A college research foundation licensed the use of its proprietary protein growth technology to a major US biotechnology company. The foundation suspected that the company was underpaying its royalty obligations, and retained CRA to perform a royalty audit. CRA consultants with expertise in microbiology interviewed the licensee’s technical personnel, revealing that numerous products, which were being produced using the licensed process, had been excluded from royalty calculations. The licensee had previously denied that these products were produced using the licensed technology. Additionally, it was discovered that the licensee had failed to pay royalties on various products produced for “research” purposes.
Biosimilars: Economic Issues for IP Litigation
In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time. This approval has...