Monday, March 31, 2008

In Context, "And" means "Or"

Ortho-McNeil Pharmaceutical, Inc, v. Mylan Laboratories, Inc., [ 2007-1223] (March 31, 2008) [RADER, Michel, Linn] The Federal Circuit affirmed the district court’s rulings claim construction, inequitable conduct, obviousness, and enablement, and resetting the effective date of Mylan's ANDA under 35 U.S.C. § 271(e)(4)(A).
SIGNIFICANCE: Claim terms must be construed in context. You can't discount the inventor's insights, willingness to confront and overcome obstacles, and yes, even serendipity in the obviousness determination.
BRIEF: At issue was the meaning of “and”. The Federal Circuit held that as used in this claim, and conjoins mutually exclusive possibilities. The Federal Circuit noted that the claim does not use and in isolation but in a larger context that clarifies its meaning. Specifically, and appears in conjunction with the adverbs independently and together. As the district court explained, these terms signal that and links alternatives that occur under the different conditions of independence or togetherness.
The Federal Circuit also rejected the argument that all the inventors did was find a compound form a limited number of alternatives, which was obvious under KSR. The Federal Circuit found that this not only was not true, but that Mylan’s evidence smacked of hindsight. The Federal Circuit said that the inventor’s pathway to the invention, of course, seems to follow the logical steps to produce these properties, but at the time of invention, the inventor's insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted.