In recent years, courts have struggled with when a generic drug company can be held liable for induced infringement, that is, encouraging doctors to prescribe a drug in a way that is still protected by a patent. This issue arises from the way the U.S. drug approval system balances innovation and access. When a brand name pharmaceutical company develops a new drug, it files a New Drug Application (NDA) with the Federal Drug Administration (FDA) and often secures multiple patents. These typically include not only patents on the drug itself, but also patents covering specific methods of using the drug to treat particular conditions. Over time, additional method of treatment patents may issue as new clinical uses are discovered. IP attorney Kimberly Vines takes a look at the issue in this Stites & Harbison Client Alert.

The United States Environmental Protection Agency (“EPA”) is proposing to change the definition of “begin actual construction” for Clean Air Act (“CAA”) New Source Review (“NSR”) permitting. EPA also published guidance on streamlining Title V operating permit reviews. EPA’s goal in both the revised definition proposed rule and the Title V operating permit review guidance is to ease permitting burdens on industry and speed permitting review for permitting authorities. Environmental attorneys Jennifer Cave and Jordan Lee take a look at the changes in this Stites & Harbison Client Alert.

An important Delaware case puts a state-of-the art spin on buyer’s remorse following an M&A transaction and provides a roadmap of mistakes to avoid post-closing. This includes the dangers of a buyer relying on an artificial intelligence (“AI”) chatbot for legal advice and strategy on how to force out the legacy management team and avoid a significant earnout payment, only to have those AI conversations, which are not protected by attorney-client privilege, become a central and damaging part of the evidence at trial. The case also highlights Delaware’s position as a contractarian jurisdiction, emphasizing freedom of contract and enforcing arms-length contracts between sophisticated parties as written. Brian Cromer takes a look at the case in this Stites & Harbison Client Alert.