Novartis v Sun Pharmaceutical: A battle over second medical use patents

Michiel Rijsdijk, Arnold + Siedsma, World Intellectual Property Review January/Februari 2016: "In January 2015 the Court of Appeal held Sun liable in preliminary proceedings for indirect infringement of Novartis’s ‘689 patent despite the carve-out of the osteoporosis indication from the summary of product characteristics and patients information leaflet. The Court of Appeal considered that Sun supplied too much of its zoledronate product in view of the size of the patient population for Paget’s disease. Sun knew that its product was being used for the protected indication osteoporosis and had not taken sufficient action to prevent infringement further down the distribution chain.

On November 25, 2015, the District Court of The Hague disagreed with the appeal court’s decision in final relief proceedings. The district court concluded that there was no indirect infringement of the Swiss-type second medical use claim. The Novartis case concerns purpose-limited process claims, which comprise the distinctive element “in the preparation of a medicament”.

According to the district court, there is no other way to read this sentence in view of article 73 of the Dutch Patent Act. Sun’s product is a so-called ready product: after Sun’s supply of the medicament, no-one is actually applying the claimed process, ie, ‘the preparation’, since no wholesaler or pharmacist will use zoledronate to prepare a pharmaceutical composition. Novartis claimed that the ‘preparation’ should be considered the same as providing a purpose to the product. This is not the case, according to the district court, since a Swiss-type claim is considered a purpose-limited process, not like an EPC 2000 claim. Therefore, a ready-to-use product cannot be regarded as an essential component of an invention defined in a Swiss claim.

The dispute will continue with the question of whether generic suppliers can be accused of direct infringement. The district court, probably inspired by judgments of the English High Court, granted Novartis the opportunity to substantiate its claim further (the English court had decided accordingly in a similar dispute). The district court itself did not exclude the possibility of direct infringement."

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