UPC finds no ‘imminent infringement’ over pre-launch activities

Catherine Drew of Pinsent Masons was commenting after the Lisbon local division (LD) of the Unified Patent Court (UPC) rejected an application made by German pharmaceutical company Boehringer Ingelheim International GmbH (Boehringer) for a PI to be issued in respect of biosimilar products made by Zentiva Portugal, LDA (Zentiva).

It is just the second time that a division of the UPC has ruled on a PI application based on claims of imminent, rather than actual, infringement.

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 administrative activities Zentiva had engaged in provided evidence of imminent infringement of a European patent it owns for one of its products, Ofev. The patent is in force in 17 of the 18 countries participating in the UPC system, including France, Germany, Italy, the Netherlands and Portugal.

Ofev is used to treat various types of lung disease, including idiopathic pulmonary fibrosis (IPF). Ofev’s active ingredient is nintedanib, as esylate. Boehringer’s patent is due to expire on 21 December 2025, though it claims its exclusive rights to sell products containing nintedanib do not actually expire until 9 April 2026 owing to rights it holds under 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.

Before the Lisbon LD, Boehringer argued that there was a risk of imminent infringement of its patent. That risk, it claimed, has arisen since 12 December 2024, when Portugal’s medicines authority, Infarmed, wrote to public health bodies in Portugal to advise them that, from that date, they could start purchasing two biosimilar products that Zentiva had developed which are based on Ofev, for treatment of IPF, among other conditions. Earlier in 2024, Zentiva had obtained marketing authorisation from Infarmed for its two products as well as a prior evaluation procedure (PEP) notice, which is required if an marketing authorisation holder wishes to sell a medicine to public hospitals in Portugal.

Boehringer argued that Zentiva’s preparatory administrative activities meant that it was gearing up to launch in Portugal – and this was evidence of imminent infringement. The Lisbon LD disagreed (15-page / 528KB PDF).

Zentiva had argued that it is normal in Portugal to request a PEP before patent expiry. The Lisbon LD noted that obtaining a PEP more than a year before expiry, as Zentiva had done here, would be considered unusual.  However, the court found that merely requesting a PEP after marketing authorisation has been granted does not indicate the timing of when a rival product will enter the market and provides no indication that the would-be competitor intends to enter the market before the expiry of the patent. 

The court noted that infringement is only imminent if the potential infringer has engaged in conduct that will more likely than not result in infringement. In this regard, the burden of proof is on the PI applicant. The court said it will undertake a case-by-case assessment on the point.

In this case, the Lisbon LD considered there was no evidence indicating that Zentiva intended to market the product before Boehringer’s rights expired. It said requesting a marketing authorisation and PEP are merely administrative actions and that, even the issuance of a PEP by Infarmed was not sufficient evidence to show imminent infringement. It therefore refused the PI application.

In reaching its decision, the Lisbon LD acknowledged that different UPC contracting member states have different regulatory requirements when it comes to approval of medicines for use in their jurisdiction but said that these are not directly relevant to the assessment of a risk of infringement. It also confirmed that the UPC must assess imminent infringement independently based solely on the interpretation of the UPCA and not on national legislation. 

The Lisbon LD confirmed the approach taken by the Dusseldorf LD of the UPC in the case of Novartis v Celltrion – the only other time to-date that a UPC division has ruled on a PI application based on claims of imminent infringement. This means it must be established on a case-by-case basis that the potential infringer has carried out acts that make it more likely than not that it intends to offer or place the product on the market before the patent expires. Imminent infringement must then be assessed from the point of view of the concrete likelihood that, in light of the circumstances of the case, the alleged would-be infringer is more likely than not to commit an act of infringement. 

Drew said the ruling places a relatively high burden on a PI applicant to show evidence that there is a risk of imminent infringement. She said this could prove difficult. She said, however, that the ruling also provides some comfort to generic and biosimilar companies that administrative activities required to obtain marketing authorisation approval or place the product on the market will not, on the basis of UPC case law developed so far, amount to imminent infringement. She said, though, that it will ultimately fall to the UPC Court of Appeal to provide binding case law on the definitive test for evidencing imminent infringement.   

“What Boehringer was arguing was essentially linkage of administrative pricing and reimbursement processes to patent infringement, but the court rejected that approach,” Drew said.

“The decision is consistent with EU pharma law reforms on the horizon in relation to the planned broadening of the so-called Bolar exemption. That exemption currently exempts from patent infringement the conduct of studies and trials by generic or biosimilar medicines manufacturers for the purpose of obtaining marketing authorisation. The reform proposals envisage the exemption being extended to applying for public tenders. In this context, it has to be right that obtaining an administrative approval to enable a product to be sold into a hospital does not constitute an act of imminent infringement, rather simply getting ducks in a row prior to actual launch,” she said.