Out-Law / Die wichtigsten Infos des Tages

The Unified Patent Court has accepted jurisdiction in a medtech patent dispute despite the existence of parallel proceedings in German courts. It has revoked the European patent in issue across all participating UPC countries.

This contrasts with the UPC’s first substantive decision, handed down a day earlier by the Dusseldorf Local Division, which, in a win for the patentee, saw the new court issue its first ever permanent injunction

The present proceedings before the Paris Local Division are part of wider global litigation between medical technology competitors DexCom Inc and Abbott Laboratories. Both are manufacturers of continuous glucose monitoring (CGM) devices used in the management of diabetes. CGMs are currently the subject of a number of UPC disputes, with the Hague Local Division recently granting Abbott a preliminary injunction against SiBio Technology.    

There are parallel proceedings in respect of the patent - European patent EP 3435866 (EP866) - asserted in the present case in Germany, where, before the start of the UPC, Dexcom initiated an infringement action before the Mannheim Regional Court, and in response Abbott commenced a nullity action before the Federal Patent Court. The UK designation of the patent was recently revoked by the High Court of England & Wales by consent.

The UPC proceedings were commenced on 7 July 2023, and the decision issued on 4 July 2024. Sarah Taylor, patent litigation expert at Pinsent Masons said “This is another example of the UPC meeting its aim of delivering substantive first instance decisions within one year of proceedings being commenced, demonstrating its attractiveness for businesses seeking to resolve disputes in a timely manner.” 

Dexcom asserted EP866 against ten named Abbott entities in respect of all countries that had ratified the UPC Agreement at the time of the hearing, including Germany, with the exception of acts committed by Abbott entities already subject of the pending German proceedings.

In response, Abbott counterclaimed for revocation of EP866 on the grounds of added-subject matter, lack of novelty, and lack of inventive step.

Before considering infringement and validity, the Paris Local Division had to decide whether it had jurisdiction to hear the case. While Abbott sought revocation of the patent in its entirety across all designated UPC countries, Dexcom argued that the UPC should decline jurisdiction in respect of the revocation counterclaim for the German part of EP866. Dexcom relied on the lis pendens rules set out in Article 31 of the UPC Agreement and EU Regulation 1215/2012 (Brussels I Recast), which aim to avoid duplicative actions and potentially conflicting decisions on the same patent.

The court said that it was not obliged to stay the UPC proceedings under Article 29 Brussels I Recast in view of the earlier German action, because not all the parties involved in the UPC action were involved in the German action. Instead, the Paris Local Division had a discretion under Article 30(2) Brussels I Recast as to whether it should decline jurisdiction in favour of the earlier seized German court, because the actions are “related actions” which concern EP866 and involve two of the same parties.

The court decided to exercise this discretion. On the basis that the Paris Local Division would issue its judgement in July 2024, earlier than the German Federal Patent Court which is expected to deliver a decision in January 2025, the UPC considered that it was not in the interests of the proper administration of justice to either decline jurisdiction or to stay proceedings pending a decision by the German court. The UPC therefore decided to accept jurisdiction to rule on the validity of the entire European patent, including its German part.

The Paris Local Division also found that the scope of a UPC revocation counterclaim does not need to be identical to the scope of the infringement claim. This was for two reasons. First, the court said that while all ten Abbott entities are accused of infringement in all UPC territories, only three of them are involved in the German proceedings. It would be contrary to the principle of a fair trial to deprive them all of the right to defend themselves by way of a revocation counterclaim.

Second, the Paris Local Division noted that under French law, the scope of a revocation counterclaim is limited to what is asserted in the infringement claim. However, the court noted that there is no provision in the UPC Rules of Procedure which requires the same, therefore confirming that the scope of a UPC revocation can go beyond that of the infringement action.

“This departure from French national practice is interesting” said Taylor. “While we have, of course, seen national influences in some earlier UPC decisions, the overall theme seems to be that the UPC is determined to develop its own case law based on the interpretation of the UPC Agreement and the Rules of Procedure. This decision seems to support that intention," she said.

As the court accepted jurisdiction across all UPC territories, it then went on to consider the validity of the patent. Abbott’s added matter and novelty attacks were rejected. In terms of novelty, the UPC presented a clear test, outlining that it considered an invention to be part of the state of the art if it can be found “integrally, directly and unambiguously in one single piece of prior art”. Using this test, EP 866 was found the be novel.

Concerning obviousness, the UPC defined inventive step “in terms of the specific problem encountered by the person skilled in the art”, appearing to adopt the EPO’s tried and tested problem-solution approach. In its earlier decision, the Dusseldorf Local Division also adopted an approach akin to the EPO’s test.  However, the Court of Appeal, in 10x Genomics v NanoString, neither approved nor criticized the problem-solution approach. 

“The approach taken by the Paris and Dusseldorf Local Divisions to inventive step assessment appears to take a lead from the EPO’s problem-solution approach, but it is not possible to say, at the moment, that the court will formally adopt this approach. We expect some clarity over the coming weeks and months as the court issues more decisions. However, clear guidance from the Court of Appeal will most probably ultimately be required," said Taylor. 

In this case, the court found that when confronted with the relevant technical problem with which EP866 was concerned, the skilled person would have had to select one of the four data transmission protocols listed in the prior art. The selection of the protocol which was included in the patent was deemed obvious, and therefore the patent was found invalid. The court also noted that the preliminary opinion issued by the German Federal Patent Court reached the same conclusion.

As the court found the patent to be invalid, it did not rule on infringement.

The effect of this decision means that the patent is revoked across all UPC member states, including Germany, as well as the UK. However, given the long-running global nature of this dispute, an appeal is expected.

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