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Why No investigation against Roche for anti-competitive practices, questions HC

Why No investigation against Roche for anti-competitive practices, questions HC

New Delhi: Can truth in vilification of a competitor be a defence against allegation of anti-competitive conduct. This was the poser by Delhi High Court to Swiss drug major Roche, facing allegations of abuse of dominant position.

Justice Vibhu Bakhru raised the query while hearing Roches plea against the Competition Commission of India’s (CCI) order initiating an inquiry into the alleged abuse of dominant position by the Swiss company.

The CCI order had come on a complaint by two Indian pharma firms, claiming to make bio-similar versions of the Swiss company’s breast cancer medication.

The two companies, Biocon and Mylan, had alleged before the CCI that Roche has written to regulatory authorities, various states as well as doctors disparaging their drugs and was trying to interdict the award of tenders to them for supply of their bio-similar versions.

During arguments in the high court, Roche, represented by senior advocate Rajiv Nayar, contended if there was truth in its allegations, it would be a defence against disparagement.

It came in response to the courts query, “Can truth in a vilification be a defence against allegation of anti- competitive conduct? That is the question here.”

The CCI, represented by Additional Solicitor General Sanjay Jain, defended its decision to probe the allegations against Roche.

After hearing hour-long arguments on behalf of Roche, the court listed the matter for further hearing on September 6.

Roche had on an earlier date of hearing told the court that the CCI order of April 21 amounts to forcing them to withdraw their suit against Biocon and Mylan for prohibiting them from referring to their breast cancer drugs as bio- similar to that of the Swiss company.

It has claimed in its suit that the two companies have not carried out the entire protocol of tests and studies, despite which the Drugs Controller General of India (DCGI) had approved marketing of their medication for two kinds of breast cancer as well as metastatic gastric cancer.

The Swiss drug major had earlier said that the complaint in the CCI was a counter blast to its suit in the high court.

A division bench of the high court on March 3 had allowed Biocon and Mylan to sell their version of Roches breast cancer drug – Trastuzumab – in view of the approvals granted by the DCGI.

The division benchs interim order had come on Roches appeal against a single judges order allowing the sale and manufacture of the cancer medicines of Biocon and Mylan but with certain restrictions on packaging and labelling.

Roche had also objected to the use of its clinical data by the two companies in the package inserts of their drugs, which was allowed by the single judge in respect of two diseases, early breast cancer and metastatic gastric cancer.

Biocon and Mylan had also appealed against the single judge order as restrictions were imposed on the use of clinical data in the package insert of their drugs, Canmab and Hertraz, respectively.

The division bench of the high court in its order had said that in view of the approvals granted by DCGI, no restriction should be imposed on Biocon and Mylan and had allowed them to sell their medicines for the three diseases with the package insert approved by the authority.

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