In INSITE VISION INCORPORATED v. SANDOZ, INC., Appeal No. 2014-1065, the Federal Circuit held that enunciating an overly narrow statement of the problem solved by the invention can represent prohibited reliance on hindsight.
Sandoz filed an Abbreviated New Drug Application for a generic version of Azasite, Inspire’s topical azithromycin solution. Inspire sued Sandoz for infringing patents directed to topical ophthalmic treatment with azithromycin. After Sandoz stipulated to infringement, the district court found Sandoz failed to show the asserted claims would have been obvious to one of ordinary skill in the art.
The Federal Circuit affirmed. Sandoz argued the district court’s framing of the obviousness question, whether it would have been obvious to develop a topical ophthalmic formulation containing azithromycin, was improperly broad. The proper question, Sandoz argued, should have been more narrow: whether it would have been obvious to use azithromycin to treat conjunctivitis. The Federal Circuit held the district court did not clearly err in its framing of the question because an overly narrow statement of the problem can represent a form of prohibited reliance on hindsight. The court also affirmed Sandoz failed to show by clear and convincing evidence the claims at issue would have been obvious. The district court did not clearly err in finding various alternatives that directed persons of ordinary skill in the art away from the invention, or in finding objective evidence of non-obviousness such as unexpected results, long-felt need, and skepticism by those of skill in the art.