Digest of Insite Vision Inc. v. Sandoz, Inc., No. 2014-1065 (Fed. Cir. Apr. 9, 2015) (precedential). On appeal from D.N.J. Before Prost, Newman, and Linn.

Procedural Posture: ANDA-filer Sandoz, Inc. appealed the District Court’s judgment that Sandoz had not shown that the asserted claims of U.S. Pat. Nos. 6,861,411; 6,239,113; 6,569,443; and 7,056,893 are invalid as obvious. CAFC affirmed.

  • Obviousness: The ’411 patent: The District Court did not clearly err in framing the obviousness question broadly as whether it would have been obvious to a person having ordinary skill in the art to develop a topical ophthalmic formulation containing azithromycin, rather than merely seeking to use azithromycin to treat conjunctivitis. Based on this question, the District Court did not clearly err in finding that there were innumerable options for ophthalmic treatments but that azithromycin was not one of them; in crediting the testimony of the plaintiff’s expert; or in discounting the relevance of Ilotycin, an alternative formulation.
  • Obviousness: The ’113, ’443, and ’893 patents: The District Court did not clearly err in finding that the asserted claims of these patents were not obvious because the patentee’s own ’535 patent did not mention azithromycin and it would not have been obvious to substitute azithromycin for erythromycin; and the patents were not obvious in view of the prior art ’411 patent. Further, the District Court did not clearly err in finding that the patentee had demonstrated a long-felt need for its drug Azasite.
  • Civil Procedure: The District Court properly refused to enter the EPO file history into evidence after the pretrial conference on the basis of prejudice to the plaintiffs with no indication of how they would have been able to cure it, and the questionable relevance and limited probative value of the file history.