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. Trastuzumab (INN; trade names Herclon, Herceptin) is a MonoclonalAntibody that interferes with the HER2/neureceptor. Its main use is to treat certain breast cancers. 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 had changed the trade name of the drug and had re-introduced an affordable version of the same in the Indian market. The new drug named Herclon would cost approximately RS 75,000 INR ($1,200 USD) in the Indian market. Biocon Ltd, announced on 26 November 2013 that it has received Marketing Authorization from the Drugs Controller General of India (DCGI) for its biosimilar Trastuzumab being developed jointly with Mylan, for the treatment of Her 2+ metastatic breast cancer. The regulatory approval for biosimilar Trastuzumab in India is the world’s first biosimilar version of trastuzumab to be brought to the market.
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.
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