MBHB Partner Kevin Noonan Authors DDNEWS Article Entitled, “What’s in a name? When the chemical structure of an API is wrong”

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “What’s in a name? When the chemical structure of an API is wrong” that appears in the March 2016 online edition of DDNEWS. Drug regulation and licensing (and the patents that claim active pharmaceutical ingredients) are based on accuracy, including accurate descriptions of the molecule, how it is formulated and (to the extent it is understood) how it works. But what happens when there is an error? After all, mistakes happen; there is even a book, entitled Human Error, that discusses how and why they happen. The Federal Circuit addressed the consequences of human error (or perhaps more accurately, instances where there was a less-than-perfect understanding of the chemical structure of a claimed invention) in a surprisingly lenient fashion in Cubist Pharmaceuticals, Inc. v. Hospira Inc. And the reasoning behind that answer harkens back to the time when the technology for determining structure was not as robust as it is now, and when biological molecules comprising chains of amino acids were not routinely defined (and disclosed) by their sequence but rather by how they were isolated or otherwise produced. view the article