Sandoz fends off PI over Eylea at Higher Regional Court Munich

In early January, the Regional Court Munich granted a PI to Regeneron and Bayer. This prohibited Stada, Sandoz/Hexal, Celltrion and Advanz Pharma from marketing their biosimilar containing the active ingredient aflibercept. This forms the basis of Regeneron’s ophthalmic drug Eylea, used to treat neovascular (wet) age-related macular degeneration and diabetic macular oedema.

The US patent holder and its European licensee Bayer are vigorously defending EP 2 364 691. The patent covers a specific formulation of the active ingredient aflibercept, including certain toning agents, stabilisers, buffers and co-solvents. After the SPC(DE 12 2013 000 041.4) for a key substance patent expired last November, EP 691 could guarantee patent protection and thus market exclusivity for Eylea until June 2027.

In February 2026, the Higher Regional Court in Munich provisionally suspended enforcement of the first instance judgement in favour of Sandoz and its German subsidiary Hexal. Earlier this week, a further interim order was issued in which the court cited the lack of urgency. Subsequently, Regeneron and Bayer withdrew their PI application (case ID: 6 U 180/26 e).

Parallel proceedings in the dispute over EP 691 between Regeneron/Bayer and Sandoz/Hexal are pending in Switzerland and Austria.

Multiple settlements

Regeneron meanwhile came to a settlement with most of the other generic companies. In a recent press release, Formycon announces its settlement with the patent holder covering key markets in Europe, Latin America and the Asia-Pacific region.

Iceland based biosimilar producer Alvotech also announced a settlement with Regeneron. This affects the distribution partners in Europe — Stada, Advanz Pharma and Biogaran — as well as Fuji Pharma in Japan.

Samsung Bioepis also settled, as confirmed by a press release. Subsequently, earlier this month the Korean company withdrew a nullity suit they had launched at the German Federal Patent Court (case ID: 3 Ni 15/23).

Market launches of these generic products across Europe will start in April and May.

One generic company left

Bayer and Regeneron once more retained a team from Hoyng ROKH Monegier. Düsseldorf-based partner Christine Kanz took the lead. Sebastian Kratzer, Valentin Wagner, Max von Leitner and Clara Martinez Berrisch assisted. Patent attorneys Tung-Gia Du and Claudia Hertzsch provided technical support. They worked with patent attorney Gregor König of Hoffmann Eitle.

Sandoz and Hexal relied on IP boutique Pentarc. Munich based partner Jan Philip Rektorschek advised Hexal, with support from Julius Zacharias. They cooperated closely with in-house counsel Katie Rooth of Sandoz.

In the first instance, another Pentarc team around Anja Lunze had represented Stada.