Insite Vision Inc. v. Sandoz, Inc.

Inspire Pharmaceuticals, Inc. (Inspire) (plaintiff) sold Azasite, a topical azithromycin solution used to treat eye infections. The solution had been approved by the Food and Drug Administration (FDA), and Inspire’s four patents regarding methods for topical use of azithromycin were listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. Prior to the patents’ expiration, Sandoz, Inc. (defendant) filed an application with the FDA for its generic version of Azasite, claiming that Inspire’s patent claims were invalid because they would be obvious to a person of ordinary skill in the art and were thus not entitled to patent protection. Inspire sued Sandoz for patent infringement. Sandoz admitted that its conduct would amount to infringement if the patent claims were valid, but it continued to assert that the claims were not valid. Before trial, but after the final pretrial conference, Sandoz moved to amend the pretrial order to add the file history for the European counterpart (EPO file) of one of Inspire’s American patents as an exhibit. Sandoz claimed that the EPO file contained factual admissions relevant to obviousness. The district court denied the motion, concluding that admitting the EPO file into evidence on the eve of trial would prejudice Inspire. At trial, the district court ultimately held in Inspire’s favor, holding that Sandoz had failed to prove obviousness. Sandoz appealed, challenging, among other things, the district court’s refusal to admit the EPO file into evidence.