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India's image as the generic capital of the world has been further bolstered after leading drug maker Roche lost an Indian patent for breast cancer drug Hereceptin as it didn't comply with the local rules for a patent. The drug maker had filed for a patent in October 2000 and was granted a patent on April 6, 2007 but faced a post grant challenge.
Indian government officials rubbished reports that the company's patent had been cancelled and instead said that the company had lapses during the procedure.
'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. (Read:Generic drugs: All you need to know)
Since the applicants didn't follow the proper steps the request for a patent was withdrawn. 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squarely on the pharmaceutical major, the ministry said: 'If the requests are not filed within time they are treated as withdrawn under section IIB(4) of the (Indian Patents) Act'.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. (Read: India vs Big Pharma: The grand battle)
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 Under these circumstances, the controller ordered that the application should be treated as withdrawn.'