Opinion ID: 216975
Heading Depth: 3
Heading Rank: 1

Heading: Solubility

Text: The district court credited the testimony of Allergan's expert witness, Dr. Valentino Stella, and found that one skilled in the art would not have expected therapeutically effective concentrations of brimonidine to be soluble at the slightly alkaline pH range of Refresh Tears®, 7.2 to 7.9. Apotex challenges the court's finding by focusing on a solubility table that it did not rely on at trial. The table is excerpted from a New Drug Application (NDA) filed by Allergan with the FDA. The table recites that at the neutral pH of 7.0, the water solubility of brimonidine is 1.94 mg/mL, or 0.194%. Every asserted claim reads on a solution with a pH of at least 7.0. Claims 11-13 of the '834 patent are directed to a 0.15% brimonidine solution at a pH of 7.0 or above, and all of the other asserted claims are directed to a therapeutically effective quantity. [1] Apotex and Allergan agree that brimonidine's solubility decreases as the pH of a solution increases. Apotex argues that the solubility table establishes that the district court was wrong in finding that brimonidine would have presented solubility problems at the elevated pH of Refresh Tears®. But Apotex did not focus on the table at trial. It did not provide any supporting testimony calling the district court's attention to the table nor did it explain how one skilled in the relevant art would have assessed the information from the table. Under these circumstances, we do not see clear error in the district court's finding as to the expected solubility of brimonidine at the 7.2 to 7.9 pH range. See H.H. Robertson, Co. v. United Steel Deck, Inc., 820 F.2d 384, 389 (Fed.Cir.1987) ([Defendants] argue that because this reference had first been offered to the district court it is not in fact presented for the first time on appeal. But this reference, although placed in the record by the district court, was not the subject of testimony or any other form of evaluation by that court. Initial consideration of evidence is not the appellate role.).