Drug: EXJADE®  deferasirox

Novartis has obtained an order prohibiting the Minister from providing an NOC to Teva for EXJADE®. At the hearing, the issues were narrowed by Teva who alleged the patent was invalid for inutility, obviousness and insufficiency.

The Court declined to find a single explicit and overarching promise that the compounds described in it have been found to be useful in treating iron overload disorders in humans. Instead, the promise of the compound claims was found to be more modest: the compounds markedly bind to iron, are soluble and induce excretion of iron in animal tests. Although Teva’s promise was a possible construction, it was not found to be the most likely.

On the other hand, the claims to the use to treat humans were considered to contain an explicit promise of a specific result. This was not found to have been demonstrated or soundly predicted as of the filing date, and therefore the use claims fell.

The patent was also not found to be obvious. Some of the alleged prior art was found to have been published in obscure journals and likely would not have been located by the skilled person looking for iron chelators. In any event, although it was possible some of the prior art compounds could have bound to iron, it would not be obvious that they would do so. The Court also noted that the inventors spent many years testing hundreds  of compounds. This also suggested to the Court that the inventive concept was far from obvious, and there was nothing in the prior art that would suggest that this class of compounds was even obvious to try.

Lastly, the patent was found to be sufficient. The Court found that the patent described the invention and told the skilled person how to put it into practice. Although a rat died after taking one of the claimed compounds, there was no evidence that the compound was toxic. In the absence of evidence of toxicity, the Court held that the inventors had no obligation to inform the skilled reader about that isolated event.