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| 7 minute read

Preliminary injunction ordered against Curio by the Düsseldorf Local Division in 10x Genomics v Curio

On 30 April 2024 the Düsseldorf Local Division handed down its decision to grant a preliminary injunction in 10x Genomics v Curio (UPC_CFI_463/2023). The patent in suit, EP 2 697 391, relates to mapping of the spatial distribution of certain nucleic acids within tissue samples. 

An overview of the Court’s reasoning and decision is set out below.

Entitlement to bring the action

The Court held that the burden of proof is on the applicant to show that it is the proprietor of a patent and therefore entitled to bring an action under Article 47(1) UPCA. 10x Genomics had met this burden by recording its ownership of the patent in the national registers for the relevant UPC member states, which according to Rule 8.5(c) RoP gave rise to a rebuttable presumption that 10x Genomics was entitled to be registered and reversed the burden of explanation and proof. 

Curio had argued that, since one of the inventors had been employed by Sweden’s Karolinska Institutet at the time the patent was filed, the employer would have had rights to the invention and therefore the rights had not been properly assigned to 10x Genomics. However, the Court rejected this, noting that further explanations (including on Swedish law) would have been necessary to rebut the presumption of entitlement.

Summary infringement and validity analysis

Under Rule 211.2 RoP, the Court may require the applicant to provide reasonable evidence to satisfy the Court with a sufficient degree of certainty that the patent in question is valid and that the applicant’s right is being infringed. The burden of proof for infringement lies with the applicant, whereas the burden of proof for invalidity lies with the defendant.

Claim construction

In construing the claims of the patent, the Court confirmed the approach in Article 69 EPC and the Protocol on its interpretation, namely that that the description and the drawings must be taken into account as explanatory aids for the interpretation of the patent claim and not just used to clarify ambiguities in the claim. However this does not mean that the patent claim serves only as a guideline. The Court noted that statements made by the patentee during the patent granting procedure are not admissible material for interpretation and are not generally to be taken into account for patent interpretation, citing the decision of the Düsseldorf Local Division in Ortovox v Mammut (UPC_CFI_452/2023, Order of 9 April 2023). The Court also referred to the decision of the Munich Local Division in SES v Hanshow (UPC_CFI_292/2023, Order of 20 December 2023), which had indicated that the wording of the application as filed could be used to interpret the granted claims (an apparent inconsistency with Ortovox v Mammut) but determined that it was not relevant for the present case and therefore required no decision.

Claim 1 of the patent sets out a method for localised detection of nucleic acids in tissue samples by providing an array of multiple “capture probes” – short sequences of nucleotides which contain information on their position in the array and regions which can bind to the nucleic acids of interest in the tissue sample. 

Claim 14 claimed the array itself, without reference to the particular method to manufacture the product. According to the wording of the patent claim, the array was “for use in the localised detection of nucleic acid in a tissue sample comprising cells”. The Court held that the reference to such use was merely a stated purpose which served to improve understanding of the invention and what was protected was the product per se, irrespective of the use to which it is actually put.

Infringement

The Court rejected 10x Genomics’ assertion that Curio was indirectly infringing claim 1 of the patent, as it was not able to establish the suitability of the Curio Products for carrying out the method of claim 1.  However, the Court held that it was more likely than not that the allegedly infringing products made by Curio (the “Curio Products”) would make literal use of the teaching of claim 14 and infringe the patent. 

Curio did not deny that it offered and supplied the Curio Products in Germany, France, Sweden and other UPC member states. As such, the Court was convinced that 10x Genomics rights were being infringed.

Validity

Since claim 1 was not found to be infringed, the Court did not conduct any assessment of its validity. 

With regard to claim 14, the Court noted that the fact that the patent had not yet survived any adversarial proceedings (such as EPO opposition or national court proceedings) did not preclude the validity of the patent from being “sufficiently certain”. The Court also indicated that the fact that the patent had been published several years earlier without challenge to its validity was an “important indication” that its validity was sufficiently certain.

On summary examination, the Court, applying Article 54 EPC, reached the preliminary finding that claim 14 was novel over four pieces of prior art cited by Curio. The Court was also unconvinced by Curio’s arguments that the patent lacked inventive step (under Article 56 EPC) over two of those pieces of prior art. 

The Court also noted that the fact that 10x Genomics had filed auxiliary requests did not give rise to any doubts as to validity. The formulation of such auxiliary requests was an expression of legal caution rather than a sign that the patentee lacked confidence in the patent as granted.

