Eliot Ward
2024 Week 43
10x Genomics and NanoString have been duking it out at the UPC since the court opened its doors in summer 2023. Litigation is also going on in the US and elsewhere in Europe. Here we look at the substance of a UPC revocation action filed by NanoString against EP 2794928 B1, owned by Harvard College and licensed to 10x.
Background – preliminary injunctions, appeals and Chapter 11
In the same family as EP 2794928 B1 are three patents granted from divisional applications. One of the divisionals is EP 4108782 B1. This was the subject of the first successful UPC preliminary injunction (PI) application in September 2023. NanoString were even the subject of a €100,000 penalty payment order in December 2023 in view of alleged breaches of that injunction. However, the UPC Court of Appeal struck down the PI in February 2024. Their view was that it was more likely than not that EP 4108782 B1 was invalid for lack of inventive step.
In July 2023, NanoString filed an application for revocation of EP 2794928 B1. Perhaps concerned about the financial position of Nanostring (which entered Chapter 11 bankruptcy proceedings in February 2024 before being acquired by Bruker), 10x persuaded the UPC to force NanoString to provide security for costs in the revocation action. Additionally, 10x had filed a PI application based on EP 2794928 B1 against NanoString, but withdrew that PI application in October 2023 without the court publishing a reasoned decision.
About 15 months after filing the application for revocation of EP 2794928 B1, we now have the result from the UPC Central Division Munich. The patent has been revoked for lack of novelty and lack of inventive step. Clearly another great result for NanoString, we review here how the court came to its conclusion and how this sheds light on the UPC approach to inventive step for life science inventions.
Technical consideration of novelty assessment
NanoString argued that the granted claims of EP 2794928 B1 lacked novelty. The patentee filed 8 auxiliary requests (claim amendments) with their defence to the revocation action.
The amendments made in the auxiliary requests established novelty over the main prior art (Göransson et al) by specifying analysis of proteins, peptides or RNA in cells/tissues by immunohistochemistry and/or fluorescence in situ hybridisation. The prior art disclosed similar methods, but for analysing circular DNA molecules derived from digested genomic DNA in acellular samples.
The patentee argued that applying the method to RNA in cells/tissues would impose a minimum threshold on the size of the primary probe (termed ‘detection reagent’), which would in turn prevent it from dissociating from its target. The view of the court was that this alleged (implied) feature would not necessarily arise by putting the auxiliary claims into practice. Therefore, the court was not persuaded that the claims excluded methods in which the initial detection reagent might dissociate before subsequent rounds of detection reagents are applied. It is worth noting that this aspect of the patentee’s defence would have established another distinguishing feature over the Göransson method in which successive detection reagents were applied after the previous detection reagent had dissociated.
Technical consideration of inventive step assessment
Having decided that the claims as granted lacked novelty, the view of the Central Division was that the claims of the auxiliary requests also lacked inventive step over Göransson.
In common with other recent decisions on the merits, the UPC in this decision did not apply the same problem-solution approach used by the EPO. We set out what we see as the key differences in this case below.
Identification of the “technical problem”
In an EPO problem-solution approach, the objective technical problem (OTP) comes from looking at the novel features that distinguish the claimed invention from the prior art and then determining what technical effects flow from the novel features. The OTP is then, typically “how would the skilled person try to achieve this technical effect starting from the prior art?”
If it’s obvious to the skilled person that adding the novel feature would achieve the effect, the claim is obvious. If not, it is inventive. If the novel feature doesn’t give rise to a technical effect, the problem becomes “provision of an alternative”, which is hardly ever considered inventive.
Instead of this approach, the UPC Central Division here referred to the underlying problem. In this case, this is the problem that the patent says that the invention solves, which is: To develop high-throughput optical multiplexing methods for detecting molecules in a sample. Göransson also addressed the same problem.
The court identified the difference between claim 1 of the first auxiliary request and the prior art as:
the sample is a biological sample comprising one or more cells and/or one or more tissues and the analytes are selected from proteins, peptides and certain RNAs
This was instead of the digested genomic DNA of the prior art. But the court didn’t ask what (if any) effect flows from this difference.
Motivation
Next the court considered the motivation of the skilled person to modify the prior art to arrive in the claim. Rather than asking how the skilled would solve the objective technical problem, the court identified passages in the prior art that suggested that its methods were ‘generic’ and could be used in quantification of certain DNA molecules from other samples. The court went on to explain their view that the skilled person would have modified Göransson to work inside the scope of the amended claims of the auxiliary requests. This led directly to the conclusion that the claims were obvious.
Late-filed claim amendments dismissed
On 6 March 2024, the patentee tried to enter a further auxiliary request into the proceedings. The amendment attempted to solidify the alleged feature (persistent binding) that the patentee had argued implicitly distinguished the granted claims from Göransson. Presumably, this further auxiliary request would have made persistent binding an explicit feature of the claims. The patentee argued that this auxiliary request was filed in view of the claim interpretation made by the UPC Court of Appeal decision dated 26 February 2024 overturning the PI based on their related patent EP 4108782 B1.
The UPC Central Division refused to admit the auxiliary request. They once again emphasised that UPC proceedings are heavily front-loaded, following strict approaches that we have seen against all parties such as in BITZER v Carrier, Abbott v Dexcom, and Dyson v SharkNinja. It is with these firm restrictions that the UPC is aiming to avoid delays in proceedings, to get to its target of issuing first instance decisions on the merits within about a year. In this case, that target was missed, but this was due to delays imposed by the Chapter 11 bankruptcy proceedings of NanoString, rather than by the UPC procedure.
Lis pendens objection
The applicant for revocation in this case was NanoString Technologies Europe Limited. A related company NanoString Technologies Germany GmbH had filed a revocation action in July 2022 against the German part of the same patent, at the German Federal Patent Court, which had revoked the patent in Germany. That decision is subject to appeal in Germany. Therefore, the UPC wanted to consider whether it must decline jurisdiction under the “lis pendens” rules.
The UPC Central Division firmly explained that the parties between the two cases are not the same and their interests are not necessarily identical. For these reasons, the court was not obliged to decline jurisdiction, following the UPC Court of Appeal guidance in Mala v Nokia. The court went on to consider whether it should exercise its discretion to stay the UPC proceedings. However, at least in view of the effect that a decision from the UPC would have on the validity of the patent in other countries such as France and the Netherlands, the court decided not to stay proceedings. To be fair, both parties also agreed with this and had accepted the jurisdiction of the court.
This blog was co-authored by Eliot Ward and Matthew Naylor.
Eliot handles a diverse client portfolio spanning the life sciences sector and a growing practice in the cross-over space between physics and biology. A skilled patent prosecutor, Eliot also has wide experience of drafting patent applications on breakthrough technologies, as well as leading offensive and defensive opposition proceedings post-grant. Eliot is also experienced in handling Freedom to Operate projects and in performing due diligence, which have led to the successful completion of high value transactions and investment rounds.
Email: eliot.ward@mewburn.com
