UPC: Another victory for NanoString

The Central Division (Munich Section) has declared an important patent null and void at NanoString's request. The decision represents another significant victory for NanoString.

We have already reported on the provisional end of the dispute between NanoString and 10x Genomics regarding the injunction proceedings. However, NanoString is still conducting further proceedings before the Unified Patent Court (UPC), including the nullity proceedings discussed in this article. The subject of these proceedings is the invalidation of EP 2 794 928 B1 (title: "Composition and method for detecting analytes"). The patent proprietor is the President and Fellows of Harvard College. By decision dated 17 October 2024 (UPC_CFI_252/2024, ORD_598480/2023), the Central Division (Munich Section) of the UPC declared the patent at issue to be invalid in its entirety in France, Germany and the Netherlands and ordered the patent proprietor as defendant to pay the costs of the proceedings.

The patent proprietor may appeal against the decision to the UPC's Court of Appeal within two months of its announcement.

Procedure

The action for a declaration of invalidity of the patent at issue was filed by NanoString (Technologies Europe Limited) on 27 July 2023. Previously, the Federal Patent Court had already declared the German part of the patent in dispute invalid at the request of NanoString Technologies Germany GmbH; the patent proprietor has appealed against this decision to the Federal Court of Justice, where it is still pending. On 10 October 2023, the Munich Local Division rejected an application for provisional measures based on the patent at issue and filed by the patent proprietor and 10x Genomics, Inc. inter alia due to a lack of conviction of the legal validity of the patent (as far as can be seen, this decision has not been published). In the present validity proceedings, the patent proprietor had filed an opposition under Rule 19 of the Rules of Procedure (RoP) due to the pending nullity action before the Federal Patent Court and the associated alleged lack of jurisdiction of the UPC. At the oral hearing on 18 September 2024, the opposition was withdrawn by the patent proprietor.

The patent at issue

The patent at issue was filed on 21 December 2012 and claims a US priority date of 22 December 2011. It was granted on 20 February 2019. No opposition was filed within the opposition period. The patent is in force in the Unified Patent Court Agreement (UPCA) member states of Germany, France and the Netherlands. It comprises one main method claim and 16 dependent sub-claims.

Arguments of the parties

NanoString challenges the patent at issue on the grounds of lack of novelty and lack of inventive step. In addition, the invention was not disclosed so clearly and unambiguously that a person skilled in the art could carry it out according to NanoString. Furthermore, the subject matter of the patent at issue goes beyond the original application.

The patent proprietor defended the patentability of the patent at issue and filed a precautionary or conditional request for amendment of the patent under Rule 30 RoP with the response to the action and submitted corresponding auxiliary requests if the Central Division were to deem the patent unpatentable in its granted version. Subsequently – after the conclusion of the written proceedings and after the interim hearing – the patent proprietor filed a further auxiliary request.

The decision of the Central Division

The Central Division denies the novelty of claim 1 of the patent at issue, since the invention was clearly and unambiguously disclosed in a prior art document. The first auxiliary request lacks inventive step with respect to this prior art. According to the Central Division, the other auxiliary requests could not change the complete declaration of invalidity of the patent at issue either.

The Central Division also considers the nullity action to be admissible and assumes its (international) jurisdiction also against the background of the nullity action pending before the Federal Patent Court. In the opposition under Rule 19 RoP, the patent proprietor had argued that the proceedings before the UPC were inadmissible or in any case to be suspended due to the nullity action pending before the Federal Patent Court with regard to the German part of the patent at issue, citing Art. 29-31 of Regulation No. 1215/2012 (Brussels I Regulation). At the oral hearing, the patent proprietor withdrew the opposition and the parties unanimously requested that the UPC assume its international jurisdiction and not stay the proceedings, including with regard to the German part of the patent at issue.

However, if – as is the case here – international jurisdiction is determined by European law, the UPC cannot simply accept this despite corresponding and concurring applications by the parties, but must examine this independently. First of all, the Central Division establishes that it has international jurisdiction in accordance with Art. 24 no. 4 Brussels I Regulation. Articles 29 and 31 of the Brussels I Regulation are not applicable in the present case, as there is no identity of parties. In the German nullity proceedings, NanoString Technologies Germany GmbH appeared as the plaintiff, whereas NanoString Technologies Europe Limited appeared before the UPC. Even if the two applicants had the same parent company, they were not to be regarded as the same parties within the meaning of Article 29 (1) Brussels I Regulation. According to the Central Division, therefore, only a stay of the nullity proceedings before the UPC with regard to the German part of the patent at issue on the basis of Art. 30 Brussels I Regulation could be considered anyway. However, the Central Division exercised its discretion not to stay the proceedings, as the interests of the parties and procedural economy outweighed the risk of conflicting decisions between the UPC's Court of Appeal and the Federal Supreme Court in the opinion of the Central Division.

An in-depth analysis of the decision and the presentation of the (technical) details would go beyond the scope of this blogpost. However, the following two generalizable statements for nullity proceedings before the UPC can be derived from the decision of the Central Division:

1. The assessment of novelty within the meaning of Art. 54 (1) of the European Patent Convention (EPC) requires the determination of the entire content of the prior publication. The decisive factor is whether the subject matter of the claim with all its features is directly and unambiguously disclosed in the prior art.
2. In the front-loaded UPC proceedings, the parties are obliged to present their entire case as early as possible. A later request for amendment of the patent pursuant to Rule 50.2 RoP in conjunction with Rule 30.2 RoP will generally not be granted, as the auxiliary request could and should have been filed earlier.

In its statement of defense, the patent proprietor had filed a total of eight auxiliary requests for amendment of the patent at issue. The Central Division considered these to be admissible. In a written submission dated 6 March 2024, the patent proprietor filed a further auxiliary request for amendment of the patent at issue. This took place against the background of the order of the Court of Appeal of 26 February 2024 in the NanoString/10x Genomics preliminary injunction proceedings, in which the Court of Appeal had expressed doubts about the legal validity of the patent at issue there, which is a divisional application of the patent at issue here. In the opinion of the Central Division, the corresponding argumentation of the nullity plaintiff, which the Court of Appeal had also used to justify its doubts as to the validity of the divisional application, was already contained in the application, which is why the (further) request to amend the patent had to be rejected as late and therefore inadmissible.

Patent owner friendliness of the UPC and possible appeal

The decision of the Central Division is one of a large number of decisions and orders of the UPC that destroy patents and/or only maintain them to a limited extent. The emerging line in nullity proceedings does not appear to be as patent proprietor-friendly as some voices had assumed, especially before the UPC commenced operations. However, it is premature to assume higher requirements for the legal status. In any case, the requirements do not yet go beyond those of national validity proceedings, such as the German nullity proceedings.

It is likely that the patent proprietor will appeal against the central chamber's order. We will follow the developments and report again in our blog if necessary.