Allergan has announced that the US District Court for the District of Delaware ruled in favor of Allergan in its patent infringement suit against Exela PharmSci, Exela PharmSci, (Exela), Apotex, Inc. and Apotex Corp. (Apotex) for seeking to market purported generic versions of Allergan’s drugs Alphagan P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%.
Reportedly, after a trial in March 2009, the Court ruled that all five patents (US Patent Nos 6627210; 6641834; 6673337; 6562873; and 5424078) asserted by Allergan are valid and enforceable, that Apotex’s proposed generic versions of Alphagan P 0.1% and 0.15% infringe each of the five patents, and that Exela’s proposed generic version of Alphagan P 0.15% infringes US Patent No 6641834, which was the only patent asserted against it. Pursuant to the Hatch-Waxman Act, the US FDA is required to delay approval of Defendants’ proposed generic products until the last to expire of the infringed patents, which is 2022.
Douglas Ingram, executive vice president, chief administrative officer and secretary of Allergan, said: “Innovation in medicine has improved lives, reduced suffering and advanced the quality of patient care, and our intellectual property embodies our commitment to and investment in medical innovation.
“It is only through a respect for intellectual property rights that the cost, time and risk of failure associated with new innovations is justified. Accordingly, this case is a victory not merely for Allergan but for the research and development process that brings new treatment choices to the medical community.”