Alfuzosin Hydrochloride Patent Litigation
The Situation
Sanofi-Aventis manufactures and sells Uroxatral®, which contains the active ingredient alfuzosin hydrochloride. It treats the signs and symptoms of Benign Prostatic Hyperplasia (BPH). Sanofi-Aventis owns the right, title, and interest in US Patent Number 4,661,491 ("'491"). The '491 patent applies to the product Uroxatral®. Subsequently, several companies, including Mylan Pharmaceuticals Inc., sought approval from the US Food and Drug Administration to sell generic versions of Uroxatral® by filing Abbreviated New Drug Applications asserting the '491 patent was invalid or not infringed. In response, Sanofi-Aventis filed a patent infringement suit in the US District Court for the District of Delaware.
NERA's Role
Counsel for Sanofi-Aventis retained NERA Special Consultant Dr. Richard Rozek to analyze whether Uroxatral® is a commercial success, a secondary consideration in assessing the non-obviousness of the invention embodied in the patent. Dr. Rozek prepared an expert report and testified at trial on the commercial success of Uroxatral®, and the nexus between the commercial success and the claimed invention.
The Result
On 14 May 2010, the Court referenced Dr. Rozek's trial testimony in finding "that the relevant secondary considerations support the conclusion that the '491 patent is not invalid as obvious over the prior art."
