-technical, cognitive activity, and does not constitute a technical effect under the EPC. This interpretation is consistent with the Enlarged Board of Appeal's decisions, such as G 1/19, which state that technical character arises from the interaction with physical reality. The decision also noted that presenting such generated data for the purpose of aiding intellectual processes, like diagnosis or treatment, does not satisfy the requirements for inventive step under Article 56 EPC.

The reasons/decision

Claim 1 of the main request reads as follows:

"A system for analyzing glucose monitoring data indicative of a glucose level in a bodily fluid, comprising:

• an input device (3),
• a data processing device (1),
• an output device (4),
• a display device (5), and
• machine readable instructions that are executed by the data processing device, wherein the machine readable instructions cause the data processing device (1) to
• receive continuous glucose monitoring data via the input device (3), the continuous glucose monitoring data
• indicating a glucose level sampled for a person in a bodily fluid at a plurality of sample times over a measurement time period in a continuous glucose level measurement, and - comprising a plurality of continuous glucose profiles, each of the glucose profiles comprising a plurality of glucose values with a glucose value for each of the plurality of sample times over the measurement period;
• for the plurality of continuous glucose profiles, determine at least one of a plurality of minimum glucose values and a plurality of maximum glucose values for a selected group or each of the plurality of sample times;
• provide first display signals representing at least one of the plurality of minimum glucose values and the plurality of maximum glucose values for the selected group or each of the plurality of sample times;
• output the first display signals via the output device (4) to the display device (5); and
• display a first graphical representation according to the first display signals on the display device (5)."

The Main Request and Auxiliary Requests 1 to 9 were rejected according to Art. 84 EPC for the reason that the temporal scope and relationship of “measurement (time) period(s)” and “sample times” is not clear. In particular, the Board saw no justification in formulating a claim so abstract that it covers a broad range of meaningless selections of measurement periods, such as one-hour periods on the same day, leaving the reader with an undue burden to speculate on the intended scope of the claims.

Claim 1 of Auxiliary Requests 10 to 14 differs, respectively, from claim 1 of Auxiliary Requests 5 to 9 as follows (with the additions underlined), such that the clarity objection is overcome:

• comprising a plurality of continuous glucose profiles, each of the glucose profiles comprising a plurality of glucose values with a glucose value for each of the plurality of sample times over the measurement period, wherein the plurality of glucose profiles is determined on different days by sampling the glucose level on each day over the measurement period, wherein the measurement period is 24 hours;

Claim 1 of Auxiliary Request 10 contains the following limiting features:

(c) [wherein the machine-readable instructions cause the data processing device to] for the plurality of continuous glucose profiles, determine a plurality of minimum glucose values and/or a plurality of maximum glucose values for a selected group or each of the plurality of respective sample times
(d) [wherein the machine-readable instructions cause the data processing device to] provide first display signals representing the plurality of minimum glucose values and/or the plurality of maximum glucose values for the selected group or each of the plurality of respective sample times.

The Board views that features (c) and (d) do not involve the actual measurement of the respective glucose level in a bodily fluid. Instead, they process already measured and received continuous glucose monitoring data to generate and display further "new data", namely a plurality of minimum/maximum glucose values, in order to support a physician in their purely intellectual deductive decision phases of diagnosis and therapy. Such subsequent processing of certain measurement data collected from the human or animal body is "predominantly of a non-technical nature" (ibid.). Thus, it cannot contribute to the technical character of the invention. Accordingly, the Auxiliary Requests 10 to 14 are rejected as lacking an inventive step over the main prior art citation, D1.

This interpretation of the Convention and of the conclusions of the Enlarged Board of Appeal have also been adopted in earlier decisions of this board (see e.g. T 1091/17, Reasons 1.8; T 1910/20, Reasons 1 and 2; T 335/21, Reasons 1.2 and 1.3).

Take Home Message

This decision provides valuable insights into drafting patent applications under EPO standards, especially in the field of medical diagnostics. The decision emphasizes that claims must demonstrate clarity and a technical contribution beyond mere data processing. Specifically, the ruling highlights that generating new data from existing physiological measurements, such as glucose monitoring data, does not inherently provide a technical effect if the interaction with physical reality (such as the initial measurement) has already occurred. Thus, claims that focus on further data manipulation or cognitive processes must establish a credible technical contribution. The Board's stance deviates from earlier case law, notably T 2681/16, reinforcing that mathematical or cognitive steps, without further interaction with physical reality, lack technical character and cannot be considered inventive.

Part 2 – Preliminary injunction denied for lack of imminency

Relevance of the decision

Preliminary injunctions (PI) have been avidly watched in the UPC’s first year, in particular as to how this significant provisional measure – amplified by the UPC’s cross-border jurisdiction – would be adjudged (as matter of procedure, substantive law and speed).

