Homburger represented Sandoz in Federal Patent Court cross-border preliminary injunction proceeding over aflibercept biosimilar Afqlir®

Homburger successfully represented Sandoz Group AG, Sandoz AG and Sandoz Pharmaceuticals AG in a landmark preliminary injunction proceeding before the Swiss Federal Patent Court (FPC), defeating claims brought by Regeneron Pharmaceuticals and Bayer in connection with Sandoz’s aflibercept biosimilar Afqlir®.

Regeneron Pharmaceuticals and Bayer had invoked European Patent EP 2 364 691 B1 – a formulation patent – to seek injunctive relief against Sandoz, not only in Switzerland but across 19 additional European jurisdictions.

The FPC dismissed the requests in their entirety, holding that Afqlir® does not infringe the patent, neither literally nor under the doctrine of equivalents.

The decision is significant in several respects, including the following:

First application of the doctrine of equivalents to multiple interdependent claim substitutions. Afqlir® departs from the asserted patent claims in several interrelated formulation features simultaneously. In a novel analytical step, the FPC declined to assess each substitution in isolation and instead applied the three-question Pemetrexed equivalence test to the totality of the bundled differences. The Court concluded that a skilled person would have no reasonable expectation that the substituted features, taken in combination, achieve the same effect as the claimed feature combination. This is understood to be the first Swiss decision in which the second question of the equivalence test – foreseeability of the same effect – proved decisive, and in which equivalence was denied precisely because of the interdependence of multiple differing features.

First-ever cross-border preliminary injunction case in Switzerland. Regeneron Pharmaceuticals and Bayer sought to obtain, in a single Swiss proceeding, injunctive relief covering not only Switzerland but the national parts of the asserted European patent in 19 further European countries – a scope of relief never before attempted in Switzerland. Drawing on the CJEU’s rulings in Solvay/Honeywell (C-616/10) and BSH/Electrolux (C-339/22), the FPC accepted jurisdiction to assess infringement across all 20 countries, relying on the uniform application of Article 69 EPC and its Protocol across EPC contracting states. Because infringement was denied, the FPC fully dismissed Regeneron Pharmaceuticals’ and Bayer’s requests.

The FPC’s decision of July 17, 2026 (case no. S2025_003) is available on the FPC’s website (www.bundespatentgericht.ch).

The Homburger team was led by Andri Hess and included Julian Schwaller (both IP / IT).