Posted: August 8th, 2019
Novartis Pharma A.G., Novartis Pharmaceutical AG and Novartis AG v. TEVA Nederland B.V., District Court The Hague, The Netherlands, Judge in Interlocutory Proceedings, 5 July 2019, Case No. ECLI:NL:RBDHA:2019:7792
Teva holds a Dutch marketing authorization for the generic version of everolimus, named Everolimus Teva. In the SmPC and and the Patient Information Leaflet of Everolimus Teva, it is stated that everolimus in combination with exemestane is indicated for the treatment of hormone receptor positive advanced breast cancer.
Novartis invokes EP 603 and EP 246 and requests an injunction against Teva for medicines containing everolimus that are indicated for hormone receptor positive advanced breast cancer, or -alternatively-, that Teva is ordered to remove the indication hormone receptor positive advanced breast cancer from the marketing authorization.
The injunction is denied as the PI judge rules that there is a real and serious chance that the invoked patents will be held invalid in proceedings on the merits (or in opposition / appeal proceedings at the EPO) as it is sufficiently plausible that the man skilled in the art would have tried the combination of everolimus and exemestane / aromatase inhibitor with the expectation that this would work in treating breast cancer.
A copy of the judgment (in Dutch) can be read here.