Protecting core technologies across the globe…
Sheridan Ross has served as counsel to a generics pharmaceutical company, since 2012.
The firm’s attorneys conduct opinion work on patents of innovator drug companies to provide the basis for the client to make Paragraph IV challenges to patents owned by innovator drug companies for early entry as a generic. Among multiple projects, the firm’s attorneys have prepared a series of opinions concerning Orange Book*-listed patents for a topical dermatological medication and based on those opinions, the client filed an Abbreviated New Drug Application (ANDA) in 2014. In addition, the firm developed a monitoring and reporting tool for use by the client in monitoring the patent status of innovator products. This tool has been described by the client as “establishing a new best practice.”
*The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA.
Based on the strength of the opinions, the client is now in settlement negotiations with the innovator.