UPC CFI 681/2024

Myriad's test kits do not perform the patented three-step normalization method of claim 1 of EP 3 346 403

Hinweis: Court accepted that the accused products use a single-step average normalization across three reference genes, which differs from the patent's required sequential normalization against each individual reference gene; the method therefore does not embody the technical teaching.

Late-filed argument that the calculation is mathematically equivalent to the patented method must be disregarded

Hinweis: Claimant's novel mathematical-equivalence argument raised for the first time at oral hearing was excluded as late-filed; defendants had no opportunity to respond.

Revocation counterclaim: EP 3 346 403 lacks validity

Hinweis: Patent was revoked in full for all seven requested territories (AT, BE, FR, DE, IT, LU, NL); the excerpt's outcome summary confirms revocation although detailed grounds are not in the visible excerpt.

Accused test kits directly infringe claim 1 because the average normalization is mathematically identical to successive per-gene normalization

Begründung: Mathematical identity of results does not equate to use of the claimed method; the actual configuration (single-step average) is decisive, and the patented method requires further steps not performed by the accused product.

Indirect infringement: the test kit is suitable and intended for the patented method using OAZ1 alone as reference gene

Begründung: Claimant did not argue that the test kit, despite its materials and reagents, is suitable and intended for normalization against OAZ1 alone; indirect infringement therefore ruled out.

Genes CALM2 and RPL37A can serve as further reference genes under the patent's multi-reference-gene reading

Begründung: The patent itself identifies CALM2 and RPL37A as candidate reference genes rejected for insufficient expression stability; using them as reference genes falls outside the claim's scope.