Allergan wins brimonidine patent infringement case

Irvine, CA

-The U.S. District Court for the District of Delaware has ruled in favor of Allergan Inc. in its patent infringement lawsuit against two sets of defendants seeking to market purported generic versions of the company’s formulations of brimonidine tartrate 0.1% and 0.15% (Alphagan P) for ocular hypertension and glaucoma. Specifically, the court ruled that Allergan’s five patents related to the ophthalmic solutions are valid and enforceable.

“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 S. 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.”

The companies named in the lawsuit, which was filed in 2007, were Exela PharmSci Inc. of Reston, VA; Exela PharmSci Pvt. Ltd. of Hyderabad, India; Apotex Inc. of Toronto; and Apotex Corp. of Weston, FL. The court ruled that Apotex’s proposed two generic brimonidine formations infringed on each of the five Allergan patents and that Exela’s proposed generic version of the 0.15% formulation infringed on the only patent asserted against it.

Under the terms of the Hatch-Waxman Act, the FDA is required to delay approval of defendants’ proposed generic products until the last infringed patent expires, which will occur in 2022.