Necessity of provisional measures

According to rules 209.2 and 211.4 RoP, both temporal and substantive circumstances are relevant for the necessity of ordering provisional measures by the UPC.

The Court held that temporal urgency will only be found lacking if the patentee has behaved in such a “negligent and hesitant manner” that it does not appear to be interested in promptly enforcing its rights. 10x Genomics submitted evidence that no relevant “decision-maker” (i.e. anyone at the levels from the Board of Directors to senior management) had knowledge of the Curio Products before October 2023. Although Curio cited a notice of launch (which included Europe) on their website in February 2023 and various conferences and public events referring to the Curio Products that had taken place subsequently, they were not able to demonstrate earlier knowledge on the part of the 10x Genomics decision-makers of specific circumstances suggesting infringement. There was also no general obligation on 10x Genomics to monitor the market that Curio could rely on. As such, 10x Genomics’ application for provisional measures in December 2023 was held to be sufficiently timely notwithstanding the fact that the application was made over 10 months after the launch of the Curio Products in Europe.

In assessing the substantive circumstances, the Court took into account that the parties were in competition with each other, with the same target audience: researchers dealing with the localised detection of nucleic acids in a tissue sample. This was further supported by documentary evidence of competition between the parties’ products. The Court also noted that, owing to the fact that the market was dynamic but customer relationships in it would likely be long-term, there was a risk that allowing Curio to remain on the market could damage sales of 10x Genomics’ products in the long term. The Court therefore held that the ordering of provisional measures was necessary from a substantive perspective.

Balancing of interests

Taking into account its preliminary findings of infringement and validity, together with its conviction that the ordering of provisional measures was both temporally and substantively necessary, the Court held them to be of greater importance than the potential damage to Curio from an injunction. The Court held that Curio had not been able to produce evidence that it had a high probability of bankruptcy as a result of the injunction, nor that the injunction would force researchers using its products to abandon their projects and suffer irreparable damage.

Orders

The Court therefore awarded the preliminary injunction against Curio, conditional on 10x Genomics making a security deposit (under rule 211.5(1) RoP) equal to the value of the dispute (EUR 2 million). The value of the dispute was considered to provide an indication of the economic significance that the applicant attached to the matter, even if it did not necessarily correspond to the risk of damages (the extent of which could not be estimated accurately by the local division). Curio was also ordered to pay to the Court a penalty payment of EUR 100,000 for each day of breach of the injunction.

10x Genomics’ request for Curio to provide security for the costs of the legal proceedings was rejected. The Court noted that Rule 158 RoP allowed for such requests by any party (and not only by a defendant) however the Court considered it to be evident from the structure of the RoP that the ordering of security of costs is only applicable in main proceedings and not in urgent proceedings. Curio’s request for compensation for reputational and other damages under Rule 68(3)(a) was also rejected.

Both parties were ordered to provisionally reimburse the other party’s costs in the amount of EUR 100,000 each, reflective of the fact that, for both parties, half of their respective requests were unsuccessful.

Commentary

This decision marks the fourth preliminary injunction to be granted by the UPC and the third preliminary injunction to be granted by the Düsseldorf Local Division, following the preliminary injunctions granted ex parte by the Düsseldorf Local Division in myStromer v Revolt (UPC_CFI_177/2023, Order of 22 June 2023) and Ortovox v Mammut (UPC_CFI_452/2023, Order of 11 December 2023) and the preliminary injunction granted following an inter partes procedure by the Munich Local Division in 10x Genomics v NanoString (UPC CFI 2/2023, Order of 19 September 2023) (subsequently revoked by the Court of Appeal in UPC_CoA_335/2023, Order of 26 February 2024).

As in the Munich Local Division’s decision in 10x Genomics v NanoString, the Court engaged in detailed infringement and validity analysis in reaching its provisional view that claim 14 is valid and infringed by the Curio Products. However, the decision was significantly shorter, running to 42 pages as compared to 106 pages for the 10x Genomics v NanoString decision. The approach to urgency and balancing of interests in this decision appears to favour patentees, with the court taking the approach that only actual knowledge by “decision-makers” (those on the Board of Directors or senior management) will be taken into account when considering whether a patentee has delayed in applying for a preliminary injunction. It will be interesting to see whether the Court of the Appeal agrees with this approach if the parties appeal the decision. 

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patent litigation, upc, life sciences, commentary