According to Unified Patent Court law, which factual circumstances are necessary for a finding of imminent infringement, and are sufficient for the grant of preliminary injunction? Author Claudio Germinario points out a recent order of the UPC’s Munich Local Division as a source of guidance.

An order issued on 27 August 2024 by the Munich Local Division (hereinafter Munich LD) of the Unified Patent Court (UPC) in case UPC_CFI_201/2024 further clarifies the notion of imminent infringement, stating which factual circumstances are necessary for a finding of imminent infringement and are sufficient for the grant of preliminary injunctions against an alleged infringer.

In the Novartis/Genentech vs Celltrion case (UPC_CFI_165/2024) discussed here by the author, the UPC Local Division of Düsseldorf (hereinafter Düsseldorf LD) had clarified that in the pharmaceutical field merely offering for sale a biosimilar (or generic) drug, as well as promoting it at a conference, cannot in itself be considered an imminent infringement if the owner of the biosimilar has not concretely and positively satisfied all the regulatory requirements – Marketing Authorisation (hereinafter MA) obtained; price set; NHS reimbursement terms issued – which allow it to place the drug on the market within a reasonable and defined period of time.

The order of the Munich LD further defines what justifies a finding of imminent infringement.

The object of the allegedly infringed patent, owned by Syngenta, was a herbicidal composition comprising three components A, B and C, where component C was represented by a fraction of free fatty acids (FFA) present in the composition in a percentage greater than 1% (1-95%).

Sumi Agro owned a similar product called “Kagura” which shared components A and B with the patented product, while there was no agreement among the parties on component C.

In 2022 and 2023 Sumi Agro obtained an MA for its product in eight European countries and it placed it on the market in the Czech Republic, a country which is not a member of the Unified Patent Court.

In 2024, Sumi Agro began several commercial promotion activities for the product in some Unified Patent Court member states including Germany, using the same commercial name “Kagura”, on the basis of the same MA and adopting the same forms of commercial strategy. However, in 2024 the product was not yet available for purchase in any Unified Patent Court member states.

Analyses conducted by Syngenta on the product found in 2023 in the Czech Republic revealed a free fatty acid content well above the minimum limit of 1% set by the patent. Therefore, Kagura was completely identical to the claimed herbicide and therefore theoretically represented a literal infringement of the Syngenta patent.

Sumi Agro’s defence was based on three arguments. First, the fatty acids present in the 2023 product were not added but the result of a natural storage degradation of the triglycerides (i.e. non-free fatty acids) in the formulation. Second, the product marketed in 2024 differed from the same product placed on the Czech market in 2023, the FFA content of the 2024 version being lower than that of the 2023 version and therefore outside the claimed range. Third and by way of counterclaim, Syngenta’s patent was invalid, justifying its opinion with a certain redundancy of legal arguments.

However, the Munich LD did not support Sumi Agro’s claims.

On the first argument, the Court clarified that it is on the manufacturer of a certain commercial product, in this case a herbicide composition, to check the stability of the composition at all times and above all to solve any problems due to natural degradation.

In any case, the patent holder’s onus in an infringement action is to prove that the allegedly infringing compound shares all the characteristics of the claimed product, in this case a percentage of FFA greater than 1%, a task fulfilled by Syngenta through experimental analysis. On the contrary, it is not on the patent holder to explain the reasons for the identity between its own product and another, namely why the Kagura product had an FFA content greater than 1%. (letter (a), p. 17 of order).

With regard to the second argument, i.e. that the 2024 version of Kagura was different from the 2023 version, the Local Division noted that Sumi Agro had not produced any analytical results that could contradict those presented by Syngenta. Therefore, not only was the second argument lacking experimental confirmation, but it was also contradicted by the use in Unified Patent Court member states of the same trade name “Kagura”, of the same MA and of the same commercial promotion strategy.

Based on these findings, the Munich LD recognized the existence in one or more Unified Patent Court member states of a concrete risk of a first infringement action pursuant to art. 25 of the Unified Patent Court Agreement (hereinafter UPCA) or of an imminent infringement pursuant to art. 62(1) UPCA.

It is worth noting that according to the Munich LD, under the circumstances of this case “in order to eliminate the risk of first infringement, the respondent should have offered a cease-and-desist declaration with a penalty clause. An actus contrarius is not sufficient.”

As for the third argument, Sumi Agro had provided a long list of claims and legal attacks in support of the alleged invalidity of the patent. However, the Local Division pointed out that due to the summary nature of the validity examination in proceedings for the grant of provisional measures for infringement, a full examination of all the arguments raised, which may be as numerous as in nullity proceedings, was not possible. Rather, the number of legal arguments raised against the validity of the patent should generally be limited to the best three from the defendant’s point of view.

Comment

The rights conferred by a product patent to its owner include the right to prevent an unauthorized third party from offering the protected product for sale (art. 25 UPCA). Therefore, in theory, merely offering the product for sale would in itself amount to an infringement of the patent and justify the granting of precautionary measures against the alleged infringer.

The question here, however, is whether this principle is applicable in absolute terms, even when the product itself has not yet been placed on the market or cannot be placed on the market within a reasonable and definite time span.

In other words, if the protected product is not yet available on the market, can we still speak of actual infringement pursuant to art. 25.1 UPCA or is it perhaps more accurate to speak of imminent infringement pursuant to art. 62.1 UPCA, or definitely of non-infringement?

The question brings us to the very definition of an “offer” for sale. This order, as well as the aforementioned order of the Düsseldorf LD, confirms the general principle that the offer for sale of a product, which can also be articulated in various collateral actions of presentation and commercial and scientific promotion of the product itself, does represent an action that justifies the granting of precautionary measures, however with clear limits of applicability.

Indeed some types of product can be marketed only after the grant of a MA and possibly after the fulfilment of other administrative formalities. This is the case for phytotherapeutic and medicinal products. The orders discussed here clarify that an offer for sale of a herbicide or a medicinal product represents an action pursuant to art. 25 and/or 62.1 UPCA only if a MA has already been obtained and, in the case of the medicinal product, if all mandatory administrative formalities have been finalised. Once these minimum conditions have been met, the Unified Patent Court judges will evaluate the context of the remaining facts on a case-by-case basis.

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