Stay updated with the latest in Intellectual Property (IP) news through our blog! We provide periodic updates on newly filed Inter Partes Reviews (IPRs), as well as patent-related news and updates from various Technological Fields. Get the latest scoop on Patent news from tech Giants like Apple, Tesla, and more, along with updates from the Pharmaceutical Industry. Stay informed and ahead of the game with our comprehensive blog on IP news and updates !

Cup of Curiosi Tea

Patent submission date in Orange Book and its impact

As part of transparency initiation, The United States Food and Drug Administration (USFDA) started addition of patent submission date in Orange Book. In accordance with FDA’s October 2016 final rule implementing portions of the 2003 Medicare Modernization Act (Also known as MMA 2003, Amendment 2016), FDA has decided to publish this information in the Orange Book prospectively.

Earlier Scenario:
  • Patent submission date only available by contacting Orange Book Staff.
  • Difficult for generic companies to determine if a patent was late-listed, relisted, or properly listed.
  • Difficult to know whether an ANDA applicant needed to include a patent certification or needed to update an application with an amended certification.

Usefulness of patent submission date to generic industry:
  • Applicants will have a much clear picture on timely listed patents and listed patents indeed require certification.
  • Knowing the submission date clarifies whether listen patent will trigger 30 months stay period in litigation.

No comments

Discovering the Unexpected: The Patented Origin of Corn Flakes

On April 14, 1896, John Harvey Kellogg was granted the patent for Flaked Cereals and process of preparing the same, U.S. Patent No. 558,393 ...