Swiss pharmaceutical major Novartis AG has been denied an Indian patent for an oral drug combination- led by a Renin inhibitor – meant to treat mild-to-moderate hypertension, citing lack of inventive step.
The patent for the triple drug combination, comprising Aliskiren (a Renin inhibitor), Amlodipine and Hydrochlorothiazide (HCTZ), was filed in 2007 as a national phase divisional application at the Chennai Patent office.
Renin inhibitors are drugs used primarily in treatment of essential hypertension or high blood pressure.
J Meena, assistant controller of patents & designs, Chennai, while rejecting the patent application by Novartis, said the Renin inhibitor compound formula and its use are disclosed in the prior documents available in the public domain.
According to the patent office, a person skilled in the art while reading a patent application will expect convincing experimental data in support of a superior efficacy or surprising effect of a claimed combination of known pharmaceutically active agents, especially in a case like the present wherein binary combinations of the ingredients of a triple combination are already known in the art.
“Otherwise, it would not seem credible to him that the combination presented in the application indeed possesses advantages or even surprising synergistic effects in comparison with the single compound of the combination or with the binary combinations which are already in the known art. Any combination with three components with specified compounds selected from each groups would only be an arbitrary selection and such selection cannot involve an inventive step,” the assistant controller said.
The patent office has further said the the company has not provided any data for any findings of any beneficial, synergistic or therapeutic effect. There is no disclosure in the complete specification to support the claimed benefits, the assistant controller said.
