Settlement ends Formycon and Johnson & Johnson FYB202 biosimilar dispute

A battle over drug Stelara has come to an end. Following a settlement between the parties in the US in August 2023, the three companies Formycon, Fresenius Kabi and Johnson & Johnson have now also reached a confidential agreement for Europe and Canada. This has ended all pending patent litigation over the FYB202 biosimilar, which was ongoing in the UK and Germany.

The active ingredient of Stelara is monoclonal antibody ustekinumab, used to treat psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. It is one of the global top-selling drugs. In 2022, according to Statista, its sales came to $9.7 billion.

In a press release, Nicola Mikulcik, chief business officer of Formycon AG, says, “Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.”

Applying the waiver

Towards the end of last year, the companies made headlines through their appearance at the Munich Regional Court. The dispute concerned the German SPC DE 12 2009 000 025.7, which is based on basic patent EP 1 309 692 B1.

In October 2023, presiding judge Georg Werner handed down a preliminary injunction against Formycon, after the pharmaceutical company announced its intention to launch its biosimilar of drug Stelara following the expiry of the patent and related SPC.

Janssen Biotech, a subsidiary of Johnson & Johnson, argued that the defendant needed to produce a relevant marketing authorisation before it could begin manufacturing upon the patent’s expiry. In one of the first rulings in which a court has applied the 2019 amendment to the SPC regulation, the judges found against Formycon due to a lack of marketing authorisation number for the biosimilar in a third country outside the EU (case ID: 21 O 12020/23).

Parallel proceedings over the manufacturing waiver also took place in the Netherlands, with Samsung Bioepis as the defendant. In January 2024, the District Court in The Hague handed down a decision pertaining to the application of the SPC waiver, where Janssen argued that the defendant must produce a relevant marketing authorisation before it could begin distributing its Sterala biosimilar upon the patent’s expiry.

However, the court dismissed the argument on all counts. It concluded that Samsung Bioepis could continue distribution of the biosimilar to third countries.

An international effort

In the UK, the dispute focused on a revocation action against Janssen’s EP 3 883 606, which covers a ‘Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody’. According to JUVE Patent information, following the settlement, Fresenius and Formycon withdrew from the UK proceedings, while litigation remains pending with the other co-claimants Accord, Samsung Bioepis and Amgen.

In the Munich proceedings, an international team led by Düsseldorf-based Rospatt Osten Pross partner Thomas Musmann represented claimant Janssen Biotech. The firm has a long-standing client relationship with the pharma company and is frequently active for Johnson & Johnson subsidiaries. One example is its work for AMO in the dispute against Alcon, although the parties have also settled this dispute.

For the Munich case, Rospatt Osten Pross teamed up with Latham & Watkins in the US. Here, partners Roger Chin and Michael Morin led the team.

Cross-border involvement

Initially, Formycon and its German company FYB202 Project relied on a team led by IP partner Marc Holtorf from Pinsent Masons in the German proceedings. The firm often advises pharma clients, in particular generic manufacturers, and is leading the coordination of litigation in Europe. Here, Jules Fabre, who is a partner in the Paris office, Charlotte Weekes, who is a partner in the London office, and associate Marina Jonon, led the effort.

However, Formycon switched advisors for the appeal proceedings, instead turning to German IP firm Maiwald. Partner Marco Stief led the team. Pinsent Masons reamined heavily involved in the UK proceedings, representing Fresenius/Formycon, as well as another defendant, Accord. The London office of Osborne Clark was in the lead for Amgen.

In the Netherlands and in the UK, Samsung Bioepis turned to regular advisors Simmons & Simmons, using a team from the Dutch and UK offices. In the Netherlands, the partners in charge are Bas Berghuis van Woortman, who is head of the firm’s IP practice, and Machteld Hiemstra, while Scott Parker leads in the UK. Marco Stief also acted as an expert in this jurisdiction.

European IP boutique Hoyng ROKH Monegier led the case for Janssen in the Netherlands, while Carpmaels & Ransford act for Janssen in the UK proceedings.

Munich proceedings
For Janssen Biotech
Rospatt Osten Pross (Düsseldorf): Thomas Musmann, Markus Lenßen (partners); associate: Tabea Schäfer
Latham & Watkins (San Francisco): Roger Chin, Michael Morin (both partners)

For Formycon/FYB202 Project
Maiwald (Munich): Marco Stief, Heike Röder-Hitschke, Tobias Matschke

UK proceedings
For Janssen Biotech
Carpmaels & Ransford (London): Camilla Balleny, David Wilson (both partners)

For Formycon/Fresenius
Pinsent Masons (London): Charlotte Weekes (partner); associate: Ian Turner

For Accord
Pinsent Masons (London): Catherine Drew

For Samsung Bioepis
Simmons & Simmons (London): Scott Parker (partner): associate: Benjamin Thomas

For Amgen
Osborne Clark (London): Will James, Trevor Crosse

Dutch proceedings
For Janssen Biotech
Hoyng ROKH Monegier (Amsterdam): Peter van Schijndel (partner); associates: Akiva Friedmann, Pien Haase, Inez ten Brink

For Samsung Bioepis
Simmons & Simmons (Amsterdam): Bas Berghuis van Woortman, Machteld Hiemstra (both partners); associate: Bouke Algie