Battle Over Patents And Drug Pricing Engulfs FDA And USPTO
President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.
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Agencies are holding public ‘listening session’ to get input on method of use patents and ‘skinny labeling,’ REMS patenting, PTAB proceedings and other topics.
Patent office requests comments on its proposed initiatives, with continuation patents appearing a particular target. PTO asks if filing a terminal disclaimer for patents that are a variation of each other should be an admission they are obvious.
The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.