A federal judge has ruled that Sanofi-Aventis' patent covering prostate treatment Uroxatral is valid and infringed by proposed generic versions from Aurobindo Pharma Ltd. and Torrent Pharma Inc.
Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware issued the decision Tuesday, basing it on an earlier ruling in favor of Sanofi in its fight against Mylan Pharmaceuticals Inc. over a copycat version of the drug.
Sanofi launched patent infringement suits against Aurobindo Pharma, Aurobindo Pharma USA Inc., Torrent Pharma, Torrent Pharmaceuticals Ltd., Mylan and others, alleging abbreviated new drug applications seeking approval of making and selling generic Uroxatral violated U.S. Patent Number 4,661,491.
The plaintiff holds the new drug application for Uroxatral, the brand name for alfuzosin hydrochloride, and is the exclusive distributor of the drug in the U.S.
After the actions were consolidated with related suits in a multidistrict litigation, Sanofi, Aurobindo and Torrent stayed their claims. Aurobindo agreed in May 2009 that if a judgment was entered in favor of Sanofi in the MDL, a judgment would be entered against it, and Torrent agreed in September that if the court sided with Sanofi and against any defendant, a judgment would also be issued against Torrent.
The court on Aug. 3 upheld the validity of the asserted claims of the patent-in-suit, found that Mylan's proposed generic infringed the claims of the '491 patent, and enjoined Mylan from making and selling the generic in the U.S. until after the patent's expiration in January.
The judgment against Mylan followed a trial ruling in May that disagreed with the defendant's argument that the patent was invalid due to obviousness.
Judge Sleet held that the three prior art references asserted by Mylan failed to invalidate the '491 patent because they did not intimate that alfuzosin hydrochloride would prove an effective treatment for frequent urination and other symptoms of benign prostatic hyperplasia.
After the Aug. 3 ruling, Sanofi filed a stipulation with Aurobindo and Torrent to enter judgment against the defendants, and the judge agreed, affirming that the defendants' proposed products violated the patent and blocked the effective date of their ANDAs until after the expiration of the patent-in-suit.
An attorney for Aurobindo declined to comment, while attorneys for Sanofi and for Torrent did not immediately return calls seeking comment.
The patent-in-suit is U.S. Patent Number 4,661,491.
Sanofi is represented by Morris Nichols Arsht & Tunnell LLP, Kirkland & Ellis LLP and Shook Hardy & Bacon LLP.
Aurobindo is represented by Morris James LLP and Rakoczy Molino Mazzochi Siwik LLP. Torrent is represented by Murphy & Landon and Locke Lord Bissell & Liddell LLP.
The case is In re: Alfuzosin Hydrochloride Patent Litigation, case number 1:08-md-01941-GMS, in the U.S. District Court for the District of Delaware.
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