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Novartis' patent held valid; Dr Reddy's withdraws case

Our Bureau

Mumbai , Sept. 3

THE global pharma major, Novartis AG, announced on Friday that it had prevailed in its US patent infringement lawsuit with Dr Reddy's Laboratories Ltd.

The lawsuit pertained to the oral antifungal agent, Lamisil Tablets (terbinafine hydrochloride), a leading prescription drug from Novartis for the treatment of onychomycosis, a fungal infection that discolours, thickens and destroys the nail plate of toenails and fingernails. An estimated 35 million Amercians suffer from onychomycosis.

According to a communiqué from the $24.9-billion Novartis, that was released in Basel, Dr Reddy's had withdrawn its challenge to a Lamisil patent held by Novartis, conceding its validity and admitting that there was an infringement.

"While generics play an important and legitimate role in offering cost-effective therapeutic alternatives, strong patent protection remains essential to fostering continuous innovation that advances medical treatment for patients," said Dr Daniel Vasella, Chairman and CEO, Novartis.

Under the terms of the consent judgment in the US District Court for the Southern District of New York, Dr Reddy's will not manufacture, use, sell or import in the US a generic version of this drug at least until the patent expiry date of December 2006 and any paediatric exclusivity extension (six months) issued by the USFDA for the patent.

Novartis has a strong patent position for Lamisil that relies on evidence showing terbinafine hydrochloride to be a distinctive molecule with a unique mode of action. Both chemically and therapeutically, terbinafine is unique in its class in the treatment of onychomycosis.

Our Hyderabad Bureau adds: Dr Reddy's Laboratories Ltd announced on Friday that it has decided not to pursue further its patent infringement lawsuit against Novartis in a US district court pertaining to terbinafine hydrochloride tablets, the generic version of Novartis' Lamisil, widely prescribed oral antifungal agent with US sales of over $460 million.

Explaining the reason for the shift in its stand on patent infringement strategy for the US generics market, Dr Reddy's said in a press release that the decision was taken because the time needed to obtain a favourable Federal Circuit decision prior to patent expiration would not be met.

While deciding not to pursue further its district court challenge, Dr Reddy's has decided to amend its abbreviated new drug application (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.

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

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