IntelGenx has reported that the New Drug Application (NDA) filing for the antidepressant – CPI-300 has been accepted by the FDA for standard review. In connection with the filing of the NDA, Cary Pharma has provided notice of the NDA filing to Biovail which holds the patent for Wellbutrin XL.
In such notice, Cary Pharma contended that CPI-300 would not infringe Biovail’s patents. On August 18, 2009, IntelGenx learned that Cary Pharma was named in a lawsuit filed by Biovail in the US District Court for the District of Delaware for patent infringement, with respect to Biovail’s US Patent No. 6,096,341.
Reportedly, the filing of the patent infringement lawsuit instituted an automatic stay of any FDA approval of the NDA, until the earlier of a judgment or January 3, 2012.
The Biovail lawsuit seeks to prevent the manufacture or sale of CPI-300 during the life of the Biovail patent. Cary Pharma and IntelGenx believe that CPI-300 does not infringe Biovail’s patent and will vigorously assert their rights.
Horst Zerbe, president and CEO of IntelGenx, said: Since litigation is often part of the Hatch-Waxman process, Biovail’s lawsuit did not take us by surprise and we are prepared for it. We have a strong position for a favorable resolution and will vigorously pursue such an outcome. We remain very excited about the potential for CPI-300.
CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL which is developed with Cary Pharma.