You cannot hang on to breast cancer drug: HC to Roche

The Delhi High Court today told Swiss pharma major 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.
"You cannot hang on to it (Trastuzumab) for the rest of your life. You have worked your patent. You enjoyed the fruits of it. You have no right now," a bench of Justices Badar Durrez Ahmed and Sanjeev Sachdeva said.
The court was hearing 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.

Roche argued 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.
To this, the bench said the advantage of biosimilarity was that it was an abbreviated process and companies like Biocon and Mylan need not go through the entire "rigmarole" as was done by Roche.
It also said that it was finding Roche's stand "difficult to digest" as it has already gained from its patent.

During arguments, Roche also alleged that Biocon and Mylan were using package inserts which contained data of tests and studies carried out by it and not their own.

It said Reliance was not doing so and Biocon and Mylan should follow the same example.
Biocon and Mylan said their package inserts contained their test data also and added that they were entitled to show data of Roche also. They also claimed that their inserts were approved by the Drugs Controller General of India (DCGI).
Package inserts are the slips of paper inside each box of the medicine containing details of the drug.
However, as Roche claimed that Biocon and Mylan's package inserts were not approved by DCGI, the bench asked the authority to check and inform the court whether the inserts of Biocon and Mylan have been approved by it and listed the matter for further hearing on March 2.

The court also observed that "prima facie the case is against you (Roche)".
It also said that Roche cannot in a civil suit challenge the approvals granted by DCGI, a view that was echoed by Additional Solicitor General (ASG) Sanjay Jain, appearing for the authority.