Novartis wins Lamisil lawsuit against Reddy's

Novartis AG on Friday said it won a US patent infringement lawsuit against India's Dr Reddy's Laboratories Ltd regarding Novartis' antifungal treatment sold as Lamisil tablets.

Dr Reddy's Laboratories has withdrawn its challenge to a Novartis' patent, which it concedes it had infringed, Switzerland-based Novartis said in a press release.

Under the terms of the judgment in the US District Court for the Southern District of New York, Dr Reddy's will not manufacture, use, sell or import into the United States a generic version of Lamisil at least until the patent expiration date of December 2006 and any pediatric exclusivity extension issued by the US Food and Drug Administration for the patent.

Meanwhile, in a press release today, the Hyderabad-based Dr Reddy's said that it had decided not to pursue a litigation concerning terbinafine hydrochloride tablets (Lamisil) in the southern district court of New York.

It took the decision as it felt that the time to get a favorable federal circuit decision prior to patent expiration of Novartis drug in 2006 would not be met.

Accordingly, the company would amend its ANDA for terbinafine hydrochloride tablets from a Paragraph IV certification to a Paragraph III certification on the remaining unexpired Orange Book Patent listed for the drug.

On July 18, 2002, Novartis had filed a lawsuit against the company in the United States district court for the Southern District of New York, alleging patent infringement of the '534 patent.

Although the court had recently granted a bifurcation motion, the court denied Reddy's request to set a trial date.