Shall we dance?

The U.S. Supreme Court will hear oral arguments Wednesday in a case that could determine how quickly biosimilars can launch after approval -- by clarifying the ground rules for when and how patent disputes are resolved.
In Sandoz Inc. v Amgen Inc., the court will consider whether biosimilars manufacturers can provide a legally required notification of intent to market a biosimilar prior to FDA approval.

This notification must be delivered at least 180 days prior to the first commercial marketing of a biosimilar, so making it contingent on FDA approval would effectively extend biologics exclusivity from 12 to 12½ years. In addition, because some patent infringement cases can’t be filed until the notification is provided, delaying notification until approval could result in biosimilar marketing delays of longer than six months depending on the time required for litigation...