Dutch diverge with English as Novartis prevails on Zoledronic Acid in Netherlands

This Kat was delighted to receive from Katfriend Rutger M. Kleemans (Freshfields Bruckhaus Deringer LLP, Amsterdam) the following news:

Rutger Kleemans

On 27 January the Hague Court of Appeal (judges Kalden, Brinkman and Van Nispen) ruled in summary proceedings in a case between Novartis AG and Sun Pharmaceutical Industries BV. The case is about indirect infringement by a so-called skinny label. Novartis’s patent EP 689 is of the Swiss type and discloses the use of zoledronic acid for the treatment of osteoporosis, administered intravenously in a unit dosage form of 2-10 mg where the period of administration is about once a year. Sun was marketing zoledronic acid in an identical dosage form but approved only for use in Paget’s disease, which indication is not covered by EP 689. The Court of Appeal granted Novartis an injunction (4.38)

“given the justified interest of Novartis to act against indirect infringement of its patent rights” which amongst others”

forbids Sun to commit indirect infringement” on pain of an immediately eligible penalty sum. The same patent was previously held invalid by the UK Courts for lack of novelty as a result an invalid priority right in Novartis v Hospira (see [2013 EWCA 516 (Pat.) and [2013] EWCA Civ 1663). Concerning the UK decisions, the Hague Court of Appeal states (4.3): 

“Departing from the said criterion the Court of Appeal, other than the judge in summary proceedings and the English High Court and Court of Appeal, partly because of different insights (more in particular after reading of the priority document) and partly because of other arguments of parties…”.

Now this is jolly interesting, thinks this moggy. First, as mentioned above, the Dutch Court has disagreed with the Courts of England and Wales on the matter of priority entitlement and hence validity (for which see Katpost here for the first instance and here and here for the appeal judgment).  But also, the judgment appears in stark contrast to the case last week where Arnold J permitted Actavis to launch a product (pregabalin) with a skinny label without requiring further measures such as overpackaging that were demanded by Pfizer; whereas here the Dutch court finds Sun Pharmaceutical guilty of indirect infringement despite the skinny label referring only to Paget's disease and not osteoporosis.

In fairness, the prescribing and dispensing systems are different between the England/Wales and the Netherlands, and there are other factual differences between the cases. For example in the Dutch case Sun had won a tender to be the exclusive supplier of zoledronic acid 5mg/100ml for the healthcare insurer VGZ.   The different outcome is not therefore necessarily to be seen as indicative of a divergent judicial approach to the efficacy of skinny labels to avoid patent infringement.

You can read the Hague Court of Appeal decision here (in English) and here (in Dutch).