Preparing A Promising Drug Candidate For ANDA Litigation (Part Two)

By Megan Leinen Johns & Michael Flibbert

If you read part one of this series, you appreciate that it is imperative that all individuals involved in drug development — including scientific, regulatory, marketing, and financial personnel — understand how their activities may affect obtaining and maintaining patent coverage in future actions to preserve U.S. market exclusivity. Indeed, anyone having reason to comment on topics potentially relevant to enforcing patents, particularly those listable in the FDA’s Orange Book, can benefit from a better understanding of patentability requirements and how patent protection might be challenged.