Biologics and biosimilars together represent a rapidly growing component of the pharmaceutical marketplace, and the unique legal issues that accompany them demand careful strategic planning to successfully navigate proceedings in the myriad venues where disputes will inevitably arise: from the US Patent and Trademark Office (USPTO) and US courts to patent offices and courts abroad. Here, we outline the regulatory and intellectual property legal regime for biosimilars in the US, including the avenues that legal disputes may take, and highlight considerations that US counsel representing clients in biosimilar disputes must weigh to coordinate a global litigation strategy.
