As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.

Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.