Gilead Sciences v. Academy of Military Medical Sciences, UPC Central Division Milan, 4 May 2026, Case no. UPC_CFI_552/2025
Upon request by Gilead, the Milan Central Division revoked due to lack of inventive step a patent held by AMMS, covering the second medical use of remdesivir for the treatment of a disease or infection caused by SARS-CoV-2.
Remdesivir at the priority date was known to have an antiviral activity against a diverse panel of viruses. Ten days before the priority date, a leading virologists published a commentary in which he stated that remdesivir was likely to work against the novel SARS-CoV-2.
Headnotes:
1. The person skilled in the art, outlined in Art. 56 EPC, is a notional figure who represents an average level of knowledge in a specific technical field and whose knowledge reflects the common general knowledge (CGK) at the priority date. This fictitious individual cannot be identified with any real person working in the technical domain of the invention. The skilled person is not required to possess (or disregard) a distinct affiliation, nor is it necessary; therefore, differentiating characteristics such as connections to a specific company are not admissible.
2. The person skilled in the art is an objective, rational figure who does not display fear of failure. The defendant incorrectly projects subjective attitudes onto this notional individual by likening them to Prof. XXXX. The skilled person questions information only when documented prejudice exists in relevant literature, and it is the party’s responsibility to highlight proven flaws. Simply suggesting unexpected outcomes is inadequate. Recognising that risk and doubt are part of scientific progress, the skilled person would not reject a solution due to subjective concerns about possible failure.
3. The difference between an expectation of success and a mere hope of success does not depend on the researcher’s subjective state of mind. There is a reasonable expectation of success when the scientific data or experiments indicate that the tested solution can yield a positive result, despite the general uncertainty arising from the necessary experimentation and the application of the scientific method. A reasonable expectation of success is therefore based on reason and knowledge of scientific data, even though the expert knows that the outcome is never certain until it is the subject of
clinical trials. Therefore, it can be said that the greater the realism or reasonableness of the starting point, the greater the expectation of success. Hope for success, on the other hand, arises when the result is based on sheer assumptions or there is a contradiction in the sources, so that the outcome is considered possible but not reasonable.
A copy of the Decision can be read here.
