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Sanofi Beats Back Apotex Generic In Uroxatral MDL

14 January 2011

A federal judge overseeing the multidistrict litigation arising from Sanofi-Aventis SA's prostate drug Uroxatral has held that the patent covering the treatment was valid and infringed by Apotex Inc.'s proposed generic copycat.

Judge Gregory Sleet of the U.S. District Court for the District of Delaware on Friday issued the decision, which was based on an earlier ruling in favor of Sanofi in its fight against Mylan Pharmaceuticals Inc. over a generic version of the drug.

Sanofi initiated patent infringement actions against Apotex, Mylan, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd. 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 ANDA 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 in the MDL, Sanofi and Apotex stayed their claims. Apotex agreed in October 2009 that if a judgment was entered in favor of Sanofi and against any defendant in the MDL, the stay would be lifted and a similar judgment would be entered against it. However, Apotex also indicated in the October 2009 stipulation that it could appeal any judgment siding with Sanofi in the MDL.

The court in August upheld the validity of the asserted claims of the patent-in-suit, found that Mylan's proposed generic infringed the '491 patent, and enjoined Mylan from making and selling the generic in the U.S. until after the patent's expiration.

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.

In light of the Aug. 3 ruling, Sanofi filed a stipulation with Apotex in December to enter judgment against the defendant, and the judge on Friday agreed, holding that the defendant's proposed product violated the patent and blocked the effective date of its ANDA until after the expiration of the patent-in-suit.

An attorney representing Apotex declined to comment, and an attorney representing Sanofi did not immediately return a request for comment.

In a similar ruling on Aug. 17, the judge held that proposed ANDAs by Aurobindo and Torrent violated Sanofi's patent. Like Apotex, Aurobindo and Torrent stipulated in 2009 that judgment would be entered against them if the court found in favor of Sanofi in the MDL.

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 Paul Hastings Janofsky & Walker LLP.

Apotex is represented by Potter Anderson & Corroon LLP and Husch Blackwell LLP.

The case is In re: Alfuzosin Hydrochloride Patent Litigation, case number 1:08-md-01941, in the U.S. District Court for the District of Delaware.

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