1. In Vivo

Battle Over Patents And Drug Pricing Engulfs FDA And USPTO

 
• By Brenda Sandburg

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.  

FDA_PTO
USPTO and FDA face pressure to take action on patents and drug pricing • Source: Nielsen Hobbs; In Vivo | Shutterstock images

Efforts to rein in the cost of prescription drugs took a new direction when President Biden called on the US Food and Drug Administration to communicate with the US Patent and Trademark Office about misuse of the patent system to delay generic drug and biosimilar competition.

The mandate, included in Biden’s June 2021 executive order on “Promoting Competition in the American Economy,” led the two agencies...

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