Federal Circuit Discounts Commercial Success Evidence Even Though Alleged Invention Helped Secure Regulatory Approval
Last Thursday, in its decision in AstraZeneca LP v Breath Ltd., the Federal Circuit affirmed Breath Ltd.’s Paragraph IV ANDA challenge of AstraZeneca’s Orange Book patent covering sterile budesonide compositions. It was undisputed that those of ordinary skill in the art would have been motivated to pursue a sterile budesonide composition, limiting the obviousness dispute…