EPO Boards for Appeal (T 0209/22)
3 June 2024
A recent case at the EPO Boards for Appeal (T 0209/22) demonstrates an important distinction between “direct and unambiguous disclosure” (for novelty), and credibility that the treatment effect is attained (for sufficiency) for the medical use of known products at the EPO. “Hope to succeed” versus “expectation of success” was also assessed for demonstration of inventive step.
Key points in this case include:
i) Novelty
A phase one clinical trial of the drug combination in healthy volunteers (and the trial summary protocol) did not anticipate the claimed therapeutic use.
ii) Sufficiency
The patent described therapeutic data for agents as monotherapies, in addition to the clinical trial in healthy volunteers showing that the combination was well-tolerated.
To meet the requirement of sufficiency of disclosure, it is not always required that achieving the technical effect in question should be “directly and unambiguously” disclosed in the application as filed. Instead, the relevant standard is that achieving the technical effect in question has to be credible.
The data was considered sufficient to show the suitability of the combination to achieve the therapeutic effect and dosage.
iii) Inventive step
“Hope to succeed” from preclinical data does not amount to “reasonable expectation of success”.
Neither agent used in combination had been established for the treatment of patients. Safety, efficacy and duration of action was to be established at the effective date of the patent.
Favourable preclinical data does not necessarily provide a “well-founded expectation of success”, particularly when neither combination agent had progressed to a clinical stage of development.
Abbie Fisher
Life Sciences & Chemistry group
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP June 2024
