Kurt Karst of the FDA Law Blog ran a nice update on patent term extension (PTE) legislation. The legislation, known as the “Dog Ate My Homework Act,” would permit the U.S. Patent and Trademark Office to exercise discretion to accept untimely filed Patent Term Extension (PTE) applications has been added to the Patent Reform Act of 2007 (S. 1145) by Senator Edward Kennedy (D-MA).
Representative William Delahunt (D-MA), who introduced a stand-alone bill earlier this year in the House, H.R. 1778, is trying to get the legislation added to the House version of the Patent Reform Act of 2007” (H.R. 1908).
This has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Pat. No. 5,196,404 for ANGIOMAX (bivalirudin) 61 days after FDA approved its New Drug Application (NDA) .
In case you haven’t already guessed, the patent term extension law requires the submission within 60-days of the date of NDA approval. You can just hear the “Doh!”
A copy of Sen. Kennedy’s amendment agreed to at the Senate Judiciary Committee Executive Business Meeting is available here.
What a Diff’rence a Day Makes!
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