Novartis and Accord settle UPC dispute over drug administration with apple sauce

The dispute centred on Novartis’ patent EP 2 501 384, which protects a method of treating proliferative disorders and other pathological conditions mediated by BCR-ABL, C-KIT, DDR1, DDR2 or PDGF-R kinase activity. In simpler terms, it protects the administration of nilotinib together with apple sauce.

Nilotinib is an anti-cancer medication used to treat chronic myelogenous leukaemia (CML). Novartis is also researching its use in treating Alzheimer’s disease. The company sells nilotinib under the brand name Tasigna.

The drug is mainly administered in capsule form. Novartis recommends taking the capsules on an empty stomach, as taking them with food can lead to side effects. However, this poses problems for patients with difficulties swallowing. Administration with apple sauce thus aims to alleviate this issue.

Market clear for generics

The basic patent for nilotinib has expired, clearing the way for generic products to enter the market. In August 2024, Accord received approval for a generic hard-capsule preparation called Nilotinib Accord.

In November 2024, the generic drug manufacturer filed a declaration of non-infringement against EP 384 at the UPC central division Milan. It is one of only four such declarations at the UPC to date. Accord aimed to establish that its nilotinib product does not infringe the Novartis patent due to skinny labeling. Accord has already carved out the new form of administration with apple sauce from its labels.

According to JUVE Patent information, the case has now concluded as the parties have reached an amicable settlement (case ID: ACT_61148/2024). The details of the agreement are confidential.

This is the latest high-profile UPC pharma case to settle in recent weeks. Earlier this month, Pfizer and GSK settled their global litigation over RSV vaccines, including the pending UPC proceedings.

International approach

For the UPC proceedings, Novartis relied on several of its go-to law firms. Bristows partners Gregory Bacon and Brian Cordery worked closely with an international Freshfields team consisting of Dutch partner Rutger Kleemans and German partners Nina Bayerl and Frank-Erich Hufnagel, especially regarding questions of second medical use.

These also cooperated with Daniella Ampollini of Italian law firm Trevisan & Cuonzo. A Novartis in-house team, consisting of Anna Hewitt (head IP haematology), Yvonne Madawela and Sandra Rueck (both principal IP counsels), coordinated the firms.

Taylor Wessing represented Accord. The firm is currently one of the busiest at the UPC. For the lawsuit against Novartis at the Milan central division, Accord chose Dutch Taylor Wessing partner Wim Maas. Alexander Rubusch from Düsseldorf, David Mulder and Iris van der Heijdt from the Amsterdam office and Charlotte Garnitsch as well as Geert Theuws from Eindhoven complete the team. They cooperated with Fabrizio Jacobacci from the law firm of the same name as local advisor in Milan.