Will inter partes review speed US generic drug entry? image

Nature Biotechnology, Issue 35
Jonathan J Darrow (Student Fellow Alumnus), Reed F Beall & Aaron S Kesselheim


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From the paper:

Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted by the US Patent and Trademark Office (USPTO), and it is the job of the more than 8,000 examiners within the USPTO to ensure that patents are granted only when they are deserved: namely, when the drug, formulation, or method of use is new, useful, and sufficiently “non-obvious” over existing products. Despite their best efforts, however, examiners have limited time and resources, and, as a result, it is well documented that some of the more than 300,000 patents issued each year are granted in error.


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health law policy pharmaceuticals regulation