Jorge Enrique de Azevedo Tinoco

Within just over two months (between April 8 and June 13), data gathered by our firm revealed that 37 new Paragraph IV infringement lawsuits (citing 21 U.S.C. §355(j)(2)(A)(vii)(IV)) were filed against Abbreviated New Drug Applications (ANDAs). These numbers underscore that litigation remains a viable option even during the early stages of regulatory approval in the United States and other countries with “patent linkage” systems. As we know, the outcomes of these cases directly impact market dynamics within the pharmaceutical industry. Consequently, both innovators and generic manufacturers should carefully weigh the implications of such litigation.