Monday, July 21, 2008

Not Obvious Because There was No Reason One Would Have Considered Mmodification of the Very Property That Made Compound Desirable

Eisai Co. Ltd. v. Dr. Reddy’s Laboratories, Ltd., [2007-1397, -1398] (July 21, 2008) [RADER, Linn, Prost] The Federal Circuit affirmed that the district court correctly determined that the ’552 patent is non-obvious over the proffered prior art and that Eisai’s alleged acts during prosecution did not rise to the level of inequitable conduct.
BRIEF: Dr. Reddy’s and Teva each filed Abbreviated New Drug Applications seeking to manufacture a generic version of Aciphex before the expiration of U.S. Patent No. 5,045,552. Where, as here, the patent at issue claims a chemical compound, the analysis of the third Graham factor (the differences between the claimed invention and the prior art) often turns on the structural similarities and differences between the claimed compound and the prior art compounds. Obviousness based on structural similarity can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound. The requisite motivation can come from any number of sources and need not necessarily be explicit in the art. The Federal Circuit held that post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound. The Federal Circuit said that defendants could not create a genuine issue of material fact on obviousness through unsupported assertion of a different lead compound, and the record contains no reasons why a skilled artisan would have considered modification of the very property that made it desirable as an identifiable, predictable solution.
The Federal Circuit found the record is devoid of any real suggestion of intent to deceive the Patent Office, much less the clear and convincing evidence required to support a finding of inequitable conduct. The Federal Circuit agreed with the district court that the failure to disclose its co-pending application along with the rejections issued in its prosecution, while not completely forthcoming, did not rise to the level of inequitable conduct.