Another path-breaking verdict after the Novartis AG case 

A two-judge bench of the Delhi High Court on March 3 lifted an earlier stay order of the same court on the issue of marketing and sale of generic drug biosimilar of Roche’s breast cancer drug ‘trastuzumab’ (group name). The appeal was filed by Indian pharma major Biocon and other pharmaceutical companies, including Biocon’s co-developer of the drug, Mylan.

This drug is used for early gastric and breast cancer treatment.

The bench of Justices BD Ahmad and Sanjeev Sachdeva heard the case and allowed the plaintiffs to also sell their drugs CANMAb and Hertraz, covering three types of cancers.

The court had earlier restricted from manufacture and sale only one drug for one type of cancer, on a challenge by the Swiss drug-maker Roche. Roche’s ‘trastuzumab’ cancer drug has a brand name Herceptin. Roche had filed a lawsuit against Biocon and Mylan, as well as against the Drugs Controller General of India (DCGI).

DCGI had approved the biosimilar ‘trastuzumab’ drug which has a brand name CANMAb by Biocon and as Hertraz by co-development partner Mylan. The case was filed last November.

Roche’s was not an IP case. They argued that Biocon did not follow “due process” before releasing the drug. They said had Biocon followed the procedures as laid down by India’s 2012 guidelines on the approval of biosimilar drugs, it would have taken much longer to launch. This did not stand the rigours of trial.

Biocon had planned to release the drug in the first week of February, pricing at 75 percent of the Roche product.

This was another big victory for the huge Indian generic drugs industry, after the landmark judgement of 2014 in which another Swiss drug giant, Novartis AG, had lost its patent application in India for another cancer drug Glivec.

—By India Legal Bureau