FDA Airs ‘Concerns’ Over IP Barriers
US Agency’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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The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”
Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.
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.