On February 24, the U.S. Patent and Trademark Office (USPTO) issued a notice in the Federal Register indicating that the nation’s patent agency was reopening the comment period related to its request for comments (RFC) on collaboration initiatives with the U.S. Food & Drug Administration (FDA). Previously closed on February 6, the comment period on USPTO-FDA collaboration initiatives is now extended until March 10. The reason stated in the Federal Register notice for reopening and extending this comment period is to “ensure that all stakeholders have a sufficient opportunity to submit comments on the questions presented” in the agency’s RFC on ways that the two agencies could cooperate to improve market entry of generic drugs and biosimilars, and to reduce the number of patent grants related to certain drugs. The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the deadline for responding to the agency’s RFC on ensuring robust and reliable patent rights. As reported at that time, while it’s understandable that the agency is interested in hearing from as many stakeholders as possible, some have said the extensions are creating uncertainty as to which stakeholders are being given more time to prepare their full comments for submission.
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