‘Good news’ for pharma companies as UPC provides clarity on imminent infringement

Catherine Drew of Pinsent Masons was speaking after the Court of Appeal of the Unified Patent Court (UPC) reversed an earlier decision by the UPC’s Lisbon local division (LD)  that certain pre-launch activities did not represent imminent infringement of a patent.

The ruling comes after pharmaceutical firm Boehringer Ingelheim International GmbH (Boehringer) had previously applied to the Lisbon LD for a preliminary injunction (PI) against Zentiva Portugal, LDA (Zentiva) for applying for approvals which would allow it to sell its own version of a medical treatment before the former’s patent rights had expired.

Article 62 of the UPC Agreement (UPCA) provides powers to the divisions of the UPC to grant 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.

Boehringer claimed previously claimed that administrative activities undertaken by Zentiva in Portugal had represented evidence of imminent infringement of a European patent it owned for one of its products - Ofev - which is in force in 17 of the UPC’s 18 member states, including France, Germany and Portugal.

Ofev is used for treating various lung diseases and has nintedanib, as esylate, as its active ingredient. Although Boehringer’s patent is due to expire on 21 December 2025, it had claimed exclusive rights to sell products containing nintedanib through to 9 April 2026 by virtue of a supplementary protection certificate (SPC).

Almost all of the sales of Ofev in Portugal are made to public hospitals. This is because Portuguese rules mean medicines containing nintedanib can only be prescribed for hospital use.

Ahead of the original hearing, Boehringer had claimed that there was a risk of imminent infringement of its patent after Portugal’s medicines authority, Infarmed, wrote to public health bodies in Portugal to advise them that from December 2024, they could start purchasing two products that Zentiva had developed which are based on Ofev. Earlier that year, Zentiva had obtained marketing authorisation from Infarmed for its two products, along with the prior evaluation procedure (PEP) notice needed to sell a medicine to public hospitals in Portugal.

The Lisbon LD noted that obtaining a PEP more than a year before expiry, as Zentiva had done here, would be considered unusual, but found no evidence indicating it intended to market the product before Boehringer’s rights expired.

That decision has now been overturned by the UPC Court of Appeal, which has provided some clarity to the criteria which will trigger imminent infringement, which, it noted will be assessed on the specific facts of each case. 

It found that, in the context of marketing of generic medicines, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation.

The Court of Appeal also said that completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement. However, this will be subject to a case-specific assessment which will take into account the national regulatory and legislative context.

On the facts of this case, the court concluded that on balance it is more likely than not that the generic had “set the stage” for offering its product in Portugal. 

“Key to the court’s decision appears to have been the temporal course of events,” said Drew.  “In other words, if a generic is too organised and completes the required administrative steps for launching a product in good time, it risks being found to have acted too early and likely to be threatening infringement.”

The circumstances required the court to consider whether a premature PEP application could constitute imminent infringement, which it said would depend on what can be done on the Portuguese market during the period of more than one year before the patent expires.

One particular factor, key to the court’s assessment, was the fact that a medicinal product will only be listed as “available” in INFARMED’s database following the pre-notification of marketing commencement by the holder of the marketing authorisation. The court found that the pre-notification to INFARMED is a formality which can be fulfilled with relative ease and at short notice. While similar systems are in place in other UPC member states, unique to Portugal is the fact that the originator has no way to determine when a generic product is to be launched and so is unable to step in at that point to police the market.  

Drew said: “This emphasises the level of detail into which the court will delve in investigating the factual matrix upon which to decide the question of whether an imminent threat of infringement exists.”

Assessing all the facts, the court therefore concluded that it was more likely than not that the PEP approval means that the generic product could be offered to public hospitals in Portugal without any further administrative steps. 

Further, the court found that, as Zentiva had failed to provide a credible explanation as to why the PEP was obtained more than a year prior to patent expiry, objectively speaking, the only conclusion available was that the only use of the PEP was for offering a generic product and so infringing the patent. 

“Although this is a positive outcome for the originator pharmaceutical company, it is fact specific, said Sarah Taylor of Pinsent Masons. “The Court of Appeal’s ruling is important because it clarifies that imminent infringement will be assessed on the facts of each case. It therefore provides essential clarity to both patentees and generics and biosimilar medicines manufacturers alike as to what steps may be undertaken before imminent infringement is likely to be found.”

Of further interest is how this decision may align with the proposed recasting of the so-called ‘Bolar exemption’ to harmonise the provision as part of the EU’s ongoing pharma law reform.

The Bolar exemption allows the use of patented medicinal products in studies and trials before the expiration of the patent or SPC for the purpose of obtaining market authorisation. This is an exception to what would otherwise be considered a patent infringement. Its aim is to facilitate the entry of generic medicinal products into the market as soon as possible after the expiration of the patent or SPC, which in turn promotes increased competition, as well as affordability and accessibility of medicinal products in the market.

However, the Bolar exemption has been interpreted differently by different EU member states. The proposed update would revise the scope of the Bolar exemption to expressly include studies, trials and other activities conducted for the purpose of obtaining a marketing authorisation and subsequent variations; conducting a health technology assessment (HTA); obtaining pricing and reimbursement approach; and the subsequent practical requirements associated with these activities.

“The current proposed revised Bolar exemption suggests a more broad scope of exclusion from patent infringement for steps necessary to bring a generic product to market,” said Drew. “This decision of the UPC Court of Appeal is perhaps at odds with the direction of travel on the Bolar provision.”