Mylan Generic Infringes Sanofi's Uroxatral Patent: Judge

A federal judge has given Sanofi-Aventis SA a boost in its multidistrict litigation over competitors' attempts to market a generic version of prostate treatment Uroxatral, ruling at trial that the drug proposed by Mylan Pharmaceutical Inc. would in fact infringe Sanofi's patent.

On Friday, Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware finalized an earlier oral ruling from the bench that Mylan's generic alfuzosin hydrochloride would infringe U.S. Patent Number 4,661,491, dashing the generic-drug maker's contention that the patent is invalid due to obviousness.

Judge Sleet held that the three prior art references asserted by Mylan fail to invalidate the '491 patent because they do not intimate that alfuzosin would prove an effective treatment for frequent urination and other symptoms of benign prostatic hyperplasia.

The ruling affirms the validity of the '491 patent, which is subject to a term extension and set to expire on Jan. 18.

The court endorsed the strength of the patent claims but refused to award Sanofi attorneys' fees, finding that "Mylan's conduct does not rise to a level of bad faith or vexatious litigation."

Mylan asserted three pieces of prior art that it claimed combined to render the '491 patent obvious. Specifically, the defendant argued that the Guinebault, Hedlund and Lepor references teach that alfuzosin is safe for human consumption and effective as a treatment for frequent urination and other BPH symptoms.

Judge Sleet noted, however, that none of the prior art references disclosed the use of alfuzosin to treat any disorder, let alone frequent urination and other related symptoms.

"In sum, the court is not persuaded that the defendants have established by clear and convincing evidence that the '491 patent is obvious in light of the prior art," Judge Sleet said. "The court finds that there are significant differences between the prior art and the claimed inventions, such that a person of ordinary skill in the art would not have been motivated to combine the Hedlund, Lepor and Guinebault references."

The multidistrict litigation thinned out in May 2009 when several defendants dropped out of the action, including Actavis South Atlantic LLC, Aurobindo Pharma Ltd., Par Pharmaceutical Inc. and Ranbaxy Inc.

Representatives for Sanofi and Mylan could not be reached for comment Monday on the court's decision.

The patents-in-suit are U.S. Patent Numbers 4,661,491 and 6,149,940.

Sanofi is represented by Morris Nichols Arsht & Tunnell LLP, Kirkland & Ellis LLP and Shook Hardy & Bacon LLP.

Mylan is represented by Potter Anderson & Corroon LLP and McGuireWoods 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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