While PIs have now been sought at the UPC based on patents covering a broad range of technical subject matter, PIs often arise in the pharma & biotech arena, especially in relation to the launch of generic or biosimilar versions of innovator reference products. The UPC’s first year has now seen at least two such PI applications:

• Alexion against Amgen and Samsung Bioepis relating to their biosimilar versions of its blockbuster Soliris®; and
• Novartis/Genentech against Celltrion relating to their biosimiliar version of its blockbuster Xolair®.

Both of these PI applications have been rejected at first instance, by the Hamburg and Düsseldorf local divisions respectively. A key difference between them is the timing of the application/hearing versus the launch of the competitor/biosimilar product: in Alexion, the PI application was made after the biosimilar product had been launched (quickly following the later grant of the patent in question); whereas in Novartis/Genentech, the PI application was made, as tends to be more common, before the launch of the biosimilar product so to try to prevent it entering the market at all pending the outcome of full proceedings.

Whether and at what point preparations to launch a competitor/biosimilar/generic product trigger a cause of action and generate standing so to commence infringement/PI proceedings has been the subject of decades of caselaw before national courts in Europe. This case therefore provided an eagerly anticipated opportunity to see how the UPC would assess such matters, not only how it would contend with the disharmony between national laws but also in the context of differences in launch timelines and regulatory procedures across the UPC’s jurisdiction. A number of other interesting issues are also considered in these decisions (two orders, as there are parallel proceedings between the various Celltrion entities), but the issue of imminency is the most interesting and so we address that first.

General Principles and Key Facts

In close alignment with the IP Enforcement Directive, Article 62(1) of the UPC Agreement (UPCA) requires that, in this scenario, an injunction may be granted “to prevent any imminent infringement” (emphasis added). In this case, the decisive issues was the imminency (or lack of) of the launch of Celltrion’s biosimilar (i.e. the performance of any infringing acts under Article 25 UPCA, such as the import or offer to sell its product in a relevant EPC country).

In this context, the underlying circumstances were as follows (to paraphrase):

• Aug 2022 - Celltrion announces an intention to launch in Europe in 2024
• July 2023 - Celltrion brings UK revocation claim vs the EP(UK) patent
• Oct 2023 -
  • Celltrion brings Dutch revocation and non-infr. claim vs the EP(NL) patent
  • Celltrion files EPO opposition against the EP patent
• Nov 2023 -
  • Celltrion states its goal is to be first Xolair biosimilar
  • Nov/Gen send letter to Celltrion requesting its rights be respected and
  • Celltrion replies that patent is invalid and not infringed
• Mar 2024 -
  • Celltrion press release stating intention to market in Europe as soon as possible after grant of its marketing authorisation (MA)
  • Celltrion conference booth displays information about its product
• Apr 2024 - Celltrion emails potential customer about a positive signal re its MA grant
• May 2024 -
  • MA granted for Celltrion’s product, Omlyclo
  • Celltrion press release announcing MA grant and plan to rapidly expand

The reasons/decision on infringement and imminency

The UPC held that Infringement was made out notwithstanding Celltrion’s challenge to the interpretation of claim 1 relating to the “0.02M histidine” feature. The decision is critical of Celltrion’s evidence in this respect, and held that it was insufficiently substantiated or comprehensible to be convincing, in particular in the context of PI proceedings. This appears to emphasise the provisional nature of PI proceedings, which resonates with commentary at recent UPC-related conferences where there is a sense that the UPC is keen to strike an appropriate balance so that PI proceedings do not become a largely determinative mini-trial.

Having found that infringement was made out, the decision quickly moves on to consider the imminency of Celltrion’s infringement in detail, eventually finding in favour of refusing a PI.

Contending with the diversity of national laws in Europe, the UPC affirmed that it must approach cases “independently, on the basis of the UPCA” and not by applying different national laws (i.e. contrary to Celltrion’s position). Indeed, there is no subsequent citation of any national case or precedent, only prior UPC cases. Indeed, this decision itself looks set to become a central of presumably often-cited reference for future UPC PI cases (even if non-binding). For that reason, the decisions are worth reviewing in full – in particular how the UPC discusses the various preparatory activities concerning biosimilar launch, in relation to both general (e.g. congresses/conferences) as well as specific acts in France, the Netherlands and Spain.

But in summary, having surveyed the relevant acts of direct infringement under Article 25 of the UPCA, the UPC finds that only “offering is seriously alleged”. In subsequently reviewing the applicants’ allegations, all of the applicants’ positions are then dismissed, especially in light of counter-evidence submitted by Celltrion’s employees.

The UPC also refers to numerous examples of what is missing from the applicants’ evidence (thereby inferring that if it had been included, the PI might have been awarded). These examples include general principles, such as proving there has been act which “creates a demand for the product” (citing one of the UPC’s earliest awarded PIs, also in the Düsseldorf local division, in myStromer v Revolt Zycling). Other examples are more specific, such as the lack of evidence either of the provision of samples or that pricing had been raised or negotiated by Celltrion.

