Patent application refused to Wockhardt for skin care drug

It was refused because the drug was found incapable of industrial application

The Patent Office has refused a patent application to Indian drug major Wockhardt Ltd for its skin care drug Nadifloxacin, stating that it does not meet the requirements to qualify as an invention involving inventive steps and capable of industrial application.

The application for its invention titled "improved process for intermediate of Nadifloxacin" containing three claims was filed on April, 2007. A first examination report with objections was issued on June, 2013, for which the company has filed its response in January, 2014.

However, the examiner observed that the submissions and the observations given by the company were not satisfactory enough to meet the requirements of the Act. The patent office said that the requirement of inventiveness and Section 3(d) of the Patents Act, 1970 have not been met.

The section specifies that, "the mere discovery of a new form of a known substance which does 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."

It added that before proceeding to dispose of the application, as per the provisions, a hearing was fixed on January 2, 2015, providing an opportunity to the applicant to be officially heard by the Controller before any adverse order. The company did not attend the hearing or filed any reply, it said.

"...Therefore I conclude that the alleged invention as claimed in the instant application does not meet the requirements of Section 2(1) (j) of the Patents Act 1970 as amended," said the order. As per the section, "invention means a new product or process involving an inventive step and capable of industrial application."

According to earlier reports, in June 2006, the Patent Office has rejected an application for product patent to Wockhardt for nadifloxacin, sold under the brand Nadoxin, after a pre-grant opposition was filed by Mumbai-based Cipla Ltd. The drug received five years of exclusive marketing rights (EMR) during December 2003, from the patent office, and Wockhardt then claimed that it was the first domestic pharmaceutical company to receive an EMR grant. Another generic major Hetero Drugs, then approached the Court challenging the constitutional validity of the grant of EMR, among other grounds. Multinational drug major Novartis' Glivec was another drug which received EMR before that.