Patent refused to Novartis on anti-diabetes formulation

Company has been engaged in litigation with some Indian companies on a patent for Vildagliptin

The Patent Office (PO) in Delhi, has refused to grant a patent for an application of Novartis, the Swiss pharmaceutical company, for a modified release formulation of its diabetes drug, Vildagliptin, which it markets under the brand name of Galvus.

Novartis has been engaged in litigation with some Indian companies on a patent for Vildagliptin in this country.

The company filed an application with the PO in November 2007.

A request for examination of the application was filed by its agent in July 2008.

The First Examination Report (FER) was issued in end-May 2012, raising objections against some of the claims in the application. The company responded in May 2013.

The examiner, after perusal of the response, said these were not satisfactory enough and raised some objections after further re-examination. The PO, after a request from the company, gave an official hearing in May 2014. Rajesh Dixit, assistant controller of patents and designs, Delhi, has said in his order that the claims failed to meet the requirements under Section 2(1)(j) of the patent law, which says an invention means a new product or process involving an inventive step and capable of industrial application. The company also failed to meet the requirements of Section 3(d) and 3(e) of the Act, he said. So, a grant of patent was refused.

Section 3(d) of the Patents Act said the mere discovery of a new form of a known substance, which did not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant, is not an invention within the meaning of the Act. Section 3(e) states a substance had by a mere admixture, resulting only in the aggregation of the properties of the components thereof, or a process for producing such a substance, is not an invention within the meaning of the Act.