On May 10, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking that, if enacted, would tie the enforceability of every claim of a patent subject to a terminal disclaimer to the validity of any claim of the reference patent. In other words, if…
In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program…
