The cholesterol-lowering drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin) are protected by a patent (US RE42461) that describes ways of making β-lactam compounds. When the case was heard by a district court, generics company Mylan challenged the patent, alleging that it was invalid because a key inventor had been deliberately omitted from the list of inventors.
Specifically, Mylan said that a scientist who had identified a way of synthesizing compounds that were used to arrive at ezetimibe was missing from the patents that led to the '461 patent. However, the district court ruled against Mylan, because Mylan was not able to prove that the inventors who were named on the patents related to ezetimibe could not have carried out the synthesis. Moreover, the district court noted that the chemicals synthesized by the omitted scientist were not claimed in patents related to ezetimibe, but were instead used as stepping stones to get to ezetimibe. Therefore, the omitted scientist did not sufficiently contribute to the invention of ezetimibe to be classed as an inventor.
