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29 Nov 2022, 06:43 HRS IST
  • PTI
  • CCI order against Roche is anti-competition: HC

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18:42 HRS IST

New Delhi, May 24 (PTI) The Delhi High Court today termed as "anti-competition and anti-legal right", a Competition Commission of India's (CCI) order initiating an inquiry into the alleged abuse of dominant position by Swiss drug major Roche.

Justice Sanjeev Sachdeva said the competition regulator's order would mean that no company in a dominant position can ever sue a competitor or make a representation to an authority against a rival as it would be held anti-competitive.

The court, however, did not pass any interim directions but issued notice to CCI and the two Indian pharma firms, on whose plea the regulator's order had come, and sought their replies by August 2.

It did not pass any interim orders after CCI said that till the next date of hearing, it would not proceed against Roche, its subsidiary Genentech or their Indian arm.

The court was hearing Roche's plea against CCI's decision which had come on a complaint by two Indian pharma firms which claimed to make bio-similar versions of the Swiss company's breast cancer medication.

The two companies, Biocon and Mylan, had alleged before 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 the hearing, the court asked CCI what inquiry it will carry on as Roche has not denied sending the letters to regulatory authorities and since the regulator had already formed a prima facie view that the Swiss company and its subsidiaries had abused their dominant position.

"When facts are admitted, you do not need a trial," it said and added "pass an order".

Roche, represented by senior advocate Rajiv Nayar, said the CCI order 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.

Roche 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.

Nayar said that the complaint in the CCI was a counter blast to its suit in the high court.

The CCI, represented by Additional Solicitor General (ASG) Sanjay Jain, said that Roche ought not to have written to doctors and prospective buyers that the medication of Biocon and Mylan have not gone through all the tests.

The ASG, however, said he would need to seek instructions on why the foreign entities were being proceeded against in the matter.

The ASG made the submission after the court said there was nothing on record before it regarding the role of the foreign entities.

Biocon, represented by senior advocate Amit Sibal, on the other hand claimed that the foreign entities were the direct beneficiaries of Roche India's acts and that is why they too need to be investigated.

It said the CCI needed to carry out an inquiry to ascertain whether Roche wrote to doctors about Biocon and Mylan's drugs and whether the letters have led to a smaller market share for the two pharma firms.

Sibal said the CCI will also investigate whether a company with a dominant position can disparage a competitor while the approvals given to it by a statutory authority are in existence.

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

The division bench's interim order had come on Roche's appeal against a single judge's 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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