Gilead Wins Landmark UPC Ruling: Remdesivir Use Patent Revoked

On May 4, 2026, the Milan Central Division of the Unified Patent Court (UPC) issued a landmark judicial ruling, completely revoking European Patent No. EP 3854403 held by the Academy of Military Medical Sciences of China. This ruling renders the pharmaceutical use patent for remdesivir in the treatment of COVID-19 infections invalid in all UPC contracting states.

According to information, the priority date of the involved EP 3854403 patent is January 21, 2020. It was officially granted by the European Patent Office (EPO) on June 18, 2025. The core scope of protection of the patent is the specific use of remdesivir for treating novel coronavirus infections, representing a typical innovation of a second medical use for a known compound. The litigation was initiated by the original developer of remdesivir, U.S.-based Gilead Sciences, Inc. On the very day the patent was granted, Gilead simultaneously filed a revocation action against the patent with the UPC and commenced opposition proceedings with the EPO, thereby initiating its defense of rights.

During the case proceedings, the Academy of Military Medical Sciences submitted its defense arguments in August 2025 and attempted to amend the patent. However, this amendment request was lawfully dismissed by the court in March 2026. Following a public oral hearing in April, the court ultimately issued a final first-instance judgment on May 4, declaring the patent entirely invalid.

As a high-value pharmaceutical patent dispute, this case involves significant commercial implications. The court ultimately determined the disputed value of the patent to be as high as €20 million. This valuation referenced the actual sales volume of the original remdesivir drug in Europe and did not accept the defendant’s low-value claim of several thousand euros based on patent application costs. Concurrently, the parties negotiated and confirmed the first-instance court fees for this case at €800,000. Pursuant to the principle that the losing party bears the costs, these fees are ultimately to be borne by the Academy of Military Medical Sciences.

The core basis of the court’s ruling is that the patent in question lacks the inventive step required under patent law, which was also the central point of contention in this decision. Upon examination, the court found that prior to the patent’s priority date, substantial public academic literature had already explicitly indicated that remdesivir possessed inhibitory effects against the SARS virus and various bat coronaviruses. Based on the homologous nature of the viruses, it was generally predictable in the field that this drug could also be used to treat the novel coronavirus that emerged in 2020.

The court held that, considering the technical context of the publicly available COVID-19 genome and its high degree of similarity to the SARS virus, a person skilled in the art could, based on the existing public research results, form a reasonable expectation of success regarding the efficacy of remdesivir in treating COVID-19. Confirmation of the efficacy would require only routine experimentation, without the need for inventive effort. Therefore, the claimed invention did not satisfy the core inventive step requirement for patent grant. Furthermore, the court also dismissed several other invalidity grounds raised by Gilead, revoking the patent solely on the basis of lack of inventive step.

This ruling solidifies Gilead’s dominant position in Europe. As the judgment remains within the appeal period, China Intellectual Property Lawyer Network will continue to monitor subsequent developments.