New Delhi: Roche Holding AG’s Indian unit on Wednesday filed a reply before the Delhi high court against an order by the Competition Commission of India (CCI) ordering an investigation against the company for alleged abuse of its dominant position in the market.
The April order allowed Roche India’s rivals Biocon Ltd and Mylan Laboratories Ltd to produce and market their biosimilars of Roche’s Trastuzumab breast cancer drug in the market.
A biosimilar involves clinically testing a drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (in this case Trastuzumab), known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness.
Biocon and Mylan had argued before the CCI that the litigation carried on by Roche against them was vexatious litigation and “attempted to affect the successful entry of almost all biosimilars by initiating legal proceedings against companies who sought requisite approvals to launch such biosimilars in the Indian market."
Rajeev Nayyar, counsel for Roche, replied to this saying, “Merely because these litigations were unsuccessful does not mean they were vexatious."
To this, Justice Vibhu Bakhru posed the question, “Are you saying that no legal proceedings can be anti-competitive?"
Nayyar dodged this question by placing reliance on the CCI order from April which also observed that “considering the long drawn legal battle between the parties before the Hon’ble Delhi High Court, the Commission is reluctant to hold that the litigations filed by Roche Group are baseless."
Roche India had sent out letters to various regulatory authorities such as Drug Controller General of India, and doctors and hospitals on safety issues in case of the Biocon and Mylan drugs.
CCI ruled that on the face of it, such efforts appeared to be an attempt by Roche to influence regulatory authorities against Biocon and Mylan’s biosimilars.
Roche argued that the CCI had not examined the contents of all of its letters before passing the order against it. However, the CCI order stated that it had carefully perused all the letters sent by Roche before passing the order.
Roche also argued that the letters contained true and genuine facts, to which the court asked whether truth could be a defence against vilification of a competitor’s products. Roche has been directed to argue in this light.