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Wednesday, May 05, 2004

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Dr Reddy's `withdraws' compound patent challenge on GSK

C.R. Sukumar

Hyderabad , May 4

INDICATING that it would not enter the US market with anti-nausea drug Ondansetron before the expiry of the compound patent, Dr Reddy's Laboratories Ltd has partially withdrawn its challenge on the compound patent of GlaxoSmithKline's (GSK) anti-nausea drug Zofran.

The compound patent for Zofran is scheduled to expire in July 2005. The case filed by GSK relating to the Zofran patent challenge against Teva is currently going on in a District Court of the US. Teva is the second filer on Zofran after Dr Reddy's Labs. Zofran had first-quarter sales of $232 million in the US.

During August 2001, GSK filed a suit against Dr Reddy's in the New Jersey District Court. This was in response to Dr Reddy's invalidity certification on three patents, including the compound patent. In July 2003, GSK sued Dr Reddy's alleging infringement of patents on Zofran.

When contacted, the Dr Reddy's spokesperson told Business Line that the company did not completely withdraw the patent challenge case. The withdrawal pertains only to `compound patent,' and the challenge on two `method of use' patents continues.

"Dr Reddy's has withdrawn the para-IV certification (patent challenge) on the `compound patent' for Ondansetron. It has not withdrawn the para-IV filing. The compound patent expires in January 2005 (if paediatric exclusivity of six months is also taken into consideration, the patent expires on July 25, 2005). The court trial for Ondansetron is set for May 25, 2004. In view of the timelines, we have taken the decision so that the process can be speeded up," the spokesperson said.

Interestingly, while the trials for this case are scheduled to begin this month, just ahead of the trials, reacting to Dr Reddy's Labs timing of the decision, analysts view that the litigation would now focus only on the two `method of use' patents.

During March 2002, GSK filed a suit against Teva in the Delaware District Court.

Teva has certified invalidity or non-infringement of the two `method of use' patents currently held by GSK. A judgment is expected anytime.

According to industry sources, "If Teva succeeds in invalidating the two `method of use' patents, then Dr Reddy's can expect to have the possibility of getting exclusivity on the drug after expiry of the compound patent. However, in case Teva loses the case, it can imply a weak case for Dr Reddy's. Further, if the District Court rules against Teva, then it imputes a similar judgment for Dr Reddy's Labs also. This could be the main reason for Dr Reddy's to withdraw its patent challenge petition."

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