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FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy

Executive Summary

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.

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

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.  

USPTO-FDA Collaboration: Stakeholders Advocate Action From PTAB Proceedings To Examiner Resources

AUTM advocates reform or elimination of inter partes review, DOJ warns of antitrust liability from misrepresentation, and AAM recommends modifying system for measuring productivity of patent examiners.

USPTO Has Not Seen ‘Deluge’ Of Inconsistent Statements From Applicants

Agency did not intend to ‘strong-arm or threaten’ anyone in its duty to disclose notice, patent office legal advisors say. Applicants should assess whether information required by FDA on new method of manufacturing or different formulation impacts patentability.

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