Imminent patent infringement in the pharma industry: guidance from recent cases

The Unified Patent Court’s (UPC’s) Düsseldorf Local Division addressed the legal standard for ‘imminent infringement’ pursuant to Article 62(1) of the Unified Patent Court Agreement in its decision of September 6 2024. Novartis had lodged an application for provisional measures, claiming that a biosimilar developed by Celltrion for Novartis’ XOLAIR product would infringe Novartis’ European patent EP 3 805 258 (EP 258).

The key points of the case were as follows:

• Market authorisation (MA) – Celltrion obtained MA for its biosimilar product in May 2024.

• Novartis' assertions – Novartis asserted that Celltrion would infringe EP 258 by engaging in price negotiations, filing reimbursement applications, and presenting samples to potential customers. These assertions were supported by several witness statements.

• Celltrion's defence – Celltrion contested these assertions and submitted rebutting witness statements.

The UPC held that Celltrion’s conduct did not constitute an imminent infringement, as Celltrion had not completed all its pre-launch preparations. The UPC provided the following legal standard for assessing imminent infringement:

• There must be concrete indications in the overall circumstances that an infringement is imminent. The burden of proof lies with the applicant, and these circumstances must be assessed on a case-by-case basis.

• It must be derived from the defendants’ conduct that, more likely than not, they intend to enter the market during the patent term without further ado.

The UPC concluded that an act of imminent infringement would be an advertisement expressing the ability to supply the challenged embodiment, in compliance with all the relevant regulatory measures, particularly by mentioning a specific price if a potential customer wished to place an order. The UPC stressed that the potential customers are familiar with the practices of the pharmaceutical industry. They are able to identify vague announcements about future market entry when the regulatory measures and pricing and reimbursement conditions have not yet been finalised.

The decision is final as no appeal was filed by Novartis. Nullity proceedings concerning EP 258 are still pending before the Dutch and UK courts and in opposition proceedings before the EPO.

The Regional Intellectual Property Court in Warsaw (case No. XXII GW 253/24) also recently considered a case concerning imminent infringement. The patentee requested a preliminary injunction, claiming that infringement was imminent due to several circumstances:

• No reaction from the generic product manufacturer to the patentee’s pre-trial request for an undertaking to cease and desist the allegedly infringing activities during the patent term;

• A request from the generic product manufacturer to the patentee for a statement on whether the marketing of the generic product would be considered an infringing act;

• Early obtainment of an MA by the generic company, more than three years before patent expiry; and

• Launching a nullity action against the patentee’s patent by the generic company.

The case raised important questions:

• Whether the actions of the generic company fall within the scope of the freedom to conduct business and were aimed solely at preparing for the commercialisation of the medicinal product after the expiry of patent protection; and

• Whether a lack of response to a pre-trial warning letter would constitute an imminent infringement and whether there is a basis, either in law or in fact, requiring an active response to such out-of-court correspondence.

Unfortunately, these questions remain unanswered as the action was withdrawn by the patentee before any decision was made. However, for future cases, Polish intellectual property courts may consider the legal framework determined by the UPC.

The recent rulings and cases highlight the complexities surrounding imminent patent infringement in the pharmaceutical industry. The legal standards set by the UPC and the considerations by the Polish regional intellectual property court provide valuable guidance for future disputes in this area.