[UPCKat] Has the UPC set too high burden to stop generic entry in Boehringer Ingelheim v Zentiva?

The IPKat is left puzzled in Lisbon...

The UPCKat is back to report on the ability to demonstrate imminent infringement, and how the Lisbon Local Division of the UPC has endorsed the approach previously taken by the Dusseldorf Local Division on assessing the risk of imminent infringement.  

Over to the team of Agathe Michel-de Cazotte, Hiske Roos and Christina Guazzi to break down the Lisbon Local Division's 8 May 2025 decision in Boehringer Ingelheim v. Zentiva:  

"The patent in suit, EP 1 830 843 B1 (EP 843) relates to the use of indolidone derivatives (nintedanib or nintedanib esylate) in the treatment or prevention of lung diseases. As the patentee, Boehringer Ingelheim brought preliminary injunction proceedings against Zentiva in relation to its product Nintedanib Zentiva covering all UPC member states but for Malta.  It will remain in force until 21 December 2025.

While it was not in dispute that Zentiva’s product falls within the scope of the patent in suit, Boehringer Ingelheim’s requests were rejected as the Court was not convinced that there was imminent infringement.

Background to the case

Boehringer Ingelheim’s nintedanib-containing blockbuster is called Ofev® and is sold as a capsule for oral administration with doses of 100mg and 150mg. According to the decision, it is their second highest selling product.

On August 30 2024, Zentiva obtained marketing authorisation in Portugal for their Nintedanib Zentiva product with Ofev® as reference medicine, also with doses of 100mg and 150mg of nintedanib.

In Portugal, medicines containing nintedanib can only be prescribed for hospital use and are therefore subject to specific rules that require a Prior Evaluation Procedure (PEP) where decisions are made on, for example, price, reimbursement and therapeutic indications.

Zentiva had requested a PEP which was completed and granted on 6 December 2024 (more than one year before patent expiry). Following the completion, a Portuguese administrative body called Infarmed issued a notice on 12 December 2024 indicating that it was possible to purchase Nintedanib Zentiva as of the date of the notification. The notice mentioned that Zentiva had one year to begin commercialising their product and otherwise the PEP would expire.

Once a PEP is completed, the PEP holder must take some further steps in order to offer or sell to the Portuguese national health service, including concluding framework agreements. There is a Framework Agreement in place for Nintedanib medicines, but Boehringer Ingelheim is the sole contractor listed for providing such products.

Furthermore, Boehringer Ingelheim had obtained a preliminary injunction against Zentiva in Portugal (only) before the Portuguese IP Court covering the Nintedanib Zentiva product based on an SPC for a different patent than EP 843. Zentiva had not defended itself against that PI application.

Boehringer Ingelheim argued that there was an imminent risk that Zentiva would infringe their patent EP 843 in light of the following facts (as summarised by the Lisbon LD):

• Zentiva requested and obtained two MAs for its medicine;
• The granting of those MAs enabled Zentiva to pursue the PEP; and
• The granting of the PEP was the final administrative step necessary for Zentiva to offer and sell its product to the public hospitals.

Zentiva raised three lines of defence:

1. The Lisbon LD lacked jurisdiction and competence because the PEP was granted by a Portuguese public administrative body, so the Portuguese court would have competence instead;
2. There was already a preliminary injunction in place in Portugal covering their Nintedanib Zentiva product and therefore the injunction based on the patent in suit would lack utility; and
3. There was no imminent risk of infringement.

While Zentiva were unsuccessful on points 1 and 2, they were successful in disputing imminent infringement.

Imminent infringement test: is the defendant more likely than not to commit an act of infringement?

The assessment of the Lisbon LD shows large similarities with the assessment applied by the LD Dusseldorf in Novartis/Genentech v. Celltrion (6 September 2024, UCP_CFI_166/2024). The decision is in fact referenced multiple times. The Lisbon LD formulated a test where imminent infringement must be assessed, on a case-by-case basis, depending on whether “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”, i.e. the “concrete likelihood that, in light of the circumstances of the case, the Defendant is more likely than not to commit an act of infringement.”

Interestingly, although the Lisbon LD acknowledged differences between UPC member states in administrative procedures to gain market access in para. 55 of their decision, the Lisbon LD comment that this should not be relevant in the assessment of imminent infringement:

“55 This dispute concerns the pharmaceutical market, which operates in a highly regulated field that constantly requires interaction with administrative entities. Before being placed on the market, a medicine must undergo several successive administrative steps, including the application for an MA, sales price determination, and reimbursement negotiations with health authorities. Furthermore, public tenders or public procurements may also be conducted. The Court further acknowledges that administrative procedures, legislation and their interaction with market access vary depending on the Contracting Member State. However, this should not be relevant to the direct assessment of the risk of infringement. As the Local Division Düsseldorf observed (Order, 6 September 2024, UPC_CFI_166/2024, ACT_18551/2024, Novartis/Genentech v. Celltrion), when dealing with European patents, the UPC must assess imminent infringement independently, solely based on the interpretation of the UPCA, and not on national legislation. In that regard, the Court must evaluate the risk of infringement in light of Art. 62 and 25 UPCA.”

The Lisbon LD underlined that the burden to prove imminent infringement lies on the claimant.

Imminent infringement not sufficiently demonstrated

The Lisbon LD decided that grant of the PEP did not create a risk of imminent infringement in the absence of any other steps taken by Zentiva that indicated that they were planning to market their Nintedanib Zentiva product. The applications for the MAs and the PEP were mere “administrative steps”. The subsequent grant of the PEP was outside of Zentiva’s control, whereas Arts. 62 and 25 UPCA require that the risk of infringement arises from the Defendant's conduct. The Lisbon LD was also unconvinced by Boehringer Ingelheim’s argument that the PEP was requested early, in light of written evidence from Zentiva’s head of scientific affairs showing that the procedure that led to the request of the PEP did not deviate from their usual procedure.

Boehringer Ingelheim also argued that the PEP was requested prematurely (+1 year before patent expiry) and pointed to the one-year expiry period mentioned in the PEP notice if Zentiva did not start commercializing their product. However, this argument wasn’t accepted either.  The Lisbon LD here, again, refers to the written statement of Zentiva’s head of scientific affair who declared that “Zentiva is not obliged to commercialize its products within 1 year since there are patent rights in force. Throughout my years of experience in the industry, I am not aware of a single case where the expiration on the one year led to the lapse of a prior hospital evaluation, when the non-marketing was due to the existence of patent rights". The Court stated that this showed that Zentiva was aware of the PEP expiry terms but that this does not indicate a market entry time.

In the absence of any further evidence, the Lisbon LD was not convinced that Zentiva’s behaviour made infringement more likely than not and rejected the requested preliminary injunction. In particular, it is possible for Zentiva to sell its generic to private hospitals rather than to wait for the next opportunity to offer it to the public hospitals as a PEP holder; however, Boehringer Ingelheim had not demonstrated that Zentiva was about to do so.

Comment  

This UPCKat wonders whether this decision sets a rather high burden on the patentee to show evidence that there is a risk of infringement - evidence that may be difficult to find. Indeed, what other steps taken by Zentiva could have proved that they were planning to launch pre-expiry? Does such evidence even exist?  Equally, this decision can be seen as reassuring for alleged infringers that if imminent infringement is argued based on the assumption that getting administrative approval for participating in public tenders is a marketing step or an offer for sale rather than on proving that such acts constitute marketing/offers or will necessarily imminently be followed by such infringing acts, it will be rejected (which probably also sets a high bar for ex parte PI requests).  We will see what the Court of Appeals makes about these ever-elevating evidence standards, in due course."