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Delhi HC questions CCI probe against Roche

LiveMint logoLiveMint 24-05-2017 Priyanka Mittal

New Delhi: The Delhi high court on Wednesday observed that an investigation initiated by the Competition Commission of India (CCI) against Roche Products (India) Pvt. Ltd for abuse of dominant position was an ‘interference in the administration of justice’.

CCI had initiated investigation against Roche and held it to be abusing its position as a market leader resulting in denial of market access to other pharmaceutical companies.

The regulator’s order was based on written communications by Roche to authorities including the Director Controller General of India (DCGI), National Pharmaceutical Pricing Authority (NPPA) and hospitals/potential buyers discouraging them from buying biosimilar versions of its cancer drug, Trastuzumab sold by its competitors— Mylan and Biocon.

Justice Sanjeev Sachdeva before whom the matter was brought refused to pass any orders at this stage and sought the response of CCI, and two other Indian pharmaceutical companies (Mylan and Biocon) on whose complaint the regulator’s order had been passed.

“A company which holds a dominant position cannot be precluded from exercising its legal remedies. If such was the case, no prominent player would be able to file a suit against their grievances,” said Justice Sanjeev Sachdeva.

The court also questioned CCI’s intent for further investigation as the communications on which it had based the investigation order were being admitted to by Roche.

“What will you investigate? They are not denying the letters. When facts are admitted, you don’t need a trial”, Justice Sachdeva remarked.

Sanjay Jain, additional solicitor general, appearing for CCI told the court that under the investigation, the authority would sent out questionnaires to pharmaceutical companies and assess if they indeed did result in abuse of dominant position or not.

Roche in its plea, had claimed that Mylan and Biocon had not successfully conducted clinical trials on their biosimilar drugs for breast cancer and were therefore, a threat to safe usage.

On 3 March, a division bench of the high court gave a green signal to pharmaceutical companies Biocon and Mylan to manufacture and sell its biosimilar drug Trastuzumab for early breast cancer and metastatic gastric cancer. It had earlier allowed them to sell its biosimilar drug for metastatic breast cancer.

The court, through an interim order, had quashed Roche’s challenge to the sale of drugs by Biocon and Mylan as the requisite approvals for both biosimilarity and product inserts had been granted by the DCGI.

Roche had submitted that Biocon failed to follow protocol and not conducted tests and was selling its drug under the name Trastuzumab—of which they claimed to be the innovator.

A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs.

Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

The matter will be heard next on 2 August.

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