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Patent Trial and Appeal Board |
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USPTO updates special report on third-party challenges to patent claims covering FDA-approved pharmaceuticals and biologics
The United States Patent and Trademark Office (USPTO) updated our report on America Invents Act (AIA) proceedings involving challenges to patent claims covering U.S. Food and Drug Administration (FDA) approved pharmaceutical products, also known as Orange Book-listed patents, and biologic patents. Access the updated report on the USPTO website.
The report makes several findings, including that the percentage of AIA petitions challenging Orange Book-listed patents has decreased from a peak of 7.5% of all petitions filed in fiscal year (FY) 2016 to less than 2% of all petitions filed this fiscal year to date. Additionally, following a peak of nearly 4% of all petitions filed in FY 2017, the percentage of biologic patents challenged under the AIA has hovered around 2% of all petitions filed in the ensuing years.
The report also finds that the all-time institution rate granting review by the Patent Trial and Appeal Board (PTAB) for claims in biologic patents is similar to the institution rate granting review for claims in Orange Book-listed patents. Orange Book-listed patents, though, have had a greater percentage of claims upheld by PTAB in a final written decision.
Learn more about the report, our methodology, and other AIA statistics on the Statistics page on the USPTO website.
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