Sun Pharmaceutical Industries (Europe) B.V. v. Novartis AG and Novartis Pharma GmbH, District Court of The Hague, The Netherlands, 25 November 2015, Case file number: C/09/469148 / HA ZA 14-770.
In January of this year the Court of Appeal of The Hague in preliminary injunction proceedings held Sun liable for indirect infringement of Novartis’ Swiss type claim on (in short) the use of zoledronic acid in a specific dosage range, form and regime for the treatment of osteoporosis, despite the fact that Sun was marketing its generic zoledronic acid under a skinny label on which the patented indication was carved out.
In these proceedings on the merits the District Court ruled otherwise. The District Court established that the claims which have been invoked by Novartis are ‘purpose limited process claims’ which comprise the distinctive element ‘in the preparation of a medicament’. In the chain after the supply of the medicament by Sun no one is actually applying the claimed process, i.e. ‘the preparation’.
Novartis’ reasoning that applying the claimed invention, ‘manufacturing’ should be considered the same as providing a purpose to the medicament (product) only holds ground if a Swiss type claim is considered as ‘a purpose limited product’, which is true for EPC 2000 claims, but not for the claims as invoked by Novartis in these proceedings. Therefore the Court rules that there is no indirect infringement.
The court grants Novartis the opportunity to further substantiate its claim for direct infringement and Sun is allowed to respond and to substantiate its defense to the alledged direct infringement claims of Novartis.