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Dr Reddy's beats retreat in GSK drug patent row
By siliconindia
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Wednesday, 05 May 2004, 19:30 IST
HYDERABAD: In a surprise move, Dr ReddyÂ’s Laboratories Ltd (DRL) has withdrawn para IV certification on its patent for GlaxoSmithKlineÂ’s (GSK) anti-nausea drug, Zofran.
This would mean DRL will not be able to enter the market before the expiry of the compound patent.
GSK had earlier filed a legal suit against DRL in August 2001 in response to the companyÂ’s invalidity certification on three patents, including the patent no. 4695578 which is scheduled to expire on July 25, 2005. This was followed by yet another legal suit in July 2003 against DRL for infringing patents on Zofran.
However, before the commencement of the trials, DRL has withdrawn its challenge on the patent. The litigation will now focus only the remaining two methods of use. The GSKÂ’s Zofran is currently notching a quarterly sale of about $232 million.
When ET contacted DRL, the spokesman said, “The court trial is set for May 25, 2004, and the patent is scheduled to expire in 2005. In view of the timelines, we have decided to withdraw the challenge on the compound patent so that the process can be speeded up with greater focus on the two method-of-use patents.”
Apart from the legal battle with DRL, GSK had also filed a lawsuit against the Israeli drug-maker Teva Pharmaceuticals for the same compound in March 2002.
Patents challenging is a declared strategy for DRL and Teva Pharmaceuticals in the US generics market.
It is part of their core strategy to weaken the existing patents. Para IV certification is a provision provided by US law for launching generics before the patents of a particular product expires.