Opinion ID: 866346
Heading Depth: 3
Heading Rank: 2

Heading: Reasonable Expectation of Success

Text: The district court found that unpredictability in the chemical arts also weighed in favor of nonobviousness. In reaching this conclusion, the district court relied both on general statements regarding the unpredictability associated with developing drug formulations and specific challenges associated with the development of Combigan®. While we agree that formulation science carries with it a degree of unpredictability, “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Here, there was a reasonable expectation of success based upon the teachings of DeSantis. DeSantis showed that alpha2-agonists and beta blockers are complementary and should be used together. DeSantis further provided that BAK could be successfully used in the formulation. In view of DeSantis, one of ordinary skill would have a reasonable expectation ALLERGAN v. SANDOZ 11 of success in formulating a fixed combination product containing brimonidine, timolol, and BAK. We find no error in the district court’s factual finding that Allergan’s formulators faced difficulties in developing Combigan®. However, these difficulties are not particularly probative with respect to obviousness for a number of reasons. For example, the claims are not drawn to the Combigan® formulation with any specificity given that Combigan® contains many elements in addition to those embodied in the claims. There is no requirement that one of ordinary skill have a reasonable expectation of success in developing Combigan®. Rather, the person of ordinary skill need only have a reasonable expectation of success of developing the claimed invention. More importantly, much of the formulators’ struggles were associated with their attempts to utilize a proprietary preservative, rather than BAK. There is little evidence that once the formulators switched their focus to BAK they struggled to develop a formulation containing the claimed composition of brimonidine, timolol, and BAK. Accordingly, we find that the district court erred in finding that there was no reasonable expectation of success in view of the general unpredictability of the formulation arts and particularized, yet irrelevant, difficulties associated with the development of Combigan®.