29 January 2025

T 1390/22 - Novelty of 2nd medical use based on omitting diagnostic step

Key points

  • "Claim 1 as granted [reads]: "[pibrentasvir] thereof for use in a method of treatment for HCV, comprising administering an effective amount of Compound 1 or a pharmaceutically acceptable salt thereof to an HCV patient, regardless of the specific HCV genotype(s) that the patient has, wherein said patient is not genotyped for said treatment."
  • "The assessment of the HCV genotype in treatment of HCV prior to the administration of antiviral therapy was standard practice at the time of the priority date for the patent. Document D19 indicates that such assessment formed part of the standard of care in order to select the appropriate type of antiviral therapy, including the dose of the medication and the duration of the treatment"
  • "The intentional omission of the HCV genotyping as defined in claim 1 of the main request therefore represents a technically meaningful characteristic of the defined therapeutic treatment."
  • "It follows from the considerations in G 2/08 (see Reasons 5.10.9), which refer to the wording "any specific use" in Article 54(5) EPC and confirm the seamless fit between the exclusion from patentability of methods of treatment by therapy and the special provisions regarding the novelty of a substance or composition for use in such a method, that this technically meaningful characteristic of the defined therapeutic treatment involving the use of pibrentasvir is suitable to characterize the claimed subject-matter in terms of a specific use as intended in Article 54(5) EPC."
EPO 
The link to the decision and an extract of it can be found after the jump.


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