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FDA-USPTO Collaboration: Stakeholders Want More Clarity On Orange Book Patent Listings

 
• By Brenda Sandburg

Officials from the two agencies note the real-world benefit of cross-training in helping patent examiners find prior art based on product labeling. A USPTO administrative patent judge also nixes a suggestion that the agency hold proceedings to determine if patents were properly listed in the Orange Book.  

FDA and USPTO
USPTO and FDA officials discussed the progress of their collaboration. • Source: Nielsen Hobbs; the Pink Sheet|Shutterstock images

A year after the US Food and Drug Administration and the US Patent and Trademark Office began their collaboration to ensure patents are not misused, an issue that has gained prominence is the FDA’s role in listing patents in the Orange Book.

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