HC allows Biocon, Mylan to sell their drug for three cancers

Roche, which invented Trastuzumab, claimed that the two co’s had not carried out the required tests prior to mfg and sale of their medicines.


The Delhi High Court today allowed drug companies Biocon and Mylan to sell their version of Trastuzumab for 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 single judge bench on April 25 last year had allowed the sale and manufacture of the cancer medicines of Indian drug company Biocon and US drug major Mylan but with certain restrictions on packaging and labelling.

The order was passed as their rival, Swiss pharma major Roche, which innovated Trastuzumab, had claimed 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.

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.

As the single judge had not set aside the approvals granted by DCGI to the drugs of Biocon and Mylan, Roche had challenged the order.

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 today 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 March 31.

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 prior to granting approvals in future, it shall take into consideration the guidelines and also the findings arrived at by the court.

The division bench today 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.

Roche had contended that neither Biocon nor Mylan have carried out the entire range of tests for three cancers as done by it and by quoting its clinical data in their package inserts, the two companies are misleading doctors and patients and "playing with people's lives".

The court, however, said that Roche had given up data exclusivity and added that all the clinical data was in the public domain.

It also questioned the right Roche had subsequent to the approval granted by DCGI and expiry of the Swiss company's patent. While DCGI had said the approvals were rightly granted, Roche had opposed the contention.

The issue raised in the appeals before the court is with regard to marketing and sale of generic breast cancer drugs, of Biocon and Mylan, which are claimed to be biosimilar to the Swiss company's Trastuzumab sold under the name of Herceptin.

It is Roche's contention that Biocon, Mylan and Reliance cannot term their medicine as merely Trastuzumab and ought to call it Biocon's Trastuzumab or Mylan's Trastuzumab as these companies have not followed the entire protocol of tests and studies, as was done by it.