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.
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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.
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.
As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.