Roche has been successful in obtaining a temporary injunction from the Delhi High Court to block the expected launch of a biosimilar of breast cancer drug Herceptin (trastuzumab) by Reliance Life Sciences.
The order dated 2nd November 2015 of Justice Manmohan Singh of Delhi High Court restrains Reliance from launching the drug in the market till the next date of hearing.
Reliance Life Sciences has recently obtained approval for its biosimilar version of Herceptin named TrastuRel. According to Roche, Reliance Life Sciences has incorrectly been granted an approval by the Drug Controller General Office for TrastuRel. Roche argued that Reliance was supposed to conduct the clinical trials of all phases (I, II and III) to obtain an approval, however the approval has been granted without the clinical trials of Phase I and Phase II.
The Counsel’s for Roche argued that the result of clinical trial of Phase III is dependent upon the results of trials of Phase I and Phase II. Thus, on the basis of clinical trial of Phase III even if valid the product of Reliance Life Sciences cannot be treated as “biosimilar product of Roche”.
Justice Manmohan Singh held that serious issues are raised in the matter which would be decided after considering the explanation and reply of the defendants and till the next hearing Reliance has been restrained from launching the product.
The Commercial Courts,Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015 has been introduced on 23rd October 2015. It envisages creation of commercial divisions in high courts, and commercial courts at the district level for ensuring that commercial disputes arising out of transactions between merchants, bankers, financier, traders etc. are disposed of expeditiously. Such transactions include mercantile documents, partnership agreements, intellectual property rights, insurance, etc.
The commercial divisions in high courts and commercial courts at district level will deal with all matters relating to commercial disputes involving an amount of Rs one crore or more.
All suits of a value of Rs one crore or more that are pending in the high court shall be transferred to the commercial division. Likewise, all suits pending in the district courts, with a value of Rs. one crore or more would be transferred to the commercial court.
The Bill further proposes to set up Commercial appellate divisions in all high courts to hear appeals against orders of commercial divisions of high courts; orders of commercial courts; and appeals arising from arbitration matters that are filed before the high courts.
Any appeal filed in a high court against the orders of tribunals like ‘Intellectual Property Appellate Board’ may be heard by the commercial appellate division of the high court if it relates to a commercial dispute.