Opinion ID: 211878
Heading Depth: 3
Heading Rank: 3

Heading: Apotex's Expert Testimony

Text: The district court, in concluding that the cited references teach away from combination, further found that the evidence produced no motivation to combine. While the question of whether to combine McCutcheon's with other references is a live issue on remand, there is another focus that needs to be appreciated to fully explore the obviousness issue. 04-1252 16 As the district court appreciated, the bare question of whether it would have been obvious to substitute one surfactant for another misplaces the proper focus on the obviousness of the invention as a whole, and likely invites hindsight conclusion, forbidden by our precedent. See Gillette Co. v. S.C. Johnson & Son., Inc., 919 F.2d 720, 724-25 (Fed. Cir. 1990). Apotex's expert testimony, however, cannot be lightly disregarded on the theory that Dr. Mitra only sought to show the obviousness of substituting octoxynol 40 for another surfactant. Mitra's testimony may be relevant on another level, which is the very point on which the examiner concluded that the otherwise suspect invention was non-obvious. Mitra's testimony has to be considered as well on the point of whether the results produced by use of octoxynol 40 are sufficiently unexpected as to secure the validity of the claims in suit. In this case, Apotex's expert provided his theory of why a person of skill in the art would not have found it unusual to seek, find, and employ octoxynol 40 in making formulations such as those claimed in the '493 patent. Dr. Mitra explained that the references at issue informed a scientist to use water-soluble, micelle-forming,9 nonionic 9 A micelle-forming compound has a hydrophilic side (water-loving) and a hydrophobic side (water-hating). When bound together in such a manner that they form a surface, the two sided nature of such compounds enable them to form little bubbles, known as micelles. When the micelle is formed such that the hydrophilic side is on the outside of the bubble and the hydrophobic side is on the inside of the bubble, a sufficiently large micelle can encapsulate hydrophobic compounds inside the bubble. A micelle formed in this manner can enable otherwise insoluble compounds to dissolve in water. 04-1252 17 surfactants act as stabilizers in a KT/BAC ophthalmic formulation.10 He also set forth a scientific rationale for the informed selection of certain nonionic surfactants, and testified that octoxynol 40 was known and used in many products, including cosmetics.11 Dr. Mitra also opined that knowledge of the chemical qualities of surfactants useful to the claimed subject matter would cause a person, as a matter of science to go into another nonionic surfactant like octoxynols. To be clear, we do not require that the district court credit all (or any) of this testimony. On remand, however, the district court should consider Apotex's claim of obviousness in light of the applicable legal principles and unencumbered by the factual errors identified above. 10 In his Expert Report, Dr. Mitra stated that [t]he Waterbury '151 patent shows that the non-ionic surfactant polysorbate 80 solubilizes BAC. Therefore, one would expect that other non-ionic surfactants such as octoxynol 40, function as a surfactant. Dr. Mitra also stated that [b]y the time of the claimed invention on or before 1987, one of ordinary skill in the art of ophthalmic pharmaceutical formulations would have known that . . . . non-ionic surfactants, such as polysorbate 80, were used in ophthalmic formulations as a surface active agent as a solubilizer, to increase spreading and to reduce surface tension. Octoxynol 40 was known as a non-ionic surfactant as shown by Grant & Hackh's Chemical Dictionary – Fifth Edition, McGraw-Hill, 1987 and GAF product brochures. 11 Dr. Mitra concluded that [t]he Waterbury '151 patent shows that the nonionic surfactant polysorbate 80 solubilizes BAC. Therefore, one would expect that other non-ionic surfactants would work equally well and one would thus look to other patents/publications which show that other non-ionic surfactants such as octoxynol 40, function as a surfactant. Dr. Mitra so concluded because the stabilizer disclosed in Waterbury, polysorbate 80, was a water-soluble, micelle-forming, nonionic surfactant. Dr. Mitra opined that since octoxynol 40 is also a water-soluble, micelle-forming, nonionic surfactant, both compounds are capable of solubilizing the KT/BAC complex by encapsulation. 04-1252 18