A federal court in Texas has determined that four combination glaucoma drug patents held by Allergan Inc. were valid and that generic drug makers infringed the patents by seeking Food and Drug Administration (FDA) approval to sell their generic versions under an abbreviated new drug application. Allergan, Inc. v. Sandoz, Inc., No. 09-97 (U.S. Dist. Ct., E.D. Tex., Marshall Div., decided August 22, 2011). Allergan asserted in separate lawsuits that four generic drug makers infringed its patents, and they responded by contending that the patents were invalid due to obviousness in light of the prior art.
Consolidating the cases for resolution, the court determined that “there are significant differences between the prior art and the claimed inventions, such that a person of ordinary skill in the art would not have been motivated to create a fixed combination composition of 0.2% brimonidine and 0.5% timolol.” In its detailed findings of fact and conclusions of law, the court discusses the history of treating glaucoma, noting the difficulties patients had with side effects, the potential for allergy development and compliance with dosage requirements when dosing themselves with eye drops containing single-ingredient, glaucoma-drug formulations. The court also addresses the challenges Allergan faced developing a safe and effective combination product. The generics will be enjoined until Allergan’s patents expire.