UPC Milan Revokes Remdesivir Patent for Lack of Inventive Step, Drawing Sharp Distinction Between Reasonable Expectation and Mere Hope of Success
Key Insights
The UPC Central Division in Milan revoked the Academy of Military Medical Sciences (search)' Remdesivir patent (EP 3 854 403) for treating SARS-CoV-2 (search) infections, finding it lacked an inventive step.
The court applied the holistic approach from Amgen v. Sanofi/Regeneron, ruling that prior art explicitly recommending Remdesivir gave the skilled person a high expectation of success, not mere hope.
The decision draws a sharp distinction between "reasonable expectation of success" (supported by scientific data) and "mere hope of success" (based on sheer assumptions).
On May 4, 2026, the Unified Patent Court (UPC) Central Division in Milan revoked European patent EP 3 854 403 in its entirety, dealing a decisive blow to the Academy of Military Medical Sciences (search) (AMMS). The patent claimed the use of Remdesivir for treating SARS-CoV-2 (search) infections and carried a priority date of January 21, 2020—shortly after the virus was sequenced but before the WHO declared a public health emergency. Gilead Sciences filed its revocation action on the very date the patent was granted, June 18, 2025.
The Court's Inventive Step Analysis
The Milan Central Division dismissed AMMS's insufficiency of disclosure attack but found the patent lacking in inventive step. Applying the holistic approach established in Amgen v. Sanofi/Regeneron (UPC_CoA 528/24), the court determined that the objective technical problem was identifying a drug with antiviral activity against SARS-CoV-2 (search).
Prior art publications explicitly recommending Remdesivir proved decisive. The court noted that Remdesivir was already known as a broad-spectrum antiviral effective against SARS-CoV-1 and MERS-CoV through inhibition of the highly conserved RdRP (search) enzyme. This body of prior art, the court held, gave the skilled person a realistic starting point with a high expectation of success.
Reasonable Expectation vs. Mere Hope
In a significant doctrinal contribution, the court drew a sharp distinction between a "reasonable expectation of success" and a "mere hope of success," holding that this distinction does not depend on the researcher's subjective state of mind.
A reasonable expectation of success exists when scientific data or experiments indicate that a tested solution can yield a positive result, despite the general uncertainty arising from necessary experimentation. Hope of success, by contrast, arises only when a result is based on sheer assumptions or contradictions in the sources.
The court described the skilled person as "an objective, rational figure who does not display fear of failure," rejecting AMMS's attempt to attribute subjective caution to this notional individual.
Rejection of AMMS's Arguments
The court also rejected arguments that prior art publications were merely "promotional" because they originated from Gilead-associated researchers. It held that speculation about industry funding cannot undermine the credibility of peer-reviewed scientific work.
Broader Implications
The decision provides further illustration of the UPC's holistic approach to assessing inventive step and reinforces the evidentiary standards expected of patentees. Gilead's parallel EPO opposition remains pending, leaving open the possibility of further developments in the European patent landscape for this high-profile COVID-19 therapeutic.