PIV certifications do not preclude ANDA filers from seeking inter partes review of Orange Book patents, according to the court in Senju Pharmaceutical Co. v. Metrics, Inc., 14-CV-3962 (D. N.J. Mar. 31, 2015). Plaintiffs Senju and Bausch & Lomb own three patents covering formulations of bromfenac, the active ingredient in Prolensa®. They sued Metrics for…
In its recent decision in Insite Vision, Inc. v. Sandoz, Inc., the Federal Circuit reminds us of the importance of properly selecting and preparing experts for trial. Insite markets Azasite®, a topical azithromycin solution approved for the treatment of bacterial conjunctivitis. Sandoz stipulated to infringement so the only issue at trial was Sandoz’s its obviousness defense. …
Yesterday’s precedential decision in Apotex v. Daiichi Sankyo, Inc. et al. v. Mylan Pharmaceuticals, Inc., 2014-1282, 2014-1291, dealt with the questions of whether declaratory judgment jurisdiction permits a second-filer to challenge a disclaimed Orange Book patent for purposes of triggering the first-filer’s exclusivity. Daiichi markets Benicar®, a drug to treat hypertension. It listed two patents…