HC to decide on whether Biocon, Mylan drugs be used for early breast cancer

Can pharma majors Biocon and Mylan’s generic breast cancer drugs, similar to that of their competitor Roche, be prescribed for early breast cancer and metastatic gastric cancer?

This is an issue on which the Delhi High Court will start hearing arguments next week.

Presently Biocon and Mylan’s medications are prescribed only for metastatic breast cancer, as a single judge bench of the high court had restrained them from selling them for the other two diseases.

However, both companies have approvals from the Drugs Controller General of India (DCGI) to sell their respective medicines for the other two cancers also, a decision which has been challenged by Roche.

A bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva on Thursday asked Swiss pharma major Roche whether, as an interim measure, the other two companies can be allowed to sell their drugs in respect of early breast cancer and metastatic gastric cancer.

Roche, represented by senior advocates Rajiv Nayar and Sandeep Sethi, sought that no orders should be passed to allow Biocon and Mylan to sell their medicine for the other two cancers, without first hearing it.

On Roche’s challenge to the approvals granted by DCGI, the bench was of the view that the company cannot challenge the approvals in a civil suit in court.

DCGI, meanwhile, told the court that the approvals were rightly given.

Biocon, represented by senior advocate Pratibha M Singh, and Mylan, represented by senior advocates C S Vaidyanathan and Amit Sibal, said they were unable to sell their medicines for early breast cancer and metastatic gastric cancer due to the single judge’s interim order of August 13, 2015 and, as a result, Roche had a monopoly on the medication for the two diseases.

The court was hearing Biocon and Mylan’s appeal against the August 13, 2015 order which was passed in Roche’s suit claiming passing off of their 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, the salt used for making the breast cancer medication.