Swiss pharma major Roche Holding lost an Indian patent for breast cancer drug ‘Herceptin’ as it did not comply with local norms after facing a post grant challenge, the government said today.
Roche had filed for patent of ‘Herceptin’ on October 11, 2000 and was granted a patent on April 6, 2007 but faced a post grant challenge.
Following it, according to the Ministry of Commerce and Industry, the Controllers of the Patent Office gave the company opportunity under three applications filed by it “of being heard before the final disposition of these cases”.
Rubbishing reports that Indian government has revoked the company’s patent, the ministry said it had lapsed due to the procedural delays on part of the Swiss company.
“Before the Controllers issued their decisions, the applicants were given due opportunity of being heard but the applicants have chosen not to attend.”
“It is submitted that in the instant cases, the Patent Office has followed the due course of principle of natural justice, gave the applicant the opportunity of being heard and then only finally disposed of the matter,” the ministry said in a statement.
In the instant cases, it is found that proper steps for filing request or filing divisional applications were not followed by the applicants, it added.
Comments from Roche could not be obtained as an e-mailed query remained unanswered.
Putting the blame squarely on the pharmaceutical major, the ministry said: “If the requests are not filed within time they are treated as withdrawn under section IIB (4) of the (Indian Patents) Act”.
Elaborating how the company had failed to adhere to deadlines, the ministry said “the patent controller found that the Request for Examination had been filed on 17.03.2006, i.e., beyond the prescribed period (which was due on 16.02.2006)” as per the Indian patent norms.
It further said two separate dates were given to the company this year by the controller to hear its case but “the agent of the applicant did not appear in the hearing and even did not submit any notes of argument. Under these circumstances, the controller ordered that the application should be treated as withdrawn.”