Pharmaceutical products are often the subject of patent disputes. One common scenario is the “at risk” launch of an AB-rated generic version of a branded drug where the branded manufacturer claims to have patent protection of its product. In such situations, generic drug manufacturers obtain an “AB” rating from the FDA which indicates its generic drug is bioequivalent to an already-FDA-approved branded drug. The generic manufacturer can then launch its product in the US, at the risk of infringement allegations from the patent-holder. The case might then proceed through various phases including a preliminary injunction phase and ultimately patent infringement damages.
The pharmaceutical cases QES has been involved in span dozens of products and multiple therapeutic areas. QES has extensive experience calculating the compensation to which the patent holder is entitled in the form of lost profits and/or reasonable royalties if the asserted patents are found to be valid and infringed, as well as in assessing commercial success and irreparable harm.
Recently, Dr. Vellturo’s damages assessment played a major role in a case in which Pfizer Inc. and Teva Pharmaceutical Industries Ltd. settled for over $2 billion.