It is a well-established strategy for a claimant to commence parallel litigation in multiple territories, to increase the pressure on a defendant. In this case it appears that Bio-Techne, which is a much larger company than Molecular Instruments, has launched a parallel UPC infringement action in an attempt to force a resolution.

It is not yet clear how the UPC will deal with the complex issues of claim interpretation and joint liability which were considered by the UK High Court. We will watch with interest how the UPC case proceeds and for any significant divergence from the decision handed down by the High Court.

Background

In September 2022, Bio-Techne, under its Advanced Cell Diagnostics Inc brand, announced that it had filed a patent infringement action against Molecular Instruments at the UK High Court. Bio-Techne alleged that Molecular Instruments' HCR 3.0 technology infringes Advanced Cell Diagnostics's European patents EP1910572 and EP2500439.

The patents at issue are directed to methods and kits for detecting nucleic acid targets within an individual cell and underpin Bio-Techne’s RNAscope in situ hybridisation (ISH) technology. The patents are from the same family, but differ in that EP1910572 has method claims and EP2500439 has product claims.

The issues considered by the High Court were technically complex. In a lengthy decision handed down on 23 April 2024, Mr Justice Meade found the patents to be invalid for obviousness. However, had the patents been valid, EP1910572 (but not EP2500439) would have been infringed by the acts considered in the trial.

Infringement: claim interpretation

Molecular Instruments denied infringement on the basis that its products and the methods for using them do not fall within the scope of the claims. In particular, that the capture probes in its products were complementary to “overlapping” regions of the label probe, whilst the claims at issue require the capture probes to be complementary to “non-overlapping” regions.

The judge considered this issue in detail and applied a purposive claim construction, in accordance with established UK case law. The purpose of the feature at issue was identified as increasing specificity by having two probes so that non-specific binding is reduced. A small amount of overlap did not undercut this purpose and therefore the judge found that "non-overlapping" did need not mean "completely non-overlapping".

It will be interesting to see whether the UPC will arrive at the same conclusion to that of the High Court. In the UPC Court of Appeal decision NanoString v 10x Genomics (UPC_CoA_335/2023), the court overturned the order of the Munich Local Division at first instance and in doing so, provided its position on claim construction. Unlike the Munich Local Division, the UPC Court of Appeal applied the principles of Article 69 EPC and its Protocol on Interpretation when assessing the claims for validity and infringement. This resulted in a more literal approach to the claim language with reference to the description and drawings as an “interpretation aid”.

Infringement: joint liability

Importation into the UK was the relevant act in relation to EP2500439, which has product claims. However, the claims at issue require the kit to comprise a permeabilising agent, which was not included within the imported product. Therefore, the judge held that even if Molecular Instruments were jointly liable for the importation, it would not amount to an infringement.

Use was the relevant act in relation to EP1910572, which has method claims. Molecular Instruments provides customers with protocols for the use of its products. Were this all that happened, then the judge indicated that this would amount to mere facilitation. However, in relation to some customers, Molecular Instruments provides "troubleshooting" support.

The judge held that Molecular Instruments would have been liable where it provided troubleshooting support. However, had the patents been valid, the judge considered that this might have led to a difficult decision in relation to relief.

It is not yet clear how the UPC will approach the same issues. Significant differences exist in existing national regimes of joint liability, for example regarding the degree of knowledge or awareness, and it will be interesting to see how the UPC attempts to harmonise these different approaches.

Validity: obviousness

Molecular Instruments submitted that the claimed subject matter was obvious in view of a combination of two prior art documents. Collins describes an in vitro branched DNA signal amplification assay for quantification of nucleic acid targets. Kern describes cruciform probes and is referred to in Collins on a number of occasions.

The critical paragraphs for the obviousness attack were the first four paragraphs of the Discussion section in Collins, in which it is disclosed that the assay should also be useful for in situ hybridization assays. Collins further disclosed that the sensitivity of the assay could be improved by the use of cruciform probes (with cross-reference to Kern), which would fall within the scope of the claims at issues.

The judge therefore found that all the features of the claim would occur to the skilled person, and that the nub of the question was simply whether there was a reasonable expectation of success. However, Bio-Techne did not put forward any specific reasons why the skilled person would think that prospects of success were lacking. In any case, the judge found that any doubts would have been allayed by a prior art document which would have been found by a routine literature search.

The Judge did not consider it necessary to apply the Pozzoli test (the general framework used to assess inventive step by UK courts). In the UPC Court of Appeal decision Nanostring v 10x Genomics the court did not appear to apply the European Patent Office’s (EPO) problem-solution approach, and instead adopted a more “classical” approach to inventive step. It will be interesting to see whether this approach leads to the same conclusion as reached by the UK High Court on obviousness in the present case.

Summary and parallel UPC action

Overall, the UK judgment appears to be largely in favour of Molecular Instruments. The judge held that Collins and Kern point to all the features of the claims of the patents and that Bio-Techne did not assert the existence of any actual problem that would prevent success. Even if the patents were valid, it is not clear what relief Bio-Techne could have sought.

However, the UK judgment has not brought an end to the dispute. Instead, Bio-Techne has launched a further patent infringement action at the UPC to maintain the pressure on Molecular Instruments. The patents at issue are currently in force in France, Germany, Italy, and the Netherlands, according to the Federated European Patent Register.

According to the UPC Register, the patents were opted out of the jurisdiction of the UPC on 16 May 2023, effectively shielding them from any pre-emptive revocation action by Molecular Instruments. The opt-outs were withdrawn on 18 April 2024, only a few days before Bio-Techne launched the UPC infringement action in the Netherlands Local Division.

Take-home messages

The dispute between Bio-Techne and Molecular Instruments involves complex issues of claim interpretation and joint liability. It will be interesting to see how the UPC case proceeds and whether it will make any reference to the decision of the UK High Court on the same patents and involving the same parties.

This dispute is a reminder that parallel litigation at the UPC is potentially an effective strategy to maintain or build pressure. Bio-Techne has also demonstrated how UPC opt-outs can be used strategically to shield patents from pre-emptive revocation actions, then withdrawn shortly before launching an infringement action. Such a strategy may allow a claimant to launch an action in a local decision which is perceived to be the most favourable to them, provided that no national action has been started in a UPC member state prior to the opt-out withdrawal being filed.

We await further developments and will provide further updates in due course. Please contact your usual D Young & Co representative if you have any questions.

Case details at a glance

Jurisdiction: England & Wales
Decision level: High Court (Patents Court)
Parties: Advanced Cell Diagnostics Inc v Molecular Instruments
Citation: [2024] EWHC 898 (Pat)
Date: 23 April 2024
Decision: dycip.com/2024-ewhc-898-pat

Decision level: UPC First Instance, Local Division (The Hague)
Case: ACT_21885/2024
Parties: Advanced Cell Diagnostics Inc (claimants) and Molecular Instruments Inc (defendants)
Date: 22 April 2024
Decision: dycip.com/act-21885-2024-upc