UPC deems publicising CE-mark for medical device evidence of ‘imminent infringement’

Sarah Taylor, patent expert at Pinsent Masons, said such measures for “imminent infringement” – i.e. where actual infringement has not yet occurred, but where the court considers that the infringer has taken every other preparatory step and has “already set the stage for it to occur” – are increasingly becoming contested battlegrounds between patent holders and alleged infringers at the Unified Patent Court (UPC).

The point was addressed by the Hamburg local division (LD) of the UPC in the context of a dispute between Swiss medical device manufacturer Occlutech and rival Chinese manufacturer Lepu Medical Technology (Lepu).

Occlutech owns a European patent for a braided occlusion device – an implantable device used for the purposes of stemming blood flow. Occlutech had previously opted the patent out of the UPC’s jurisdiction but withdrew that opt-out in May this year. The following month it brought proceedings against Lepu before the Hamburg LD seeking provisional measures in the form of a preliminary injunction (PI) against Lepu in relation to Lepu’s competitor product.

A PI is a court order that provides the party to whom it is granted with temporary relief. Article 62 of the UPC Agreement (UPCA) provides powers to the divisions of the UPC to grant such injunctions to prevent imminent infringement – and require applicants seeking such relief to provide evidence to help the court satisfy itself that there is such a risk meriting an injunction being issued. The UPC’s rules of procedure give practical effect to those provisions and provide criteria the UPC can consider when assessing applications for PIs – including in the context of imminent infringement.

Imminent infringement has already been considered by the UPC in the context of pharmaceuticals. Pre-launch activities may constitute imminent infringement of a patent and put launch activities at risk of a PI. This will depend on whether the potential infringer has “set the stage” for infringement – i.e. completed all acts aimed at preparing a rival product for launch. The mere application for, and grant of, a marketing authorisation – the approval required to place a medicinal product on the market – does not amount to imminent infringement. However, completion of national procedures, including conducting a health technology assessment, and pricing and reimbursement, may constitute imminent infringement. 

Medical devices are not subject to the same requirements as pharmaceuticals. Manufacturers must obtain CE marking – a mark that certifies a product’s conformance to EU health and safety standards – for their device, which allows it to be moved and marketed freely in the EU.   

In this case, the first time imminent infringement had been argued in relation to the potential launch of a medical device, Occlutech argued before the Hamburg LD that a PI was justified on the basis of various activities Lepu allegedly engaged in, including Lepu obtaining a CE marking for its product and then publicising that fact, both on social media and at a trade fairs.

Obtaining a CE marking is a “prerequisite” for medical device manufacturers seeking to “legally market” those products in the EU, the Hamburg LD acknowledged. However, it considered that the further steps Lepu had taken to advertise its CE marking was evidence of “imminent infringement”.

“By obtaining (and publicly announcing) CE-mark approval for the attacked embodiments after the necessary clinical evaluation, providing ‘ordering information’ and announcing to show-case their products on a trade fair … [Lepu] have set the stage to market these products,” the Hamburg LD said.

The court went on to consider various arguments from Occlutech and Lepu relevant to the scope of patent protection at issue and the patent’s validity. The Hamburg LD said, at this preliminary stage in the proceedings, that it believes the validity of the patent is reasonably certain and that Lepu's products would infringe Occlutech’s patent. Notably, the Hamburg LD was satisfied that Occlutech could not provide any further evidence in respect of “imminent infringement”, such as information about specific Lepu products or sales, because it accepted that Occlutech would have minimal visibility over any sales that would be conducted directly between Lepu and the relevant hospitals or associated purchasing companies.

As a result, the court granted Occlutech a PI that prohibits Lepu from bringing any infringing product in the relevant UPC countries in which the patent is in force – even though imminent infringement was only determined in respect of two Lepu products for which CE-mark approvals had been obtained.

The arguments around patent validity and infringement in this case are due to be heard in full at a trial in due course.

Occlutech was previously denied a PI in respect of another European patent that it attempted to enforce against Lepu in respect of the same products at issue in this case. In that earlier ruling, the Düsseldorf LD held that it was not possible to conclude at the preliminary stage with necessary certainty that the patent had been infringed by Lepu's products.