Swiss pharma major Roche cannot prima facie have a say against the sale and marketing of breast cancer medicines of drug firms Biocon and Mylan once the Drugs Controller General of India (DCGI) has approved it, Delhi High Court said today.
"Once the designated authority has given approval, you cannot say prima facie you have case over that. Till that (approval) is disturbed by an order of the court, it will remain," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said.
The observation of the court came after the DCGI, represented by Additional Solicitor General Sanjay Jain, confirmed that the medicines and the package inserts of the two companies were granted approval for marketing and sale.
The confirmation came in response to the court's query of February 22 to DCGI on whether the package inserts of Biocon and Mylan have been approved by the authority.
The court was hearing the pleas of Roche and other pharma firms like Biocon, Mylan and Reliance Life Sciences, on the issue of marketing and sale of generic drugs biosimilar to the Swiss company's Trastuzumab.
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.
During the arguments today, Roche contended that the approvals were not granted properly and Mylan has not even carried out clinical trials.
In response, Biocon said it manufactures the medicine for both the companies, but they sell it under different names. While Biocon sells it as Canmab, Mylan sells it under the name of Hertraz, the court was told.
Both companies said the DCGI had asked them to quote the clinical data of Roche's cancer medication, Trastuzumab, in their respective package inserts, which are the slips of paper inside each medicine box containing details of the drug.
On the last date of hearing, the court had told Roche
that it "cannot hang on to" breast cancer drug Trastuzumab, innovated by it, for the rest of its life after having enjoyed the fruits of its patent.
It had also said that Roche cannot in a civil suit challenge the approvals granted by DCGI.
According to Biocon and Mylan, their respective breast cancer medications are prescribed only for metastatic breast cancer, as a single judge bench of the high court had on August 13, 2015, restrained them from selling their respective Trastuzumab medicines for early breast cancer and metastatic gastric cancer.
However, both companies claim to have approvals from DCGI to sell their respective medicines for the other two cancers also, a decision which has been challenged by Roche in its civil suit claiming "passing off" of its breast cancer drugs by the two companies.
Biocon and Mylan have taken the stand that Roche no longer holds a patent in India for Trastuzumab.