Aptalis Pharma, Teva, Mylan, Par Pharmaceutical musculoskeletal news
The U.S. Court of Appeals for the Federal Circuit (CAFC) reversed and vacated a lower court's ruling last year that two patents from Aptalis and Teva's Cephalon Inc. subsidiary covering muscle relaxant Amrix cyclobenzaprine were invalid due to obviousness (see BioCentury, April 18, 2011).
In its ruling, CAFC said that the District Court for the District of Delaware erred when it made the ruling because the lower court failed to "consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation." CAFC said that because a pharmacokinetic/pharmacodynamic relationship for the immediate-release formulation of cyclobenzaprine is unknown, an extended-release formulation that achieves a known therapeutic effect is non-obvious. The court noted that establishing bioequivalence alone is not sufficient to render patent claims obvious. ...