First substantive decision of the UPC Court of Appeal overturns preliminary injunction in NanoString v 10x Genomics (UPC_CoA_335/2023)

In its first ever substantive decision, the UPC Court of Appeal (CoA) in Luxembourg has reversed the preliminary injunction ordered against NanoString by the Munich Local Division in 10x Genomics v NanoString (IPKat). The first instance decision was hailed as a clear sign that the UPC is seeking to establish itself as patentee-friendly. The reversal of the first instance decision by the UPC CoA in UPC_CoA_335/2023 puts pay to some of these initial hopes/criticisms. The UPC CoA interpreted the claims of the patent more broadly than the Local Division and found the patent likely to be invalid for lack of inventive step. 

Case Background: Munich Local Divisions strikes patentee friendly approach

The patent at issue (EP 4108782), exclusively licensed to 10x Genomics by Harvard, relates to methods and compositions for detecting analytes such as DNA or protein molecules in cell and tissue samples. 10x Genomics alleged that NanoString's commercial molecular imaging devices and detection probes directly and indirectly infringed the patent. 

At first instance before the Munich Local Division of the UPC, 10x Genomics requested a preliminary injunction against NanoString (UPC CFI 2/2023, IPKat). The Munich Local Division was satisfied that the patent was novel, sufficiently disclosed and inventive. The Local Division also provisionally found that the patent was infringed, and that the interest of 10x Genomics in not having its IP rights infringed outweighed the interest of NanoString in obtaining and retaining market share. The Local Division concluded that there was no reason to deny the request for a preliminary injunction against NanoString.

Maine coon detection

The Munich Local Division ordered that NanoString would have to pay penalty payments of €250k for each and every individual breach of the order. The preliminary injunction was also granted without even the need for 10x Genomics to provide a security. 

For further details of the first instance decision, see Katfriend Léon Dijkman's excellent review

UPC CoA considers the correct approach to claim interpretation

On appeal, the UPC CoA reassessed the first instance decision on the patent's validity. Claim interpretation, as is so often the case, was key.

The patent related to the problem of how to test biological samples for the presence of many different biological molecules at once, instead of having to run many separate tests for the presence of each type of molecule. Applying Article 69 EPC, CoA UPC considered "[t]he patent claim is not only the starting point, but the decisive basis for determining the protective scope of a European patent". However, the UPC CoA also found that the description and the drawings should be used as an aid to determine the scope of protection of the claims (and not just resolve ambiguities in the literal claim wording). 

The granted claims specified a method for analysing "cell and tissue samples". The description included examples in which cell and tissue samples were processed (e.g. preserved or mounted on a solid support), including methods in which nucleic acids and proteins were isolated from the sample. 

The UPC CoA agreed with the construction of the term "cell and tissue samples" arrived at by the Munich Local Division. The term was construed by both courts as requiring a sample that is still structurally recognisable as a cell or tissue. The UPC CoA reasoned that the claim clearly distinguished "the cell and tissue sample" from "a plurality of nucleic and protein analytes". The UPC CoA was also not persuaded that the examples provided in the description, in which samples were pre-processed to isolate the analytes (so that the samples were no longer recognisably cells or tissues), broadened the definition to include such samples. The UPC CoA also found that the definition provided in the description that "an analyte can be a component of a whole cell, a tissue or a body fluid, a cell or tissue extract, a fractionated lysate thereof or a substantially purified molecule", was irrelevant to the construction of the claim. 

The UPC CoA disagreed with the first instance division, however, on the construction of another term in the claim. Claim 1 of the patent specified method steps comprising (c) incubating detection regents with the analytes to be detected, to allow the detection regents to bind the analytes and (d) detecting detection reagents bound to the analytes. The UPC CoA did not agree with the Munich Local Division that this wording required the detection reagents to remain bound to the analytes throughout the entire detection step. For the UPC CoA the claim did not preclude the incubation and detection begin carried out in cycles. 

10x Genomics argued that a method involving multiple incubation steps would be understood by a skilled person as being impractical. However, the UPC CoA pointed to the wording in the description that the incubation step could be carried out over a wide range of possible time frames, ranging from 30 seconds to 48 hours. With the possibility of such long incubation times, the UPC CoA did not think a skilled person would rule out multiple incubations times as being so impractical as to be not covered by the claim. 

UPC CoA: The Munich Local Division incorrectly assumed inventive step

On the basis of its different interpretation of the claims, the UPC CoA was not convinced that the validity of the patent had been established with a sufficient degree of certainty to justify the requested preliminary injunction. 

The UPC CoA did agree with the Munich Local Division that the claim was novel in view of the prior art (Göransson et al.), given that the prior art related to methods of analysing samples of extracted DNA that were clearly no longer recognisable as cells or tissues. However, contrary to the Local Munich Division, the UPC CoA also found that the cycling incubation and detection steps of the prior art did fall under the claim. Therefore, the question for inventive step became merely whether the method of the prior art could be applied directly to cell and tissue samples. 

British shorthair detection

The UPC CoA did not outline or discuss what approach should be taken in the assessment of inventive step. However, whilst not explicitly mentioning the EPO's problem-solution approach, the UPC CoA's analysis broadly followed a similar outline. 

The UPC CoA found that it would have been obvious for a skilled person to modify the method described in the prior art to one using tissue or cell samples. The UPC CoA noted the mention in the prior art of detection methods carried out directly on tissues and cells (in situ). The UPC CoA found that there was no reason "that would have prevented a person skilled in the art from applying the [method] disclosed in vitro in D6 to an in situ environment with cell or tissue samples". The patentee pointed to numerous technical difficulties that a skilled person would face in modifying the method of the prior art to work in situ, and argued that the skilled person would thus have had no reasonable expectation of success. The UPC CoA was not convinced by this argument. The UPC CoA also noted that the patent covered in situ methods but provided no particular guidance on how the invention may be carried out in this specific setting, effectively placing the patentee in a sufficiency-inventive step squeeze. 

The UPC CoA concluded that since "it is more likely than not that the patent at issue will prove to be invalid in proceedings on the merits due to a lack of inventive step, there is no sufficient basis for the issuance of a preliminary injunction". 

Final thoughts

The decision of the Munich Local Division in 10x Genomics v NanoString was broadly taken as a signal that the UPC was seeking to encourage participation by establishing itself as a patentee friendly court. The decision of the UPC CoA in 10x Genomics v NanoString, overturning the Munich Local Division's decision, suggests that these initial observations may have been premature. Notably, however, the UPC CoA did not object to the approach taken by the Local Division to the assessment of whether a preliminary injunction should or should not be awarded. The difference between the decisions of the UPC CoA and the Local Division primarily came down to a difference of claim construction. 

Interestingly, in their approach to claim interpretation, both the Local Division and Court of Appeal were reluctant to import definitions from the description into the claims. How much the description should be used to interpret the claims is currently a hot-topic at the EPO (IPKat). 

The dispute between 10x Genomics and NanoString is a global one, including ongoing US litigation relating to multiple 10x Genomics patents. Running concurrently to the UPC proceedings, there is also an ongoing opposition at the EPO against the same patent (EP 4108782). The dispute between 10x Genomics and NanoString is therefore likely to be the first case in which we will be able to directly compare the UPC and EPO approaches to patent validity. 

 Further reading

First substantive decision of the UPC Court of Appeal overturns preliminary injunction in NanoString v 10x Genomics (UPC_CoA_335/2023) First substantive decision of the UPC Court of Appeal overturns preliminary injunction in NanoString v 10x Genomics (UPC_CoA_335/2023) Reviewed by Rose Hughes on Thursday, March 21, 2024 Rating: 5

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