Background

The patent at issue, EP 4 108 782, relates to optical multiplexing methods for detecting target molecules in a sample, and was granted on 07 June 2023. On the first day of the UPC, 01 June 2023, the applicants, including 10x Genomics, applied to the Munich Local Division as Court of First Instance for an order for a preliminary injunction against the defendants, NanoString Technologies group companies.

In September 2023, within two weeks of the hearing, the Munich Local Division found “with a sufficient degree of certainty”, that the patent was most likely valid and infringed, and an order for a preliminary injunction was issued. The order, which stretched over one hundred pages, demonstrated the Munich Local Division’s desire and ability to consider complex technical and legal issues swiftly.

NanoString Technologies appealed this order to the UPC Court of Appeal pleading, among other things, that the Munich Local Division had erred in its narrow interpretation of claim 1 of the patent, and in its finding that the patent was most likely valid.

The order

Starting with claim construction, in line with Article 69 of the European Patent Convention (EPC), the UPC Court of Appeal acknowledged that the description and drawings of the patent must be used as explanatory aids for the interpretation of the patent claim. In doing so it disagreed with the Court of First Instance’s interpretation of the patent claim, in particular with regard to whether the detection reagents must remain bound to the respective analytes throughout the entire detection procedure. Unlike the first instance order, the UPC Court of Appeal decided that there is nothing to preclude the decoder samples, once they have been bound to the respective analytes, from being removed again at a later stage.

Although the UPC Court of Appeal agreed with the Court of First Instance that claim 1 of the patent would more likely than not be found to be novel, it found fewer novel features when compared to the disclosure of document D6, a research paper disclosing method for detecting a plurality of amplified single molecules (ASMs) by encoding and decoding the single molecules. In particular, the UPC Court of Appeal considered the only novel feature to be that claim 1 of the patent allows the detection of a plurality of analytes “in a cell or issue sample”, whereas D6 relates to the detection of ASMs ordered in vitro in an array format.

As a result, in contrast to the first instance order, the UPC Court of Appeal decided that claim 1 of the patent would “more likely than not” be considered obvious. Emphasis was placed on the presence of the two technically qualified judges when stating that not only was there a need for multiplex analysis techniques at the priority date of the patent, but that the skilled person would consider transferring the encoding and decoding techniques disclosure in D6 to the detection of ASMs in cell or tissue samples. Further, the UPC Court of Appeal considered the skilled person to have sufficient expertise to be able to deal with the problems that could be encountered when combining the disclosures of different documents, noting that such problems regularly arise in connection with in situ detection. Equally, the judges considered there to be an incentive in D6 to modify the method towards that claimed in the patent, referring to a footnote in D6 referring to in situ genotyping of individual DNA molecules. The UPC Court of Appeal therefore concluded that the skilled person would arrive at the subject matter of claim 1 of the patent, either from the disclosure of D6 alone or in combination with D30, a different document related to in situ detection of non-polyadenylated Ribonucleic acid (RNA) molecules.

As a result of finding that it is more likely than not that the patent will prove to be invalid the first instance order was revoked, and the request from 10x Genomics for an injunction was rejected.

Stay of proceedings

In a related order, the UPC Court of Appeal ruled that the proceedings were not required to be stayed as a result of NanoString Techologies, opening insolvency proceedings under Chapter 11 of the Bankruptcy Code in the USA.

The judges noted that the Rules of Procedure of the UPC are to be interpreted to ensure a fair balance between the legitimate interests of all the parties, and that the proceedings are to be conducted in the most efficient and cost effective manner. The judges particularly emphasised the need for a timely order on proceedings related to preliminary injections.

Since NanoString Techologies was only declared insolvent after the oral hearing in this case had concluded the judges decided all procedural steps had been taken by the parties and all costs already incurred, so any decision or order on the case after the declaration of insolvency would have had the same effect as if the decision or order were issued before the declaration of insolvency.

Further, the judges referred to comparable provisions in the codes of procedure in France, Germany, Italy and the Netherlands for not staying proceedings if a party is declared insolvent after the oral hearing, or if the case is ready for an order. Accordingly, the UPC Court of Appeal ordered the requests for a stay of proceedings to be dismissed.

Discussion

In overturning the Munich Local Division’s conclusion on the validity of the patent the UPC Court of Appeal does not identify any legal error made in the first instance order, nor does it make any comment on the methodology used in assessing whether a preliminary injunction should be granted. Instead, the UPC Court of Appeal reassessed the construction of the claim and the resulting impact on the novel features over the prior art. Although the disclosure of D6 is discussed at length a formal “problem and solution” approach as used at the EPO is not expressly used in the order. Instead, the UPC Court of Appeal identifies the problem the invention seeks to address, then analyses whether the skilled person would be motivated to modify the disclosures in the prior art to arrive at the claimed subject matter. It is still not clear how the UPC will assess inventive step and whether the ‘problem and solution’ approach will be formally adopted; we will continue to watch how inventiveness is assessed as more decisions come out.

In finding the patent more likely than not invalid, the UPC Court of Appeal did not consider the issue of infringement, and in particular whether carrying out part of process on a server operating outside the territory of the UPC constituted infringement, which was one of the defences of NanoString Techologies’ during proceedings at the Court of First Instance.

The order does, however, confirm that the burden of proof is on 10x Genomics to satisfy the court to “a sufficient degree of certainty” that 10x Genomics is entitled to apply for provisional measures, and that the patent is valid and infringed. In particular, the judges set out that the court must consider it “at least more likely than not” that the patent is infringed, and such “a sufficient degree of certainty” is lacking if, on the balance of probabilities, the patent is more likely than not to be invalid. Despite this, the discussion of inventiveness in the order spans multiple pages, with a detailed discussion as to why the skilled person would not only be motivated to provide all of the features of claim 1 of the patent, but would also have sufficient expertise to do so.

The patent is currently under opposition at the EPO, and NanoString Techologies were quick to file the UPC Court of Appeal’s order as a document in opposition proceedings. We await with interest to see how the Opposition Division uses the UPC Court of Appeal’s order during opposition proceedings.

Although the order from the UPC Court of Appeal lifts the preliminary injunction in the seventeen UPC contracting member states a separate injunction in Germany remains in place, and NanoString Techologies has announced it is evaluating its next steps in Germany.

Useful link

• Order 6653/2024, UPC Court of Appeal, 26 February 2024: dycip.com/order6653-upc-coa