US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’
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With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.
Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.
A Republican congressman and witness discuss shortened IP protections while criticizing Nancy Pelosi's drug price negotiation plan.