Cumberland Beats Mylan Challenge to Acetadote Patent Right

On January 26, 2017 the Federal Circuit ruled in favor of Finnegan client Cumberland Pharmaceuticals, affirming a lower court ruling that rejected Mylan Institutional's claim that the Food and Drug Administration (FDA) was the source of the invention leading to Cumberland's patented antidote for acetaminophen overdose.

The patent is on an acetylcysteine composition that contains no chelating agent. For its Acetadote antidote, Cumberland was asked by the FDA to provide justification for using edetate disodium (EDTA), an ingredient that provides stability that is also known to have negative side effects. In conjunction with Bioniche Pharma Group, Cumberland was able devise a test that showed stability both with and without EDTA. In 2010, Mylan acquired Bioniche and Myland filed its abbreviated new drug application for the generic acetylcysteine about a year after Cumberland's patent was issued. Cumberland then sued Mylan in 2012 and Mylan's defense was that the patent was invalid on the basis that it was derived from a suggestion from someone at the FDA.

As a result of the Federal Circuit decision, Mylan's generic version of the drug could be kept off the market until 2025.