Delhi HC blocks Reliance from launching copies of Roche's breast cancer drug

New Delhi: The Delhi High Court has blocked Reliance Life Sciences from launching copies of Swiss drug maker Roche’s breast cancer drug trastuzmab, branded as Herceptin. The November 2 order has directed both parties to file written submissions by November 16, following which the court 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 clinical trial and tests that prove it is similar to its own original brand.

Justice Manmohan Singh in his 8-page order 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 raised issues related to quality if the product is not taken through all the stages of tests before being developed into the final product.

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

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