One may say that the infringement of patents within the pharmaceutical industry does not happen overnight and that pharmaceutical companies holding patents covering their products know when/if a generic product is emerging in the market. In order to put a (generic) product on the market, marketing authorisation approval, health technology assessment (HTA), pricing and reimbursement must be obtained. A pharmaceutical company will (or should) be aware of these activities from potential generic competitors, but when can potential infringement actions be initiated? In particular, if the actual generic product is not yet on the market, and physical infringement is not present? But once the generic product is available, significant damage to the pharmaceutical company’s market share and profit will be observed. Can these damages be reversed if successful in infringement actions? All of these questions are relevant for any pharmaceutical company protecting its business.
The Bar for Establishing Imminent Infringement
Before actual infringement happens, an intermediate period may be present: Imminent Infringement. But this is somewhat of a grey zone and may be difficult to pinpoint when to take action.
Indications of when ‘imminent infringement’ can be established were given by the Düsseldorf Local Division of the Unified Patent Court by issuance on 6 September 2024 of an order relevant for this exact matter. The Order stated that ‘there must be concrete indications in the overall circumstances that an infringement is imminent’. In the present case of the Düsseldorf Local Division, the infringement had not yet occurred. Still, the potential infringer had already set the stage for it to happen, i.e., it was therefore only a matter of starting the action, and thereby all preparations must have been fully executed and completed.
Another and more recent Order was issued on 13 August 2025 by the Court of Appeal of the Unified Patent Court in the appeal case between Boehringer Ingelheim International GmbH and Zentiva Portugal, LDA. The case is interesting as it cuts more clearly the bar for when a preliminary injunction may be issued against the generic entry of a pharmaceutical product.
The patent dispute was based on the Boehringer Ingelheim (BI) EP patent EP 1 830 843, which is in force until 21 December 2025 and relates to second medical use claims. BI holds the marketing authorisation (MA), markets and sells its medicinal product with the active ingredient nintedanib, under the tradename Ofev® in Portugal, with the labelled indication for the treatment of idiopathic pulmonary fibrosis (IPF). The product is solely prescription medicines for hospital use and therefore not available directly to patients via pharmacies.
On 30 August 2024, Zentiva obtained two marketing authorisations in Portugal for generic medicines comprising nintedanib as the active ingredient, referencing Ofev® as the reference medicine. Zentiva further applied to INFARMED (the Portuguese governmental division within health care) for an agreed price, an agreed reimbursement rate and establishment of the conditions for the acquisition of medicines by the public hospitals. The application was granted on 6 December 2024 and consequently communicated in a notice to the national health care system INFARMED on 12 December 2024.
BI initiated court proceedings with the Lisbon Local Division alleging that the generic product falls within the scope of the patent and that there was a serious threat of infringement by Zentiva through the offer and/or placing on the market of the generics in the Portuguese market.
The Lisbon Local Division denied provisional measures, holding that a risk of imminent infringement had not been demonstrated. The Local Division considered that merely requesting a marketing authorisation or a Prior Evaluation Procedure is a mere administrative action that does not, in itself, establish a risk of imminent infringement.
The decision was appealed, and the Court of Appeal (CoA) has now issued its Order in the case, reversing the decision from the first instance.
CoA Outcome
The CoA found that the mere application for a marketing authorisation by a generic company does not amount to an imminent infringement, nor does the grant of such an MA. However, completion of the national procedures for HTA, pricing and reimbursement for a generic medicine can amount to an imminent infringement. Such an imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to happen. The infringement is only a matter of starting the action.
It further states that the circumstances must be assessed on a case-by-case basis. And finally, the Order covers the territory of all the Contracting Member States for which the EP patent has effect.
Conclusion
Monitoring your competitors, not only from a patent perspective, but also through close collaboration with the regulatory, commercial and legal functions, is crucial. The in-house patent counsels must be the primary driver in these activities, ensuring that competitive intelligence is shared across functions, necessary actions are taken, and complete files for a potential infringement action are compiled and kept within the IP function. Should it be required to initiate court actions through the Unified Patent Court, timelines are tight, and the case will be expedited very swiftly. Late-filed documents will not be accepted, and there is a very low likelihood of acceptance during an appeal procedure.
Link to Order: https://www.unifiedpatentcourt.org/sites/default/files/files/api_order/7A7FFD070CC8131C27B3E40343EEDD74_en.pdf
