Appellate Court Invalidates 2nd-Generation Altace ® (ramipril) Patent 5061722

Implications: In my prior Tue 31 Jul 2007 Analysis available here http://news.glgroup.com/CM/Analysis/PostDetail.aspx?pid=14722 I stated: 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.  In today's 19-page Opinion by the United States Court of Appeals for the Federal Circuit [2006-1530, 2006-1555], this exact scenario has now occurred.  Sweeping generalizations about the fate of 2nd-generation, single-isomer active product ingredient patents are not helpful.  Only an individualized assessment of the particular marketed drug product in question is likely to be meaningful.

Analysis: Note first that in the recent Lexapro ® Opinion by the Federal Circuit, the Innovator Company - Forest Labs [NYSE:FRX] - successfully sued Ivax and Cipla for patent infringement based upon a 2nd-generation single-enantiomer variant of the active product ingredient (escitalopram oxalate).  In my corresponding Analysis of last week, I cautioned against concluding that 2nd-generation, optically-pure API patents will routinely withstand the invalidation arguments asserted by the Defendant Generic Companies. In other words, the specific facts of each particular Paragraph (IV) patent infringement litigation are of the utmost importance and they must not be lightly assumed to apply to a different but similar situation.

Turning to the details of this major defeat for King Pharmaceuticals, the Appellate Court: (a) reversed the trial court [the US District Court for the Eastern District of Virgina or USDC/EDVA] in holding that, as a matter of law, all of the asserted claims of 5061722 - i.e., Claims 1,2,4,5 - are invalid as being obvious under § 103 of the Patent Laws; (b) declared all remaining issues as having been rendered moot; and (c) stated that accordingly the Defendant Lupin Pharmaceuticals is entitled to entry of judgment in its favor. The different outcomes of Lexapro ® (victory for Plaintiff) in comparison to Altace ® (defeat for Plaintiff) arise from the different facts in existence for these 2 different prescription drug products. The Court noted, among other items, that the Lexapro ® molecule was one in which the "evidence indicated that the isomers would have been difficult for a person of ordinary skill in the art to separate").  Unfortunately for Plaintiff King Pharmaceuticals, evidence pointing to factual considerations in favor of establishing nonobviousness were, simply stated, thin and weak.  Thus, the ultimate result is not surprising.