Biosimilars and Biologics

It is well recognized that most licensed biologic products are covered by a multitude of patents. The biosimilars regime created a defined pathway to identify and litigate the patents covering a licensed product as part of a biosimilar challenge. The recent implementation of the America Invents Act provides further mechanisms to challenge patents outside of the courts. These mechanisms, notably an inter partes review or post grant review, have many advantages that should be understood by those contemplating or expecting a biosimilars challenge.

• Patents
• Trademarks
• Copyright Law
• Litigation