2026-05-04 - CD Milan - Gilead Sciences v. Academy of Military Medical Sciences - UPC_CFI_552/2025
- Aktenzeichen:
- UPC_CFI_552/2025
- Datum:
- Spruchkörper:
- Court of First Instance - Milan (IT) Central Division- Section
- Art:
- Final Decision
- Parteien:
- Gilead Sciences, Inc. v. Academy of Military Medical Sciences
Kernaussage: ENGLISH:
2026-05-04 - CD Milan - Gilead Sciences
v.
Academy of Military Medical Sciences - UPC_CFI_552/2025
ENGLISH:
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.
landmark
The Central Division Milan seat (Postiglione presiding, Knijff LQJ, Dorland-Galliot TQJ) revoked EP 3 854 403, AMMS's 'further medical use' patent on Remdesivir (GS-5734) for treating SARS-CoV-2 / COVID-19 infections, in its entirety for all UPCA Contracting Member States. Applying the CoA's holistic inventive-step framework from Amgen v Sanofi (UPC_CoA_528/2024) and Meril v Edwards (UPC_CoA_464/2024) and confirming that the problem-solution approach reaches the same outcome, the panel held that two Sheahan publications of 10 January 2020 (HRM 09 commentary and HRM 10 editorial), eleven days before the 21 January 2020 priority date, were realistic starting points (and equivalently the 'closest prior art') because they expressly identified Remdesivir as a likely active agent against the newly emerging SARS-CoV-2 within the broader pan-coronavirus context. The decision establishes three important normative propositions about the person skilled in the art (headnotes 1-3): the skilled person is a notional figure free of any corporate affiliation; the skilled person is objective and rational, does not display fear of failure, and would not reject a solution on subjective concerns absent documented prejudice; and 'reasonable expectation of success' is an objective concept grounded in scientific data — distinct from a mere subjective 'hope of success' — increasing with the realism of the starting point and following T 207/94. Applying these standards, the panel found that the skilled person would have had a high expectation of success on the basis of pan-coronavirus structural conservation of the RdRP (≈95-98% homology), Remdesivir's documented efficacy against SARS-CoV-1 and MERS-CoV (HRM 11 Sheahan 2017, HRM 16 Agostini 2018, HRM 12, HRM 13), and the explicit Sheahan suggestion in HRM 09/10 that 'remdesivir works against SARS and SARS-like viruses…and is likely to work against coronaviruses that are emerging now in Wuhan'. The insufficient-disclosure attack on the undefined phosphorus stereochemistry in claim formula I was rejected because isomeric separation by chiral HPLC is CGK and the patent description teaches the relevant formulations. The patent's main and 8 auxiliary requests were dismissed; costs of EUR 800,000 (agreed by the parties) and value of EUR 20 million (based on Veklury European sales of ~$284M in 2024) were set.
Nichtigkeitsgründe
Art. 138 EPCInventive Step
Patent invalid (this ground)Art. 56 EPC · Art. 138(1)(a) EPC
“Patent revoked for lack of inventive step over HRM 09 / HRM 10 as realistic starting point; skilled person had a high reasonable expectation of success based on pan-coronavirus RdRP conservation and prior Remdesivir efficacy against SARS-CoV-1 and MERS-CoV [82]-[135].”
Insufficiency of Disclosure
Patent survived (this ground)Art. 83 EPC · Art. 138(1)(b) EPC
“Claimant's insufficiency attack on phosphorus stereochemistry rejected — chiral HPLC isomeric separation is CGK (Exhibit 48); description teaches preparation of formulations [71]-[78].”
Priority
Not decidedArt. 87 EPC · derivative
“Claimant's alternative argument that 'SARS-CoV-2' in granted claim 1 differs from '2019-nCoV' in priority document rejected on construction — patent's own lexicon equates them; priority validity not separately decided [69], [70].”