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. The district court ruled that Sandoz had failed to show by clear and convincing evidence that the asserted claims would have been obvious.
Sandoz appealed the judgment. The primary dispute was whether it would have been obvious to develop a topical ophthalmic formulation containing azithromycin. The judge concluded it would not have been obvious due to certain properties of azithromycin, such as logP, molecular weight, solubility, and charge, that the judge believed would have militated against its use in treating an ocular infection. In reaching its decision, the judge gave little weight to testimony from Sandoz’s expert that azithromycin was merely a substitute for erythromycin, previously marketed as Ilotycin® for treating conjunctivitis, in part because the expert’s own patent for ophthalmic treatments listed 24 antibiotics, including erythromycin, but failed to list azithromycin. The Federal Circuit upheld the judgement that the patents were not obvious.
This case serves as a reminder to fully vet your testifying experts. It is certainly appealing to select an expert with directly relevant experience, but it also presents a greater risk that he or she has made statements in the past that are in tension with the opinions being presented at trial.