Scientific reality is taken into account by The Hague Local Division of the UPC in granting preliminary injunction

The Hague Local Division of the Unified Patent Court (UPC) recently granted a preliminary injunction to stop the defendant from direct infringement of European patent EP1993350B2 by marketing the brown mushroom strain ‘Cayene’ in the territories of The Netherlands, Germany, France and Italy (UPC_CFI_195/2024).

The claimant Amycel LLC (briefly “Amycel”) owns European patent EP1993350B2 entitled ‘Brown mushrooms for commercial production’. The European patent (B1 version) was initially granted with 16 claims. After opposition proceedings the patent was maintained in amended form (B2 version) with the only remaining claim relating to: 

“A hybrid Agaricus bisporus mushroom strain BR06, wherein a representative culture of BR06 is available from ATCC under Accession No. PTA-6876”. 

The BR06 strain was generated by using three different mushroom strains. First a commercial white mushroom strain (a U1 derivative) was crossed with a commercial brown mushroom strain (Amycel 2400) to create a ‘bridging cross strain’ called 4x29, which in turn was crossed with the wild mushroom strain AA-0096 (patent [0012], [0017]-[0020]). The BR06 strain has improved characteristics vis-à-vis the ‘old fashioned brown’ such as the strain Amycel 2400. The patent is in force in UPC Contracting Member states The Netherlands, Germany, France and Italy, and in other non-UPC countries including Poland. Amycel sells the mushroom strain BR06 as ‘Heirloom’. 

The defendant is a Polish farmer who is offering for sale various white and brown mushroom strains. One of the brown strains offered for sale by the defendant is called ‘Cayene’ and has been sold under this name in Poland since 2017 according to the defendant.

Amycel found that the defendant infringes the patent in Poland with Cayene and started infringement proceedings on the merits in July 2023 after failing to reach an amicable settlement. These proceedings are still pending.

Amycel became aware that Cayene was also sold in UPC territory, particularly in The Netherlands, late July 2023. Amycel managed to obtain samples of Cayene which it sent to specialised laboratories for genetic and phenotypic analysis to verify whether this strain indeed infringes the patent.

The defendant filed an invalidity action to revoke the patent with the Milan Central Division of the UPC asserting that the patent’s claim contravenes Art. 53(b) EPC, which relates to the exclusion of “plant or animal varieties” from patentability. The defendant reasoned that a mushroom strain should be equated to a plant variety and, therefore, the subject matter is excluded from patentability. 

Before the Local Division in The Hague, Amycel filed an application for provisional measures requesting a preliminary injunction against the defendant based on the sale of the Cayene mushroom strain in The Netherlands. In support of its position, Amycel filed genetic analysis reports based on Amplified Fragment Length Polymorphism and Whole Genome Sequencing analysis of several mushroom strains, including the deposited BR06 strain, Amycel’s Heirloom strain, and defendant’s Cayene strain, and a report concerning a phenotypical comparison of the Cayene strain with the BR06 strain described in the patent.

The Court decided on two main issues: first, whether there was an unreasonable delay of Amycel in starting the application for provisional measures after it became aware of the alleged infringement, and second, the validity of the patent, or in other words, whether the mushroom strain of the patent’s claim should be equated to a plant variety, thereby excluding it from patentability under Art. 53(b) EPC.

Regarding the unreasonable delay, the court stated that Amycel acted diligently to anticipate the defences raised by the defendant pre-trial by performing both genetical and morphological experiments. The court appreciated that it is time-consuming to collect both genetical and morphological evidence and found Amycel’s explanation of the timeline plausible. Since Amycel started proceedings as soon as it had gathered the reasonable evidence, the court considered that there was no unreasonable delay.

With respect to the validity of the patent, the court concluded that mushroom varieties are not excluded from patentability by Art. 53(b) EPC. The exclusion under Art. 53(b) EPC concerns plant and animal varieties only and therefore does not encompass organisms other than plants and animals, such as mushrooms which belong to the fungi kingdom that is taxonomically distinct from the plant and animal kingdoms. Consequently, the defendant’s invalidity arguments were rejected, and the patent was assumed to be valid.

Regarding the infringement, the court was convinced with a sufficient degree of certainty that Amycel’s right was infringed by the offer and distribution of the contested mushroom strain Cayene within the Contracting Member State of The Netherlands. The court was sufficiently certain that – based on the evidence – Cayene and the Heirloom/BR06 can be considered so genetically similar that this is indistinguishable from genetical identity within the applicable limits of experimental error. All results showed that Cayene and BR06 are, when subjected to sequencing, found to have genetic identity at least to the same degree as would be expected for biological replicates of the same strain. Hence, the court considered it on the balance of probabilities to be more likely than not that (claim 1 of) the patent is infringed with the sale or offering Cayene spawn. As a result of the above, the court granted the injunction as it is considered necessary to stop further infringement.

When reflecting on the order, it is interesting to see that the scientific reality is taken into account by the UPC when assessing the urgency requirement and validity. Indeed, generating scientific evidence can be time-consuming. Given the importance of gathering sufficient scientific evidence when preparing for front-loaded proceedings before the UPC, it is important to note the court’s acknowledgement in this respect. Further, the order by the court is based on the scientific knowledge that fungi and plants belong to different kingdoms, revealing that established taxonomical principles are taken into account by the UPC.

At De Clercq & Partners, we are happy to assist you on patenting your inventions in all kind of fields including the life sciences. Please reach out to us at info@dcp-ip.com.