Insite Vision Inc. v. Sandoz, Inc.

Case Name: Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853 (Fed. Cir. Apr. 9, 2015) (Circuit Judges Prost, Newman, and Linn presiding; Opinion by Linn, J.) (Appeal from D.N.J., Cooper, J.) 

Drug Product and Patent(s)-in-Suit: Azasite^® (azithromycin); U.S. Patents Nos. 6,861,411 ("the '411 patent"), 6,239,113 ("the '113 patent"), 6,569,443 ("the '443 patent"), and 7,056,893 ("the '893 patent")

Nature of the Case and Issue(s) Presented: Sandoz appealed a finding that it had failed to prove by clear and convincing evidence that the patents-in-suit were obvious. The patents-in-suit covered the use of azithromycin in a topical administration for treating eye infections. Sandoz argued that the district erred in framing the obviousness question too broadly such that it would not be possible to show that one of skill would have been able to solve the problem. Insite asserted that the district court properly defined the problem broadly as nothing in the patent limited the problem narrowly as suggested by Sandoz. The Federal Circuit affirmed the district court’s ruling on all accounts.

Why Insite Prevailed: Sandoz argued that that one of skill would have been motivated to combine references disclosing erythromycin and topical administration to arrive at the claimed inventions. Insite countered that azithromycin was thought to be insoluble, had a limited range of effectiveness, and was not included in the list of potential options identified in the art relied upon by Sandoz. Sandoz further argued that the district court erred in precluding it from introducing a foreign file history related to one of the patents-in-suit. Insite argued that the district court properly excluded this late-offered evidence as Sandoz did not identify it as an exhibit until after the pre-trial conference and briefing concerning motions in limine had been completed.

The Federal Circuit first held that the district court properly framed the problem to be solved by the patents-in-suit broadly as failing to identify the problem broadly could import hindsight. Nevertheless, Sandoz was not foreclosed from demonstrating obviousness with its proposed combinations under the broader interpretation. Rather, it failed to bring forth clear and convincing evidence. The references relied on by Sandoz did not identify azithromycin as an option for topical administration. Also, it was believed at the time of invention that azithromycin was insoluble, making topical administration ineffective. In addition, expert testimony demonstrated that azithromycin had a limited effective range as compared to other antibiotics that could be administered topically.

Concerning the issue of the admission of the foreign file history, the Federal Circuit held that the district court did not abuse its discretion because there was ample prejudice to Insite, including having to prepare for and explain at such late stage in the litigation the difference in US versus foreign patent prosecution and laws. Moreover, the relevance of the statements in the foreign file history was questionable at best.