Sun’s Indian Nilotinib Plans Blocked By Novartis
Firms Battle Over Tasigna Intellectual Property
Novartis thwarts Sun’s efforts to commercialize nilotinib in India, though the Indian firm indicates that its actions are covered under a local Bolar-type provision and that it has no plans to market the oncology drug while the originator's patent stands valid.
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The Delhi High Court has rejected Bayer’s contention around certain key aspects of India’s Bolar provision – the experimental use or early working exception – and held that “sale” both within the country and abroad is permitted under these norms, subject to certain conditions.
Sun Pharma has launched its generic version of Novartis' blockbuster anticancer Gleevec (imatinib mesylate) in the US at a savings of around 30%, putting the spotlight on the specialty segment which is probably, for the first time, witnessing genericization of such a high cost therapy.
More patent-related turbulence appears ahead for Novartis’s sacubitril/valsartan combination in India, with Torrent emerging as the new challenger. The companies are engaged in a legal battle and the Indian firm is also seeking a revocation of the patent on the star heart failure treatment.