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news.The United States District Court of Delaware has dismissed the lawsuit against drug delivery company IntelGenx, relating to its once daily high dose 450 mg Bupropion hydrochloride tablet, initiated by Biovail Laboratories International in August 2009.
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Earlier on 4 January 2011 the court had ruled in favor of IntelGenx regarding claim construction for the two patent terms at issue in the patent infringement action brought forward by Biovail under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act).
The ruling arose from a special proceeding required under US patent law called a ‘Markman Hearing’ where both sides presented to the court their arguments on how they believed the patent terms at issue should be interpreted.
Subsequent to the ruling on the Markman Hearing, Biovail agreed to dismissal of the action.
IntelGenx president and CEO Horst Zerbe said the litigation was a major obstacle in their partnership discussions for CPI-300, a novel, high strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL, so they are delighted to have this legal process behind them.
"We are in the final steps of accumulating the data necessary to address FDA’s questions from the Complete Response Letter and submit our response to the Agency in the coming months," Zerbe said.