Govt says Roche didn't follow norms for cancer drug patent
The government today said it had "treated as withdrawn" patent applications by Swiss pharma major Roche Holding for offshoot medicines of its breast cancer drug 'Herceptin' because the company did not comply with local norms.
New Delhi: The government today said it had "treated as withdrawn" patent applications by Swiss pharma major Roche Holding for offshoot medicines of its breast cancer drug 'Herceptin' because the company did not comply with local norms.
Three divisional applications by the company for its sub-inventions of Herceptin "have not been revoked but were treated as withdrawn" because they were not filed within the prescribed time or incorrectly filed, the Ministry of Commerce and Industry said in a statement today.
Before Controllers of the Patent Office "issued their decisions, the applicants were given due opportunity of being heard but the applicants have chosen not to attend, the ministry said.
When contacted, a Roche spokesperson said: "We can confirm that the Assistant Controller of Patents at the Kolkata Patent Office has refused divisional patents of Herceptin and that we are now considering the further course of action".
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squarely on the pharmaceutical major, the ministry said: "If the requests are not filed within time they are treated as withdrawn under section IIB(4) of the (Indian Patents) Act".
The Patent Office had followed the due course of principle of natural justice, gave the applicant the opportunity of being heard and then only disposed of the matter" the ministry said in the statement.
Referring to the first divisional application, 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.
Although two dates were given to the company this year by the controller to hear its case, "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 Under these circumstances, the controller ordered that the application should be treated as withdrawn."