CRA provided expert reports and trial testimony in a breach of contract litigation involving the development of a novel botanical drug on behalf of the defendant. The plaintiff licensor alleged that the licensee had failed to appropriately develop the product pursuant to its contractual obligations. CRA assessed the licensee’s commercial launch plan and its investments in the development process with respect to the licensee’s “commercially reasonable efforts” obligations and the potential market for the novel product.
Law360: Economics Of Harm From Biologic-Biosimilar Competition
For more than two decades and despite the Biologics Price Competition and Innovation Act of 2009, the Hatch-Waxman brand-generic disputes have dominated the...