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Today, the Federal Circuit Court of Appeals held in favor of Cephalon in a patent case involving the muscle relaxant drug, Amrix.
The Federal Circuit Court ruling reversed and vacated the lower court ruling which found the two patents invalid as obvious.
Essentially, the appeals court held that the failure to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation resulted in error on the trial court's part when it considered the obviousness issue.
Translation: The court did not invalidate the patents properly when it applied the analysis required for "obviousness." In order to invalidate a patent for obviousness, the prior information on the invention would have to be so obvious that a "skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art."
Last year, Mylan Inc. began selling the generic Amrix after a lower court ruling that Cephalon's patents covered obvious variations of earlier known research, reports Businessweek.
The sale was stayed, pending appeal, and will remain halted until the case
goes back to the U.S. District Court.
The obviousness analysis.
The law states that a patent may not issue
"if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains."
An analysis on obviousness is based on facts and circumstances. The court looks at (1) the scope and the content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective considerations of nonobviousness.
The trial court could not determine obviousness without an analysis on the known therapeutic effect of the drug, the appeals court held. The absence of such analysis rendered the entire obviousness analysis improper.
The case has been remanded back to U.S. District Court Judge Sue Robinson.