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India: Roche faces antitrust investigation over trastuzumab

In April 2017, the Competition Commission of India (CCI) passed a prima facie order directing initiation of an investigation for alleged abuse of dominance by Roche. The case pertained to the drug trastuzumab and biosimilars. The case was initiated by Biocon and Mylan, who were otherwise drawn into litigation initiated by Roche before the Delhi High Court based on regulatory and IP issues. Biocon and Mylan thereafter initiated the case before the CCI, alleging frivolous litigations and other actions that created entry barriers in the market.

The CCI rejected the allegation pertaining to frivolous litigation, after applying a two-factor test: (1) whether the litigation, on an objective view, is baseless and appears to be an instrument to harass; and (2) whether the litigation appears to be conceived with an anti-competitive plan to eliminate the competition.

Nevertheless, the CCI still found prima facie abuse of dominance in view of certain communications by Roche to influence the regulatory authorities and doctors, hospitals, tender authorities etc. The CCI noted in its prima facie order that in these communications, Roche raised questions concerning the clinical trials conducted by Biocon and Mylan, with an attempt to create a perception that the biosimilar versions of Biocon and Mylan may pose unknown risks to patients. The CCI further observed that Roche apparently did not provide a complete picture of the litigation – it appears that Roche only referred to the orders passed by the Delhi High Court that were in its favour and not those against it. In the CCI's prima facie opinion, given that the biosimilars in question did have regulatory approval that have not been revoked to date, Roche's communications to create a negative impression of the proprietary of the approvals granted, the safety and efficacy of the drug and the outcome of the legal proceedings were found to adversely affect the penetration of the biosimilars in the market.

The CCI also rejected the defence of Roche that since the case involved intellectual property, it was outside the jurisdiction of the CCI. The CCI relied upon the Delhi High Court's judgments in Ericsson v Competition Commission of India.

This is only a prima facie order and one has to await the completion of the investigation before any conclusions are drawn. In addition, this decision to initiate an investigation has been challenged before the Delhi High Court. These are important developments to keep track of. Nevertheless, even this prima facie order of the CCI raises very important issues that pharmaceutical companies should keep in mind in their marketing efforts.

R Parthasarathy

Lakshmi Kumaran & Sridharan
B6/10 Safdarjung Enclave
New Delhi 110029, India
Tel: +91 11 41299800
Fax:91 11 41299899


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