Delhi HC blocks Reliance from launching copy of Roche’s breast cancer drug

49668511ET Healthworld; November 6, 2015. NEW DELHI: The Delhi High Court has blocked Reliance Life Sciences from launching a copy of Swiss pharma company Roche’s breast cancer drug trastuzumab.

In its November 2 order, the court directed both parties to file written submissions by November 16, following which it will hear the case on a day-to-day basis and not permit adjournments.

According to experts in the area of intellectual property and patents, Roche has argued that Reliance has not conducted certain tests that prove its product is similar to Roche’s drug, which sells under the brandname Herceptin.

In his eight-page order, Justice Manmohan Singh noted that “serious issues are raised” and that Reliance has not launched the product despite regulatory approvals granted to it in June this year.

Roche has said that if the product is not taken through all the stages of tests before being developed into the final product it could raise quality issues.

The drugmaker is also fighting a drawn-out court battle with Biocon and its ally Mylan on charges that the two companies have used product inserts that compare their products with Herceptin.

Roche had abandoned its patent claims for Herceptin in India in 2013. Since India has no laws on data exclusivity, legal experts said the final court verdict on the two cases will be watched carefully.

Biocon and Mylan have their respective copies of Herceptin in the Indian market.

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