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Novartis Drags DRL to Court over Gleevec

Published: 21st October 2014 06:00 AM  |   Last Updated: 20th October 2014 11:01 PM   |  A+A-

HYDERABAD:  Basel-headquartered Novartis Pharmaceuticals Corporation and Novartis AG dragged city-based Dr Reddy's Laboratories Ltd (DRL) and its US subsidiary Dr Reddy's Laboratories Inc to the US court over alleged patent infringement.

As per Novartis' petition filed on October, 8 at the District Court of Delaware, DRL infringed its patents pertaining to Novartis’ anti-cancer drug — Gleevec. Originally, patent was issued to inventors Jurg Zimmermann in May, 2005 and Novartis was an exclusive licensee. It was reissued in January, 2013 to Jurg, which was also exlusively licensed to Novartis.

“DRL’s commercial manufacture, use, offer to sell or sale of its Imatinib Mesylate ANDA Tablets, prior to the expiration of the ’051 Patent and the RE932 Patent, would constitute infringement of the ’051 Patent and the RE932 Patent under 35 U.S.C. § 271,” Novartis said.

In a letter dated August 27, 2014, DRL notified Novartis that it had submitted ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer to sell or sale of capsules containing 400 mg of imatinib mesylate, imatinib mesylate capsules, EQ 400 mg Base.

Novartis claims that the effective date of any FDA approval for DRL to make, use or sell its 400 mg Imatinib Mesylate ANDA capsules be no earlier than the date on which last-expiring its patents, including any associated regulatory exclusivities.

The petition also seeks a judgement awarding Novartis damages resulting from such infringement and if DRL engages in the commercial production, use or sale of the drug prior to patent enpiry.



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