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In September last year, the Munich local division granted a preliminary injunction to 10x Genomics pending the outcome of the main proceedings. 10x Genomics claims that its patent relating to a method for detecting a plurality of analytes in a cell or tissue sample (EP 4 108 782) is infringed by NanoString’s CosMx Spatial Molecular Imager and related products. The preliminary injunction applied to all UPC Member States.


In its judgment dated 26 February 2024, though, the Court of Appeal overturned this decision, stating that the validity of the patent was not established with sufficient certainty to warrant a preliminary injunction. The judgment followed a one-day hearing at the Court of Appeal in Luxembourg in December 2023.


The ruling, by a panel of three legal judges and two technical judges, provides useful pointers on the standard of review, how the UPC will assess obviousness (particularly in life sciences cases) and the threshold for granting interim relief at the UPC.

Interpreting the patent claim


In its judgment, the Court of Appeal summarised key principles applicable to the case, namely:


  • The patent claim is the decisive basis for determining the scope of a patent (in accordance with Article 69 EPC and the Protocol on its Interpretation).
  • The interpretation of the claim does not depend solely on the literal meaning and the description and drawings must be used as explanatory aids.
  • The patent claim is not merely a guideline, but its subject-matter extends to what (after examination of the description and drawings) appears to be the subject-matter for which the proprietor seeks protection.
  • The patent claim is to be interpreted from the point of view of a person skilled in the art.


The Court added: “In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties.”


The Court also stated: “A sufficient degree of certainty requires that the court considers on the balance of probabilities that it is more likely than not that the applicant is entitled to initiate proceedings and that the patent is infringed. This sufficient degree of certainty is lacking if the court considers on the balance of probabilities it to be more likely than not that the patent is not valid.”


Obviousness attack


Turning to the meat of the patent, the Court of Appeal identified that the problem underlying the invention is to develop high-throughput optical multiplexing methods for detecting target molecules in a sample. Claim 1 of the patent solved this problem through a method based on five key steps.


NanoString had argued that this claim lacked inventive step over the prior art, specifically over D6, a patent relating to an array format with a decoding scheme for targeted digital multiplex molecular analyses. D6 disclosed multiplex encoding and decoding of genomic loci.


The Court found that D6 disclosed all the features of claim 1 of the patent except for the feature that the method is intended to detect a plurality of analytes “in a cell or tissue sample”. Instead, D6 disclosed a method for detecting a plurality of amplified single molecules (ASMs).


It found that D6 would have been of interest to a person skilled in the art who was seeking to develop high-throughput optical multiplexing methods for detecting target molecules in a sample, and that at this date there was a need to consider “whether the encoding and decoding method disclosed in D6 could be transferred to the detection of ASMs in cell or tissue samples”.


Based on another publication (B30), the Court found that, for a person skilled in the art, after successful application of an in vitro multiplex method for detecting ASMs, the next step was to consider transferring the method to an in situ environment. The Court stated: “there is no reason that would have prevented a person skilled in the art from applying the multiplex method for the detection of nucleic acids disclosed in vitro in D6 to an in situ environment with cell or tissue samples”.


Moreover, the patent at issue did not provide any information on how to deal with problems with in situ detection, such as molecular crowding or autofluorescence. Finally, the Court found that the patent at issue “also assumes that a person skilled in the art would be capable of correctly measuring the time component based on his or her general qualification.”


It concluded that “it is more likely than not that the subject-matter of claim 1 in the version of the main request will prove to be obvious” and the preliminary injunction was not justified.


Next steps


The consequence of the judgment is that the UPC preliminary injunction is lifted, though a separate injunction in favour of 10x Genomics is still in place nationally in Germany.


The proceedings on the merits will now continue before the first instance of the UPC, with hearings on both infringement and validity expected in the next few months. We can expect these proceedings to provide a deeper insight into the UPC’s approach to infringement and validity, with a decision on both points in relation to this case anticipated.


In a separate judgment in the same case, the UPC Court of Appeal refused an application to stay proceedings after NanoString entered Chapter 11 insolvency proceedings in the US on 4 February 2024 (after the oral hearing). The Court said: “it would not be compatible with the principles of procedural economy and cost efficiency if the proceedings had to be stayed even in a case in which a party was only declared insolvent after the oral hearing had concluded and the legal dispute was ready for a decision.”


Impact of judgment


It is noted that this decision does not refer to established case law of any other jurisdiction, highlighting how the UPC is beginning to build its own methodologies and precedent.


Therefore, while the judgment is confined to the facts of the case, it provides an initial insight into the assessment of preliminary injunctions at the UPC. The decision additionally comments on claim construction, beginning to build the UPC precedent in this area. 


Notably, this is also the first UPC Court of Appeal case to focus heavily on obviousness, and therefore this decision also provides an initial indication of how obviousness will be considered. It will be interesting to see the UPC consider this in more detail at the main UPC proceedings for this case in due course.


This is not the final word, and the patent at issue may yet be upheld as valid in the main UPC proceedings and/or at the EPO. But this first judgment considering substantive points from the UPC Court of Appeal suggests that it is prepared to make bold decisions, drawing on established law while making its own interpretation of the facts in the case.

Continue reading about UPC Court of Appeal reverses Preliminary Injunction in first substantive decision
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