[Ip-health] Delhi HC blocks Reliance from launching copy of Roche's breast cancer drug | ET HealthWorld

Elizabeth Rajasingh elizabeth.rajasingh at keionline.org
Thu Nov 5 06:35:43 PST 2015


http://health.economictimes.indiatimes.com/news/pharma/delhi-hc-blocks-reliance-from-launching-copy-of-roches-breast-cancer-drug/49668497​

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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Elizabeth Rajasingh
Perls Research and Policy Fellow, Knowledge Ecology International
1621 Connecticut Ave. NW, Suite 500
Washington, DC 20009
*elizabeth.rajasingh at keionline.org <elizabeth.rajasingh at keionline.org>* |
 1-202-332-2670



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