Patent for anti-hypertension combination drug Valturna revoked

The Indian Patent Office lately revoked the Patent Number IN212199 issued to Novartis claiming single-pill combination of aliskiren and valsartan marketed as Valturna. The patent was revoked after Novartis failed to overcome the post-grant opposition filed by Sun Pharmaceuticals Ltd. The decision is yet another case where combination claim was found lacking inventive step on the ground of ‘obvious-to-try’. Interestingly, one of the grounds of revocation was lack of enablement and best method requirements as none of the examples exemplified the combination of aliskiren and valsartan. More interestingly, another ground of revocation was lack of sufficiency of disclosure as one of the dependent claims used the generic name ‘aliskiren’ but the whole specification disclosure nowhere used the generic name. Complete review of the decision can be read here.