Delhi HC allows Biocon, Mylan to sell generic drug for three types of cancers

The Delhi High Court on Friday allowed drug companies Biocon and Mylan to sell their version of Trastuzumab, which is used for the treatment of two kinds of breast cancer and metastatic gastric cancer, in view of the approval granted to it by the Drugs Controller General of India (DCGI).

''In view of the fact that appropriate authority has approved the package insert and the drug for all three indications (diseases), we feel there should be no restriction imposed at this stage with regard to second and third indication also,'' a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said.

''Consequently, till further orders, Biocon and Mylan are permitted to sell Trastuzumab under their respective brand names for all three indications (metastatic breast cancer, early breast cancer and metastatic gastric cancer) on the basis of the approved package insert,'' the bench said in its interim order.

The order was passed on an appeal filed by Indian biotech major Biocon and its partner US-based Mylan against certain restrictions place by an earlier order by the high court.

Swiss pharma major Roche, which innovated Trastuzumab, had last year moved the high court claiming that the two companies had not carried out all the required tests prior to manufacture and sale of their medicines, as was done by it.

A single-judge bench of the high court had, on 25 April last year, allowed the sale and manufacture of the cancer drugs by Biocon and Mylan but with certain restrictions on packaging and labelling.

Roche had also objected to the use of its clinical data by the two companies in the package inserts of their drugs, which was allowed by the single judge in respect of two diseases, early breast cancer and metastatic gastric cancer. However, the single judge had not set aside the approvals granted by DCGI to the drugs of Biocon and Mylan.

Biocon and Mylan had appealed against the single judge order as restrictions were imposed on the use of clinical data in the package insert of their drugs, Canmab and Hertraz, respectively. The division bench of the high court on Friday said that in view of the approvals granted by DCGI, no restriction should be imposed on Biocon and Mylan and allowed them to sell their medicines for the three diseases with the package insert approved by the authority.

The court also directed Biocon and Mylan to maintain records of their sales and listed all the appeals for further hearing on 31 March. The division bench did not approve of the single judge's decision issuing directions to DCGI after deleting it from the array of parties, saying it was ''an absurd order''.

The single judge had directed DCGI that it should take into consideration the guidelines and findings of the court before granting approvals in future.

The division bench on Friday said the directions given to DCGI by the single judge shall not be operational till the next date of hearing.

During the hour-and-a-half long arguments before the interim order was passed, the bench said it was ''totally not convinced'' by Roche's contentions and added that the Swiss pharma major, which innovated Trastuzumab, ''does not have a case at all'' in view of the approvals granted by DCGI. ''Your patent expired. There is no passing off. There is nothing in this. In fact the suit should have been dismissed,'' the court said.