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NL – Sun v. Novartis / No skinny label injunction

03 Dec 2015

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.

Contrary to the ruling of the District Court in preliminary proceedings, the English High Court (Arnold J) and the English Court of Appeal (Floyd LJ) the Court is of the opinion that Novartis’ claim for priority on the basis of US 689 is justified, which keeps potentially novelty destroying (targetted at claim 7) document Reid in the prior art. Sun did not bring forward any independent arguments which could lead to a unfounded claim of priority for claim 1 to 6. The new arguments in this respect, which have only been produced by Sun not earlier than during the oral hearing, were not accepted a contrary to the principles of due process.

Alos Sun’s claim for lack of inventive step (re claim 7) was dismissed. The Court ruled that WO 421 is not the most promising spring board, but if it were, the skilled person would not come to the invention without inventive step, beacuse the prior art does not contain any pointers for applying specific zoledronic acid for the treatment of osteoporosis by intravenous application in a dosing range of 2-10 mg and a interval of a year. Sun’s new inventive steps arguments as brought forward only for the first time during the oral hearing, which were based on prior art document ‘The Pink Sheet’ as closest prior art, were not accepted as contrary to the principles of due process.

Read the decision (in Dutch) here.