Battle Over Patents And Drug Pricing Engulfs FDA And USPTO
Executive Summary
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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What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Proposed Initiatives
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 Process Reforms Proposed By US PTO Could Be ‘Quite Burdensome’ For Applicants
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.
FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy
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.