You Cannot Hang on to Breast Cancer Drug, HC Tells Roche
New Delhi: The Delhi High Court on Wednesday 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 drug’s biosimilar as Trastuzumab only.
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.
The court was hearing pleas of Roche and other pharma firms on the issue of marketing and sale of generic drug’s biosimilar as Trastuzumab