The US District Court for the District of Delaware has ruled in favor of drugmaker Allergan, its patent infringement suit against Exela PharmSci and Apotex seeking to market purported generic versions of Allergan's drugs Alphagan (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%.
Specifically, after a trial in March of 2009, the Court ruled that all five patents (US Patent Nos 6,627,210; 6,641,834; 6,673,337; 6,562,873; and 5,424,078) asserted by Allergan are valid and enforceable, that Apotex' proposed generic versions infringe each of the five patents, and that Exela's P015% product infringes US Patent No 6,641,834, which was the only patent asserted against it. Under the Hatch-Waxman Act, the US Food and Drug Administration is required to delay approval of defendants' proposed generic products until the last to expire of the infringed patents, which is 2022.
'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,' said Douglas Ingram, Allergan's executive vice president, chief administrative officer and secretary. '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,' he stressed.
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