Other points

The decision contains other interesting issues arising in this scenario, including:

• Parallel proceedings in the UPC: In this case, perhaps to avoid any delays by service, the applicants started separate proceedings: one against the parent company (Celltrion Inc, based in Korea); and another against EU-based entities (albeit not all UPC contracting states). The cases were subsequently enjoined and heard together but produced two, separate judgments (aligned on the core issues but distinguished in considering e.g. competence and jurisdiction against the relevant defendants).

• European entities enjoined: The UPC rejected Celltrion’s challenge that its European entities (in Hungary, France, Finland, Italy, Belgium and Netherlands) were not subject to the competence of the claim commenced based on the domicile of the German entity. The UPC ruled that it had competence under Article 33(1)(b) UPCA provided there is a commercial relationship and if there are related actions to the alleged infringement. The UPC held these criteria to have been met based on Celltrion’s distribution network. More fundamentally, the decision states that Article 33(1)(b) UPCA “must be applied, regardless of whether the other Defendants are located inside or outside the Contracting Member States or inside or outside the European Union.”. Thus, the UPC took a far reaching view on the scope of Article 33(1)(b) UPCA that it provides competence and jurisdiction to draw related defendants into PI proceedings from anywhere in the world.

• Foreign parent company enjoined: Celltrion’s challenge to the UPC’s jurisdiction against the Korean parent company was also rejected, and the UPC held that it had jurisdiction due to the “spider in the web” position of the Korean parent company in the supply chain. Notably, this was via Article 33(1)(a) UPCA and by reasoning that the acts of the Korean company were part of alleged threatened infringement that may occur in Germany via Celltrion’s local entity. This was independent of the issue of imminency. The decision ultimately appears to agree with Novartis/Genentech that Celltrion’s Korean parent company would act as the “gatekeeper” for European launch and so deemed that it would be cumulatively liable with all of the European entities.

• Parallel proceedings in UPC state / lis pendens: Celltrion sought a stay of the proceedings due to the parallel proceedings in the Netherlands, but this was rejected. In particular, the applicants had not sought a PI in Netherlands (having excluded it from their claim due to the parallel proceedings). The UPC reasoned there was no automatic stay as the parties and/or causes of action were not identical (i.e. according to Articles 29/31 of the Brussels Regulation). While the UPC accepted that it might have discretion to stay according to Article 30 of the Brussels Regulation, it considered the urgency of the PI to be paramount and so refused.

• General powers to stay do not apply – similarly to above, the UPC refused to use its general discretions to stay, but this time reasoned this more fundamentally: on the basis that RoP 295 applies to an “action”, which the UPC interpreted to apply only to a main action and not, as here, an application for provisional measures.

• Security for costs – in what seems to be becoming one of the most common applications at the UPC, Celltrion’s request for security for costs was swiftly dismissed based on lack of evidence of any alarming financial situation of Novartis/Genentech, or their unwillingness to pay interim costs if awarded. The decision emphasises that such orders will not (and were not intended to) be made against any or all ex-EU parties (in this case Switzerland and the US) simply on the basis of difficulty of enforcing any costs order.

• An order for interim costs – the end of the decision discusses an interesting (and what it describes as unintended) gap that arises in relation to costs where a PI is not awarded and so no main action is ordered (as is the case here). The decision finds a way through to award interim costs to Celltrion to an unusually precise figure of €277,125.6‬0 (€138,562.80 in each order). Given the value of the proceedings is set at €7.5m, this amounts to approximately 23% of the €600,000 costs ceiling (but there is no reference to how this number was calculated).

Take Home Message

As mentioned, as we have seen in relation to the influence of the early 10x Genomics decision, this decision (and its likely appeal) look set to become key early decisions informing on the UPC’s approach to PIs in relation to threatened infringement.

Given the UPC did not find infringement in this case (due to imminency), it did not go on to consider validity at all, which raises the question of whether the parties may return to court to attest PI. Indeed, it seems feasible, if not very likely, that significant changes to the facts and circumstances may occur between now and any appeal. Accordingly, this may test the ability to introduce new evidence on appeal in PI proceedings. Given the partial decision and the potential that Celltrion’s launch will become imminent (if not soon, at some point before this patent expires in September 2025), this could also raise the issue of whether the Court of Appeal might hear all of the issues (i.e. including validity) or send the case back to the first instance for full determination.

Lastly, the UPC has certainly affirmed its mantra of taking ‘a UPC approach'. It is notable that infringement counterclaims are ongoing in both parallel proceedings in the Netherlands and the UK, presumably without challenge. It is not known (at least to this author) whether PIs have not been sought in those parallel proceedings, or whether the parties have reached agreement. Indeed, it remains to be seen if and when Celltrion will actually launch their biosimilar product and whether, with hindsight, this decision ages well in terms of offering suitable protection for the patentee, especially as the patent is held to be infringed (albeit with the question on validity outstanding). Should Celltrion’s launch in due course suggest it was imminent already, such circumstances could influence the UPC’s future approach, either to swing back in favour of applicants more generally, or specifically in relation to this defendant. However, that is not to say that this decision is wrong. But as these orders show, each outcome will turn carefully on the assessment of its facts and the weight of the submitted evidence.