The Federal Circuit's application of KSR within Life Sciences is bad news for Branded Pharmaceuticals.

Implications: KSR involved mechanical technologies, but its rulings apply to all different arts, including biotechnology, medical devices, and pharmaceuticals.  The applications of KSR analysis by the Federal Circuit are multiplying and the results are not in favor of patent owners, including those patent owners within Life Sciences.  The upcoming Altace ® Opinion will most likely fall in line with this noted trend.  In other words, King Pharmaceutical [NYSE:KG]'s patent protection for Altace ® (ramipril) appears to be a prime candidate for invalidation due to § 103 obviousness.

Analysis: The hyperlinked Mon 23 Jul 2007 Federal Circuit Opinion affirms the trial court's invalidation of USPN 5081154 for Toprol-XL ® (metoprolol succinate) for double patenting.  Footnote 2 reads as follows - "Moreover, the omission of the known elements from the composition in this case is "the product not of innovation but of ordinary skill and common sense." KSR Int’l Co. v. Teleflex Inc., 550 U.S. ----, 127 S. Ct. 1727, 1742 (2007). "  Logic similar to this was expressed during oral arguments held Thu 12 Jul 2007 in the Altace ® litigation - albeit in the slighly different context of the selection/purification of a particular enantiomer of ramipril.