UPC rejects injunction against Celltrion omalizumab biosimilar

Life sciences patent law expert Krishna Kakkaiyadi of Pinsent Masons was commenting after the Düsseldorf local division (LD) of the UPC rejected Novartis’ and Genentech’s request for a preliminary injunction to stop Celltrion’s pre-launch activities for its omalizumab biosimilar, Omlyclo. The court rejected the application on the basis that Celltrion’s activities did not constitute imminent infringement because it had not completed all pre-launch preparations to enable it to launch its product.

Patent specialist Sarah Taylor, also of Pinsent Masons, said the decision was hotly anticipated by pharmaceutical manufacturers. She said the ruling provides guidance to other patent holders on the right timing for seeking preliminary injunctions before the UPC, as well as to parties defending claims of infringement before the UPC as to the substance of technical arguments they might need to put forward.

In the latest iteration of proceedings, Novartis and Genentech applied to the UPC for provisional measures in April 2024, alleging that Celltrion and some of its European subsidiaries have been engaged in various pre-marketing activities since at least August 2022. The alleged activities include public announcements of Celltrion’s intention to launch Omlyclo as soon as possible after obtaining the MA in Europe, and other specific instances of targeted approaches made by Celltrion’s agents or representatives to sell their product or offer their samples to interested customers and dermatologists at medical events and exhibitions.

Novartis and Genentech applied to the LD for an order against: the parent company in the Celltrion corporate group, Celltrion Inc.; a Hungarian company in the group that is the MA holder; as well as six other subsidiaries, seeking to restrain them from continuing these activities and launching Omlyclo pending a main action in the UPC.

Celltrion contested the application citing various reasons.

UPC preliminary injunctions are available under Article 62 of the UPC Agreement (UPCA), which is substantiated by Rule 211.2 of the UPC Rules of Procedure. Article 62(1) provides: “In taking its decision the Court may require the applicant to provide reasonable evidence to satisfy the Court with a sufficient degree of certainty that the applicant is entitled to commence proceedings pursuant to Article 47, that the patent in question is valid and that his right is being infringed, or that such infringement is imminent.”

The LD found that, on the evidence before it, Celltrion’s product would infringe the patent. In particular, it noted that Celltrion had “not substantially disputed” the allegation that Omlyclo came within the scope of one of the claims of the patent. Nevertheless, Celltrion’s proposed interpretation of the relevant claim meant that Novartis and Genentech’s own XOLAIR® product would not come within the scope of the claim. However, the LD was not satisfied that Celltrion had made good this assertion: it stated that it was necessary for a party to make their technical arguments in a “focused and precise” manner and that a “mere reference” to a party’s expert report or where “a party’s expert report is copied verbatim into the brief” would not suffice.

Kakkaiyadi said: “It appears that the court was expecting a fuller articulation of the technical argumentation from Celltrion as to why it contended XOLAIR® did not fall within the scope of the relevant patent claim and for this to be backed by suitable expert evidence, consequent to which, Celltrion were presumably arguing that as a biosimilar, Omlyclo would also not fall within the patent’s scope. The panel hearing the application included a technically qualified judge with a chemistry background, and therefore it would bode well for UPC cases to pay attention to the detail of the technical arguments presented in the submissions and strike the right balance between argumentation and supporting expert evidence.”

Having found that Celltrion’s product would infringe the patent, the LD then had to determine whether Celltrion’s activities were such that infringement was imminent. The LD found that they were not.

In reaching that view, Kakkayaidi said the court helpfully confirmed that EU law, in accordance with the UPCA, would apply in determining this issue, rather than different national laws. The key question, the court considered, was whether any or all of the complained activities proven to be undertaken by Celltrion constituted an offer to sell Omlyclo in the relevant member states, which would directly infringe the patent. The LD held that it would suffice if Novartis and Genentech were able to show the act in question actually creates a demand for the product, which the offer, short of a concrete offer, is likely to satisfy.

Noting that potential customers in the pharmaceutical industry were very likely to regard generic statements of future market entry, when all relevant regulatory measures and pricing and reimbursement steps had not been fulfilled, as “vague announcements”, the LD held that, in fact, Celltrion had not completed all the pre-launch preparations, and in particular, had not even initiated the pricing and reimbursement procedure in certain countries such as France, as Novartis and Genentech had alleged.

“The court’s analysis suggests that it took into account Celltrion not initiating pricing and reimbursement steps, but also that it informed some potential customers upfront that exact dates of launch were not yet known because of the outstanding patent issues,” Kakkaiyadi said. “The other important fact appearing to influence the Court’s decision is from a written witness statement of a Celltrion employee who appears to have clarified to the French pricing authorities that the company did not have any intention of commercialising its biosimilar product as long as the Novartis and Genentech patents are valid.”

“If a consistent approach is taken by the UPC in future decisions, contemporaneous evidence, such as correspondence exchanged, especially with pricing and reimbursement authorities, setting out intentions to launch and potential launch dates, is likely to be critical in proving imminent infringement,” Kakkaiyadi added.

The parties had 15 days to appeal the LD’s decision.