UPC Court of Appeal lifts preliminary injunction in Genomics vs NanoString

By order dated 26.02.2024 (UPC_CoA_335/2023, App_576355/2023), the UPC Court of Appeal (CoA) lifted the preliminary injunction (PI) issued by the Munich Local Division of the Court of First Instance (CFI) on 19.09.2023 against NanoString Technoligies (NanoString) in favour of 10x Genomics (Genomics).

Specifically, Genomics claimed direct and indirect infringement of its European patent with

unitary effect no. 4 108 782 (EP ‘782), relating to compositions and methods for analyte detection. The Court of First Instance issued the requested PI – together with a penalty of € 250,000 for each individual breach of the same – on the following grounds:

a)    it could be concluded, with sufficient certainty for the purposes of preliminary relief, that the patent was valid and infringed. In reaching this conclusion, the LD seemed to apply the EPO’s problem-solution approach for the assessment of inventive step;

b)    the commercialisation of NanoString’s products would cause Genomics significant, long-lasting harm;

c)     the interest of the right holder in not having their rights infringed outweighed the interest of the potential infringer in securing now, through the continuation of the infringement, market share which it might be impossible for them to obtain at a later stage;

d)    the urgency requirement was also met. In this respect, the LD noted that possible unreasonable delay in taking action should be evaluated as from when the UPC started operating on 1 June 2023, since: i) this was the date after which the remedies granted by the UPA could be requested; whilst ii) national courts would not be able to grant equivalent remedies in favour of a unitary patent.

The CFI also dismissed NanoString’s request that they be permitted to continue the allegedly infringing activity against the provision of security and, in the alternative, that the granting of the PI be made dependent on the provision of security by Genomics.

By the order under discussion, the CoA overturned this decision finding that, contrary to the judgement of the CFI, the validity of the patent at issue was not established with a sufficient degree of certainty for the injunction to be issued. The key points of the decision are as follows.

a)    The patent claim - which is to be interpreted from the point of view of a person skilled in the art - is not only the starting point, but the decisive basis for determining the protective scope of a European patent. However, its interpretation does not depend solely on the strict, literal meaning of the wording used: the patent’s description and the drawings must always be used as explanatory aids. In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties.

b)    Since an order for provisional measures is issued by way of summary proceedings, in which the opportunities for the parties to present facts and evidence are limited, the standard of proof must not be set too high, in particular if delays associated with a reference to proceedings on the merits would cause irreparable harm to the proprietor of the patent. On the other hand, it must not be set too low, to prevent the defendant from being harmed by a provisional measure that is later revoked.

c)     The applicant for provisional measures shall provide reasonable evidence to satisfy the court to a sufficient degree of certainty that the patent is valid and that his right is being infringed, or that such infringement is imminent. Such a sufficient degree of certainty requires that the court considers it at least more likely than not that the patent is infringed; it lacks if the court considers it to be more likely than not that the patent is not valid.

d)    Contrary to the opinion of the CFI, in the judgement of the CoA it is, on the balance of probability, more likely than not that the subject-matter of claim 1 of the patent will prove to be not patentable due to lack of inventive step, hence there is no sufficient basis for the issuance of the requested PI.

In reaching this conclusion, the CoA (including two technically qualified judges) made its own technical analysis, which however did not apparently apply the EPO’s problem-solution approach, particularly as it did not make a strict analysis of the closest prior art. Therefore, the CoA approach appeared different from that of the CFI.

However, this is just a decision on a preliminary injunction, issued within the limits of summary proceedings. We will have to wait for other decisions to see which approach on inventive steps will be followed by the UPC.

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